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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15HealthcarePatients’ Gratification Towards Service Delivery Among Government Hospitals with Particular Orientation Towards Primary Health Centres
English0106Ajai Krishnan GopalakrishnanEnglish Athira K NairEnglishIntroduction: The quality-of-service delivery in health care system is a foremost apprehension in most of hospitals especially primary health centres. The study discusses about the patient’s satisfaction towards service delivery in government hospitals, especially with the primary health centres. Materials and Methods: This study employed a descriptive research design. The data were collected using a structured questionnaire and was conducted among the patients of a primary health centre. Patients’ responses were collected and are grouped under various factors and listed out and analysed. Results: The results of the study demonstrated that participants had diverse levels of expectation about the service delivery factors of primary health centre based on their age, income and educational qualification level. There is a significant influence of patient’s hospital visit and availability of medicines in the pharmacy on reason for the service delivery satisfaction(p=0.000). The study further revealed that primary health centres need to take care of their service delivery factors like waiting area, parking facilities, patient care, space in OPD, toilet facilities, feeding rooms, and cafeteria, for improving the patient’s service delivery satisfaction. Conclusion: The study showed that the majority of the patients are not satisfied with service delivery factors of the primary health centre. So, the government need to take immediate initiatives for improving the facilities in the primary health centres and upgrade it to the next level.
English Hospital Care, Patients Satisfaction, Primary Health Centres, Service Delivery, Primary Care, Service QualityINTRODUCTION
The enhancement of health of a country’s population is the result of its upgraded economy and a robust improved economy is based on a healthy population. This is factual because advancement of the citizen’s health can be directly associated to constructive economic growth as a greater number of people in good health will be active to conduct productive activities in the workforce. Simultaneously higher-level healthcare also affects the standard of life more than any other service sector.1,2 Nowadays quality of service delivery in health care has become a major concern for patients in all over the world especially in Kerala. So, it is very much important for the service delivery providers in health care sector like hospitals to emphasize the importance of service delivery quality that will satisfy their patients and retain them to their hospitals or healthcare centres. That is why customer satisfaction being observed as the key factor that leads to sustainable opulence for the respective organization.3 The Primary Health Centre (PHC) is the elementary structural and everyday unit of the public health services of a Country. PHCs were established to deliver accessible, reasonable and obtainable primary health care to public, in harmony with the Alma Ata Declaration of 1978 by the member nations of the World Health Organization. Kerala is a perfect model to other States of India in the Health care sector and has been able to accomplish attainments akin to the developed countries. The health indicators like The Child Mortality Rate, Maternal Mortality Rate, and Life expectancy highlight this based on Government of India Ministry of Health and Family welfare, Bulletin of Rural Health Statistics 2016-17.4 And all these activities are executed through the Primary Health Centres at the grassroots level.
Right is not based so much on the individual’s guest’s standing as it is upon the fact that the guest is a human being, and life itself is an ethical power.5 That is citizens have a genuine right to equal access to services, and public servants must not suppress that right from them. Technical quality falls petite of being a truly valuable measure for unfolding how patients assess the quality of a medical service encounter.6 Since most of patient’s dearth the essential knowledge for assessing the technical quality of services, their assessment of quality is based on the medical care process. Quality of service stimulates consumer loyalty and the quality of service is characteristically a point of reference for consumer loyalty.7 Perceived health care quality has a positive weight on customer satisfaction.8 That is, overall perceived service quality has a positive relationship with patient satisfaction. Most of the research on dealing customer perceived service quality in the private healthcare sector has been partial to developed countries.9 There is a deficiency of evidence in knowing the customer perceived service quality; customer perceived value with arbitrating role of customer satisfaction to customer loyalty and behavioural intention in the context of exclusive private healthcare sector in India.
The staff observes quality as the core for customer satisfaction.10 That is, co-operative and helpful staffs are able to inculcate confidence among the customer of the industry. Private hospitals had lesser gaps than public hospitals in three of the services quality dimensions, that is, reliability namely confidence, empathy and tangible.11 Service quality has noteworthy and positive influence on student satisfaction, and the majority of students are satisfied with the amenities provided by the universities.12
MATERIALS AND METHODS
Objectives of the study
To study the demographic profile of patients visiting the Primary Health Centres in Kottayam District, to study the Patients medical treatment experience towards Primary Health Centres, and to assess the Patients Service Delivery Satisfaction towards the Primary Health Centres.
Hypothesis of the study
With regard to the objectives mentioned, the following null hypothesis were developed.
H0: There is no significant influence of hospital visit and availability of medicines in the pharmacy on reason for the service delivery satisfaction.
H0: There is no significant difference in the visit to different types of clinics among the various age groups of patients.
H0: There is no significant difference in the service delivery satisfaction among the various age groups of patients and various income groups of patients.
Methodology
The study is descriptive in nature. The population comprises of primary health centre’s patients in Kottayam district. The study was conducted at a primary health centre in Kottayam for a period of two months. The total number of samples drawn was 250 and the fully responded samples were 223 patients from the primary health centre. Judgement sampling is used for the study. The data were collected with the help of a questionnaire, contains questions on the facets about their demographic and socio-economic background, influencing factors, and other associated facets. The questionnaire was subjected to reliability testing and the Cronbach’s coefficient Alpha was calculated to test the reliability of questionnaire and the result of the reliability analysis is 0.79. The secondary data has been composed from diverse sources of literature like journals, textbooks and internet. The standard statistical tools such as tables, percentages, pie charts, bar charts, chi-square test, and ANOVA are used for analysing the data and reaching the conclusion.
DATA ANALYSIS
Table 1 reveals that, 35 percent respondents are male and 65 percent are female. 8 percent respondents belong to the age group of below 20 years, 11 percent respondents belong to the age group of 20 to 34 years, 14 percent respondents belong to the age group of 35 to 49 years, 31 percent respondents belong to the age group of 50 to 64 years, and 36 percent respondents are above 64 years of age. 72 percent of respondents are married and 28 percent of respondents are single. 61 percent of respondents are school level, 31 percent of respondents are graduates, and 8 percent are postgraduates. 64 percent of respondents are having yearly income up to 1,00,000, 25 percent are from the income group of 1,00,001-3,00,000 rupees, 9 percent are from the income group of 3,00,001-5,00,000 rupees, and 2 percent are having yearly income above 5,00,000. 96 percent of respondents are Keralites and 4 percent of respondents belong to non-Keralites.
Figure 1 reveals that, 20 percent of respondents are showing one time visit to the hospital and 80 percent of respondents showing repeat visits to the hospital.
Figure 2 reveals that, 9 percent of respondents visit antenatal clinics, 16 percent of respondents visit immunization clinics, 31 percent of respondents visit general clinics, and 44 percent respondents visit NCD clinics.
Figure 3 reveals that, 8 percent respondents say it takes more than 2 hours to meet the doctor, 14 percent respondents says that within 2 hours they can meet the doctor, 39 percent respondents says that within 1 hour they can meet the doctor, 25 percent respondents says that within 30 minutes they can meet the doctor, and 14 percent respondents says that within 15 minutes they can meet the doctor.
Figure 4 reveals that, 11 percent respondents says that medicines are very much available in the pharmacy, 41 percent of respondents says that medicines are available in the pharmacy, 16 percent respondents says that medicines availability in the pharmacy is average, 26 percent of respondents says that medicines are not available in the pharmacy, and 6 percent respondents says that medicines are not at all available in the pharmacy.
Figure5 reveals that, majority of the respondents having an overall opinion that they are getting sufficient time with medical officer (48 percent), majority of the respondents having an overall opinion that they get respect and dignity (50 percent), majority of the respondents having an overall opinion that they get good quality of healthcare (57 percent), majority of the respondents having an overall opinion that medical officer is displaying promptness (71 percent), majority of the respondents having an overall opinion that staff nurse is displaying promptness (64 percent), majority of the respondents having an overall opinion that pharmacist is displaying promptness (63 percent).
Figure6 reveals that, majority of the respondents having an overall opinion that hospital staff are polite in their behaviour (75 percent), majority of the respondents having an overall opinion that hospital staff are willing to help (80 percent), majority of the respondents having an overall opinion that hospital staff are not rude in their behaviour (84 percent), majority of the respondents having an overall opinion that hospital staff are not having attitude problem (80 percent), and majority of the respondents having an overall opinion that hospital staff are normal in their behaviour (79 percent).
Figure7reveals that, majority of the respondents having an overall opinion that they are not satisfied with the waiting area (76 percent), majority of the respondents having an overall opinion that they are not satisfied with the parking facilities (83 percent), majority of the respondents having an overall opinion that they are satisfied with the staff communication (66 percent), majority of the respondents having an overall opinion that they are satisfied with the patient care (69 percent), majority of the respondents having an overall opinion that they are satisfied with the space in OPD (70 percent), majority of the respondents having an overall opinion that they are satisfied with the cleanliness of waiting area (65 percent), majority of the respondents having an overall opinion that they are not satisfied with the toilet facilities (81 percent), majority of the respondents having an overall opinion that they are not satisfied with the facilities for people with special needs (89 percent), majority of the respondents having an overall opinion that they are not satisfied with the feeding rooms (71 percent), and majority of the respondents having an overall opinion that they are not satisfied with the cafeteria (90 percent).
Figure8 reveals that, 11 percent respondents says that they are highly satisfied with the service delivery, 12 percent respondents says that they are having neutral opinion towards the service delivery, 22 percent respondents says that they are satisfied with the service delivery, 27 percent respondents says that they are dissatisfied with the service delivery, and 28 percent respondents says that they are highly dissatisfied with the service delivery.
Table 2 reveals that calculated value is 148.500 and p-value is less than 0.05 (p=0.000) at 5% level of significance. Hence the null hypothesis is rejected. It means that there is a significant influence of patients hospital visit on reason for the service delivery satisfaction.
Table 3 reveals that calculated value is 453.764 and p-value is less than 0.05 (p=0.000) at 5% level of significance. Hence the null hypothesis is rejected. It means that there is a significant influence of availability of medicines in the pharmacy on reason for the service delivery satisfaction.
Table 4 reveals that, the F value of 301.295 at 5% level of significance (p=0.000). So, the null hypothesis is rejected (pEnglishhttp://ijcrr.com/abstract.php?article_id=4366http://ijcrr.com/article_html.php?did=4366
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Sodani PR, Kumar RK, Srivastava J, Sharma L. Measuring patient satisfaction: A case study to improve quality of care at public health facilities. Indian J. Community Med. 2010, 35(1), 52-56.
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15HealthcareCorrelation and Regression Analysis to Determine the Percentage Existence of Physicochemical Parameters on Electrical Conductivity in the Industrial Area Drinking Water Around Cuddalore Old Town, Tamilnadu
English0714R. SelvarajuEnglish B. AnithaEnglish K. AnandalakshmiEnglishIntroduction: Pure water is an acceptable one for persistent health. The superficial view on drinking water does not give much idea about the presence of minerals in it. Analyzing the physicochemical properties of groundwater samples helps in determining the constituents present in them as well as identifying quality standards. For this study, drinking water samples were collected from fifteen bore wells in and around the industrial area of Cuddalore old town. The Physico-chemical properties such as Potential of Hydrogen (pH), Electrical Conductivity (EC), Total Hardness (TH), Total Dissolved Solids (TDS), Total Alkalinity (TA), Calcium (Ca), Magnesium (Mg), Sodium (Na), Potassium (K), Chloride (Cl-) and Sulphate ( SO42-) are studied and then compared with the standard values of World Health Organization (WHO). Pure water does not have any conducting property. The drinking water may have a high value of Electrical Conductivity due to the presence of elements and salts which are not at the standard level. Objectives: The acquisition of knowledge about the correlation matrix reveals the interrelation between any two parameters. Using this, the relationship between electrical conductivity and all other parameters is analyzed in this present study. The regression equation is formed to calculate the impact of individual parameters on electrical conductivity. Method: Statistical analysis helped to calculate the effect of each parameter on the high value of contamination in the groundwater due to electrical conductivity. Result: It is found that the presence of cations is highest in the order Sodium, Calcium, Potassium, Magnesium and the abundance of anions is highest in the order Sulphate and Chloride. Conclusion: The effect of each parameter on electrical conductivity has been studied. It showed that the percentage of TDS and Sodium was the maximum responsible for electrical conductivity. This study may be helpful to determine the quantity of each parameter that affects the quality of the groundwater and also used to evaluate the percentage of constituents present in it.
EnglishGroundwater, Contamination, Correlation, Regression, Electrical conductivity and Sodium ChlorideIntroduction
Water is one of the basic needs of living beings. The availability of fresh water is being reduced due to population growth and the development of industries. So maintaining the good quality of groundwater is most important to save living beings. The presence of minerals, organic, and inorganic matter in fresh water determines its quality. Many authors have noted that it may be polluted as a result of the landfill, sewage, domestic, industrial, and agricultural activities11. The high salinity of groundwater in the coastal region is caused by seawater intrusion, and the researchers also stated that the most of groundwater samples have Ca–Mg–Cl, Na–Cl, Ca–HCO3, and Na–HCO3 hydro – chemical5,6,8,16-17,21. The contaminated groundwater has a higher value of electrical conductivity, which indicates a large number of chemical compounds dissolved in it than that in pure water. The high value of TDS and EC due to the dumped solid wastes also affects the groundwater quality.14,1 Consumption of this impure water will suffer human health. Men Baohui stated that in the future the concentration of hardness and conductivity will change in the fastest manner.3 The presence of calcium and magnesium causes hardness, while high chloride levels produce a saline taste and increase the corrosive nature. Industrial wastes, sewage wastes, and landfills may add sodium concentration. The dominated concentration of Sodium and Chloride may be due to the presence of septic effluent and also the rock-water interaction.15 The presence of Sulphate is due to the sedimentary rocks, and the existence of Potassium may be the availability of clay. The contamination of groundwater may be due to ion exchange, weathering, and saltwater intrusion as well. If the ratio of Calcium and Magnesium is more than two in the number indicates the dissolution of silicate minerals.10In the study area, Cuddalore district, already noted that the parameters total dissolved solids (TDS), total alkalinity (TA), total hardness (TH), and Chloride (Cl-) are in the higher value and also the salinity of the groundwater is heavy since the high value of TDS. The high salinity value may be caused by climate change or rising sea levels, and as a result, hypertension will rise in humans if it is used as drinking water. It represents that the dissolution of more inorganic compounds in groundwater will lead to elevated electrical conductivity value.7,23 The current study focuses on the role of pH, TDS, TA, TH, positive ions, and negative ions in electrical conductivity.
Correlation matrix is used in this study to learn whether a positive or a negative relationship between the electrical conductivity and other variables.9 A scatter plot shows a better illustration of this relationship. Linear regression foretells the value of each dependent variable using an independent variable. So the effect of individual physicochemical parameters on electrical conductivity has been calculated in this study using the regression equation.
Materials and Methods
Study Area& Sample collection
The study area, Cuddalore, is situated along with the Eastern Coastal Region of Tamilnadu state. Its geographical area is 3678 square kilometers. During October, November, and December, the rainfall is heavy in the Cuddalore district. It receives 1168.08mm of rain per year on average.19Since 1971, the State Industries Promotion Corporation of Tamilnadu (SIPCOT) has been maintaining industrial complexes around Tamilnadu in order to achieve economic progress. In Cuddalore, SIPCOT Industrial Estate is functioning in Kudikadu. The district has highly polluting industries like dye, pesticides, drugs, pharmaceuticals, and chemical industries. Water samples were taken from fifteen sites near the SIPCOT industrial area of Cuddalore district in July month and named as S1 to S15. The sample sites are shown in Fig.1.
Before filling with samples, the sampling containers were rinsed and checked for contaminants. After collecting the samples, the containers were carefully labeled with sample codes S1 to S15, and analyses of the desired parameters began in the Chennai Testing Laboratory, Private Limited, Gundy, Chennai, Tamilnadu, within twenty-four hours. The samples were collected and analyzed in accordance with the established procedures.2,18
Analytical Methods
Physicochemical properties
The various parameters such as Potential of Hydrogen (pH), Electrical Conductivity (EC), Total Hardness (TH), Total Dissolved Solids (TDS), Total Alkalinity (TA), Calcium (Ca), Magnesium (Mg), Sodium (Na), Potassium (K), Chloride (Cl-), and Sulphate (SO42-) were determined using APHA standard procedures.2 The pH is measured by a pH metre, electrical conductivity is tested using a conductivity metre, and titration methods were used to calculate the concentration of total hardness, total dissolved solids, calcium, magnesium, and chloride. The value of sodium is determined by a flame photometer. The concentration of sulphate is estimated using a spectrophotometer. Table 1 displays the results of all the received parameters. A bar diagram in Fig.2 depicts the concentrations of individual parameters in each of the fifteen sites.
Data Analysis
All the obtained data were analyzed statistically. Table 2 depicts the minimum, maximum and Standard Deviation (SD) of all the observed values. The standard deviation demonstrates the deviation of each parameter from its mean value. In addition, the Correlation matrix has been constructed to provide such a clear picture of the interrelationship of each parameter. To determine the effect of individual parameters on electrical conductivity, linear regression equations for each parameter is calculated. After determining the best fit line, the linear regression equation is written as y = ax + c, where ‘y’ is the dependent variable and ‘x’ is an independent variable, electrical conductivity.
Results
Fig.2. shows that, other than pH, TA, Mg, and K, all other parameters are high in sample S5 than the remaining samples. The obtained data were compared to the World Health Organization's(WHO) standard values. The minimum pH value observed among the fifteen locations is 5.4 in sample site S10 and the maximum is 7.9 in sample S11. The acceptable pH range, according to WHO standards, is 7.0 to 8.5. It has a permissible limit of 6.5 to 9.225. Except for S8, S9, S10 and S13, all the other samples S1, S2, S3, S4, S5, S6, S7, S11, S12, S14 and S15 are within the permissible limit of WHO. In comparison to all other parameters, pH has a very low standard deviation of 0.672 mg/l. It indicates that the pH values aren't too far off from the mean. The observed value of electrical conductivity is ranged from 294 µS/cm(S10) to3940 µS/cm (S5). The average value of electrical conductivity is 1148.4µS/cm. The samples S3, S4, S5, S11 and S14 are having an excess concentration than this mean value. High value of electrical conductivity shows that the high quantity of total dissolved solids, it means that more amounts of chemicals and minerals are dissolved in it or may be the intrusion of salt water. Among the eleven parameters electrical conductivity has the highest amount of standard deviation which is determined as 978.152µS/cm. It concludes that it is significantly deviated from the mean value of 1148.40µS/cm.
The maximum total hardness was recorded in the sample name S5 which is noted as 700 mg/l. According to WHO, the permissible limit of total hardness is 500 mg/l and its acceptable limit is 100 mg/l. The lowest value 40 mg/l is observed in sample S6. The samples S3, S4, S5 and S14 have TH which is greater than the permissible limit. The standard deviation of total hardness is 227.17 mg/l. The presence of Calcium and Magnesium are in the form of their salts like bicarbonate, Sulphate, and Chloride. It determines the presence of hardness. High hardness causes stones in the urinary tract. In this study, sample S5 has the highest concentration of total hardness, Calcium, Chloride, and Sulphate.
As per World Health Organization standards, the acceptable and the permissible limit of total dissolved solids are 500mg/l and 1500 mg/l. The highest observed value of TDS is 2330 mg/lin S5, which is greater than the permissible limits. In this present study the TDS varies from 168 to 2330 mg/l. The concentrations in the samples with the names S3, S4, S5, S7, S11, S12, and S14 are higher than the acceptable limit. The standard deviation is 578.195 mg/l and the mean value is 680 mg/l.
The presence of carbonate, bicarbonate, and hydroxides indicates total alkalinity. Its concentration varies from 9 to 302mg/l among fifteen samples. The BIS (Bureau of Indian Standards) permissible limit of it is 600 mg/l. All the samples are within this permissible limit. As per the record of BIS, the acceptable limit of TA is 200 mg/l.4 The samples S4, S5, S7, S11, and S12 are not within the acceptable limit. Calcium is essential for bone formation, but if it is present in excess, it can cause severe muscle problems. The samples S3, S4, S5, S7, and S14 have Calcium excess value that exceeds the WHO's acceptable limit 75mg/l. Sample S5 has the highest value of 196mg/l. The permissible limit of Calcium in WHO standards is 200 mg/l. In this current observation, all fifteen samples have Calcium levels that are within the permissible range.
Magnesium concentration levels in the fifteen samples vary from 3 to 56mg/l. According to the WHO, the acceptable and permissible limits of magnesium are 30mg/l and 150mg/l, respectively. The magnesium ion concentration in the samples S3, S4, S5, S7, S11, and S14 is above the acceptable limit. But all the samples are within the permissible levels. In this present work, Sodium levels ranged from 36.2 to 331mg/l. The taste of groundwater drastically changes when the concentration of sodium exceeds 200 mg/l. The sodium levels in samples S4, S5, and S11 are higher than 200 mg/l. The presence of mineral deposits, salt water intrusion, sewage effluents, as well as the occurrence of sodium fluoride and sodium bicarbonate may all contribute to the excess sodium.15,24In this work, the level of Potassium varies from 7.4 to 59 mg/l. Among fifteen samples, S5 has the lowest value of Potassium as 7.4 mg/l, but it has the highest value of Sodium as 331 mg/l and Chloride as 1280 mg/l. As a result, it is clear that the presence of Sodium and Chloride reduces the concentration of Potassium. Potassium in groundwater has a maximum allowable limit of 12 mg/l.13 But the highest potassium concentration, 59 mg/l, was found in samples S2 and S12.
Chloride has an acceptable limit of 200mg/l and a permissible limit of 600 mg/l as per WHO. Sample S5 seemed to have the highest concentration of chloride (1280 mg/l). The samples S3, S4, S5, and S14 have more than the WHO's acceptable limit. S5 is the only location where Chloride levels exceed the WHO permissible limit. The average chloride concentration is 243.33 mg/l, with a standard deviation of 325.163 mg/l. S5 has the highest Sulphate concentration (214 mg/l), S10 and S12 have the smallest values. It has a permissible limit of 400 mg/l and an acceptable limit of 200 mg/l, according to the WHO standards. All of the samples in this study are within WHO's permissible limit. S5 is the only sample with Sulphate levels above the WHO's acceptable limit.
Correlation Analysis
The statistical Pearson correlation coefficient(r) identifies whether the two variables are in strong positive (if r = +1) relationship or strong negative relationship (if r = -1). A correlation matrix is developed using the various parameters pH, EC, TH, TDS, TA, Ca, Mg, Na, K, Cl-, and SO42- to determine the relationship of one variable with another, and it is tabulated in Table 3. The variables TH, TA, Mg, Na, and SO42- have a moderately positive correlation with pH. Electrical conductivity is strongly positive relation with TDS, Na, and Cl-, and it is also positively related to TH and Ca. Since EC has a perfect positive relationship with TH, TDS, Ca, Na, and Cl-, it is confirmed that these parameters are more responsible for this study. It is clear that TA, Mg, and SO42-have moderately positively correlated with electrical conductivity. TDS, Ca, Mg, Na, and Cl- all have a strong positive relationship with the parameter TH. The parameter TA and SO42- moderately positively correlated with TH. The TDS has a strong positive correlation with Ca, Na, and Cl-. It is linearly correlated with TA, Mg, and SO42- Total alkalinity has moderate relation with Ca, Mg, Na, Cl-and SO42-. Calcium has a strong positive correlation with Chloride and has moderately correlated with Mg, Na, and SO42-. Magnesium has a moderate correlation with Na, Cl- and SO42-. The sodium has a perfect positive correlation with Cl and moderately correlated with SO42-.Cl- has a moderately positive correlation with SO42-. Potassium has a weakly negative relationship with EC, TH, TDS, Ca, Cl-, and SO42-. It is necessary to draw the scatter diagram for all of the parameters with electrical conductivity for better illustration.
Scatter diagrams are used to find the best fit, with electrical conductivity on the X-axis and each dependent variable on the Y-axis (Fig.3.(a), 3.(b), 3.(c),3.(d), 3.(e),3.(f),3.(g),3.(h),3.(i),3.(j) ). In addition, the regression equation is formed in the form of a straight line equation, y = ax + c, using the line's Y-intercept (c) and slope (a). The "c" shows that the value of each dependent variable along the Y-axis when the independent variable (Electrical Conductivity) along the X-axis is equal to zero. The adjusted R2indicates how long all of the data points fit perfectly. The scatter diagrams and regression calculations are done in Microsoft Excel only.20, 22 Table 4 summarizes the calculated values. In this study, a high value of adjusted R2, 0.9982, is obtained in the correlation of EC with TDS, denoting that the relationship is highly perfect one. The relation EC with Chloride has 0.9303, with Sodium has 0.8363, with TH has 0.7766, and EC with Calcium has 0.7696 as adjusted R2. It is 0.6102 for Sulphate. Now it is necessary to determine the role of each parameter that contributes to the electrical conductivity. For safe drinking water, the electrical conductivity should be less than or equal to 400 µS/cm.12. Using this limit, while calculating the value of each dependent variable it confirms the perfect fit of TDS. The contribution of TDS to electrical conductivity is 38.28%. When compared to such contribution of other variables to electrical conductivity, it is considerably greater. The contributions of TH and TA seem to be 22.2 percent and 11.64 percent, respectively. Sodium contributes 8.6 percent, Sulphate 6.05, Calcium 5.36, Potassium 4.29, and Magnesium 2.11 percent only. The pH and Chloride make up only a very small percentage of the total, 1.06 and 0.42 %.
Discussion
The sample taken from Vandippalayam(S5) has the highest concentration of EC, TH, TDS, Ca, Na, Cl- and SO42-. But potassium concentration is a less value. Low potassium will cause heart related diseases. The value of TA and Mg are also beyond the acceptable limit of BIS. So it has to monitor and do the proper treatment before consumption. The correlation analysis showed that the electrical conductivity is strongly positively correlated with Total Dissolved Solids (TDS). And also it is strongly positively correlated with Total Hardness (TH), Calcium (Ca), Chloride (Cl-), and Sodium (Na). Similarly, TH is strongly positively correlated with Calcium (Ca) and TDS. There is a strong relationship between TDS with Calcium, Chloride, and Sodium. The above parameters are highly related to one another. The regression analysis proved that the total dissolved solids contribute 38.28 percent to electrical conductivity and followed by TH and TA as 22.2 and 11.64 respectively. The most important parameter related to electrical conductivity is total dissolved solids and, its percentage contribution showed that the groundwater samples contain more elements. Sodium, Calcium, Potassium, and Magnesium contribute 8.6, 5.36, 4.29, and 2.11 percent to electrical conductivity. Sulphate and Chloride contribute 6.05 and 0.42 percentage. This type of groundwater may be polluted due to intrusion of saltwater, sewage effluents, and sedimentary rock-water interaction. And also the samples were taken from Kodikalkuppam, Brookspet, and Periyakaraikadu have electrical conductivity beyond 1500mg/l. In this study region, the high value of sodium chloride reduces the potassium concentration.
Conclusion
The physicochemical properties were analyzed for water samples collected from fifteen bore wells in and around the industrial area of the Cuddalore old town. The mean and standard deviation of all the parameters have been determined and analyzed. The correlation and regression studies determine the percentage existence of each parameter on electrical conductivity. It shows that it is due to the high percentage of TDS and followed by sodium. So the presence of constituents in the groundwater should be continuously monitored and needs proper treatment to save the people who live in and around the industrial area of the Cuddalore district.
Acknowledgement: The authors thank to all the people who rendered help in collecting samples. They also want to thank the Managing Director of Chennai Testing Laboratory Guindy, Chennai for their support in this study.
Source of funding: No funds, grants, or other support was received
Conflict of Interest: The authors of this article declare that they have no conflict of interest
Authors’ Contribution: All authors involved in the planning, implementation and analysis of this study.
Englishhttp://ijcrr.com/abstract.php?article_id=4367http://ijcrr.com/article_html.php?did=4367
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
Giant Hydronephrosis: A Rare Case Report in a 64-years-old Male Patient
English2427Nawaz AliEnglish Khumukcham SomarendraEnglish
Introduction: Giant hydronephrosis is a rare entity and mostly in the literature, it is published from developing countries.
Case Report: We reported a case report in a 64-year-old male patient who presented with a big abdominal lump occupying almost half of the right side abdomen. Ultrasonography and Contrast-enhanced computed tomography were done for the diagnosis and further characterization. After decompression by percutaneous nephrostomy (PCN), elective nephrectomy was done as the kidney was non-functioning.
Conclusion: We should never forget this unexpected entity in the differential diagnosis of an abdominal lump in this age group.
EnglishGiant hydronephrosis, Nephrectomy, Percutaneous nephrostomy, Elective nephrectomy, Ultrasonography, Abdominal lump
Introduction:
Giant hydronephrosis has a varied definition, as the presence of more than 1 liter of urine in the pelvicalyceal system (PCS), when the kidney occupies a hemi-abdomen which meets or crosses the midline lump and some have reported as the involvement of more than 5 vertebral heights.1,2,3 It is a rare entity and is mostly found in developing and low socioeconomic countries.4 Majority of reported cases has been reported as congenital and found commonly in infants and children.3,4 Here we report a case report of unilateral right side giant hydronephrosis in a 64-year-old male patient.
Case report:
A 64-year-old male patient presented with a big swelling in the right side of the abdomen and mild flank pain. According to the patient he had mild pain one year back, the pain subsided after taking medications and the patient noticed the swelling after 2 months in the right flank region but was not consulted to any medical practitioner. The swelling was progressive and reached the present size occupying almost the right hemi abdomen. There was a history of dysuria and increased frequency of micturition. There was no history of fever, hematuria, vomiting, or evening rise of temperature. On his general examination, his vitals were pulse 84/m, blood pressure 134/ 84, temp 98.4, and no significant lymphadenopathy elsewhere in the body. On abdominal examination a huge non-tender lump was palpable on the right side of the abdomen reaching, superiorly up to the right subcostal area, inferiorly reaching the iliac fossa, and medially extending up to the midline. (Figure 1) No costovertebral tenderness was present.
His biochemical analysis shows, cloudy acidic urine with pus cells > 50/HPF and RBCs of 10-15/HPF. His urea and creatinine were 25mg /1.0mg. Liver function tests, coagulation profile, and viral serology were unremarkable. Ultrasonography of the abdomen reveals a big cystic swelling in the right kidney with multiple septations with a stone size of around 2.5 cm in the pelvis. (Figure 2) X-ray abdomen erect showing radio-opaque shadow in the right pelvis, the displacement of bowels on the left side and inferiorly toward the pelvic cavity. (Figure 3) Non-contrast computed tomography (NCCT) shows a hugely dilated right kidney with multiple septations occupying almost half of the abdominal cavity with a pelvic calculus of size 2.4cm and very thinned-out renal parenchyma. The left kidney was normal. (Figure 4)
After admitting the patient, right percutaneous nephrostomy (PCN) was placed and around 2 liters of urine drained out stat and then the nephrostomy tube was kept clamped overnight to prevent decompression hematuria. Urine culture and sensitivity revealed E. coli. Subsequently, the next day clamp was unclamped and around 1 liter urine came out. Screening USG was done on the 3rd day of admission and shows still three loculated cystic swellings in the right iliac fossa and right hypochondrium. Another PCN was placed in the dominant swelling and the rest of the cystic cavities were drained by percutaneous drainage by using a PCNL puncture needle. (Figure 5) The total amount of urine drained out was 5.4 liters. The patients remain hemodynamically stable during admission in the ward. After 5 days both the PCN catheter were draining around 50-100ml/24 hours. The patient was discharged on both the PCN catheters and told to come for the follow-up after 3 weeks with intravenous pyelography (IVP).
Follow up: After 3 weeks both the PCN output wasEnglishhttp://ijcrr.com/abstract.php?article_id=4368http://ijcrr.com/article_html.php?did=4368
Sterling WC. Massive hydronephrosis complicated by hydroureter. Report of 3 cases. J Urol 1939;42:520–33.
Crooks KK, Hendren WH, Pfister RC. Giant hydronephrosis in children.J Pediatr Surg 1979;14:844–50
Kaura KS, Kumar M, Sokhal AK, Gupta AK, Purkait B, Saini D, et al. Giant hydronephrosis: still a reality!. Turk J Urol 2017; 43: 337-44
RabeaAhmedG. Bilateral Giant Hydronephrosis with Normal Serum Creatinine Level in an Elderly Female. Dubai Med J 2019;2:36–40
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Yang WT, Metreweli C. Giant hydronephrosis in adults: the great mimic. Early diagnosis with ultrasound. Postgrad Med J 1995;71:409-12.a
Shah SA, Ranka P, Dodiya S, Jain R, Kadam G. Giant hydrone-phrosis: What is the ideal treatment? Indian J Urol 2004;20:118
Yapanolu T, Alper F, Özbey, Aksoy Y, Demirel A. Giant hydro-nephrosis mimicking an intraabdominal mass. Turk J Med Sci 2007;37:177-9.
Sunder G1, Rajesh A2, Snigdha G. Giant hydronephrosis of kidney mimicking ascites: A case report. J. Med. Res. 2016; 2(2): 30-31
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nephrosis mimicking an intraabdominal mass. Turk J Med Sci 2007;37:177-9.
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
Effect of Art Therapy versus Bubble Breaths on Anxiety among Children Undergoing Surgery in Selected Hospitals
English1523Manisha PadekarEnglish Shweta JoshiEnglish Rupali SalviEnglish Nisha NaikEnglish
Introduction: Anxiety among children undergoing surgery has an impact on postoperative outcomes, and is an extremely unpleasant experience for children and their family. To reduce preoperative anxiety art therapy and bubble breaths were tested in this study. Aim: To compare and evaluate the effect of art therapy and bubble breaths on anxiety among children undergoing surgery in selected hospitals. Methods and Material: Quasi-experimental pre-test post-test control group design was adapted. The study was conducted among children undergoing surgery. 90 samples were selected using non-probability purposive sampling and data collection was done using demographic variables and Modified Short State-Trait Anxiety Inventory. Art Therapy & Bubble Breaths were administered to Experimental Group1 & Experimental Group 2 respectively. Both groups received interventions 2 times. Results: Bubble breaths were significantly more effective in reducing anxiety among children undergoing surgery as compared to art therapy. Conclusion: This study concludes that bubble breaths are more effective in reducing pre-operative anxiety and are enjoyable for children of all ages. This is cost-effective and can be included as a preoperative routine for reducing anxiety among children in preoperative period.
EnglishArt Therapy, Anxiety, Bubble Breaths, Children, Effect, Surgery
Introduction:
Anxiety among children undergoing surgery is usually characterized by subjective feelings of tension, nervousness, apprehension and worry that may be expressed in various forms such as crying. Postoperative maladaptive behaviours include, feeding difficulties, apathy and withdrawal, new onset enuresis and sleep disturbances, these may also result from anxiety before surgery.1
Children are human being in the stage of birth and puberty. They are innovative, active, bubbling and happy when their parents are in their house. A hospital stay can be a painful experience for a child as children miss home and normal everyday life. They may experience unfamiliarity with events, fear and confusion.2
Apart from the impact on postoperative outcomes, preoperative anxiety is an extremely unpleasant experience for children and their family. Some children prefer to vocalize their fears while others manifest it in behaviours such as agitation, crying and cessation of conversation or play and also attempting to escape from care providers. This is also accompanied by significant physiological changes such as secretion of stress hormones and increase in heart rate.3
Anxiety is defined as “apprehension without apparent cause”. It is a normal emotional state that we all experience at different times in our life. It is usually associated with anticipated fear of something that might happen in future. Anxiety is a psychological and physiological state characterized by cognitive, somatic, emotional and behavioral components.4
Total number of children in India is 164.5 millions. Childhood is often associated with illness and hospitalization. The National Center for Health Statistics has estimated that around 3.5 million children below 15 years of age are getting hospitalized every year.5
Reports of preoperative anxiety in children are varied, but are estimated to be 60.0% among children who are admitted for surgeries.6
A scheduled surgical procedure in children is a stressful procedure for child &family. Operative procedures in paediatrics is an unpleasant & potentially threatening experience which leads to preoperative anxiety due to child’s illness, hospitalization, fear of surgical intervention etc. Moreover it is well known that preoperative anxiety in children lead to negative postoperative responses, including long term behavioural problems, longer period of hospitalization and more pain.7
Preoperative anxiety can be seen commonly during the surgical experience in all age groups, higher levels of anxiety alter a patient's surgical course and cause increased postoperative pain.8
Preoperative anxiety among pediatric patients is very common,it has been associated with the display of maladaptive behaviors post-surgery, including high postoperative pain, parent-child conflict and increased anxiety and sleeping disturbances.9
Children who exhibit more anxiety preoperatively are 3 times more likely to exhibit post-operative negative behaviors. As many as sixty-seven percentages of children may develop postoperative negative behavioral changes including general anxiety, apathy and withdrawal, separation anxiety, sleep disturbances, aggression towards authority, and eating disturbances.10
Kaine and co-workers stated that negative behavioural response in 54.0% children (2 to 10 years) after 2 weeks, 20.0% after six months and 7.3% after one year of surgery.11
Material and Methods:
Research Design
In this study Quasi-experimental, pre-test post-test control group design was used to assess the effect of art therapy versus bubble breaths on anxiety among children undergoing surgery in selected hospitals.
Setting
The setting of the study was Dr. D. Y. Patil Hospital.
Sample
The sample selected for present study comprised of the children undergoing surgery from 6 to 12 years of age admitted in Dr. D. Y. Patil Hospital.
Instrument
In this study, the tool consisted of following:-
Demographic Variables: This includes 12 questions which obtain information regarding demographic data such as age, gender, religion, education of the child, father’s education, father’s occupation, mother’s education, mother’s occupation, family income, presence of caregiver with child, duration of hospitalization, and play activities of the child during hospitalization.
Modified Short State-Trait Anxiety Inventory: The Modified Short State-Trait Anxiety Inventory has 10 elements related to anxiety, with score 0, 1, 2, 3. In that Not at all is rated as score 0, somewhat is rated as score 1, moderately is rated as score 2 and very much is rated as score 3.
Scoring Key:
0 -10: Severe anxiety
11 – 20: Moderate anxiety
21 – 30: Mild anxiety
Art Therapy Profile
Bubble Breaths Profile
Intervention
The samples were selected considering inclusion & exclusion criteria. The researcher introduced herself to the subjects and their parents, assurance of confidentiality was given to the subjects and their parents and consent/assent was obtained from subjects. Socio-demographic data was collected from each subject. Pre-test was conducted for all three the groups using Modified Short State Trait Anxiety Inventory. On the same day 2 times art therapy was given for 30 – 40 minutes to children in experimental group 1 once in morning & then in evening. Bubble breaths were given 2 times to children in experimental group 2 for 15 – 20 minutes once in morning & then in evening. Post-Test data was collected following each intervention. Data collection from control group was also done.
Ethical consideration
The research study was carried out after obtaining permission of Sub Ethical Committee (DYPV / CON/ 523/ 2020), Research& Recognition Committee (DPU / 656 / - 15 / 2020) of Dr. D. Y. Patil Vidyapeeth Pune.
Data Collection
After obtaining administrative permissions from hospital authorities the actual data was collected from 14.12.2020 to 23.01.2021
Figure 1 depicts the step by step procedure followed during the study for collection of data.
Schematic Diagram
Population
Data Analysis:
Descriptive and analytical statistics were done. The data is represented in mean and standard deviation. The association of the level of anxiety with selected socio-demographic variables was analysed by Fisher’s exact test. The independent sample t-test and paired sample t-test were used to check to mean differences. The level of significance was kept at pEnglishhttp://ijcrr.com/abstract.php?article_id=4369http://ijcrr.com/article_html.php?did=4369
1. Ahmed MI, Farrell MA, Parrish K, Karla A. Preoperative anxiety in children -risk factors and non-pharmacological management. Middle East J Anaesthesiol 2011;21(2):153-64
2. Definitions of Children. www.kathyeugster.com
3. Kain ZN, Cicchetti DV, Mayes LC, O’Connor TZ. Preoperative anxiety in children: predictors and outcomes. Arch Pediatr Adolesc Med 1996; 150:1238–45.
4. Anxiety in Children, Teen Stress and Teenage Depression. www.lifepositive.com
5. India Population (2021) - Worldometerwww.worldometers.infoworld-population/india-population/
6. Mc Cann ME, Kain ZN. The management of preoperative anxiety in children: An update.Anesth Analg 2001; 93(1):98-105
7. Aikaterini C, Gregory T, Vasiliki M, Georgios V, Christos I, Pelagis C. Preoperative anxiety in Greek children and their parents when presenting for routine surgery. Anesthesiol Res Pract 2018;2018:5135203.
8. Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain. AORN J.2007; 85 (3):589-604
9. Agnieszka T, Beata B. Anxiety and need for information in parents of children prepared for surgery under general anesthesia. PMID: 313105593
10. Zuwala R, Barber KR. Reducing anxiety in parents before and during pediatric anesthesia induction. AANA J 69(1):21-5
11. Wright Kristi D, Stewart Sherry H, Allen Finley G, Buffett-Jerrott Susan E.Prevention and intervention strategies to alleviate preoperative anxiety in children: a critical review Behav Modif. 2007; 31(1):52-79.
12. Dalei SR, Nayak GR, Pradhan R. Effect of art therapy and play therapy on anxiety among hospitalized preschool children. J. Biomed. Sci.2020;7(2):71-76
13. Longobardi C, Prino Laura E. Soap bubbles as a distraction technique in the management of pain, anxiety, and fear in children at the paediatric emergency room: A pilot study. Child Care Health Dev. 2019;45(2):300-305.
14. Louise Amália de M, Iohanna Maria Guimaraes D, Lilian Varanda P. Prevalence and factors associated with preoperative anxiety in children aged 5-12 years. Rev Lat Am Enfermagem. 2016; 24: e2708.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
Comparative Study of the Antiurolithiatic Activity of Leea macrophylla, Alangium lamarkii, Saccharum officinarum, Marsdenia tenacissima, Chonemorpha macrophylla, Maerua oblongifolia
English2833Nangare N BEnglish Deshpande M MEnglish Arulmozhi SEnglish Kurulkar M AEnglish
Introduction: Incidence of urinary tract disorders and kidney disorder including nephropathies is on the rise. In spite of tremendous development of modern medicine, still there is no appropriate medical treatment for these problems.
Aim: In Ayurved, the plant Morat mentioned in Veeratarvadi gana’ [type of classification], which has prime indication in Ashmari (Urolithiasis). Under the name of Morat, botanical identity such as Leea macrophylla, Saccharum officinarum, Alangium lamarkii, Marsdenia tenacissima, Maerua arenaria, Chonemorpha macrophylla are considered as they exhibit same medicinal properties
Methodology: The purpose of this work was to compare anti-urolithiatic activity of these plants by Ethylene glycol induced model method. Also, comparison of antiurolithiatic property of these plants and Cystone is studied.
Result: In this article effect on urine output, pH, and concentrations of urinary calcium, phosphate, oxalate & total protein, serum concentrations of Creatinine, Uric Acid, Calcium Phosphate and BUN is studied. Saccharum officinarum L, Chonemorpha macrophylla (Roxb) G. Don, Maerua arenaria Hook, Marsdenia tenacissima exhibited significant antiurolithiactic activity.
Conclusion: Comparison suggests that Chonemorpha macrophylla is the most suitable source of Morat for Antiurolithiatic Activity is.
EnglishMorat, Veeratarvadi gana, Ashmari, Cystone, Antiurolithiactic activity, Ayurveda
Introduction:
The incidence of urinary tract disorders and kidney disorders including nephropathies is on the rise. The incidence is higher in developing countries including India. UTI, Urolithiasis, Diabetic Nephropathy & Nephrotoxic drugs are the most common conditions which cause injury to the kidney. Prevalent environment, lifestyle, and socioeconomic conditions have contributed to the rising incidence of the same. In spite of the tremendous development of modern medicine, still there is no appropriate medical treatment for these problems. There is, therefore continuous rising demand for safe & effective herbal drugs. Hence in recent years, plants documented in Ayurvedic literature like Charaka Samhita, Sushruta Samhita, and Ashtanga Hridaya has been received much attention. In Ayurved, many categories of drugs (Gana) are mentioned which could be useful in kidney disorders. ‘Veeratarvadi gana’ is one of them, which has prime indication in Ashmari (Urolithiasis).1 Morat is one of the controversial plants, which is mentioned in this group. Plants can be considered as Morat are of L. macrophylla, A. lamarkii, S. officinarum, M. tenacissima, C. macrophylla. M. oblongifolia.2 This study was conducted to evaluate & the anti-urolithiatic activity of species that are mentioned under the name of Morat in animal.
Material and Method:
Plant collection and authentication: All plants self-collected from their natural habitats & identified on the basis of their morphological characters with the help of by Dr. S. D. Jagtap (Senior Taxonomist & Head, Herbal Biotechnology, IRSHA, Bharati Vidyapeeth, Pune, India.) & flora. Voucher specimens of all six plants have been deposited in Regional Ayurveda Institute for Fundamental Research(RAIFR), Pune, India.
Processing of plant material: Collected plant samples were shade dried, powdered with a mechanical grinder, sieved through 80# mesh and stored in air tight glass vessel. These powders were utilized for various experimental studies. Kwatha (decoction) of test drugs were freshly prepared prior to administration to the animals. It was prepared according to the procedure mentioned in the “Sharngadhar Samhita” Madhyam khand 2/77 i.e. 16 parts water and one part drug which was boiled on low flame till 1/8th part remained. This was filtered and allowed to cool before administering to the animals.9
Pharmacological screening for antiurolithiatic activity
Animals: Wistar strain albino rats of either sex; weighing 180 to 250 g were obtained from the National Institute of Biosciences, 1091/ABC/07/CPCSEA & maintained in the animal house of Bharati Vidyapeeth University, Poona College of Pharmacy, Pune. Animals were housed on straw bedding 6 per cage & exposed to natural day and night cycles with ideal laboratory conditions in term of ambient temperature and humidity. The Institutional Animal Ethics Committee approved the protocol of this study (CPCSEA Number: CPCSEA/PCP/PCL05/2018)
Grouping and posology: Animals were divided into nine groups containing 6 animals in each group. The dose for experimental animals was calculated on the basis of body surface area ratio by referring to the standard table of Paget and Barnes (1969). 10
Ethylene glycol-induced urolithiasis model: The method of Ethylene glycol-induced model 11 was employed for the assessment of antilithiatic activity. Rats were divided in nine groups containing six in each. Ethylene glycol (0.75% v/v) in drinking water was feed to all groups except control for induction of renal calculi till the 28th day. In the study all the groups except the control received test drugs from 15th day till 28th day.11 Cystone was used as a standard drug. During the study animals were allowed free access to food.12, 13
Treatment protocol
From day 1 to day 14, ethylene glycol (0.75%) in drinking water was fed orally (q.s.) to rats from group II to IX for rendering them hyperoxaluric. The state of hyperoxaluria was checked and confirmed by collection and examination of urine after day 14. Then onwards till day 28, rats from group III to IX received curative treatments with individual drugs and group I and II received saline water (5 ml/kg). All doses were administered once daily by oral route.
Collection and assessment of urine: Rats were kept in individual metabolic cages for collection of 24 h urine. They had free access to drinking water during the urine collection period. During the entire study period, rats were subjected to 24 h urine collection twice. After day 14, urine was collected and analyzed to check and confirm the extent of Urolithiasis. After completion of study period (i.e. day 28), urine was collected and analyzed for biochemical parameters.
Routine urinalysis: Routine urinalysis was carried out using diagnostic reagents & kits (Coral Clinical Systems, Gitanjali, Tulip Block, Dr Antonio DO Rego Bagh, Bambolim Complex P.O. Goa) including quantitative determination of pH and specific gravity along with the presence of occult blood, bilirubin, urobilinogen, ketone bodies, proteins, nitrite, glucose and leucocytes in urine.
Urine biochemistry: A drop of concentrated hydrochloric acid was added to the urine before being stored at 4ºC. Using biochemical estimation kits, urine was analyzed for calcium and phosphate content; while, urinary oxalate content was estimated using a modified method of Hodgkinson and Williams (1972).
Assessment of serum: After the experimental period, blood was collected from the retro-orbital vein under anesthetic conditions. Serum was separated by centrifugation at 10,000 rpm for 10 min and analyzed for creatinine, uric acid and urea nitrogen.
Assessment of kidney: Finally all rats were sacrificed using an appropriate method of euthanasia. The abdomen was cut open to remove either kidney from each rat. Isolated kidneys were cleaned off extraneous tissue and preserved in 10% neutral formalin. One kidney (randomly selected) from each rat was processed for preparing kidney homogenate. From the remaining kidneys, one kidney as representative of the whole group was selected randomly and processed for a histopathology examination.
Kidney homogenate analysis: Each selected kidney was dried at 80ºC in a hot air oven. A sample of 100 mg of the dried kidney was boiled in 10 ml of 1 N hydrochloric acid for 30 min and homogenized. The homogenate was centrifuged at 2000 rpm for 10 min and the supernatant was separated. The calcium, phosphate and oxalate content in kidney homogenate were determined as mg/g of kidney weight using the methods as described earlier.
Histopathological examination of kidney: Each selected kidney was embedded in paraffin using conventional methods and cut into 5 µm thick sections and stained using hematoxylin-eosin dye and finally mounted in diphenyl xylene. Then each section was observed under a microscope for histopathological changes in kidney architecture and their photomicrographs were taken at x50 magnification. By visualizing different fields, a general method of scoring was adopted to observe the extent of nephritic damage and recovery. A minimum of 10 fields for each kidney slide were examined and assigned for the severity of renal damage and progression of recovery using scores on a scale of none (ND), mild (+), moderate (++) and severe (+++) damage.
Statistical analysis Results were expressed as mean ± SEM. Differences among data were determined using one-way ANOVA followed by Dunnett’s posttest using Graph pad Prism software (Graph pad Prism software Inc., Version 4.00.255). Differences between the data were considered significant at pEnglishhttp://ijcrr.com/abstract.php?article_id=4370http://ijcrr.com/article_html.php?did=4370
Acharya JT. Sushrut Samhita Dalhanacharya’s Nibandhasangraha Commentary. Varanasi: Chaukhambha Amabharati Prakashan; 1994. 112.
Vaidya B. Some controversial drugs in Indian medicine. Varanasi: Chaukhambha Orientalis;1982. 49.
Singh NP, Karthikeyan S., Flora of Maharashtra State. Dicotyledones-Vol. I (Ranunculaceae - Rhizophoraceae). Calcutta: B. S. I.; 2000. 568.
Singh NP, Karthikeyan S., Flora of Maharashtra State. Dicotyledons-Vol. II (Combretaceae - Ceratophyllaceae) Calcutta: B. S. I.; 2001. 114.
Singh NP, Karthikeyan S., Flora of Maharashtra State. Dicotyledons- Vol. II (Combretaceae - Ceratophyllaceae) Calcutta: B. S. I.; 2001. 322.
Mudgal V, Khanna KK, Hajra PK., Flora of Madhya Pradesh Vol. II. Calcutta: Botanical Survey of India; 1997. 231.
Sharma BD, Karthikeyan S, Singh NP. Flora of Maharashtra State. Monocotyledons[1]Vol. III Calcutta: B. S. I.; 1996. 167.
Singh NP, Karthikeyan S., Flora of Maharashtra State. Dicotyledones-Vol. I (Ranunculaceae - Rhizophoraceae) Calcutta: B. S. I.; 2000. 226.
Sharangadhar, Sharangadhara samhita Adhamalla's Dipika and Kasiramas Gudhartha Dipika, fourth edition. Varanasi: Chaukhambha orientalia; 2000; 231
Paget GE, Barnes JM., In: Evaluation of drug activities. Pharmacometrics. Lawrence DR, Bacharach AL, editors. Vol.1. New York: Academic press; 1969; 161.
Atmani F., Slimani Y., Mostafa M., Hacht B., Prophylaxis Calcium oxalate stones by Herniaria hirsute on experimentally induced Nephrolilhiasis in rats. Br. J. Urol.. 92: 2003; 137-140.
Jaiswal, Diuretic action of Palasha Kshara in rats. Int J Cur Res Rev 2020; 12 (22:149.
Patnaik, A survey study on etiological factors of mutrashmari (urolithiasis) in perspective of ayurved. Int J Cur Res Rev 2020; 12(22):86-88.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
Importance and Possible Approaches in Adoption of Indoor Fruit Culture for Indian Families
English3439Vijayalakshmi KEnglish S. SenthilkumarEnglish U.S. Akshara GovindEnglish S. ManivannanEnglishEnglishFood and Nutritional security, Urbanization, Indoor fruit cultivation, Ultimate goal, Nutritional recommendations, Possible approaches
Introduction
FAO predicted that a continuous increase in the global population would reach 11 billion in 2100. As a result, we must increase our production capacity in order to feed an additional 2.5-3 billion people. To do so, we'll need an additional 140 million hectares of arable land, which will be difficult to come by given the current rate of urbanization.1 Meanwhile, due to the indiscriminate use of all inputs, intensive agriculture is recognized to contribute considerably to climate change.2 Overall, conventional agriculture exploits our natural resources at maximum and made them scarce or extinct.3 According to a report produced by FAO-UN1 (2017), agriculture alone utilizes about 70 % of the freshwater of our planet.
Climate change, pollution, depletion of natural resources, and global loss of biodiversity due to deforestation for agricultural land conversion requirements continue to threaten our planet's agricultural potential.4 According to Defries et al.5 agricultural land conversion alone has resulted in considerable forest loss in 41 tropical nations during the Green Revolution Era through 2005.
Agriculture, forestry, and other land uses account for around 21% of total world GHG emissions. As a result, we must minimize water use and GHG emissions per unit of food. From all of this, it is obvious that preserving a sustainable natural resource base and improving agricultural productivity are the two most pressing problems in food security, both of which require attention from both rural and urban agriculture.1 This is where the importance of indoor horticulture comes into play.
Nonetheless, due to competition for land, pollution risks from the urban ecosystem to agriculture and vice versa, contamination of food products by heavy metals and organic chemicals, and rising health concerns due to sanitation and vector diseases, urban agriculture continues to face land insecurity issues.4,6,7,8,9. Game and Primus10 categorized urban agriculture into 2 spheres namely, Uncontrolled Environment Agriculture (UEA) and Controlled Environment Agriculture CEA. UEA consists of open-space vegetable gardens, rooftop gardens, and community gardens, all of which are widely acknowledged to play a part in food security in cities throughout the world. CEA, on the other hand, comprises agricultural methods that optimize the environment, often in combination with neighboring urban buildings. Greenhouses, indoor farming, vertical farming, and building-integrated agriculture are some examples.10,11
Optimization of food production can be achieved by incorporating innovations such as indoor agriculture, remote sensing, vertical agriculture, hydroponic, aeroponic, aquaponic, and soilless agriculture, precision agriculture, and other novel technologies in Urban Agriculture, regardless of whether it concerns an open or closed system2,12,13
Agriculture is often ignored in India's peri-urban areas, which are plagued by institutional uncertainty, unplanned expansion, insufficient infrastructure, and environmental deterioration.14 Land availability for cultivation is also decreasing from year to year in India. However, for land requirements for various socio-economic processes, urbanization is inevitable. This made lot of people to lose their farmland.15 Under this situation indoor horticulture will be one of the best solutions to meet out individual food as well as nutritional security. When speaking about indoor horticulture instantly the question of growing fruits indoors will arise. Surely this article will reveal the answers for all the questions in your mind regarding indoor fruit cultivation.
Importance of fruits
It is certain that fruits and vegetables are rich sources of vitamins and minerals. Their nutritional wealth places them on the crest of our diet.
Having fruits on our daily diet strengthens our vitality. As per the ICMR recommendation individuals must take 120 g of fruits in their daily food intake.
Vitamins A, B, and C are abundant in fruits such as papaya, mango, guava, jackfruit, pineapple, lemon, and so on. Calcium, magnesium, iron, and potassium are also included in them. In wood apple, litchi, almond, karamcha, and other plants, phosphorus and amino acids are abundant.16
In India rice and wheat are the staple food which made us far away from nutritionally sound fruits. In contrast, many other countries people are taking fruits as their staple food. Fruits such as bananas, jackfruit, guava, pineapple, etc. can minimize our food deficit to a great extent.
Growing food crops inside provides access to fresh, high-nutrient-value produce and serves as a significant remedy for malnutrition.
In developing countries, urban horticulture helps to livelihoods, ensuring food security.17
Fruit trees with low inputs not only enrich the environment but also act as a source of income to the population.
Dubbing et al.18 reported that an achievable yield from 1m2 land via fruit and vegetable cultivation was about 50 kg/annum. Fruits give a comparatively very high yield.
This shows that indoor fruit and vegetable production has the ability to provide a certain level of self-sufficiency for inhabitants' nutritional security.
Home gardens feature a variety of fruits, vegetables, trees, and condiments that serve as additional food and revenue sources.
Fruits are high in phytochemicals, which act as antioxidants, phytoestrogens, anti-inflammatory agents, and other protective processes in addition to vitamins and minerals.19
Incorporating fruits and vegetables into our daily diet can help to avoid a variety of non-communicable illnesses, including cardiovascular disease, type 2 diabetes, and some cancers.20
Why indoor?
To lessen the burden on an agricultural production system
To reduce over-exploitation of natural resources in order to increase the productivity of intensive agricultural systems to feed the growing population at the cost of environmental degradation.21
No need of additional space
Because this method does not need extra area, it is referred to as indoor farming or zero farming.22
Reviviscency of urban environment
This has the ability to use household or industrial wastewater, sunshine, and sequester larger levels of carbon dioxide utilizing CO2 created within the building or in cities while taking up no more space. This may be a small space resource recycling or saving method that could minimize a city's ecological impact and contribute to sustainability.22
Requirements for indoor fruit cultivation
Containers
The container is important for plant growth because it provides support and regulates environmental variables including temperature, gaseous exchange, and relative humidity.23Suitable container size for different fruit crops is furnished under Table 1.
Varietal selection and other considerations for successful indoor fruit culture
For effective indoor fruit growing, choosing the right fruit crop variety is crucial. Suitable fruit crops for indoor cultivation are furnished in Table 2. The size of the tree is the most important factor to consider, as dwarf trees are preferred. And understanding the temperature requirements is necessary to assure their indoor adaptation. It's best to choose types that can thrive at room temperature. Recommendations for varietal selection of different fruit crops are given in Table 3.
Special operations in indoor fruit cultivation
Media
Containerized plants need different potting soil of different physical properties. So, it is wise to avoid garden soil as it may act as a source for some soil-borne diseases. The best potting mixture will be peat moss: bagged topsoil or potting soil at 1:1 ratio, some weed-free compost. While potting leave 2 inches gap on the top for an organic mulch. Plants may need repotting for every 3-5 years in order to cope up with nutrient depletion in media.24
Optimum irrigation
Appropriate and sufficient irrigation is required to obtain appropriate yields and healthy products.9 The amount of water required and how often it is watered are determined by the kind and size of the plant, the type and size of the container, the temperature, humidity, potting media, and other factors. Before watering most plants, let the upper surface of the soil to become dry to the touch. Then, carefully fill the container with water to completely wet it. The ability to remove surplus water from the containers is critical.
Plastic, metal, and ceramic containers keep the soil moist for longer than wood or clay containers, which allow water to evaporate through the sides. Because chilly weather slows plant development and so lowers the demand for moisture, watering should be done less often during this time.24
Rain, collected water, tap water, or wastewater can all be used as a source of water. Untreated wastewater poses a significant risk to human health, and modern treatment equipment is still too costly.9
Despite the fact that using wastewater for fertilizer and irrigation in UA is considered a positive wastewater treatment25, it has been linked to a rise in health problems.8 Eating contaminated food can create epidemics if it is used improperly or insufficiently handled.26 As a result, using high-quality water for irrigation is critical.
Nutrition
Organic waste, such as animal manure, plant leftovers, or waste from the food industry or homes, can be utilized for nutrition and fertilization.
Commercial hydroponics is a contemporary technology that involves plant development in a nutrient solution without the need of soil as a rooting media (suitable for specific fruit crops such as strawberries, grapes, raspberries, blackberries, and blueberries). This technique uses irrigation water to apply inorganic fertilizers and then recirculates the nutrient solution to prevent leaching and waste.27
Excess fertilization and/or water containing significant soluble salts can occasionally cause salt buildup, which is frequently indicated by a white crust on the soil or container. By carefully flowing water through the container for many minutes, the container should be thoroughly leached. Excess salts will be carried down through the soil and out the drainage holes.28,24
Light requirement
Plants growing outdoors will meet their light requirement from solar radiation. But plants growing under controlled conditions or closed environments sometimes need light sources to carry out photosynthesis in an effective manner.
Traditional light sources, such as high-pressure sodium and metal halide lamps, produce a lot of heat and aren't very energy efficient or cost-effective for plant development. To address these issues and improve the quality of the product, solid-state light-emitting diode (LED) lights have been created. LED lights are energy-efficient, low-maintenance, and long-lasting.29 Three light characteristics should be considered: intensity, quality, and duration, all of which have varied effects on crop development and product quality.30 In an experiment on the indoor cultivation of basil and strawberry, it was discovered that when the plants were treated with LEDs with the highest energy use efficiency than traditional fluorescent lamps, the plants produced more biomass, fruit yield, antioxidant content, and reduced nitrate content, and that a spectral red: blue ratio of 0.7 was required for proper plant growth with enhanced nutraceutical properties.31
Grooming
Grooming refers to cleaning and pruning of indoor plants periodically to remove dust, keep them at peak of their productivity since the dust deposition on leaves will affect the photosynthetic capacity of the plant. Indoor plants' leaves, on the other hand, can quickly become covered in a thick coating of dust. These dust particles block stomata, impairing gas exchange. As a result, grooming is critical.
Different techniques of grooming,
Clean glabrous leaves with a soft, damp towel; clean pubescent leaves with a make-up or soft painter brush; place plants in the shower to wash away dust
If it's warm outside, rinse them with a garden hose.
Use warm water between 60° and 75°F to avoid harming the plant's development by exposing it to overly hot or cold conditions.24
Training and pruning
Pruning is highly essential to maintain optimum plant height. Training the plants into well-defined structure wisely reduce their space requirement. If the space availability is very less than training them into vertical or columnar shape (in case of apple and peaches) will be ideal. 24
Rootstock selection
While focusing on growing plants in containers, it is wise to choose dwarf varieties (Table 4) that made keeping plants height optimum with less care. The size of the plants is determined either by nursery pruning or plant genetics. But the role of rootstock is highly significant in inducing dwarfness. Dwarfing rootstocks are enlisted in Table 5.
Plant protection
As per the report presented by Lada et al.32 there is no or very less incidence of pest and diseases in indoor cultivation which doesn’t require the application of pesticides.
Discussion
Fruits certainly play a vital role in achieving food and nutritional security. By standardizing techniques for growing them indoors we can surely ensure the food and nutritional security of each and every individual. It provides the city dwellers with nutritious food along with aesthetic recreation and its socio-economic importance will develop further as the overall advancement of society is progressing at a rapid pace. It will also become a more significant aspect of horticulture business entrepreneurship.
The significant issue for indoor fruit cultivation is tree size. As most of fruit crops are tends to grow much larger, it is essential to control tree size. This can be done by using dwarfing rootstock, dwarfing scion, proper training and pruning, and by the usage of growth retardants.
Apart from these tree size-reducing approaches, indoor fruit crops require mere attention to light availability, ventilation, optimum temperature and relative humidity. To ensure these requirements it is advisable to place the plants near the windows or any other light source. Water can be provided based on the media's dryness. Root pruning and changing depleted media have to be done once in a long while to ensure proper growth and development.
Conclusion
Indoor fruit culture's full potential as a food and livelihood provider, on the other hand, can only be realized if it is integrated into urban land use planning and policy-making, addressing both potential advantages and hazards for nutritional benefits and nutritional empowerment. In many developing country cities, well-managed urban horticulture will be an essential tool for reducing poverty, improving environmental management, and advancing economic growth. When these ideas are turned into practical norms and activities, urban horticulture may help with food security, food safety, and livelihoods while also providing a lot of room for creativity.
Overall, it is evident that an indoor fruit culture is a viable option for providing healthy, fresh, and safe food to the globe in the twenty-first century.
Acknowledgement:
The authors gratefully recognize the enormous assistance provided by the academics whose publications are mentioned and included in the references to this manuscript. The authors would also like to thank the authors/editors/publishers of all the papers, journals, and books that were used to evaluate and debate the literature for this study.
Source of funding: There is no source of funding for this article's work.
Conflict of Interest: There is no conflict of interest among the authors.
Authors’ Contribution:
S. Senthilkumar given this ideology, analyzed and reviewed the article.
Vijayalakshmi K collected and analyzed the information and prepared the report.
U.S. Akshara Govind reviewed the article.
S. Manivannan analysed and reviewed the article.
Englishhttp://ijcrr.com/abstract.php?article_id=4371http://ijcrr.com/article_html.php?did=4371
FAO F. The future of food and agriculture–Trends and challenges. Annual Report. 2017 Oct 15;296.
Benis K, Ferrão P. Commercial farming within the urban built environment–Taking stock of an evolving field in northern countries. Glob. Food Sec. 2018 Jun 1;17:30-7.
Clark M, Tilman D. Comparative analysis of environmental impacts of agricultural production systems, agricultural input efficiency, and food choice. Environ. Res. Lett. 2017 Jun 16;12(6):064016.
Mok HF, Williamson VG, Grove JR, Burry K, Barker SF, Hamilton AJ. Strawberry fields forever? Urban agriculture in developed countries: a review. Agron. Sustain. Dev. 2014 Jan;34(1):21-43.
DeFries RS, Rudel T, Uriarte M, Hansen M. Deforestation is driven by urban population growth and agricultural trade in the twenty-first century. Nat. Geosci. 2010 Mar;3(3):178-81.
Van Veenhuizen R, Danso G. Profitability and sustainability of urban and periurban agriculture. Food & Agriculture Org.; 2007.
Russo A, Escobedo FJ, Cirella GT, Zerbe S. Edible green infrastructure: An approach and review of provisioning ecosystem services and disservices in urban environments. Agric Ecosyst Environ. 2017 May 1;242:53-66.
Cofie OO, Kranjac-Berisavljevic G, Drechsel P. The use of human waste for peri-urban agriculture in Northern Ghana. Renew. Agric. Food Syst. 2005 Jun;20(2):73-80.
Hamilton AJ, Burry K, Mok HF, Barker SF, Grove JR, Williamson VG. Give peas a chance? Urban agriculture in developing countries. A review. Agron Sustain Dev 2014 Jan;34(1):45-73.
Game I, Primus R. GSDR 2015 brief urban agriculture. State University of New York College of Forestry and Environmental Science. 2015.
Al-Kodmany K. The vertical farm: A review of developments and implications for the vertical city. Buildings. 2018 Feb;8(2):24.
Armanda DT, Guinée JB, Tukker A. The second green revolution: Innovative urban agriculture's contribution to food security and sustainability–A review. Glob. Food Sec. 2019 Sep 1;22:13-24.
Gwynn-Jones D, Dunne H, Donnison I, Robson P, Sanfratello GM, Schlarb-Ridley B, et al. Can the optimization of pop-up agriculture in remote communities help feed the world?. Glob. Food Sec. 2018 Sep 1;18:35-43.
Kumar SS. Land accounting in India: Issues and concerns. Central Statistics Office, Ministry of Statistics & Programme Implementation, New Delhi, India. 2011.
Suman M, Bhatnagar P. Urban Horticulture Prospective to Secure Food Provisions in Urban and Peri-Urban Environments. Int. J. Pure Appl. Biosci. 2019;7:133-40.
Kazi NA, Yadav JP, Agale MG. Nutritional value of fruits. SRJIS. 2015;3(16):2937-43.
Parrot L, Dongmo C, Ndoumbé M, Poubom C. Horticulture, livelihoods, and urban transition in Africa: evidence from South?West Cameroon. J Agric Econ. 2008 Sep;39(2):245-56.
Dubbeling M, Zeeuw HD, Veenhuizen RV. Cities, poverty and food: multi-stakeholder policy and planning in urban agriculture. Practical Action Publishing; 2010.
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Rajan P, Lada RR, MacDonald MT. Advancement in indoor vertical farming for microgreen production. Am J Plant Sci. 2019 Aug 27;10(08):1397.
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15HealthcareAn Update on Silver Diamine Fluoride and Its Use in Special Needs Individuals
English4044Kiran KEnglish Bhargavi R VojjalaEnglish Arshiya ShakirEnglishDental care was determined to be one of the most common unmet health care in Special needs patients. As special needs patients have certain limitations, routine dental treatment cannot be performed. Radical treatment modalities such as sedation or general anaesthesia are often required. However, these treatment modalities have their own risks. During recent times, there has been a revival in interest in using silver diamine fluoride to arrest dental caries. This review makes a case for using the silver fluoride bulletin special needs individuals to simplify the treatment procedure and make radical treatment modalities unnecessary.
English Cariostatic agents, Dental caries, Silver compounds, Silver diamine fluoride, Topical fluoridesINTRODUCTION
In the field of dentistry, special needs patients are individuals who present with physical, sensory, mental, growth medical limitations, whether they are transitory or permanent.Due to their limitations, these individuals need differentiated dental treatment.1 The US Maternal and Child Health Bureau stated that Children with Special Health Care Needs (CSHCN) are “those who have or are at increased risk for a chronic physical, developmental, behavioural, or emotional condition and who also require health and related services of a type or amount beyond that required by children generally”.2 Special Care Dentistry (SCD) is concerned with providing and enabling the delivery of oral care for people with an impairment or disability.3
According to the World Health Organization (WHO), nearly 600 million persons around the world or 1 in every 10 persons have some form of disability.4 In the United States, nearly 15 million children or 1 in 5 children have special health care needs.5 In India, a total of 2.21% of the population or 2.68 Crore persons are disabled. The prevalence of disability is highest in the age group 10-19 years. It consists of 46.2 lakhs persons and makes up 17% of the total disabled population.6
Informally collected evidence suggested that CSHCN are at increased risk for poor oral health.7 Dental care was determined to be the most common unmet health care need for these children.8,9 Several factors are associated with the unmet dental care needs. These factors encompass the difficulties associated with the treatment. CSHCN often require advanced pharmacologic behaviour guidance modalities such as sedation or general anaesthesia. These modalities are not always available and have risks inclusive of effects on brain development in young children and mortality.10
Due to the hurdles expected during the treatment of CSHCN, an agent which is capable of preventing and limiting the damage and discomfort caused by dental caries is required. In turn, this agent will constrain the difficulties associated with more radical treatment modalities. One such agent is silver diamine fluoride (SDF). Though not new, the solution has recently been in the limelight. Clinicians throughout the world have been showing interest in SDF due to its effectiveness in arresting the progression of carious lesions.11,12
However, even with global acceptance, very few articles have explained the use of SDF in individuals with special needs. This update attempts to encourage the use of SDF in these individuals to provide for their unmet dental needs and improve their health and quality of life.
SILVER DIAMINE FLUORIDE
SDF is a clear, colourless, odourless solution of silver, fluoride and ammonium ions. It is also known as Ammoniated Silver Fluoride, Ammoniacal Silver Fluoride, Silver Ammonium Fluoride, Silver Fluoride Diamine, Diamine Silver Fluoride, Silver Diamine Fluoride, Diamine Silver Fluoride, Silver Fluoride.13-17 Additionally, due to its hypothesized ability to halt the caries process and simultaneously prevent the formation of new caries, it is referred to as “silver fluoride bullet”. 18
In 1917, Percy Howe was the first to add ammonia to silver nitrate and prepare a solution that became known as “Howe’s solution” (ammoniacal silver nitrate).18 This solution was used to arrest caries for the next 50 yrs. This initial combination acted as the backbone for the formation of silver diamine fluoride solution.
In 1969, Nishino was the first to study Silver diamine fluoride at Osaka University in Japan. Later, The Central Pharmaceutical Council of the Ministry of Health and Welfare of Japan approved “Diamine silver fluoride” for caries prevention.19 The solution was marketed as Saforide solution (Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan).20,21,22 Since then, more than four decades have witnessed the effective use of SDF as a preventive material.
In August 2014, The U.S. Food and Drug Administration (FDA) gave clearance to SDF for dental use in the United States.23 The solution is available as a 38% concentration comprising of 24.4–28.8% (w/v) silver and 5.0–5.9% fluoride, at pH 10, and marketed as Advantage Arrest by Elevate Oral Care, LLC, West Palm Beach, Florida. Currently, SDF is marketed in different concentrations across the globe. Table 1 summarizes its availability.13,14
Mechanism of Action:
The mechanisms by which SDF arrests and/or prevents dental caries are:
Obturation of dentinal tubules:
When applied topically, a squamous layer of silver protein conjugate is formed on the exposed dentinal area. The dentinal tubules are partially plugged and there is increased resistance to acid dissolution and enzymatic digestion. Hydroxyapatite, fluorapatite, silver chloride, and metallic silver form a protective layer on the exposed organic matrix.25,26
Anti-microbial action of silver:
Silver ions act directly against bacteria by breaking membranes, denaturing proteins, and inhibiting DNA replication.24
Additionally, silver present in the SDF solution is reactivated when the dead bacteria (bacteria killed by silver ions) are added to the living bacteria. This reactivated silver again effectively kills the living bacteria. The dead bacteria act as a reservoir and show biocidal activity towards the viable bacterial population. This reservoir effect helps explain why silver deposited on bacteria and dentin proteins within a cavity has sustained antimicrobial effects. This concept of the dead bacteria killing the living bacteria is called as the “zombie effect”.27
Cariostatic action mediated by fluorapatite
Remineralisation of the demineralised inorganic tooth mineral is supported by the fluoride ions in SDF. Fluorapatite, silver phosphate and calcium fluoride are formed. They produce a surface more resistant to acid dissolution.28
Anti-enzymatic action on organic component
Silver diamine fluoride specifically inhibits the proteins that break down the exposed dentine organic matrix.29 These include matrix metalloproteinases, cathepsins, and bacterial collagenases.30
DISCUSSION:
SDF can be used in a variety of clinical conditions. It can be used in cases of active cavitated dental carious lesions, carious lesions which may not be treated in one visit, and extensive lesions which need to be temporarily controlled due to the presence of external factors (such as financial restraints) which do not allow for completion of treatment.26 Later, the arrested lesions can be restored via Silver Modified Atraumatic Restorative Technique (SMART).
All these indications, suggest the SDF can be a great alternative for the treatment of untreated decay in young children. In case of CHSCN, caregivers reported higher unmet dental care needs when compared with their medically unremarkable peers. 31-33 A National Survey conducted in 2007 on CSHCN stated that 22.8% of caregivers reported presence of cavities in the previous 6 months in children younger than 18 years.34 In addition, about 15% to 18.7% of caregivers reported that their child had toothache in the previous 6 months.35
SDF can also be used in conditions where traditional restorations fail to stop disease progression and caries risk is extremely high. The “zombie effect” mentioned earlier may help to restrict the carious process in such circumstances. These conditions include severe early childhood caries, recurrent caries, and xerostomia.
Xerostomia can be a frequent oral health concern for special needs individuals. Potential causes of xerostomia include mouth breathing, dehydration, medications such as anticholinergics, antidepressants, antipsychotic agents, diuretics, antihypertensive drugs, sedatives, anxiolytics, muscle relaxants, analgesics (opioids and nonsteroidal anti-inflammatories), bronchodilators, and antihistamines. Other causes include salivary gland disorders, malignancies or other medical conditions affecting salivation. 36,37 These potential risk factors are more common in paediatric patients with special needs. Thus, application of diamine silver fluoride can be considered as a treatment modality for these patients.
Another important indication is in treatment of behaviourally or medically challenged individuals. These include uncooperative children, pre-cooperative children, those with severe cognitive or physical disabilities, and patients with dental phobias. CSHCN patients may fall into one or more of these categories, thereby justifying the application of SDF.
In addition to all these scenarios, SDF can also be used as a desensitizer and improve hypersensitivity symptoms within 24 hours. Studies have reported a significant number of children and adults with special needs experience tooth sensitivity.38,39 These individuals can be treated with SDF.
However, the versatile nature of SDF which allows for it to be used in numerous clinical situations should not be the only reason for clinicians to consider its use. Several other advantages also make it an exceptional treatment modality. These advantages include affordability (cost per pennies), simplicity of application, and non-invasive nature.19
Research has stated the reasons for increased unmet dental needs in CSHCN include living in low-income households or rural area, failure to receive medical care, increased special needs severity and lower degree of functioning, poor psychological adjustment, caregiver burden, not having a personal dentist, lack of preventive medical care, and the absence of coordination among community-based organizations.7,40-43 All of these reasons can be countered by the above-mentioned benefits of diamine silver fluoride.
Furthermore, no serious adverse events, inclusive of allergic reactions, toxicity or pulpal irritations have been reported by any randomised control trial till date. Gingival reactions and chemical burns to skin were rare too. SDF is also safe even when applied to several carious lesions at the same visit, in terms of the pharmacokinetics of the solution.24 Thus, while using SDF, the clinician can be rest assured.
Unfortunately, this “silver fluoride bullet” is not without disadvantages. It does not restore form and function to teeth as do other restorative procedures. Therefore, it can only be used as an adjunct to restorative therapy.44 In addition, it has a transient metallic or bitter taste, and causes dark discoloration. The staining is more of a concern when SDF is applied in the aesthetic zones.45,46,47 Studies have shown that parents have concerns in relation to the staining of the teeth but prefer SDF over other more radical options such as general anaesthesia for treatment.48,49 Thus, it can be stated that the undesirable effects caused by the solution are outweighed by its desirable properties.10
CONCLUSION:
Silver diamine fluoride is a simple, safe, cost-effective, and efficient topical solution that can be used for treating dental caries. The solution is readily available throughout the world. Its easy application makes the solution a go-to therapeutic, especially in case of behaviourally or medically challenged patients.50
These inherent properties of SDF suggest that it possesses significant potential in treatment of CSHCN. SDF will allow for the dental needs of special needs individuals to be met and improve their quality of life. However, limited research has been conducted on CSHCN and the suggestions made by this article are based on it. Hence, we recommend that further high-quality, systematic, condition-specific epidemiologic studies be performed with regard to CSHCN.
CONFLICTS OF INTEREST: No conflicts of interest.
SOURCE OF FUNDING: Nil
ACKNOWLEDGEMENTS: Authors acknowledge the immense help received from the scholars whose articles are cited and included in references of this manuscript. The authors are also grateful to authors of all those articles, journals and books from where the literature for this article has been reviewed and discussed.
AUTHORS’ CONTRIBUTION:
Author 1: Concept and Design off Article, Manuscript Editing, Manuscript Review
Author 2: Literature Search, Manuscript Preparation, Manuscript Editing
Author 3: Definition of Intellectual Content, Manuscript Review
Englishhttp://ijcrr.com/abstract.php?article_id=4372http://ijcrr.com/article_html.php?did=4372
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15HealthcareLiterature and Human Resilience in the Time of Crises Like Coronavirus Pandemics
English4549Arvind M. NawaleEnglishThe COVID-19 pandemic has compelled us to rethink our way of life. In such pandemics or epidemics or other sorts of calamities and crises, the literature provides artistic relief and comfort in such agonies. In addition, it makes us aware of the universality of death and the necessary precautions for our recovery and survival. To explore how literature offers a worth reading to console our hearts and foster resilience in pandemic crises like COVID-19. Studying, reviewing and analyzing relevant literary texts to reach conclusion. Literature gives us an opportunity to study texts written on pandemics and how such events have historically been projected and how they have served as guiding forces. It helps people by inspiring them to act fairly. In such pandemic situations, it is a worthwhile read to soothe our hearts. Reading literature during the period of crises encourages us in driving away isolation, retaining sanity, fostering resilience and above all, instill the courage to face and hope.
English Pandemic literature, Epidemics, Covid-19, Coronavirus Disease, Literature and CalamitiesINTRODUCTION:
The Coronavirus infection initially appeared in Wuhan, China, at the end of 2020. Because of its fast worldwide spread, the World Health Organization (WHO) declared it as a "pandemic"1 on March 11, 2020. In India, "the first COVID-19 positive case was disclosed in Kerala"2 on 30th January 2020, with a student who travelled from Wuhan University in China to Kerala. The number of COVID-19 cases in India is currently skyrocketing. According to World Corona Meter numbers as on 10th Nov. 2021, India had documented 34,386,786 COVID-19 infections across the country, resulting in 461,827 fatalities, compared to 251,560,303 confirmed cases and 5,079,851 deaths globally.3 Almost all governments throughout the world have set asingle objective to cope up with the spread of this exceedingly infectious disease by lockdown, social/physical distancing, the use of face masks, ‘Work from Home’, the avoidance of face-to-face interactions, vaccination and so on.
The COVID-19 outbreak triggered a global health crisis that endangers our financial stability, economy, employment, security and social well-being. The shutdown has put people in a deplorable, unsettling situation. Social distance and physical isolation cause acute stress disorders, irritability, anxiety, depression, psychological distress and other mental health effects. Citizens from almost every part of the world are forced to go home confined.
LITERATURE AND HUMAN RESILIENCE IN THE TIME OF CRISES:
Is this the first pandemic that the world is facing? Obviously, the answer is no. Since its beginning, the earth has undergone through several epidemics, pandemics and time of crises like Black Death (also called as the Plague), the deadliest pandemic of influenza ever seen in 1918 (also known as Spanish flu), the Smallpox outbreak, Swine flu, AIDS, Ebola or Zika virus, disasters like the two World Wars or some other social/global crisis and so on.
Crises like this are not new to human nature, there is also possibility to confront with anything like this again in our future too. So, what's going to help us get through this? And the answer is simple- resilience. Resilience is the capacity to recover quickly from adversities, worries and hard time. It is an ability to adjust easily to misfortunes and to recover readily from illness, depression, calamities and crises. It is an aptitude to cope or adapt when confronted with adverse life events. One can build resilience by cultivating character, coping with stress, treating problems as challenges; learning to accept things that you can't change and we can attain all these things only by reading literature.
Let's see how the literature has responded, how the literature can play a role in times of such calamities. How literature is helpful to mankind in such emergencies?
DISCUSSION
Whether it was epidemics, pandemics or other sorts of crises, the literature never took the back seat. Instead, literature raises the spirit and provides artistic relief and comfort in such lock-down or house arrest and quarantine agonies. In addition, it makes us aware of the universality of death and the necessary precautions for our recovery and survival. As stated by Avijit Ghosh, “Literature provides us deepest and insightful record of events during pandemics and tries to provide consolation in times of need”.4 Catharsis has always been one of the functions of literature, whether Indian or Western—a way of coping with deep emotions, a manner of purgation, a way of healing. In such times, literature has a vital role in moulding our emotions, bringing solace and consolation.
Literature gives us an opportunity to study texts written on pandemics and how such events have historically been projected by authors and how they have served as guiding force and can now be accepted to face pandemic like COVID-19. Some of such prominent literary texts like Homer's ‘Iliad’, Giovanni Boccaccio’s ‘Decameron’, Albert Camus’ ‘The Plague’, Stephen King's ‘The Stand’, Ling Ma's ‘Severance’; Randy Shilts' ‘And the Band Played on: Politics, People, and the AIDS Epidemic’; Steven John's ‘The Ghost Map’; Gina Kolata's ‘Flu: The Story of the Great Influenza Pandemic of 1918 and the Search for the Virus That Caused It’; Sonia Shah's ‘The Fever: How Malaria Has Ruled Humankind for 500,000 Years’, Richard Preston's ‘The Hot Zone: The Terrifying True Story of the Origins of the Ebola Virus and so on are worth to mention here which provide hopes and ways to deal with such disasters.
‘The Decameron’ is a collection of 100 allegorical tales written by Giovanni Boccaccio around the year 1353. It accounts the stories of ten young Florentines who have fled from the Black Plague to reside in Naples villa. It prominently narrates the struggle between life and death in the context of the Black Plague that fell upon Florence in 1348.
Edgar Allan Poe’s short story “The Masque of the Red Death” (1842) relates a horrifying tale of a fictional plague- a disease known as the Red Death sweeping through the land which causes its victims to die quickly within 30 minutes after getting infected where even the prince, Prospero brings together his 1000 special guests and seals the gates of his palace in order to make himself and his 1000 friends home quarantined and get protected from the plague. But at last, the plague reaches in the castle and Prince Prospero and all of his 1000 guests die of the Red Death. Poe describes it as: “And now was acknowledged the presence of the Red Death. He had come like a thief in the night. And one by one dropped the revelers in the blood-bedewed halls of their revel and died each in the despairing posture of his fall. And the life of the ebony clock went out with that of the last of the gay. And the flames of the tripods expired. And Darkness and Decay and the Red Death held illimitable dominion over all”.5Prince Prospero and his guests thought they had found a way to escape from the plague, but they too were infected and found dead.
The current situation in COVID-19 is similar to the scenario written by Nobel laureate Albert Camus in his short novel ‘The Plague’ (1947) in which he describes the 19th century Plague outburst, which led to the alienation and isolation in the human beings succeeding their panic condition. Camus describes: "How should they have given a thought to anything like the plague, which rules out any future, cancel journeys and silences the exchange of views. They fancied themselves free, and no one will ever be free so long as there are pestilences.6Similar sort of terror and fearful characteristics can be traced in COVID-19. Camus’ exile and isolation in his novel ‘The Plague’ is close to the COVID-19 emergency quarantine system. For today’s COVID-19 affected humanity, this novel is like a mental and psychological antidote. It has a new meaning, urgency and lessons to learn. According to the World Economic Forum COVID Action Platform, Albert Camus’ novel ‘The Plague’ is one of “5 books to read for context on the coronavirus outbreak”. The World Economic Forum further states: “It was written more than 70 years ago, but Albert Camus’ celebrated classic La Peste (The Plague) is speaking to us as loudly as ever. The book, which tells of the spread of a plague in a North African town and the human response to death, has seen a major uptick in sales since the outbreak of the coronavirus”.7
‘The Great Influenza: The Story of the Deadliest Plague in History’ (2004) by John M. Barry is also a worth book to mention here. When American President George Bush read this book, he acknowledged that it helped him to assess the federal government's future policy on pandemics and said, “If we wait for a pandemic to appear, it will be too late to prepare”.8Even Bill Gates agreed that “This book taught me a lot about the Spanish Flu”.9
Such literary texts look compassionately at every person and go deeper than statistics or historical records. It does not counter modern science but serves as a source of comfort and means of expressing our common humanistic concerns.
Is it a reality or assumptions is the matter of investigation and debate but according to the Greek myths and literature, such epidemics are caused as the punishment by the Almighty God for some sins committed by the people on the Earth. For example, In Sophocles’ ‘Oedipus, the King’, the king unknowingly kills his father and marries with his own mother. In this context, it is believed that the dreadful pestilence which was appeared in the form of the plague was due to the anger of God over the misdeed of man, Oedipus the king. Even today, it is often believed that men's misdeeds lead to this kind of epidemics. Isn't COVID-19 a global tragedy of human misdeeds? Was it not the outcome of the misdeed of men in the Wuhan Wet market in China, where many wild animals were killed, including dogs, snakes, rats and bats? Is this, not the result of our unfaithfulness to God, animals, and the environment? Literature often predicts such abuses and their consequences. Everyone recognizes the importance of literature which gives lessons in restoring shattered trust and losing the core values of life in a disaster.
Literature is, therefore, a universal tool for building life during such a pandemic crisis. It helps people by inspiring them to act fairly in their lives.
‘A Journal of the Plague Year’ (1722) by Daniel Defoe serves as a practical handbook of ‘things to be done’ before and during the deadly outbreak, thereby acting as an alarm. Mary Shelley’s pandemic novel, ‘The Last Man’ (1826) elucidates the narratives of life-saving message. Jack London's post-apocalyptic book, Scarlet Plague (1912) is a robust study of today like pandemic eruptions. Max Brook’s ‘World War Z’ (2006) teaches how to resist the plague and how to uphold the spirit of the age as well as the spirit of body and mind. Colin Diyen Ayeah in ‘The Earth in Peril’ (2010) aptly narrates pandemic culture for healing and transformation of humanity. Such narratives have the power to preserve and rebuild the universe as it falls apart due to the deadly diseases.
Not only pandemic literature but other pieces of literature, too, offer a worth reading to console our hearts in such pandemic crises.
‘The Second Coming’, a well-known poem by W.B. Yeats is worth to be remembered in such time of chaos and uncertainty. He wrote the poem in the year 1919, after witnessing the Irish Civil War of 1916 and the end of the First World War, giving voice to the hopelessness for the future of humankind.
“Turning and turning in the widening gyre
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;
Mere anarchy is loosed upon the world”.10
The metaphor of falcon and falconer stands for nature and humanity therein where Nature found no longer remain connected to the human world.
"Ode to the West Wind" by P. B. Shelly which talks about power, human limitations and the natural world is famous for its prophetic message of hope.
“The trumpet of a prophecy! O Wind,
If Winter comes, can Spring be far behind?”11
The optimistic message in last line ‘If Winter comes, can Spring be far behind?’ is inspiring in such pandemonium situation.
Reading the 'Daffodils' by William Wordsworth, the 'Ode to Autumn' by John Keats, or the sonnets by William Shakespeare on Fair Youth and Dark Lady or the sonnets by Philip Sidney on Astrophel and Stella, bring pure pleasure, something healing that any lover of poetry would agree with. The beauty of such works promotes peace of mind and the spirit delights with its artistic creativity. While one is in home quarantine due to the Covid-19 pandemic, one can escape to strange and unknown realms through the descriptions of writers- from the Moors of Charlotte Bronte to Coleridge’s Xanadu, from Thomas Hardy’s Wessex novels toR. K. Narayan’s Malgudi world, we can meet people, interact with them and go through situations which would provide relief to us! ‘The Alchemist’ by Paulo Coelho, ‘The Old Man and the Sea’ by Earnest Hemingway and so many are too good to read and get inspired to face the crises.
Especially at the present time of crises, reading literature is even more imperative, considering our mental well-being. Some of the key roles of literature are to provide readers with a variety of opportunities to explore ease, motivation, humour, intelligence, inspiration, and imagination. In addition, literature sends us messages, whether in prose or poetry, to help make our lives happy and hopeful.
For example, Antony Chekov, in his short story 'The Bet' (1889) depicts two men, a banker and a lawyer who make a bet on the idea of the death penalty and life imprisonment. The banker is promising $2 million for a 15-year prison term for the defendant. It's also interesting to hear how the prosecutor spends his time in lockup. The lawyer started reading books, after doing other things of interest for many years. These books are of different types. At the end of the story, through these books, the lawyer discovers that he has met plants, creatures, places and people. He has experienced all feelings, emotions, comfort through these stories and has gained knowledge of many things including the purpose of life. He realized that it is his achievement and he no more needs money for which he spent 15 years in solitary confinement. He breaks the bet a few hours before the last day by leaving a note of what he has gained. This teaches us how the reading of books is important in life.
O Henry's short story ‘The Last Leaf’ depicts Johnsy, a delicate, serious young woman affected with pneumonia. She is worried about her condition and has lost all hopes of recovery. She starts watching the ivy plant on the wall outside her door. She compares her illness with the falling leaves of the plant. She thinks she is going to die when this ivy plant would lose its last leaf. Her friend who was much concerned of her situation gets the same leaf painted on the wall with the help of an artist. Johnsy recovers as that last leaf remain for a long time. Her positive energy helps her to cure.
Robert Frost's poem ‘Stopping the Woods on a Snowy Evening’ (1923) portrays a traveler who pauses to watch the snowfall all around him and got attracted to the deep, dark silence of his surrounding, but he realizes that it's not his destination, because he needs to go miles and miles before sleep. With this confidence, we can fight with this pandemic and post-pandemic life.
Literature plays instructive roles too. It often shows us what to do and sometimes shows what not to do. This helps to reinforce our ability to think objectively. It shows the true picture in front of us and leaves it to us to make a decision. It helps man most when he is in oppress, pessimistic mood when he is not able to face the world around him. Even the religious texts, such as the ‘Ramayana’, ‘Mahabharata’, ‘Bhagwat Geeta’, ‘Dnyaneshwari’, tells us the meaning of life when we suffer and try to find the purpose of life. Literature plays an important role in sensitizing and informing people with intent and truth about any kind of misfortune, making them prepared for facing any disaster with reason and reality without resorting to outburst and emotions.
CONCLUSION
Literature plays a key role in crisis management. Therefore, we should get inspired and motivated by revisiting and rethinking literary books to fight against the moments of crises like Coronavirus. Literature has had a major impact on the development of society. It has shaped civilizations and nations. It plays an important role in transforming society and contributing significantly to the growth of nations.
Literature also helps people consider certain aspects of life when society gets trapped in a natural disaster or crisis. In particular, it inspires compassion and gives people a new perspective on their lives and the lives of others. Literature offers tips on how to tap and build your inner resilience. A resilient person looks for a silver liner in a crisis and move forward with a sense of hope for a better future. In such crises, the important of individual and societal resilience is a must. And we need to do it all without falling apart and only literature can help you to achieve it. Literature has the power to uplift you, expose you to new ideas. That’s something you need in these tense times. Reading literature during the period of crises encourages you driving away isolation, retain sanity, fostering resilience, infusing empathy, and above all, instill the courage to face and hope. Sometimes a single line you read can stay with you for a long time to build resilience and inspire you during the tough time of life.
Acknowledgement:
I whole-heartedly acknowledge all the sources and thankful to my friends, students and the teachers and students, who took the time to suggest me literary texts related to this paper and thanks are also due to authors / editors / publishers of all those sources.
Source of Funding:
None
Conflict of Interest: The author declares no conflict of interest.
Englishhttp://ijcrr.com/abstract.php?article_id=4373http://ijcrr.com/article_html.php?did=4373
WHO Director-General’s opening remarks at the media briefing on COVID-19 - 11 March 2020. [Internet]. www.who.int. 2020. Available from: https://www.who.int/director-general/speeches/detail
Responding to COVID-19 - Learnings from Kerala [Internet]. www.who.int. 2020. Available from: https://www.who.int/india/news/feature-stories/detail/responding-to-covid-19---learnings-from-kerala
Worldometer. Coronavirus toll update: Cases & deaths by country [Internet]. Worldometers. 2021. Available from: https://www.worldometers.info/coronavirus/
Ghosh A. How literature has helped us make sense of pandemics - Times of India [Internet]. The Times of India. 2020 [cited 2021 Dec 3]. Available from: https://timesofindia.indiatimes.com/india/how-literature-has-helped-us-make-sense-of-pandemics/articleshow/74841225.cms
Poe E. The Masque of the Red Death. [Internet]. The Public’s Library and Digital Archive. 1942 [cited 2021 Dec 3]. Available from: http://www.ibiblio.org/.
Camus A. Albert Camus THE PLAGUE TRANSLATED FROM THE FRENCH BY Stuart Gilbert [Internet]. 1948. Available from: https://www.24grammata.com/wp-content/uploads/2013/06/The_Plague__Albert_Camus-24grammata.com_.pdf
Edmond C. 5 books to read for context on the Coronavirus outbreak [Internet]. World Economic Forum. 2020 [cited 2021 Dec 3]. Available from: https://www.weforum.org/agenda/2020/03/coronavirus-books-pandemic-reading-covid19
News ABC. George W. Bush in 2005: “If we wait for a pandemic to appear, it will be too late to prepare” [Internet]. ABC News. [cited 2020 Mar 5]. Available from: https://abcnews.go.com/Politics/george-bush-2005-wait-pandemic-late-prepare/story?id=69979013
Gates B. This Book Taught Me a Lot about the Spanish Flu [Internet]. gatesnotes.com. 2020. Available from: https://www.gatesnotes.com/Books/The-Great-Influenza
Poetry Foundation. Poetry Foundation [Internet]. Poetry Foundation. 2015. Available from: https://www.poetryfoundation.org/poems/43290/the-second-coming
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15HealthcareA Novel Liquid Chromatography-Electrospray Ionization-Mass Spectrometry (LC/ESI/MS/ MS) Method Development and Validation for the Quantification of Erdafitinib in Human Plasma
English5055Yarra RavitejaEnglish G. SureshEnglishIntroduction: A new specific, accurate and selective liquid chromatography/tandem mass spectrometry (LC-MS/MS) technique was desirable for the assessment of erdafitinib in human plasma. Aim: To develop an LC–ESI-MS/MS method for the quantification of anticancer agent erdafitinib in human plasma and its validation as per the USFDA guidelines. Methodology: Propranolol (internal standard) reference drug utilized for the quantification of erdafitinib. Extraction of 250μL plasma with liquid extraction technique, analyte components were eluted on symmetry (50 × 4.6mm; 5μm) C18 analytical column. Mass detection system was executed by utilizing MRM (multiple reaction monitoring) with +ve ionization mode and electrospray ionization. Developed procedure was subjected for validation according to FDA guidelines in concentration levels between 69.95–2798.00ng/mL for erdafitinib with r2 value of 0.9992. Results: The intraday and interday precision were within 4.11% and the assay accuracy was 97.95–104.91 % of the nominal values. Matrix factor ranges from 95.61– 103.84 % with a %CV of 3.63 for analyte at HQC and MQC levels, matrix factor range was 94.32–104.01% with a %CV of 3.89. Conclusion: The developed process can be successfully applied for routine analysis in quality control, pharmacokinetic and forensic studies of biological samples.
English FGFR tyrosine kinase inhibitor, Erdafitinib, FDA, Accuracy, Linearity, Nominal valuesINTRODUCTION
Erdafitinib is an inhibitor of FGFR (pan-fibroblast growth factor receptor) tyrosine kinases that is directed to treat patients with metastatic urothelial or locally advanced cancer which has: i) vulnerable FGFR 3 or FGFR 2 genetic alterations and ii) progressed during or following at least one line of prior platinum having chemotherapy with twelve months of adjuvant or neoadjuvant platinum comprising chemical therapy. Erdafitinib designated as N′-(3,5-Dimethoxy phenyl) -N′- [3- (1-methyl pyrazol -4-yl) quinoxalin -6-yl] -N-propan -2- ylethane-1,2- diamine with molecular formula and weight of C25H30N6O2 and 446.555 g·mol−1 respectively.1-5
FGFR is a transmembrane protein which express universally in normal tissue and also involved in numerous endogenous bio physiological procedures containing homeostasis of phosphate and cell proliferation, cell migration, vitamin D and cell anti-apoptotic signaling in different type of cells. Genetic changes or mutations like FGFR abnormalities like point mutations, gene amplification, and deregulation and chromosomal translocations of FGFR paths have been associated in pathogenesis of urothelial cancer, containing possibilities of such variations to all 4 FGFR-genes (FGFR-1, FGFR-2, FGFR-3, and FGFR-4).3,6,7 Deviations to the FGFRgenes are subsequently thought to stimulate cell propagation, relocation, anti-apoptosis and angiogenesis in many malignances comprising urothelial cancer. Drug is an oral specific pan-FGFR kinase inhibitor that bound and obstructs enzymatic action of expressed FGFR-1, FGFR-2, FGFR-3, and FGFR-4 based on in vitro data. In particular, erdafitinib demonstrates inhibition of FGFR phosphorylation and signaling as well as decreased cell viability in cell lines expressing FGFR genetic alterations, including point mutations, amplifications, and fusions.2,4,7
Literature on erdafitinib revealed that few analytical methods were reported on liquid chromatography8 and LC-MS/MS.9 The development of specific method alike LC-MS/MS is very vital for the quantification of erdafitinib in biological matrix.
MATERIALS AND METHODS
Chemicals and reagents
Erdafitinib (98.9 % purity) and propranolol (98.8 % purity) were acquired from Alembic Pharmaceuticals, Hyderabad, India. HPLC grade acetonitrile and methanol, ammonium acetate, ethyl acetate and HCOOH of the high grade quality were procured locally. Purified milli-Q water (Milford, MA) was utilized for entire research work.
Standards preparation
Processing of individual analyte stock solution(1000μg/ml) was done in methyl alcohol. The resulting solution was subjected for serial dilutions to get concentration range of 69.95–2798.00ng/mL with methanol.
Calibration standard solutions
For the processing of calibration standards, 20μl of erdafitinib diluted sample was mixed with 960μl of K2EDTA pooled plasma. To the resultant solution, 20μl of IS dilution was transferred to get final solution. The concentration range, 69.95–2798.00 ng/ml solutions were prepared and stored below −20 °C in a freezer.
Preparation of quality control samples
Quality control standard were processed at 3 dissimilar concentrations of high quality control(HQC) standards, median quality control(MQC) standards and low quality control(LQC) standards. These QC (quality control) solutions were processed as per the calibration standard solutions to get 2098.5, 1399.00 and 195.86, ng/mL for HQC, MQC and LQC correspondingly.
Preparation of solution of internal standards
Propranolol was used as internal standard and 1mg/mL stock concentrations in methyl alcohol were processed in a separate conical flask. Resulting stock was made dilution with methyl alcohol to get 1µg/mL solution.
Sample preparation
Drug solution was executed by relocating 250µl of plasma and 50µL of propranolol (1µg/mL) in to a pre-labeled tube and sonicated for 2.0 min. Erdafitinib and propranolol were isolated with 5.0mL of ethyl acetate solvent system and the solution was subjected for centrifugation at 5000rpm/min for 25min. Organic layer was isolated and dried with lyophiliser. Residue after the drying was made solubilize in 250µl of movable solvent and then translocated to LC-vials. These vials were placed and injected into LC-MS/MS instrument.
Chromatography
10µL of sample was injected on reversed phase symmetry (50 × 4.6mm) 5 μm C18 analytical column with an isocratic movable phase comprising of methyl alcohol and 5mM ammonium acetate in 0.1% HCOOH in Proportion of 80:20, (%v/v) was utilized at a flow rate of 0.80ml/min. Analytical column was retained at 45°C and total chromatographic time was 3.5min. Chromatographic system was equipped with HPLC-Shimadzu combined with API-5000 Mass instrument of Applied Bio systems, America.
Mass instrument
Electro spray ionization technique was utilized and functioned in +ve ionization method for MRM. By injecting dilute stock solution of drug, the operating parameters were improvised as mentioned in Table 1. Auxiliary gas (GS2) and nebulizer gas (GS1) flows were 40 and 45 psi, respectively. Source temperature was set at 250 °C. Q3 and Q1 were monitored under unit resolution. Upon addition of HCOOH to the mobile phase, protonation of analytes were improvised and excellent peak intensities were obtained. MRM mode monitored at: m/z 447.25 → 388.17 for erdafitinib and m/z 260.16 → 72.08 for propranolol. Concentrations of samples were estimated by regression line with the help of analyst software1.5.1. In this peak response ratio method was utilized.
Validation of analytical method
Developed LC–MS/MS work was subjected for validation according to USFDA-guidelines for sensitivity, inter and intraday precision, specificity, linearity, stability and accuracy.10,11
RESULTS AND DISCUSSION
Method validation
Selectivity
Method selectivity was executed with 8 distinct human K2 EDTA human plasma samples including 1-hemolytic and 1-lipemic lot. Interferences observed were negligible during the analysis of analytes at respective retention times over the spiked response of LLOQ with IS (Fig.2).12-14
Recovery
Analyte recovery from extraction sample was evaluated by equating peak responses from six plasma sample solutions spiked prior to extraction against aqueous sample solutions.15, 16 Overall average recoveries of all three quality control standards was 93.15%. The recovery of IS was found to be 96.56 % and the findings were shown in Table 2 (Fig. 3 to 5).
Sensitivity and linearity
Eight points calibration curve was processed with analyte samples from 69.95 ng/ml to 2798.00 ng/ml. Peak response ratio(y) of analyte to IS was taken against nominal concentration(x) of analyte to evaluate linearity. Regression line has r2 value of 0.9992 with equation y= 0.005412 x+ 0.00128.16,17 Erdafitinib LLOQ was 69.95 ng/ml, which indicates the developed method sensitivity.
Accuracy and precision
Inter and intraday accuracy and precision was evaluated by considering 6 replicates for LLOQ, LQC, MQC and HQC standard solutions18, 19. The corresponding erdafitinib concentrations were 69.95, 195.86, 1399.00 and 2098.50 ng/ml. Accuracy and precision findings were represented in Table 3. Inter and intraday precision findings were ≤4.11% and the assay accuracy was 97.95–104.91 %.
Matrix effect
This parameter was evaluated by extracting 8 variable blank plasma samples including 1-lepemic and 1-hemolytic lot. From each blank plasma lot 100 microliters of sample was subjected for processing as per the sample preparation. Individual aqueous sample at HQC or LQC level was mixed to final solution(post-extraction matrix samples).16, 20 In a similar way individual aqueous sample solution at HQC or LQC level was executed with moveable solvent(aqueous sample without matrix).
Above processed solutions were injected six times at HQC and LQC levels and analyte and IS peak responses were compared. This parameter was evaluated by: Matrix effect (%) = A2/A1 × 100(%), where A1 = response of aqueous concentrations and A2 is the response of post-extracted concentrations. Average (n = 6) matrix factor ranges from 95.61– 103.84 % with a %CV of 3.63 for analyte at low and at high QC levels, the matrix factor range was 94.32–104.01% with a %CV of 3.89 (Table 4).
Carryover effect
In this cleaning capability of washing solution utilized for infusion port and needle was evaluated.21 It was evaluated by injecting the samples in order of: LLOQQC, blank and ULOQQC and again blank solution. There was no effect of carryover observed throughout the study.
Dilution integrity
Developed process was subjected for dilution integrity at fourfold and twofold dilution. Six duplicate sample solutions were executed and subjected for evaluation over the fresh spiked standards. Upper limit was expandable upto 2798.00.ng/mL. Average back-calculation concentration values were present in between 94.46–104.52 % with a % CV of ≤2.83 for the analyte.15
Stability
Bench-top, freeze-thaw, in-injector and wet extract stability studies were executed for the evaluation human plasma sample stability. All these studies were evaluated at HQC and LQC levels. To process benchtop stability, standard QC samples were collected from freezer(−20°C) and thawed(25°C) upto 6 hours. The percentage of stabilities were evaluated against the fresh sample solutions and found in between 95.97–98.11 %. To process the freeze-thaw stability, standard QC samples were subjected for freeze and thaw rotations for four times. The percentage of stabilities were evaluated against the fresh sample solutions and found in between 93.85 to 102.06 % .
To process the in-injector stability, standard QC samples were kept in an autosampler at 10°C for 24 hours. The percentage of stabilities were evaluated against the fresh sample solutions and found in between 98.35–103.61 %. Wet extract stability was processed at 8 hours at 25°C and The percentage of stabilities were evaluated against the fresh sample solutions and found in between 99.49–102.71 % (Table 5).
Extended accuracy and precision
To process the extended accuracy and precision, 1-set of calibration standards and forty sets of HQC and LQC standards, total ninety samples, were injected and subjected for the evaluation. The resultant findings were shown in Table 6. The precision for erdafitinib was Englishhttp://ijcrr.com/abstract.php?article_id=4374http://ijcrr.com/article_html.php?did=4374
Nishina T, Takahashi S, Iwasawa R, Noguchi H, Aoki M, Doi T. Safety, pharmacokinetic, and pharmacodynamics of erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in patients with advanced or refractory solid tumors. Invest New Drugs. 2018;36(3):424-434.
Perera TPS, Jovcheva E, Mevellec L, Vialard J, De Lange D, Verhulst T, Paulussen C, Van De Ven K, King P, Freyne E, Rees DC, Squires M, Saxty G, Page M, Murray CW, Gilissen R, Ward G, Thompson NT, Newell DR, Cheng N, Xie L, Yang J, Platero SJ, Karkera JD, Moy C, Angibaud P, Laquerre S, Lorenzi MV: Discovery and Pharmacological Characterization of JNJ-42756493 (Erdafitinib), a Functionally Selective Small-Molecule FGFR Family Inhibitor. Mol Cancer Ther. 2017 Jun;16(6):1010-1020.
Tabernero J, Bahleda R, Dienstmann R, Infante JR, Mita A, Italiano A, Calvo E, Moreno V, Adamo B, Gazzah A, Zhong B, Platero SJ, Smit JW, Stuyckens K, Chatterjee-Kishore M, Rodon Peddareddigari JV, Luo FR, Soria JC. Phase I Dose-Escalation Study of JNJ-42756493, an Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients With Advanced Solid Tumors. J Clin Oncol. 2015;20;33(30):3401-8.
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
Development and Assessment of In-vitro Antioxidant Potential of Differently Flavoured Poly Herbal Green Tea Formulations
English5662Samidha M. PawaskarEnglish Ketan RanadeEnglishEnglishCamellia sinensis (L) Kuntz, Cymbopogon citratus (DC) Stapf., Rosemarinus officinalis (Linn.), Rosa Centifolia (Linn.), Hibiscus rosa-sinensis (Linn.), Ocimum tenuiflorum (Linn.), Zingiber officinale (Rosc.), Mentha piperita (Linn.), Total antioxidant capacity, Total phenolic content, Reducing power and scavenging activities
Introduction:
Antioxidants are compounds that protect cells against the damaging effects of free radicals and reactive oxygen species. Any imbalance between the antioxidants and reactive oxygen species results in oxidative stress. 1 In normal physiological conditions also free radicals and reactive oxygen species (ROS) are generated during metabolic processes leading to oxidative stress. However if they are not eliminated then the conditions could lead to complications.2 Oxidative stress can cause oxidative damage to large biomolecules such as proteins, DNA and lipids, resulting in an increased risk of cancer, cardiovascular disease, neural disease, Alzheimer’s disease, Parkinson’s disease, ulcerative disease, aging and atherosclerosis.2,3Antioxidant compounds such as carotenes, phenols, phytates, etc. present in food are important for neutralizing free radicals, thus preventing ageing process and also reducing the risk from various related diseases.4,5
Synthetic antioxidants could reduce oxidative damages but could lead to carcinogenic negative effects on liver and lungs. Thus, studies of antioxidants are focused on naturally occurring substances, especially on plant phytochemicals.
Thus the present study aimed to formulate a naturally flavoured poly herbal green tea, using leaves of Camellia sinensis (L) Kuntz(Tea), Cymbopogon citratus (DC) Stapf (Lemon grass), Rosemarinus officinalis (Linn.) (rosemary), and petals of Rosa Centifolia(Linn.) and Hibiscus rosa-sinensis (Linn.)and to assess the in-vitro antioxidant capacity for these formulations. Three variants of the above-mentioned base formulation were made by flavouring them with leaves of Ocimum tenuiflorum (Linn.) (Holy Basil or Tulsi), Mentha piperita (Linn.) (Peppermint) and roots of Zingiber officinale (Rosc.) (ginger).
Tea (Camellia sinensis (L) Kuntz) is the most widely consumed beverage in the world6 and green tea is known to have several groups of polyphenols.1,7 Thus combinations made of such natural drinks would be useful to deliver health benefits to the masses.
Materials and Methods:
Preparation of polyherbal flavoured green tea formulations:
Ingredients used in the preparation of base formulation of polyherbal green tea were Camellia sinensis (L) Kuntzleaves, Cymbopogon citratus (DC) Stapfleaves, Rosemarinus officinalis (Linn.) leaves, Rosa Centifolia (Linn.) petals and Hibiscus rosa-sinensis (Linn.) petals. Three variants of this base formulation was made by flavouring them with the leaves of Ocimum tenuiflorum (Linn.) and Mentha piperita (Linn.)and roots of Zingiber officinale (Rosc.). All the ingredients were procured from local market, washed thoroughly with water and were oven dried.
Extract Preparation:
All the samples were prepared by adding hot water to tea leaves (10 mg/ml), then the mixture was kept at room temperature for 10 minutes before starting the experiments.
The assays for total antioxidant capacity, total phenol content, total flavonoid Content (flavones and flavonols), reducing power, scavenging ability for hydroxyl radicals, nitric oxide radical scavenging, were performed using known and standardized methods.8 – 14
Statistical Analysis:
All data were expressed as the means ± SD of three independent experiments carried out in triplicate.
Results:
The results of the antioxidant potential of differently flavoured polyherbal tea formulations viz., total antioxidant capacity, total phenolic content and total flavonoid content has been represented in table 2, table 3 and table 4, respectively. Results of reducing power assay has been represented in table 5. NO scavenging assay and OH scavenging assay has been represented in table 6 and graph 1, graph 2, and graph 3 respectively.
Discussion:
Polyherbal flavoured green tea formulations:
Dried ingredients were ground and mixed in exact quantity to make the base formulations of polyherbal green tea. Three different flavours were created. The exact composition is as shown in (Table 1). Cymbopogon citratus (DC) Stapf.(Lemon grass)has various phytoconstituents such as flavonoids and phenolic compounds, which consist of luteolin, isoorientin 2'-O-rhamnoside, quercetin, kaempferol and apigenin reported to have antioxidant effects.15Rosemarinus officinalis (Linn.) has been known as a versatile, aromatic herb known for its powerful antioxidant activity, antibacterial and antimutagenic properties as it contains high concentration of phenolic substances obtained from the leaves of the plant. The antioxidant activity of rosemary was found mainly due to phenolic compounds responsible for rosemary antioxidant activity like phenolic di-terpenes such as carnosol, carnosic acid, rosmanol, epirosmanol and isorosmanol.16 The rose flowers and leaf extracts of Hibiscus rosa-sinensis (Linn.)were also found to have high antioxidant activities.17
In the present study, three variants of the above-mentioned base formulation were made by flavouring them with leaves of Ocimum tenuiflorum(Linn.) (Holy Basil or Tulsi), Mentha piperita (Linn.) (Peppermint) and roots of Zingiber officinale (Rosc.) (ginger).
Total antioxidant activity:
The total antioxidant activities of all three flavoured natural polyherbal green tea formulations were examined and expressed as gallic acid equivalents (Table 2)
The total antioxidant capacity of Ocimum tenuiflorum(Linn.), Zingiber officinale (Rosc.)and Mentha piperita (Linn.)flavoured poly herbal green tea in our study is reported in Table 2. We found that the total antioxidant capacity of Ocimum tenuiflorum(Linn.) flavoured poly herbal green tea was 30% more than Zingiber officinale (Rosc.)flavoured poly herbal green tea.(Table 2). Pandey et al, 2014 reported that Ocimum tenuiflorumof family Labiateae is a good source of linalool, eugenol, methyl charicol and cineole. Presence of eugenol contributes to its antioxidant property and is also thought to be responsible for inhibition of lipid peroxidation.6This could be the reason for very high antioxidant activity of Ocimum tenuiflorum(Linn.) found inthe present study.
Total Phenolic Content and Flavanoid content:
Total phenolic content of all three flavoured natural polyherbal green tea formulations was examined and expressed gallic acid equivalents. Standard graph of gallic acid for total phenolic content is represented in Table 3 and Total flavonoid content was examined and expressed as mg of Quercetin equivalents (QE)/g of the plant material. (standard graph of quercetin for total flavanoid content is represented in (Table 4)
The total phenolic content of Ocimum tenuiflorum (Linn.), Zingiber officinale( Rosc.) and Mentha piperita (Linn.)flavoured poly herbal green tea was found to be 482.4 + 22 , of 360.0 + 24 and 280.0 +18mgs of gallic acid equivalents (GAE)/g of the plant material respectively. It was found that phenolic content of Ocimum tenuiflorum(Linn.) flavoured tea was 34% higher than the Zingiber officinale (Rosc.) flavoured poly herbal green tea. Our results are nearly similar to the results of Somia Lessed et al who reported total phenolic content of 394.66+ 22.67 mgs of gallic acid equivalents (GAE)/g of the plant material.18 Kaurinovic B et al. also reported significant amount of total phenolic content in the water extracts of Ocimum basilicum.19
The total flavonoid content of Ocimum tenuiflorum(Linn.), Zingiber officinale (Rosc.)and Mentha piperita (Linn.) flavoured poly herbal green tea was found to be 32.60 + 1.60, 20.69 + 0.60 and 31.661 +0.98mgs of Quercetin equivalents (QE)/g of the plant material. One such study reported the total flavonoid content of 5.04 + 0.59 mgs of Quercetin equivalents (QE)/g of the plant material.18 However the medium used for the extraction by them was chloroform, whereas we had used plain water for the said extraction. Mckay et al. reported that the Mentha piperita (Linn.)leaves contain phenolic constituents including rosmarinic acid and several flavonoids, primarily eriocitrin, luteolin and hesperidin and show strong antioxidant potential.20
Reducing Power Assay:
The results in this study showed that the reducing power was observed to be increasing with the concentration of the extract (Figure1) (Table5). The reducing capacity was found to be increasing in the order Mentha piperita (Linn.) flavoured poly herbal green tea Zingiber officinale (Rosc.)flavoured poly herbal green tea >Mentha piperita (Linn.) flavoured poly herbal green tea. It increased as the concertation of standard and the extracts increased (Figure 3) (Table 6).
Conclusion:
Natural polyherbal green tea formulations in three flavours were developed. All three flavours were studied for their total antioxidant capacity, total phenolic content and scavenging activities. All three flavours of natural polyherbal green tea formulation developed were proved to have good antioxidant potential and can have potential application as therapeutics.
Acknowledgement: Authors acknowledge the immense help received from the scholars whose articles are cited and included in references of this manuscript. The authors are also grateful to authors / editors / publishers of all those articles, journals and books from where the literature for this article has been reviewed and discussed.
Source of funding: University of Mumbai
Conflicts of interest: The authors declare no competing interests.
Authors’ Contribution: All the authors of this paper equally contributed towards the experimental work as well as the writing of this paper.
Englishhttp://ijcrr.com/abstract.php?article_id=4375http://ijcrr.com/article_html.php?did=4375
Chacko SM, Thambi PT, Kuttan R, Nishigaki I. Beneficial effects of green tea: a literature review. Chinese Medicine.2010:5-13.
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Raghavendra M, Araveeti Madhusudhana R, Pulala Raghuveer Y, Sudharshan Raju A, Siva Kumar L.Comparative studies on the in vitro antioxidant properties of methanolic leafy extracts from six edible leafy vegetables of India. Asian J Pharm Clin Res. 2013;6(3):96-99.
Sanjeevkumar CB., Londonkar R, Umesh MK and Asha NK.Tukapp. Screening of In-vitro Antioxidant Activity of Chloroform Extracts of Bryonopsis laciniosa Fruits, Int.J.Curr.Microbiol.App.Sci.2016; 5(3): 590-597.
Abhay Kumar P, Pooja S, Nijendra Nath T. Chemistry and bioactivities of essential oils of some Ocimum species: an overview, Asian Pac J Trop Biomed.2014;4(9):682-694
Ahmad M, Baba WN, Shah U, Gani A, Gani A.Nutraceutical Properties of the Green Tea Polyphenols, J Food Process Technol.2014;5:390.
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
A Specific LC-ESI-MS/MS Method Development and Validation for the Quantification of Saquinavir in Biological Matrices
English6368Bandaru Anil KumarEnglish Bomma RameshEnglish
Introduction: Saquinavir is the first protease inhibitor. Proteases are enzymes that cleave protein molecules into smaller fragments. No analytical procedure was reported for the estimation of saquinavir by LC-MS/MS. Aims: The objective of the present research was to develop a specific liquid chromatography-electrospray ionization tandem mass spectrometric technique for the quantitation of saquinavir in biological matrices. Methodology: Chromatographic elution was attained thru a Thermo Hypersil ODS stationary column having the dimensions of 50 × 4.6 mm and particle size of 2.4 μm. Isocratic elution was processed with methanol and 0.1%V/V formic acid in the ratio of 90:10 V/V as mobile phase with flow rate of 0.50 ml/min. Liquid-liquid extraction was performed for drug and internal standard isolation with an ethyl acetate solvent. Parent and productions were monitored at m/z 671.3 → 654.3 for saquinavir and 614.3 → 596.3 for indinavir internal standardon multiple reaction monitoring. Result: Linearity graph of drug was rectilinear in concentration over 260.4. to 10416ng/ml having r2(correlation coefficient) value more than 0.999. Percentage of RSD findings were ≤5.3% for inter and intraday accuracy and precision. This procedure has good recoveries and %recovery findings of lower quality control (LQC), median quality control (MQC) and higher quality control (HQC) samples were 94.6%, 92.4 and 104.2% respectively. Conclusion: Saquinavir has more stability for longer time when subjected for different stability environments and the technique was effectively relevant to routine analysis of saquinavir in biological matrix.
EnglishProtease inhibitor, Saquinavir, LC-ESI-MS/MS, FDA guidelines, Specificity, Linearity
INTRODUCTION
Human immunodeficiency virus (HIV) infection and its clinical syndrome acquired immunodeficiency syndrome (AIDS) continue to be a major health problem worldwide. The development of highly effective antiretroviral chemotherapy for AIDS is found very useful in curbing the pandemic of this disease.1,2 The drug is sold as Fortovase and Invirase brand names and it acts as an antiretroviral agent utilized along with other medicines to prevent or treat HIV/AIDS. Normally it is combined with ritonavir/lopinavir or ritonavir to improve its outcome. Saquinavir is the first protease inhibitor. Proteases are enzymes that cleave protein molecules into smaller fragments.3
The bioavailability of saquinavir increases with ritonavir (PI) in dosage forms which was observed clinically. It will benefit to the patients for taking less dose of saquinavir and also for maintaining adequate plasma levels of saquinavir to produce effective against HIV. In this connection, it was observed that ritonavir prevents isozyme cytochromeP450 3A4, which metabolizes the saquinavir into its inactive metabolite.4
Drug bounds to the effective part of viral protease and inhibits the breakdown of viral polyprotein components, inhibiting the maturation of virus. Saquinavir inhibits both HIV-1 and HIV-2 proteases. It is a potent inhibitor of HIV replication in vitro and suppresses viral load and increases CD4+ cell counts in HIV patients in vivo. Chemically saquinavir designated as (2S)-N-[(2S,3R)-4- [(3S)-3- (tert-butylcarbamoyl)-decahydroisoquinoline -2-yl] -3-hydroxy -1-phenylbutan -2-yl] -2- (quinolin- 2- ylformamido) butanediamide with a molecular weight and formula of 670.841 and C38H50N6O5(Figure 1).5,6
Literature on saquinavirrevealed that no analytical procedure for the estimation of drug in bulk and formulations was reported on LC-MS/MS. Few methods were reported on spectroscopy,7 liquid chromatography 8-11 and ion pair chromatography.12 The development of specific method like LC-MS/MS is highly essential for the quantification of saquinavir in biological matrices.
MATERIALS AND METHODS
Chemicals and reagents
Saquinavir (99.91% purity) was acquired from Hetero drugs, Hyderabad, India. Methyl indinavir (Internal standard) of 99.89% was received from MSN Labs, Hyderabad, India. Acetonitrile and methanol of HPLC-grade and formic acid of analytical grade were procured from J.T.Baker, Hyderabad, India. The water of Milli-Q was utilized during the processing of the movable phase and washing solvents, acquired from the in-built Milli-Q®RO system.
Liquid chromatographic-MS/MS system
An LC-MS/MS SCIEX API4000 instrument furnished with a positive Electro-spray ionization (ESI) source and Shimadzu prominence HPLC comprising of SIL-HTC autosampler, binary pumps and column oven was utilized in the present work. Analyte quantitation, acquisition of data and it’s integration were processed by utilizing analyst software-1.6.3 version.
Liquid chromatography
Chromatographic elution was attained on a Thermo Hypersil ODS stationary column having the dimensions of 50 × 4.6 mm and a particle size of 2.4 μm. The column oven temperature was monitored at 30.0 °C and 0.5 mL/min flow rate. The injection volume was 5 μL. Isocratic elution was processed with methanol and 0.1%V/V formic acid in the ratio of 90:10 V/V as the mobile phase. Saquinavir and indinavir internal standard were separated in a total runtime of 6 minutes. The autosampler temperature and analytical Column temperatures were kept at 5.0 °C and 30.0 °C respectively.
Mass system conditions
The mass spectrometer was operated under multiple reactions monitoring (MRM) mode in positive ion mode for both saquinavir and internal standard (IS). The adjusted mass system parameters for saquinavir and IS were: both of drying gas and sheath gas temperatures were 350 °C. Nebulizer pressure was monitored at 25.0 psi. The sheath gas and drying gas flow rates were 10.0 L/min and 5.0 L/min, respectively. Capillary voltage was set at 3.0 kV. Collision energy and fragment or voltage were 15 eV and 120 V for saquinavir, 15 eV and 100 V for IS. The transitions (precursor to product) monitored were m/z 671.3 → 654.3 for saquinavir and 614.3 → 596.3 for IS. The dwell time was 200 ms for each transition.
Calibration standards
A stock solution of 1mg/mL solution of saquinavir was prepared freshly by dissolving 10mg of drug in 10mL of 70% methanol. Calibration standards of eight different concentration levels were processed by spiking blank plasma with saquinavir standard solution to get the concentrations of 260.4, 520.8, 1302, 3100, 5100, 6950, 8750 and 10416 ng/mL.
Quality Control Standards
These solutions were prepared at three different levels of lowest quality control(LQC), standards, median quality control(MQC) standards and highest quality control(HQC) standards. These quality control(QC) samples were prepared according to calibration standards to get the concentration of 729.1, 5208 and 7812 ng/mL for LQC, MQC and HQC respectively. Prepared solutions were store at -200c till the time of analysis.
Sample Preparation Method
Sample solution was prepared by transferring 300 µl of plasma and 50µl of indinavir (1µg/mL) into a polypropylene tube and vortexed for 2 min. Saquinavir and IS were extracted with 4mL of ethyl acetate as solvent followed by centrifugation of the solution at 4500 rpm/min for 20min. After centrifugation, organic phase was separated and it was dried using lyophiliser. The resulting product was made solubilize in 250µl of mobile phase and then it transferred into a pre-labeled vials. The vials were kept in an auto-sampler and infused into LC-MS/MS system.
Method validation
The developed method was validated for the parameters: specificity, selectivity, linearity, stability, matrix effect, recovery, precision and accuracy.13, 14
RESULTS
Mass system conditions
For the mass determination, we applied the MRM in positive mode with saquinavir to achieve higher sensitivity and better specificity. ESI was expected to be the best source of ions for LC–MS/MS and the precursor ions and product ions were ascertained by infusing the standard solutions into the mass instrument through a syringe pump. The product ions mass spectra of saquinavir and IS were obtained at m/z 654.3 an 596.3 which were selected as detection ions. Meanwhile, the parameters of mass spectrum environments (capillary voltage, ION-spray voltage and temperature, heater gas, nebulizer gas, collision gas and curtain gas and so on) were optimized to acquire higher mass response.
Internal standard selection
In the present study, indinavir was selected as the IS because it had similar chromatographic behaviors, ionization, extraction efficiency and retention action as the saquinavir and there was no obvious interferences found at the retention times of analytes and IS according to the method validation results.
Method validation
Specificity
Blank plasma samples obtained from six different batches of human plasma was spiked with the saquinavir at LLOQ and IS to assess the specificity. As Figure 2 showed, the retention times of saquinavir and IS were found to be 5.0 and 3.2 min, respectively. There was no noticeable intrusion of matrix substance and internal standard on saquinavir analytical data, and the response of all interfering peaks were less than 20% of LLOQ samples. 14, 15
Sensitivity and linearity
The method linearity was established for saquinavir and excellent linearity was exhibited in the concentration range of 260.4 to 10416 ng/ml (Table 1). The linearity graphs were produced by the peak area ratios (y) of the saquinavir to the IS versus the concentrations (x) with the 1/C2 weighting factor. The developed method linearity equation of the calibration graphs was y = 0.00843x + 0.00249 with a correlation coefficient (r2) value of 0.9991. The LLOQ of saquinavir was 260.4 ng/ml (signal-to-noise ratio > 5.0) assessed by 5 replicate sample solutions which were adequate for reliable quantitation of saquinavir in the plasma samples study.16
Accuracy and precision
The intra-batch and inter-batch precision and accuracy were evaluated by six spiked samples of plasma with saquinavir at LLOQ, LQC, MQC and HQC levels in a batch and in 3 succeeding batches, respectively. The results of precision and accuracy for the quantitation of saquinavir were represented in the Table 2. The percentage relative standard deviation values of inter and intra-batch precision were present in the range of 2.8 to 5.3. The deviation of relative error in the accuracy of inter and intra-batch values were present in between -4.52 to 5.88. 16, 17-21
Extraction recovery
The biological samples were effectively pretreated before the analysis. The extraction recovery was evaluated by calculating the peak area ratio of LQC, MQC and HQC level solutions (n=6) of saquinavir to the extracted spiked samples at respective concentration levels. In same manner, extraction recovery of indinavir was assessed by calculating the peak area ratio of quality control plasma sample solutions (n=6) to spiked human plasma samples at respective concentration levels. The mean extraction recovery of saquinavir was 94.6%, 92.4 and 104.2% at low, medium and high QC levels respectively. The mean extraction recovery of indinavir was 94.8% at a concentration of 100 ng/L. The results were represented in Table 3 and Figures 3 to 5.15, 18-21
Matrix effect
Co-eluting matrix constituents can reduce or increase ionization process in mass system, which may not produce a detectable response in blank matrix due to accuracy of the method. Hence, the different matrix-related component ions dominance was assessed by estimating the IS normalized matrix factor in eight individual sources (consisting of 2-hemolytic and 2-lipemic batches) of human plasma. The average IS normalized matrix factor for all the analytes were present in between 0.95 and 1.06 with a %RSD of ≤4.99 and the results were shown in Table 4. 16
Dilution integrity
The dilution integrity was processed at twice the concentration ULOQ (upper limit of quantification) for saquinavir. After the 1:4 dilution the average back-calculated drug content for dilution quality control samples were within 85–115% of the nominal value with a %RSD of ≤4.5.
Stability
Stability of saquinavir was evaluated in both matrix and aqueous-based samples. Saquinavir and indinavir in-stock solutions were not affected at 1–10°C for 70 days and stock solutions in diluent were not affected at 1–10°C for 48 h. Matrix stability was assessed at −70 and −20°C for 60 days. Matrix stability was analyzed against freshly prepared spiked linearity standards. The findings of stability data were represented in Table 5. Drug was not degraded upto 20 h at the bench-top at a temperature of below 10°C and after six freeze-thaw cycles. The prepared sample solutions were stable at 10°C for 72 h in the auto-sampler. 17
DISCUSSION
Method development was processed with different mobile phases and finally optimized with methanol and 0.1%V/V formic acid in the ratio of 90:10 V/V thru Thermo Hypersil ODS (50 × 4.6 mm, 2.4 μm) column. The optimized method was validated as per the FDA and EMA guidelines for the specificity, selectivity, linearity, stability, matrix effect, recovery, precision and accuracy parameters. The LLOQQC was analyzed with satisfactory accuracy, < 20% of precision and > 5 of signal-to-noise (S/N) ratio. To evaluate the carry-over effect, the blank plasma solution was infused into the chromatographic system after analyzing the highest concentration level of calibration standard in an analytical run and there was no visible carry-over effect was found. The method has linearity in the concentration range of 260.4 to 10416 ng/ml. These findings of precision and accuracy proved that they were reliable for the estimation of saquinavir in human plasma. Method has good extraction recovery with mean recovery of 97.07%. Method was subjected for freeze-thaw, refrigerator, bench-top, long term and in-injector stability and has high degree of stability.
CONCLUSION
In the present research work, a sensitive and accurate LC-MS/MS technique was developed and validated for the successful determination of saquinavir in human plasma. This method exhibited excellent specificity, linearity, accuracy, precision and stability. The linearity equation and correlation coefficient (r2) findings were y = 0.00843x + 0.00249 and 0.9991 respectively. The %RSD of intra and inter-day precision of the developed technique was found between 2.8 to 5.3% for the QC samples (260.4, 729.1, 5208 and 7812 ng/ml). Hence, the validated method can be applied for the pharmacokinetic and toxicokinetic studies in the clinical and forensic analysis of saquinavir in different kinds of biological matrices successfully.
ACKNOWLEDGEMENT
Authors acknowledge immense help received from the scholars whose articles are cited and included in reference to the manuscript. The authors are grateful to all the authors/ editors/publisher of those articles, journals, and books from where the literature of this article has been reviewed and discussed. There is no source of funding for this study. There is no conflict of interest in this study.
Source(s) of funding: No funding is involved.
Conflicts of interest: The authors declare no conflicting interest.
Author’s contribution: All the authors contributed equally.
Englishhttp://ijcrr.com/abstract.php?article_id=4376http://ijcrr.com/article_html.php?did=4376
Invirase (saquinavir mesylate) Capsules and Tablets, for Oral Use. Full Prescribing Information (PDF). Genentech, Inc. Archived (PDF) from the original on 24 November 2015. Retrieved 23 November 2015.
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
In-vitro Antimicrobial Analysis of the Leaf Extracts of Annonasquamosa Linn.
English6973Samidha M. PawaskarEnglish K.C. SasanganEnglish
Introduction: The plant kingdom offers an infinite and therapeutic unexploited source of medicines. Various parts of some plants viz. fruits, flowers, bark, stem and roots, are seen to possess enormous bactericidal and fungicidal potential. Aim/objective: The aim of the study was to evaluate the in vitro-antimicrobial activity of Annona squamosa Linn. leaf extract. Methods: In-vitro antimicrobial activity of the sequential leaf extracts of Annona squamosa Linn. in different solvents like petroleum ether, chloroform, ethyl acetate, acetone, ethyl alcohol, methyl alcohol, and water, was studied against various gram-positive & gram-negative bacterial strains using zone of inhibition. Agar well diffusion method & Agar disc diffusion methods were selected to evaluate the antibacterial efficacy and the minimum inhibitory concentration (MIC) of all the extracts was done using Agar well diffusion method. The reference Antibacterial antibiotics viz., Chloramphenicol & Ampicillin; and Antifungal antibiotics viz., Nystatin & Clotrimazole were also tested against these standard microorganisms used in the assay and the results were compared with that of the plant extracts. Results: The study results revealed that all the seven sequential Annona squamosa Linn. leaf extracts showed significant bactericidal and fungicidal potential against the microorganisms under study. Highly polar solvents i.e. ethyl alcohol, methyl alcohol, and water showed the most significant antibacterial and antifungal activity against all tested organisms. Conclusion: It can thereby be concluded that the plant material under study can be considered as a possible source of various phytochemical constituents having an in vitro antimicrobial potential.
EnglishAnnonasquamosa Linn., In-vitro antimicrobial activity, Agar well diffusion, Agar disc diffusion, Minimum inhibitory concentration (MIC), Antibacterial antibiotics, Antifungal antibiotics
Introduction: Medicinal plants have always played a governing role in the upkeeping of human health since primordial time.1Medicinal plants are rendered to be the best sources offering an array of novel herbal medications. 2 Use of crude plant extracts as medicines although currently becoming popular all over the world, in India it was a common practice since Vedic times. Use of plant-based traditional folk medicine is still a major practice in most of developing countries including India.3,4
The matchless availability of the chemical diversity offered by these herbal remedies provides limitless opportunities for new drug formulations. Infectious diseases being amongst the prominent causes of death in the world and owing to the advent of multiple drug-resistant pathogens, researchers are now focusing their search for new, better antimicrobial compounds from plant sources.5,6,7
Annona squamosa (Annonacea) is a medium-height, well-branched, flower-bearing shrub with sweet edible fruits. It is believed to be native of West-indies and USA. Every part of A. squamosa Linn. is claimed to possess medicinal properties viz. roots, leaves, fruits, seeds and bark.
A. squamosa leaves due to their high fiber and antioxidant content are believed to help in the regulation of blood sugar and quenching of free radicals, preventing cell damage. Thereby possessing anti-aging properties. It is also believed to have anti-inflammatory properties which aids in faster healing of wounds.
Considering the aforesaid, it is believed that the need of the hour is to search for new antimicrobials. With this in mind, in the present work, the leaf extracts of Annona squamosa Linn. were screened for their probable antimicrobial activity.
Materials and methods
In-vitro Antimicrobial Study:
Plant Material:
The plant material to be screened was collected from Mumbai and Talegaon – Dabhade (district - Maval, Pune). The plant sample was authenticated by the expert taxonomist of St. Xavier’s College, Mumbai. (Acc.no.-102268, 00469). Matured leaves were selected for the study. The plant material was thoroughly washed, 3-4 times with tap water and once with distilled water, so as to remove all the impurities and foreign organic matter. These samples were then placed in between filter paper pads to remove maximum moisture and then shade-dried in the beginning and further dried in an oven at 50-600C for 25 minutes. The dried material was powdered to obtain a fine powder (mesh size 2 mm) and then sieved. This was then stored in plastic containers at 4°C until use.
Preparation of extract of plant leaf powder for the assay:
The dried and finely ground leaf powder of Annona squamosa Linn., (20g each) was sequentially extracted with petroleum ether, chloroform, ethyl acetate, acetone, ethyl alcohol, methyl alcohol and water were performed using known and standardized methods.8
Preparation of standard antibiotics solution:
Two standard broad spectrum antibacterial antibiotics (for both gram-positive & gram-negative bacterial strains) viz. Ampicillin (Bacteriocidal) – from Beta-Lactum medicines, Chloramphenicol (Bacteriostatic) – Other antibacterials and two commonly used antifungal antibiotics viz. Nystatin and Clotrimazol (used for fungal infections; especially for mold and yeast infections - most notably Candida) were used for the assay for comparative analysis of the leaf extract of Annona squamosa Linn. (According to WHO Model List of Essential medicines, 1977; 18th edition).8
Commercially available powdered forms of the antibiotics were dissolved in distilled water to make up standard antibiotic solutions of concentration 0.5mg/ml, (Potency specifications of antibiotics, WHO, 1997) which were further used for the assay.8
Preparation of culture (inoculum):
The bacterial and the fungal cultures were isolated and stored in the refrigerator and used whenever required following the known and standardized methods.8
Preparation of culture suspension:
Loopful of culture from the slants was suspended in small amount of nutrient broth or saline as required.8
Agar well diffusion method:
Agar well diffusion method was followed as standardized by Bauer and Kirby,1996 and Pawaskar and Sasangan, 2015.8, 9
Agar disc diffusion method:
Agar disc diffusion method was followed as standardized by Bauer and Kirby,1996 and Pawaskar and Sasangan, 2015.8, 9
Minimum Inhibitory Concentration:
Minimum inhibitory concentrations i.e., the agar well containing the least concentration of the plant extract; showing inhibitory zone was performed following the standard protocol by Bauer and Kirby., 1996 and Pawaskar and Sasangan, 2015.8, 9
Result:
The percentage of extraction in various solvents for the leaf powder of Annona squamosa Linn is shown in Table-1.
The zones of inhibition for the selected organisms using sequential extracts of the leaf powders of Annona squamousa Linn. by Agar well diffusion method and Agar disc diffusion method are presented in Table-2 and Table-3 respectively and the minimum inhibitory concentration (mg/ml) of the leaf extracts of Annona squamosa Linn. in different solvents is presented in Table-4.
All the seven sequential extracts of the leaf powder of Annona squamosa Linn. exhibited prominent antimicrobial and antifungal activity against all microorganisms used in the study. In Agar well diffusion method, highly polar solvents i.e. ethyl alcohol, methyl alcohol and water exhibited the most promising antibacterial and antifungal activity against all tested organisms for the leaf extracts of Annona squamosa Linn.; with the methyl alcohol extract showing maximum inhibition in the range of 12 mm - 17 mm for the leaf extract of Annona squamosa Linn.
Similar pattern of results was also observed in Agar disc diffusion method. Highly polar solvents i.e. ethyl alcohol, methyl alcohol and water showed the most significant antibacterial and antifungal activity against all tested organisms for the leaf extracts of Annona squamosa Linn.; with the methyl alcohol extract showing maximum inhibition in the range of 9 mm - 14 mm for the leaf extract of Annona squamosa Linn.
The minimum inhibitory concentration results of the leaf extracts of Annona squamosa Linn. in all the different solvents, indicated that – Salmonella typhi and Salmonella paratyphi A and Pseudomonas aeruginosa were the least susceptible among the organisms tested for Annona squamosa Linn.
The results of the entire study revealed that the leaf extracts of Annona squamosa Linn. in all the different solvents used for extraction, possesses potential antimicrobial activity against the pathogens used for screening.
Discussion:
The effects of plant extracts on bacteria have been studied by a number of researchers in different parts of the world. Plants have been reported to possess mild to significant antimicrobial, antifungal and other activities. This has been elucidated by various workers. 8, 10, 11, 12, 13
The results of the antimicrobial activity study of the leaf extract of Annona squamosa Linn. by Patel and Kumar, (2008) showed the highest zone of inhibition observed in methyl alcohol extract against P. aeruginosa followed by petroleum ether extract against P. aeruginosa and methyl alcohol extract against E. coli.14 Agar diffusion method was chosen to check antibacterial activity. However, our study showed that the maximum zone of inhibition in methyl alcohol extract was observed against Bacillus subtilis and Streptococcus pyogenes followed by Staphylococcus aureus and Vibrio cholerae. Petroleum ether extract appears to be more effective against Vibrio cholera. Escherichia coli appear to have highest susceptibility in ethyl alcoholic leaf extract of Annona squamosa Linn. Results parallel to our study have also been reported by Padhi, et al. (2011).15 Their screening results exhibited that highest inhibition was observed by the methyl alcohol extract followed by petroleum ether and aqueous extracts of Annona squamosa leaf. Some of the most sensitive bacterial strains used by them were, Staphylococcus aureus, Staphylococcus epidermidis, Bacillus subtilis and Vibrio alginolyticus.
Conclusion:
In conclusion, the results of the present study have provided supportive scientific evidence that the leaf extracts of Annona squamosa Linn. possess a potential and broad spectrum of activity against a panel of bacteria. These promissory results form a primary platform for finding new clinically effective antibacterial compounds.
Acknowledgement: Authors acknowledge the immense help received from the scholars whose articles are cited and included in references of this manuscript. The authors are also grateful to authors/editors / publishers of all those articles, journals and books from where the literature for this article has been reviewed and discussed.
Source of funding: Nil
Conflicts of interest: The authors declare no competing interests.
Authors’ Contribution: Dr. Pawaskar has solely contributed towards the experimental work as well as the writing of this paper under the guidance and supervision of Dr. K. C. Sasangan
In the table: PE: Pet ether extract; CL: Chloroform extract; EA: Ethyl acetate extract; AC: Acetone extract; ET: Ethyl alcohol extract; ME: Methyl alcohol extract; WT: Water extract; AMP: Ampicillin; CLP: Chloramphenicol; NYT: Nystatin and CLZ: Clotrimazol.
Englishhttp://ijcrr.com/abstract.php?article_id=4377http://ijcrr.com/article_html.php?did=4377
1. Farombi EO. African indigenous plants with chemotherapeutic potentials and biotechnological approach to the production of bioactive prophylactic agents. African J. Biotech., 2003. 2;662-671.
2. Prusti A, Mishra SR, Sahoo S. and Mishra SK. Antibacterial Activity of Some Indian Medicinal Plants. Ethnobotanical Leaflets. 2008. 12;227-230.
3. Farnsworth NR. The role of medicinal plants in drug development. In : Krogsgaard-Larsen, S., Brogger-Christense, S., Kofod, H. (Eds.). Natural Products and Drug Development. 1994.Munksgaard, Copenhagen.
4. Srivastava J, Lambert J and Vietmeyer N. Medicinal plants: An expanding role in development. World Bank Technical Paper No. WTP 320. The International Bank for Reconstruction and Development/The World Bank, Washington, DC., USA. April 1996. 1-36.
5. Westh H, Zinn CS, Rosdahl VT. An international multicenter study of antimicrobial consumption and resistance in Staphylococcus aureus isolates from 15 hospitals in 14 countries. Microb. Drug Resist. 2004. 10;169-176.
6. Monroe S, Polk R. Antimicrobial use and bacterial resistance. Curr. Opin. Microbiol. 2000.3; 496-501.
7. Benkeblia N. Antimicrobial activity of essential oil extracts of various onions (Allium cepa) and garlic (Allium sativum). Lebensm-Wiss u-Technol. 2004. 37;263-268.
8. Pawaskar SM and Sasangan KC. In vitro antimicrobial activity of cynodon dactylon (l.) Pers. Leaf extracts. Antimicrobial activity by zone of inhibition estimation. Indian Drugs. 2015. 52(04);37-41.
9. Bauer AW, Kirby WMM and Sherris JC. Antibiotic susceptibility testing by a standardized single disk method. Am. J. Clin. Pathol. 1996. 45;493-496.
10. Sasidharan VK, Krishnakumar T and Manjula, CB. Antimicrobial Activity of Nine Common Plants in Kerala, India. PJS. 1998. 127(1);59-67.
11. Pawaskar SM and Kale K. Antibacterial activity of sequential extracts of Mimosa pudica. Indian drugs. 2006. 43(6);476-480.
12. SudharameshwariK and Radhika J. Antibacterial screening of Aeglemarmelos, Lawsonia inermis and Albizzialibbeck. African J Trad, Complementary and Alt Med. 2007. 4(2);205-210.
13. Ramya S, Govindaraji V, Kannan NK and Jayakumararaj R. In vitro evaluation of antibacterial activity using crude extracts of Catharanthus roseus L. (G.) Don. Ethnobotanical Leaflets. 2008. 12;1013-1018.
14. PatelJ and Kumar V. Annona squamosa: Phytochemical analysis and Antimicrobial Screening. J of Pharmacy Res. 2008. 1(1);34-38
15. Padhi LP, Panda SK, Satapathy SN and Dutta SK. In vitro evaluation of the antibacterial potential of Annona squamosa and Annona reticulate L. from Similipal. Biosphere Reserve, Orissa, India. J of Agricultural Tech. 2011. 7(1);133-142.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15HealthcareMethod Development and Validation for the Analysis of Apalutamide in Human Plasma by LC-MS/MS
English7479G Sai Uday KiranEnglish P SandhyaEnglishIntroduction: Highly specific, selective and accurate liquid chromatography/tandem mass spectrometry (LC–MS/MS) technique was desirable for the assessment of apalutamide in human plasma. Aims: To develop and validate LC-MS/MS method for the analysis of apalutamide in human plasma. Methodology: Drug and internal standard were extracted utilizing liquid-liquid extraction was performed using ethyl acetate. Reversed-phase high performace liquid chromatography (RP-HPLC) was carried out using Inertsil (50×4.6 mm i.d., 5 µm) C18 analytical column with a simple isocratic mobile phase composed of 0.1% formic acid and acetonitrile, (20:80, v/v). Detection was executed on a triple quadrupole mass spectrometer retaining electrospray ionization method, operating in multiple reaction monitoring (MRM), with the transitions of m/z 478.09→ 447.05, m/z 445.14 → 267.12 for apalutamide, canagliflozin, respectively, in the positive ionization mode. The linearity was processed a concentration range of 300–12000 ng/mL for the analyte. Results: The method was validated in accordance with the FDA guidelines for bioanalytical method. All obtained recoveries were higher than 93.0% while the accuracy was in the range of −4.32 to 2.45% of relative error and the relative standard deviation was below 4.21% for all investigated drugs by the proposed method. Conclusion: The validated method has highly sensitive and nice recoveries values from plasma, utilized for the bioequivalence and pharmacokinetic studies.
English Apalutamide, Prostate cancer, LC–MS/MS, Validation, Linearity, Accuracyhttp://ijcrr.com/abstract.php?article_id=4378http://ijcrr.com/article_html.php?did=4378Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
Effect of Slump Neural Mobilization vs Mulligan Bent Leg Raise in Subjects with Lumbar Radiculopathy
English8086Agrawal REnglish Shah KEnglish
Introduction: Low back pain is a problem worldwide with a lifetime prevalence reported as 34% by WHO1. Low back pain(LBP) is experienced by at least 80% of adults, both men and women equally at least once in their lifetime. 2 Direct nerve mobilization uses sliders, tensioners and nerve mobilization crossing single joint addressing the interface between various surfaces. The Mulligan BLR technique has been described as means of improving range of SLR(Straight leg raise), AKE(active knee extension) and hamstring flexibility in subjects with LBP or referred thigh pain. Aims: The aim of this study was to compare the effectiveness of both techniques in treating patients with lumbar radiculopathy. Methodology: After receiving permission from Institutional Ethics committee, sixty subjects were randomly allocated to Mulligan Bent knee raise and Neural tissue Mobilization group. Lumbar stabilization exercises were given to both groups. Intervention was given for 3 days/week for 3 weeks. Results: Data was analyzed using SPSS VERSION 17.0. The results showed significant difference in all 3 outcome measures ie SLR, Modified Oswestry Disability Index( MODI) score and NPRS scale in intra- group comparison. But inter-group comparison was non-significant for pain score (NPRS scale) and disability (MODI score) but showed significant difference for passive SLR range where the range improved to a greater extent with slump neural mobilization technique than mulligan bent leg raise. Conclusion: We conclude that both mulligan bent leg raise and slump neural mobilization are equally effective in reducing pain and disability. Also, both the techniques improve range of SLR but slump neural mobilization increases SLR range to a greater extent than mulligan bent leg raise.
EnglishMulligan bent leg raise, Slump neural mobilization, Lumbar radiculopathy, Modified ODI, NPRS, SLR
Introduction
Low back pain is a problem worldwide with a lifetime prevalence reported as 34% by WHO.1 Low back pain(LBP) is experienced by at least 80% of adults, both men and women equally atleast once in their lifetime.2 It is the most common cause of disability in individuals under 45 years of age and 3rd most common cause in 45-60 year age group. Various spinal structures such as paravertebral muscles, ligaments, facet joints annulus fibrosus and spinal nerve roots have been suggested as the cause of pain apart from disc herniation and stenosis. It has been suggested that if nociceptive inputs continue over time it may result in functional, chemical and structural alterations in peripheral and central nervous systems.3
The nervous system is a viscoelastic organ. Mechanics and physiology of the nervous system are interdependent and forms the basis for the concept of neurodynamics. Neurodynamic sliding (NDS) integrates both the musculoskeletal and nervous systems to achieve pain reduction or increased ROM in the extremities4 Neural mobilization is a set of techniques designed to restore elasticity of nervous system, defined as ability of nerve mechanical interphase to shift in relation to other structures.5 The structures which can be moved by these techniques include neuraxis, meninges, nerve roots and peripheral nerves.4
Direct nerve mobilization uses sliders, tensioners and nerve mobilization crossing single joint addressing the interface between various surfaces, correcting the posture and ergonomic adjustment.6,7Sliders utilize combinations of joint movements to encourage peripheral nerve excursion by increasing elongation at one end of the nerve bed, thereby creating tension from the other end of the nerve. In contrast, tensioners make use of combinations of joint movements that lengthen the nerve bed from both ends, in an effort to elongate the neural connective tissues.8
The Mulligan BLR technique has been described as means of improving range of SLR (Straight leg raise), AKE(active knee extension) and hamstring flexibility in subjects with LBP or referred thigh pain. This technique was designed to restore altered activation of hamstring muscle Mulligan Bent Leg Raise technique consists of gentle isometric stretching of hamstring in specific directions in progressively greater positions of hip flexion. It can be tried in patients with gross bilateral limitation of SLR. Mobilization of nervous tissue has been postulated as one of the causes for improvements seen post-mulligan BLR. The aim of this technique is to restore normal mobility and decrease low back pain and associated disability.9,10
Studies have been conducted to check the effectiveness of both Mulligan bent leg raise and slump neural mobilization in LBP and results are found to be significant but very few studies have compared two techniques for its effectiveness in lumbar radiculopathies. The purpose of this study is to compare the effectiveness of both techniques in treating patients with lumbar radiculopathy.
METHODOLOGY
After receiving permission from the Institutional Ethics committee MCES/EC/ZVM/452/18, pre and post-experimental study with purposive sampling was done. Duration of study intervention was 3 weeks. Seventy subjects in the age group of 18 to 60 years, both males and females, having LBP radiating distal to the buttocks with reproduction of symptoms during slump stretching with active knee extension more than 15 degrees in bedside sitting position, subjects with SLR less than 60 degrees with radiation of symptoms were included.
Subjects with symptoms of spinal infection, neoplasm, spinal fractures, positive signs or symptoms suggesting UMN lesion, conditions where SLR is contra-indicated were excluded from the study.
Group A. (Mulligan bent leg raise)11,12
Subject was in supine lying. Therapist stood on painful side of patient or the side with limited straight leg raise. The therapist placed the patient’s flexed knee over his shoulder. Now therapist asked the patient to push the flexed knee in the direction of therapist and then relax. At this point, the therapist pushed his bent knee up as far as possible in the direction of the patient's shoulder on the same side provided there is no pain. If it was painful the patient's leg was rotated medially or laterally. The stretch has to be sustained for several seconds and then the leg is lowered to the bed. After three repetitions marked improvement in straight leg raise was noted .11 This was carried in five progressively greater positions of hip flexion.
Group B. (Slump neural mobilization) 13
The subject was seated at the edge of bed with knees at 90 degrees of flexion and popliteal surface in contact with the plinth. The patient was asked to slouch the shoulders and thoracic spine while the therapist applied cervical over pressure to ensure consistent pressure, maintaining fully flexed position, and the patient was asked to actively extend the knee.30 sliders i.e neck flexion with ankle plantarflexion and neck extension with ankle dorsiflexion were performed by the patient actively. For both groups, the treatment was provided thrice weekly for 3 weeks resulting in 9 total treatment sessions.
Lumbar spine stabilization exercises:14
Lumbar spine stabilization exercises were common to both groups under supervision for core muscle strengthening as weakness of core muscle plays a significant role in LBP. These exercises were given following Mulligan’s bent leg raise and slump neural mobilization in the form of following with 5 seconds hold and 10 repetitions 1 set per day. Exercises included were
Abdominal draw-in, Abdominal draw-in with bridging, Quadruped with abdominal draw-in, Quadruped alternate arm and leg lift with abdominal draw-in, Quadripud with arm lift, Quadripud with leg lift. All exercises were carried out under supervision.
Results
Comparison of age and sex in bent leg raise group and slump mobilization group was not statistically significant. Hence, they are comparable. Comparison of VAS, SLR and Modified MODI score in Neural Tissue Mobilization and mulligan bent leg raise group showed a significant reduction in pain and thus the VAS score reduced consistently from baseline to 3 weeks.
Discussion
The present study was conducted on sample size of 70 patients for a period of three weeks comparing Mulligan bent leg raise and Slump neural mobilization in subjects with lumbar radiculopathy. The three outcome measures used were a numerical pain rating scale for pain intensity, Modified ODI for disability and SLR (Straight leg raise).
There was significant reduction in pain and thus the NPRS score reduced consistently from baseline to 3 weeks in Mulligan bent leg raise. One of the reasons for reduction in pain with mulligan bent leg raise technique is improved mechanics of neural structures.12 It facilitates caudal movement of neural structures which improves excursion of lumbosacral nerve roots and sciatic nerve at the level of pelvis (hip is kept in flexed position). Also, there is opening of inter-vertebral foramina and central canal which helps disperse intra-neural oedema, relieving pressure gradients and thus hypoxia and hence the pain.15,16,17
Also, the bent leg raise technique may have effect on neurophysiological responses which affects muscle stretch tolerance and increase hamstring flexibility18 It is suggested in previous studies that increase in hamstring extensibility offloads pelvis of its excessive posterior rotation and provides lumbar range of motion by providing efficient lumbo-pelvic rhythm thus by improving the biomechanics, there is a reduction in pain.19 Another mechanism for reduction in pain by bent leg raise technique is altered pain perception. Afferent input from muscles and joints during Mulligan bent leg raise may interfere with nociceptive fibres which is consistent with gate control theory proposed by Melzack and Wall. The afferent input blocks the slow C fibres which subsequently inhibits individuals perception of pain. Alternatively, changes in pain responsiveness may be psychologically mediated, sometimes giving a placebo effect on pain reduction.12,20
Table 1 shows intra-group comparison of NPRS score in slump neural mobilization group where patient was given neural sliders. The NPRS score showed a significant reduction (p0.05).
When effect on SLR were seen in MBR group as in Table 3 it is seen that there is considerable improvement in range of SLR from baseline to 3 weeks. The p-value is extremely significant (p=Englishhttp://ijcrr.com/abstract.php?article_id=4379http://ijcrr.com/article_html.php?did=4379
Wilson E, Payton O, Donegan-Shoaf L, Dec K. Muscle energy technique in patients with acute low back pain: a pilot clinical trial. Journal of Orthopaedic & sports Physical therapy. 2003 Sep;33(9):502-12.
Nagrale AV, Patil SP, Gandhi RA, Learman K. Effect of slump stretching versus lumbar mobilization with exercise in subjects with non-radicular low back pain: a randomized clinical trial. Journal of Manual & Manipulative Therapy. 2012 Feb 1;20(1):35-42.
Nee RJ, Butler D. Management of peripheral neuropathic pain: integrating neurobiology, neurodynamics, and clinical evidence. Physical Therapy in sport. 2006 Feb 1;7(1):36-49.
Shacklock M. Neurodynamics. Physiotherapy. 1995 Jan 1;81(1):9-16.
Modic MT, Obuchowski NA, Ross JS, Brant-Zawadzki MN, Grooff PN, Mazanec DJ et al. Acute low back pain and radiculopathy: MR imaging findings and their prognostic role and effect on outcome. Radiology. 2005 Nov; 237(2):597-604.
Devillé WL, van der Windt DA, Dzaferagic A, Bezemer PD, Bouter LM. The test of Lasegue: systematic review of the accuracy in diagnosing herniated discs. Spine. 2000 May 1;25(9):1140-7.
Meszaros TF, Olson R, Kulig K, Creighton D, Czarnecki E. Effect of 10%, 30%, and 60% body weight traction on the straight leg raise test of symptomatic patients with low back pain. Journal of Orthopaedic & Sports Physical Therapy. 2000 Oct;30(10):595-601.
Stankovic R, Johnell O, Maly P, Wilmer S. Use of lumbar extension, slump test, physical and neurological examination in the evaluation of patients with suspected herniated nucleurs pulposus. A prospective clinical study. Manual therapy. 1999 Feb 1;4(1):25-32.
Hall T, Hardt S, Schäfer A, Wallin L. Mulligan bent leg raise technique—a preliminary randomized trial of immediate effects after a single intervention. Manual therapy. 2006 May 1;11(2):130-5.
Phadnis TR, Bhave SM. Comparative. Study of Mulligan Bent Leg Raise vs. Hold Relax ProprioceptiveNeuromuscularFacilitationonHamstringTightnessinHighSchoolStudent.JournalofPhysiotherapy & Physical Rehabilitation.2018;03(01).
Mulligan BR. Manual therapy. NAGS, SNAGS, MWM etc. 1999:120.
Babu VK, Akalwadi A, Kumar SN, Mahendrabhai UM. Immediate effect Of neurodynamic sliding technique versus mulligan bent leg raise technique on hamstring flexibility in asymptomatic individuals. International Journal of Physiotherapy. 2015 Aug 1;2(4):658-66.
Lee JH, Kim TH. The treatment effect of hamstring stretching and nerve mobilization for patients with radicular lower back pain. Journal of physical therapy science. 2017;29(9):1578-82.
Kisner C, Colby LA, Borstad J. Therapeutic exercise: foundations and techniques. Fa Davis; 2017 Oct 18.
Kmiecik J, Frattini C, DiNicola A, Wallace S, Cooper K. ART vs. Graston and Their Effects on Hamstring Flexibility. September 2011. Accessed February. 2012.
Panjabi MM, Takata KO, Goel VK. Kinematics of lumbar intervertebral foramen. Spine. 1983;8(4):348-57.
Louis R. Vertebral radicular and vertebromedullary dynamics. Anatomiaclinica 1981;3:1-11
Harvey LA, Byak AJ, Ostrovskaya M, Glinsky J, Katte L, Randomised trial of the effects of four weeks of daily stretch on extensibility of hamstring muscles in people with spinal cord injuries. Australian Journal of Physiotherapy. 2003 Jan 1;49(3):176-81.
Phansopkar PA, Kage V. Efficacy of mulligan's two leg rotation and bent leg raise techniques in hamstring flexibility in subjects with acute non-specific low back pain: randomized clinical trial. Int J Physiother Res 2014;2:733-41
Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9.
Beltran-Alacreu H, Jiménez-Sanz L, Carnero JF, La Touche R. Comparison of hypoalgesic effects of neural stretching vs neural gliding: a randomized controlled trial. Journal of Manipulative and Physiological Therapeutics. 2015 Nov 1;38(9):644-52.
Shacklock M. Improving application of neurodynamic (neural tension) testing and treatments: a message to researchers and clinicians. Manual therapy. 2005;3(10):175-9.
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Patel G. To Compare the effectiveness of Mulligan Bent Leg Raising and Slump Stretching in Patient with Low Back Pain. Indian Journal of Physiotherapy and Occupational Therapy - An International Journal.2014;8(3):24.
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Malik N, Kataria C, Sachdev NB. Comparative effectiveness of straight leg raise and slump stretching in subjects with low back pain with adverse neural tension. Int J Health Rehabil Sci.2012;1(1):2-10.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
Diagnostic Value of Post Decontamination Smear Microscopy for Enhanced Detection of Tuberculosis
English8790Swati SalilaEnglish U. N. GaikwadEnglish
Introduction: A direct smear microscopy is a universal tool used for the diagnosis of tuberculosis under programmatic settings. Early diagnosis of TB is crucial both clinically and epidemiologically. It is essential to ensure proper and early identification of cases, and good treatment outcomes to be able to limit its transmission and obtain successful TB control especially in low-income countries. The study aims to evaluate the efficacy of smear microscopy performed on post-NaLC–NaOH decontaminated samples in the diagnosis of Tuberculosis. Materials and Methods: The samples were subjected to direct smear microscopy using Ziehl-Neelson (ZN) stain followed by decontamination and concentration by NALC-NaOH method and culture on Lowenstein Jensen media as well as in MGIT 960 system. Results of direct smear microscopy and post decontamination smear microscopy were compared against culture as the gold standard. Results: A total 705 samples were processed of which 658 were negative for acid-fast bacilli by direct microscopy. We observed that direct microscopy showed 41.22% (47) positivity whereas microscopy by post decontamination showed 60.52% (69) positive. A true diagnostic yield of 24% was obtained by post decontamination smear microscopy over direct microscopy.The overall sensitivity, specificity, PPV and NPV for direct and post decontamination smear was calculated as 36.84%, 99.15%, 89.36%, 89.06% and 60.52%, 97.96%, 85.19%, 92.79% respectively.Thus, the sensitivity of detection was increased by 23.68% on post decontamination smear microscopy with a diagnostic accuracy of 91.91%. Conclusion: Post decontamination smears showed a significant increase in diagnostic yield as compared to direct smear microscopy. Performing and reporting PDSM on samples requested for culture, as an additional step, inappropriate laboratory settings can have a greater impact in providing rapid and accurate diagnosis especially in smear-negative and extra-pulmonary TB cases.
EnglishConcentration methods, Smear-negative pulmonary TB, Post decontamination smear microscopy, EPTB, Diagnostic accuracy, Sensitivity
Introduction:
A direct smear microscopy is a universal tool used for the diagnosis of tuberculosis(TB) under programmatic settings. Sputum smear microscopy is a century-old test but remains the primary tool for diagnosing TB in low-income countries. The Ziehl–Neelsen method has endured as a reliable and effective way to demonstrate acid-fast bacteria.1 It is an important tool in the initial screening of the disease as it can differentiate MTB which appears as long, curved, and beaded bacilli from Non-Tuberculous Mycobacteria (NTM) which appear as short, straight bacilli with no specific morphology.2,3 However, the threshold for detection of acid-fast bacilli (AFB) in samples under optimal conditions is very high (104 to 105 bacilli/ml) making smear microscopy a less sensitive tool for diagnosing pulmonary TB.4
Although simple and cost-effective, it significantly lacks sensitivity and specificity in detecting tubercle bacilli, especially in extrapulmonary tuberculosis (EPTB) due to its paucibacillary nature of the disease, the variable clinical presentations, needs for invasive procedures to secure appropriate samples, and lack of laboratory facilities in the resource-limited settings5. The conventional methods of diagnosis of TB has various limitations hence the rapid diagnosis of EPTB is a challenging task. Moreover, in a developing country like India where healthcare professionals are facing difficulties in diagnosing the disease due to limited infrastructure, better methods are gravely needed for control programs.
Under the TB program conditions and due to technical constraints, the yield is further decreased (IUATLD, 2005).6 Definitive and rapid diagnosis of extrapulmonary tuberculosis is challenging since conventional techniques have limitations. Smear-negative pulmonary TB (SNPT) represents 30–60% of all pulmonary TB cases, according to region.7 Early diagnosis of TB is crucial both clinically and epidemiologically. It is essential to ensure proper and early identification of cases, and good treatment outcomes to be able to limit its transmission and obtain successful TB control. In laboratory settings with culture facilities, the diagnostic capacity of smear-negative pulmonary and extrapulmonary samples can be increased by examining the post-decontamination smears adding to the rapidity of diagnosis. This is especially helpful in direct smear-negative and EPTB samples. With this hypothesis for increased diagnostic yield, the study aims to evaluate the efficacy of smear microscopy performed on post-NaLC–NaOH decontaminated samples in the diagnosis of Tuberculosis.
Materials and Methods
A cross-sectional analysis of samples requested for mycobacterial culture from clinically suspected tuberculosis cases, over a period of 18 months(Jan 2018 - Jun 2019) was done in the department of Microbiology, AIIMS, Raipur. The samples were subjected to direct smear microscopy using Ziehl-Neelson (ZN) stain followed by decontamination and concentration by NALC-NaOH method and culture on Lowenstein Jensen media as well as in MGIT 960 system. ZN smears were prepared from the decontaminated samples. The growth on culture was confirmed for MTB by MPT-64 antigen immuno-chromatography test. Results of direct smear microscopy and post-decontamination smear microscopy were compared against culture as gold standard.
Data Analysis
Results of direct smear microscopy and post-decontamination smear microscopy were compared against culture as the gold standard to find out: Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and Diagnostic Accuracy. The p-value cervical LN>gastric aspirate, pus, peritoneal fluid, urine).
The overall sensitivity, specificity, PPV and NPV for direct and post-decontamination smear (Table – 2) was calculated as 36.84%, 99.15%, 89.36%, 89.06% and 60.52%, 97.96%, 85.19%, 92.79% respectively. Thus, the sensitivity of detection was increased by 23.68% on post-decontamination smear microscopy with a diagnostic accuracy of 91.91%.
Discussion
Microscopy detection rates before and after the concentration of specimens were compared. The sensitivity of detection by microscopy increased by 23.68% over those without concentration. It is comparable to the study conducted by Morcillo et al. which shows increased sensitivity of concentrated microscopy by 15.2% (Hypertonic Saline-SodiumHydroxide: 73.5%) to 16.7% (NALC-NaOH: 75.0%) over those without concentration (58.3%)8.
Ganozaet al. had conducted similar study which showed sensitivity for AFB smears was increased from 28.6 % using the direct method to 71.4 % (Hypertonic Saline-Sodium Hydroxide) and 66.7 % (NALC-NaOH) using decontamination and concentration methods9.
Hence the use of the concentrated method for preparing smears for AFB microscopy increases sensitivity in identifying positive TB cases, compared to the direct method.
There were 2 samples positive with the direct method but negative with the concentrated method one of which was found to be positive by culture. It might have occurred due to inappropriate sample concentration and smear preparation, smear preparation from a negative sample accidentally, faulty staining process, or inappropriate microscopic observation. Four specimens which were positive in both direct and concentrated smear microscopy but negative in culture. Probably these patients were taking anti-TB drugs while collecting the specimens and the dead bacilli failed to grow on L-J media. No change in Sensitivity was observed by both the methods as described 81.6% for direct smear and 82.7% for the concentrated smear in a study conducted by Barez, et al.10 In another study, Cattamanchi et al.11 failed to find a difference in sensitivity between direct and concentrated sputum smear microscopy, the calculated sensitivity of direct and concentrated smear microscopy was not significantly different (51% vs. 52%).A recent study conducted by Uddin et al. showed a sensitivity of direct and concentrated smear microscopy was different when using positive culture as the gold standard (71% vs. 83%)12.
Limitations of this study - The effect of increased diagnostic yield by post-decontamination smear microscopy on therapeutic decisions could not be assessed.
Conclusion & Recommendation:
Post-decontamination smears showed a significant increase in diagnostic yield as compared to direct smear microscopy. Performing and reporting post-decontamination smear microscopy on samples requested for culture, as an additional step, inappropriate laboratory settings can have a greater impact in providing rapid and accurate diagnosis especially in smear-negative and extra-pulmonary TB cases.
Acknowledgement: I thank Dr. U. N. Gaikwad, Addl. Prof., Deptt. of Microbiology, AIIMS Raipur for her full support in conducting this study.
Source of Funding: None
Conflict of Interest: None
Authors’ Contribution: Dr. U. N. Gaikwad conceived the idea and encouraged Dr. Swati Salila to investigate on the hypothesis and supervised throughout the study. Data compilation and drafting was done by Dr. Swati Salila. Both authors discussed the results and contributed to the final manuscript.
Englishhttp://ijcrr.com/abstract.php?article_id=4380http://ijcrr.com/article_html.php?did=4380
Bishop P.J., Neuman G. The history of the Ziehl–Neelsen stain Tubercle, 51 (1970), pp. 196-206
Ritu Singhal, Vithal Prasad Myneedu. Microscopy as a diagnostic tool in pulmonary tuberculosis, Int J of Mycobacteriology, Volume 4, Issue 1, 2015, Pages 1-6, ISSN 2212-5531.
C. Dye, C.J. Watt, D.M. Bleed, S.M. Hosseini, M.C. Raviglione. Evolution of tuberculosis control and prospects for reducing tuberculosis incidence, prevalence, and deaths globally JAMA, 293 (22) (2005), pp. 2767-2775
Magalhães JLO, Lima JFC, Araújo AA, Coutinho IO, Leal NC and Almeida AMP.Microscopic detection of Mycobacterium tuberculosis in direct or processed sputum smears, Rev Soc Bras Med Trop 51(2):237-239, March-April, 2018 doi: 10.1590/0037-8682-0238-2017
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241144EnglishN2022February15Healthcare
Assessing the Impact of Educational Interventions on Quality of Life: Measuring by Minnesota Living with Heart Failure Questionnaire
English9197Shaheen NazakatEnglish Kabir Ozigi AbdullahiEnglish Asif HaneefEnglish Adnan YaqoobEnglish Syed Amir GillaniEnglish Muhammad AfzalEnglish Umm-E-HabibaEnglish Muhammad SajidEnglish
Introduction: Heart failure is one of the most common cardiovascular diseases which decrease the quality of life. Most of the factors influencing the quality of life can be modified with educational interventions. Therefore, this study examined the impact of educational program on quality of life of congestive heart failure patients. Aims: The aim of the study was to access the impact of educational intervention on quality of life among congestive heart failure patients. Methodology: The study was conducted at Faisalabad Institute of Cardiology, Faisalabad Pakistan. Quasi-experimental design was used concerned study. The study participants were recruited through the process of convenient sampling. The sample consisted of men and women admitted to cardiac units, the researcher took data from patient’s file for primary and secondary diagnosis of heart failure and was obtain consent from those participants, who fulfill the eligibility criteria. Results: The intervention showed significant (pEnglishEducational interventions, Heart Failure, Quality of Life, Minnesota living with heart failure, Impact, Questionnaire
Introduction
Heart failure is a prevalent cardiovascular condition that has a negative impact on one's quality of life. The heart is unable to properly pump enough blood throughout the body, resulting in a deficiency of blood flow supply throughout the body away from the heart.1 As a result, the oxygen delivery to human organs and tissues is insufficient.2 When heart failure strikes, the right ventricle frequently collapses as a result of the left ventricle's failing. The right ventricle, on the other hand, might sometimes fail on its own. Acute heart failure and chronic heart failure are the two types of heart failure. Acute heart failure manifests itself as the fast onset of symptoms and rapid worsening of heart failure symptoms.3
Heart failure has been one of the major clinical and economic burdens in the United States. On average, each patient's total annual medical costs amount to $6,199, with 95% of hospitalization costs.4 The high hospitalization and medical care costs have often prevented many patients from accessing high-quality medical care. As a result, most of them have succumbed to illnesses. While several patients have had insurance covers, many have had to spend their financial resources to cater to their medication.5
The educational program has played a pivotal role in improving the patient's knowledge about the disease process, self-care, and cost-effectiveness which in turn reduced the hospitalization stay of the patients.6 Moreover, this program has helped improve adherence to treatment. For instance, the improvement of self-care has promoted a healthy lifestyle among patients suffering from heart failure disease. Knowing the signs and symptoms of the disease, the process of treatments, and the appropriate actions required in the management of the disease has helped prevent the disease from worsening and hence reduce hospitalization stay for the patients. It is therefore essential for all healthcare directors to initiate such programs in their healthcare facilities to enhance disease awareness, self-care, and cost-effectiveness for the sake of patients suffering from heart failure.7
Quality of life explains the extent to which a person is comfortable, healthy, and in a position to enjoy or take part in life events. The concept of quality of life is seen as multifaceted in care delivery, incorporating social, material, physical and emotional well-being.8 The concept of quality of life can be explored in the case of congestive cardiac failure patients. There are various consequences of poor quality of life for congestive heart failure patients. Congestive heart failure (CHF) involves a chronic and progressive disorder that mainly affects the heart muscle pumping power in an individual. Whereas the condition is frequently known as heart failure, congestive heart failure includes the phase in which there is an accumulation of fluid inside the heart, resulting in inefficient pumping power.9
Hospital discharge education for patients with congestive heart failure (CHF) is important since it will help patients how to prevent future re-admission, improves self-care, and assists patients in determining problems early; hence it will increase the chances for improved patients results and adoption of best health interventions1.10 The Center for Medicare and Medicaid Service (CMS) reviewed how to reduce reimbursement by adding penalties for a patient with CHF (Congestive Heart Failure) for those who are re-admitted after hospital discharge within 30 days of their earlier heart failure admission. Re-admission of patients with CHF occurs due to inadequate planning discharge teaching from the patient's non-adherence to guidelines are illustrated as factor that lead to re-hospitalization, hence discharge teaching for patients with CHF is important since it improves the quality of life for patients and also improves patient outcomes.11
Multiple factors influence self-care behavior. To begin with, experience and skills become the first factor. The experience becomes an influential contributor to skill development in self-care. Therefore, patients must have sufficient knowledge and skills, to enable them to take the physician's advice to the latter.13 The study is necessary to ensure that more people acquire the appropriate knowledge needed to improve their general health. The importance of developing education programs is to ensure that there is adequate adherence to the medical recommendations during the treatment that eliminates any medical errors that may lead to ultimate readmissions.12 This way, the treatment of congestive heart failure is made more effective. When there is the presence of therapeutic interventions and educational sessions, it can lead to the improvement of a patient’s self-care, increase their awareness, and lead to positive health outcomes. When a patient lacks basic knowledge on their issues, it leads to low rates of compliance, and it is a great contributor to poor quality of life and readmissions in the hospital.14
The rationale of this study is to determine the effectiveness of educational programs in improving their quality of life through conducting a literature review on various articles related to educational programs and the quality of life of congestive heart failure patients. The general aim of the study is to throw light on the educational program on quality of life, whether the patient is faced with heart problems. According to the literature review many researchers conducted about the impact of educational programs on the quality of life of congestive heart failure patients. On each variable define separately, in many different countries and continents on different populations but no anyone try to find out collectively the above-mentioned variables among the married male and female patients with an educational program on quality of life. There is a very scarce research literature found with relevance to Pakistan. In the previous studies on the educational programs on quality of life in congestive heart failure patients, there was lack of a control group and sample size that does not permit the meaningful evaluation of the large numbers of variables that can influence the quality of life. In the previous studies of the relationship of educational program on quality of life of congestive heart failure patients with mortality different tools were used in each study caused a lack of correlation between mortality and all domains of educational program.
Objective:
To access the impact of educational intervention on quality of life among congestive heart failure patients.
Research Hypothesis
So, the hypothesis generated are as follows:
H0 : The intervention has no significant effect on the quality of life in heart failure patients
Ha : The intervention has a significant effect on the quality of life in heart failure patients.
Significance of the Study
This study aims to provide a better understanding of the quality of life lived by HF patients and how educational programs can be used to improve the quality of life of such patients. The findings of this study will not only benefit the HF patients themselves by helping to improve their quality of life but will also benefit nurses and healthcare practitioners in general to improve the outcome of their patients. Further, this study will significantly help the educational program develops better programs that would enhance HF patients' life quality even better.
Operational Definitions
Independent Variable
Educational Program/ Discharge Teaching: A health education program is a planning and treatment process that will help the patient to enhance quality of life to reduce the re-hospitalization of heart failure patients.
Dependent Variable
A Quality of Life is the ability to perform physica1 and socia1 activities, maintaining happiness, and relationships. Quantity of 1ife wi11 be measured through MLHFQ.
MLHFQ Sca1e scores represent the average of 21 items in the sca1e that the respondent answered MLHFQ total scoring 0-105:
A score 0f 1ess than 24 (good qua1ity of 1ife),
A score 0f 24 t0 45 (average qua1ity of 1ife),
A score greater than 45 were determined as the cutting points for the (poor quality of 1ife) questionnaire.
Study Designs
This study used a quasi-experimental design concerned with quantitative statistics investigation and was explanatory in character. A quasi-experiment is a type of research design that attempts to establish a cause-and-effect relationship. The main difference with a true experiment is that the groups are not randomly assigned.
Setting
The study was conducted at the Faisalabad Institute of Cardiology, Faisalabad Pakistan.
Duration of Study
The duration of the study was 9 months after the approval of IRB.
Sampling Technique
A convenient sample was used in this study to collect data from the Faisalabad Institute of Cardiology (FIC).
Sample Size
The total calculated sample size is 36.
The calculated sample size is 1. This sample size is small to perform the statistical test with good efficiency. So, 30 participants will be taken after adding 20% dropout rate final. Sample size n=36
The sample size is calculated by using the following formula: -
Sample Selection
The study participants were recruited through the process of convenient sampling. The sample consisted of men and women admitted to cardiac units, the researcher took data from patient's file for primary and secondary diagnoses of heart failure and was obtain consent from those participants, who fulfill the eligibility criteria. The majority of patients in this sample were in NYHA classes II and III (New York Heart Association Classification) with scores of having an ejection fraction of less than 40 %.
Inclusion Criteria
The following inclusion criteria was followed for this study.
All heart failure patients admitted to the cardiac units with ECHO report indicating Congestive heart failure (CHF)
Both genders will be included equally.
Patients age 18 to 70 years old.
EF< 40 % and > 20%
Dyspnea
The patients were discharged to home and have cell phone/landline no.
Patients are able to give written or verbal consent for themselves.
Exclusion Criteria
The following exclusion criteria will be followed for this study.
Already taken any educational sessions or counseling regarding disease
Severe neuropsychiatric condition
Planned major surgery/intervention as a treatment of congestive heart failure.
Cerebrovascular accident, end-stage kidney disease, malignancy end stage
Patient with congenital heart disease
Bedridden
Data Collection Procedure
The data was collected after approval of the synopsis. The researcher checked the record for diagnosis of heart failure and eligibility. After receiving the verbal or written consent for enrollment, the researcher will contact the eligible patients. Before signing written informed consent, participants were briefed with a complete introduction to the research, its objective and its process. And researcher was also brief the risks and benefits and confidentiality of the data. The demographic data of the participants were collected through one-to-one interviews and medical records. MLHFQ was given to the respondents to fill out on the second day at hospital admission with the guidance of the researcher/facilitator. After taking the appointment from the participants, the researcher approached the patient at their bedside and educate the participants through a booklet which is an evidence-based comprehensive heart failure patient education booklet for four consecutive day for 15 mints. Booklet and Visual color-coded (Green, Yellow, and Red) guide for patients to monitor the symptoms at home according to the color zoon participants contacted the related nurse or Doctor.
Post-test 1 was conducted 30 days after completion of the intervention with a filling of questionnaires collected by the researcher/ facilitator on a one-month clinical follow-up visit.
Post test 2 was conducted at 90 days after intervention at each participant on a three-month follow-up visit.
Before the patient education, a one-hour training session for three consecutive days will be provided to facilitator/nurses in the cardiac units. The nurses' training sessions will be held over six days. Nurses will be asked to recapitulate the material in their own words and use the Robert Woods Johnson Foundation (RWJF) Live with Heart Failure guidance to facilitate comprehension and continuity.
An Instructional Guide for patients. Content for the standardized RWJF patient information materials for heart failure is based on the ACCF/AHA recommendations on nutrition, exercise, weight monitoring, avoidance of smoking, limiting of fluids, adherence to drugs, and follow-up appointments. The researcher will take advance permission from hospital administration for any adjustment regarding early patient visits or any investigation.
The researcher/ facilitator took the baseline data during hospital admission before discharge. The researcher will adjust the time participants to visit the hospital at the 30th day and the 90th day before discharge accordingly with the help of the hospital cardiologist.
Study Variables
Independent Variable: -The independent variable will be:
The Educational intervention/tech back technique is the independent variable.
Dependent Variable: -The dependent variable will be:
Quality of life will be measured by, MLHFQ
RESULTS
Table 1 shows the background detail of heart failure patients with regard to age, gender, qualification, work experience, and work setting. The sample consisted of 36 heart failure patients from the Faisalabad Institute of Cardiology. The findings of this study show that the majority 27.8% of participants are 61-65 years old. Also, a good majority 72.2% male participants and 55.6% of participants were literate. A huge majority 91.7% of participants are married. The participant's occupations were 44.4% employees, 47.2% unemployed and 8.3% retired. The BMI of the participants 22.3% were 31-39 category and 2nd highest fall four values 25, 27, 28 and 30 were 4 (11.1%). The total cholesterol of the participants 22.2% 300 cholesterol and 19.4% were 250 cholesterol. The Ejection friction status of the participants 13.3% 35 friction ejection and were 17 (19.4%), 30 were 7 (19.4%) and 40 were 5 (13.9%). The Classification NYHA status 72.2% were class and 19.4% NYHA class 2. The smoking status of the participant 61.1% were smokers and 38.9% were non-smoker. The residency status 50.0% were rural areas and 50.0% belong urban areas.
Distribution of respondents on the basis of cholesterol level:
The incidence of heart failure (HF) is constantly increasing in the Western world. Treatment with statins is well established for the primary and secondary prevention of cardiac events by lowering low-density lipoprotein (LDL) cholesterol levels. There are conflicting reports on the role of LDL cholesterol as an adverse prognostic predictor in patients with advanced HF. So the cholesterol level of respondents was measured.
The total cholesterol of the participants 230 were 13(36.1%), 250 were (19.4%) and 300 were 8 (22.2%).
Ejection friction-wise distribution of the respondents:
The Ejection friction wise classification of the participants depicted that 17 participants have 30 points Ejection friction, 7 participants having ejection friction of 30 points and least i-e 5 respondents have ejection friction up to 40 points.
The smoking status of the participant were smoker 22 (61.1%) and non-smoker were 14 (38.9%).
The BMI of the participants under 20 value were only 1 (2.8%), 24 value were maximum 5(13.9%), 2nd highest fall four values 25, 27, 28 and 30 were 4 (11.1%) and 31-39 category fall were 8 (22.3%).
Physical: Based on the results of ANOVA (repeated measure analysis of variance), there was a significant difference found in Baseline Data, (M=37.69, SD=1.62). After 30 days’ educational intervention were found significant differences (M=29.58, SD=1.46) based on Teck Back techniques on quality of life in heart failure patients and After 90 days’ educational intervention were found significant differences (M=29.83, SD=1.59) based on Teck Back techniques on quality of life in heart failure patients.
Emotional: Further results show that there was a significant difference found between baseline Data and 30 days’ educational intervention (Mean Difference =4.81, Std. Error =0.39, P= Englishhttp://ijcrr.com/abstract.php?article_id=4381http://ijcrr.com/article_html.php?did=4381
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