A study on treatment outcome and adverse drug reactions among extra pulmonary tuberculosis patients treated under DOTS in a tertiary care hospital

Background: Pulmonary tuberculosis being the predominant manifestation of the disease Extra-Pulmonary sites can also involve as a result of dissemination from a chief focus. The present study aims to determine the presentation and outcome of patients with extra-pulmonary tuberculosis treated with category I DOTS and to identify the incidence and pattern of ADRs caused by anti-tubercular drugs and to assess the causality and severity of the reported ADRs.Methods: Data was collected from cases of Tuberculosis patients diagnosed and treated under category I DOTS at Sri Siddhartha Medical College for the period of one year (during 2015). These patients were monitored for ADRs during OPDs and hospital stay. Any Adverse effects observed were recorded in ‘Adverse Drug Event Reporting Form’ prepared by the CDSCO, Govt. of India. The data were evaluated for patient demography, types of TB, incidence of ADRs, onset and outcome of the ADRs. ADRs were also assessed for their causality and severity by using WHO-UMC criteria and Hartwig’s scale.Results: Extra-pulmonary cases accounted for 32.2% of total TB cases. Among 224 cases of extra-pulmonary TB studied, 136 (60.7%) were males and 88 (39.3%) were females. Among these patients 82.2% completed treatment, 7.5% were defaulted, 9.9% died and 0.4% treatment failure. The most common reason for default was irregular treatment (29.5%) followed by alcohol abuse (23.5%). Among 224 patients of EPTB who were started on ATT as per DOTS, we noted ADR in 52 patients and 73 ADRs. Gastritis was the most common ADR (25%) followed by anorexia (14%) and skin reactions (9.6%) and multiple drug therapy was the major predisposing factor for these ADR’s.Conclusions: Extra-pulmonary Tuberculosis accounts for 32.2% of the total cases studied. Treatment irregularities and alcohol abuse are the two most common reasons for default. On evaluation of the causality of ADRs, majority of them were found to be ‘possible’ by WHO-UMC and Naronjo’s causality assessment scale. The severity assessment of ADRs showed that 42% reactions were moderate and 58% were of the ‘mild’ nature

A study on concept of P- drug selection among rural general practitioners

Background: The objective of the study was to assess the awareness of P- drug selection among rural general practitioners’s (GP) for common medical conditions.Methods: Fifty general practitioners in Tumakuru district were provided with proformas for selection of P- drugs for mild to moderate hypertension, diabetes, upper respiratory tract infections and acid peptic disease based on safety, affordability, need, and efficacy (SANE criteria).Results: Forty one GP’s responded by completing the proformas. Seventeen of them were aware of the concept of P- drug selection. In hypertension, beta blockers followed by Angiotensin Converting Enzyme (ACE) inhibitors were most commonly preferred. In diabetes, biguanides followed by sulfonylureas were preferred as oral hypoglycemic agents. Ampicillin, Ciprofloxacin and Cotrimoxazole were the commonly used antibiotics for upper respiratory tract infections. Ranitidine and antacids were preferred for acid peptic disease. Affordability followed by efficacy was the deciding criteria for P- drug selection.Conclusions: There is lack of awareness of P- drug selection among many rural GP’s. Therefore, there is necessity to create awareness about P- drug selection through continued medical education for rational use of drugs

A study of adverse drug reactions among pulmonary tuberculosis patients treated under dots in a tertiary care hospital

Background: DOTS under RNTCP is the current treatment available for Pulmonary Tuberculosis. This treatment exhibit a greater level of efficacy with a small degree of toxicity. The present study aims to determine demography of patients with pulmonary tuberculosis and to study the ADRs caused by anti tubercular drugs and to assess the causality and severity of the reported ADRs.Methods: We studied cases of Pulmonary Tuberculosis diagnosed and treated under category I DOTS at Department of Pulmonary Medicine for the period of one year (during 2015). Adverse effects observed during treatment course were recorded in standard ‘Adverse Drug Event Reporting Form’. ADRs were also assessed for their causality and severity by using WHO-UMC criteria and Hartwig’s scale.Results: Pulmonary cases accounted for 67.6% of total TB cases. Among 434 cases of pulmonary tuberculosis 33 (7.6%) patients were defaulters; among them 3(9.5%) cases were defaulters due to ADRs. In our study 96 patients developed 123 ADRs of various types and most of the ADRs noted within first 2 weeks of initiation of treatment. Gastritis was the most common ADRs (28/22.7%) followed by anorexia (26/21.1%).Conclusions: In our study 22.1% of patients developed ADRs. ADRs recorded in our study were categorised under ‘probable’ and ‘possible’ causes and severity assessment showed 48% are moderate and 52% are ‘mild’ in nature. Still ADRs accounted for 9% default rate. Hence implementations of good patient care oriented programs are needed for early diagnosis and to reduce default rate and drug resistance

Implementing standardised rhodes index to measure the efficacy of ginger extract (Zingiber officinale) in pregnancy induced nausea and vomiting

Background: Although nausea and vomiting are natural signs of pregnancy affecting about half the pregnant women during their first trimester of pregnancy, it is unpleasant and difficult symptom to deal with. Considering the fact that medication during pregnancy is not advised, we decided to study the efficacy of a natural product to control nausea and vomiting during early pregnancy. Our study was directed to estimate the efficacy of ginger extract (Zingiber officinale) in pregnancy induced nausea and vomiting.Methods: A total of 30 women with pregnancy of 4-16 weeks, suffering from nausea and vomiting were included in this study (n=30). Subjects were given ginger extract 250mg, to be taken 3 times a day half an hour before food for 1 week. Severity of vomiting was assessed by Rhodes Index of Nausea and Vomiting by the patients. Baseline scores were compared with the score at the end of 7 day. The findings were analysed statistically.Results: Effect with the ginger extract in pregnancy induced nausea and vomiting was assessed at the end of treatment (day 7) and compared with the baseline values. Four patients reported symptoms of heartburn. Otherwise, there were no other reports of any adverse effects. The results showed significance (p <0.005).Conclusions: Ginger extract (Zingiber officinale) helps in reducing severity and frequency of pregnancy induced nausea and vomiting. Therefore, we conclude that ginger extract can be used for mild to moderate nausea and vomiting induced by pregnancy during first trimester

Modified Goff Symptom Index : Simple triage tool for ovarian malignancy

Objectives: Ovarian cancer often goes undiagnosed or misdiagnosed in the early stages. The present study aimed to validate a modified version of the Goff Symptom Index (GSI) in an Indian population. Methods: This prospective case-control study was conducted between July 2010 and June 2012 in a university hospital in Manipal, Karnataka, India. A total of 305 inpatients admitted for ovarian pathology investigations and outpatients undergoing routine gynaecological check-ups were included in the study. The modified GSI (MGSI) was used to investigate the presence, severity, frequency and duration of 10 ovarian cancer symptoms on a scale of 1–5. Four additional symptoms were included with those of the original GSI (two symptoms from a previous MGSI and two new symptoms). Patients were regarded as positive for ovarian cancer if symptoms occurred &gt;12 times per month and time since onset was &lt;1 year. Histopathology confirmed the diagnosis of ovarian tumours. Results: A total of 13 patients were excluded. The final sample (n = 292) was divided into a test group (n = 74) and a control group (n = 218) based on histopathology. Within the controls, 144 women were found to have benign tumours. The MGSI was positive in 71.6% of the test group as opposed to only 11.5% of the control group. The addition of two symptoms (loss of appetite and weight) to the GSI increased the test’s sensitivity from 71.6% to 77% without compromising specificity (88.5%). Conclusion: Based on these findings, the addition of two new symptoms (loss of appetite and weight) to the GSI is proposed in order to increase the test’s sensitivity. However, the addition of urinary symptoms to the GSI requires further validation

Efficacy of terbutaline in preterm labour - our experience

Background: Preterm birth is one of the important causes of perinatal mortality and morbidity in developed countries after congenital malformations. Postponement of delivery plays essential role in preventing such incidences by allowing fetal lung maturity.Methods: This is a prospective study conducted over a period of 20 months among the patients admitted for preterm labour with gestational period between 27 to 36 weeks. After the patients obeyed all the inclusion criteria, they were administered terbutaline 250 µg subcutaneously every 8th hourly followed by 5 mg tablet orally twice daily till contractions ceased. The patients were analysed for gestational period at which they presented with preterm labour contractions, associated risk factors, response to terbutaline, and gestational period at delivery, perinatal complications, neonatal and maternal outcomes. The data obtained were analysed by descriptive analysis.Results: There were 1,678 deliveries during study period, out of which 207 (12%) presented with preterm labour and 20 (~10%) patients received terbutaline. Idiopathic (50%) and vaginal infections (25%) were common causes of preterm labour among the patients who received terbutaline. The labour was prolonged by 3 - 5 days among 8 patients, 7 - 15 days in 9 patients and 15 - 30 days in 3 patients. Common maternal side effects were nausea and tremors. Neonatal outcome was good in most of the cases except in 5 (25%) neonates who required NICU admission but they all recovered well without any morbidity.Conclusions: Administration of terbutaline prolonged labour without any serious maternal complications and better neonatal outcome as 90% of the neonates were born without any complications. Hence, terbutaline can be used as a safe and effective tocolytic agent among patients presenting with preterm labour

A GATA-binding protein expressed predominantly in the pupal ovary of the silkworm, Bombyx mori

Preferential localization of Bkm (Banded krait minor-satellite) DNA sequences on Y/W chromosomes of higher eukaryotes, which remain highly condensed in somatic cells but undergo extensive decondensation in the germ cells during early stages of development, led to the postulation for the existence of a sex- and tissue-specific Bkm-binding protein (BBP). Accordingly, we purified and characterized a BmBBP expressed predominantly in pupal ovary of the silkworm (Bombyx mori). 2D-PAGE revealed BmBBP as moderately basic (pI 7.8-8, in the range expected for DNA-binding proteins) and Matrix Assisted Laser Desorption/Ionization Time of Flight exhibited a value of 37.5-kDa. BmBBP neither contains nor requires divalent metal ions for its DNA-binding activity, suggesting that it does not belong to the well-studied GATA-family of transcription factors. BmBBP is unusually strong in its DNA-binding characteristics to Bkm (GATA-repeats), which suggests its probable role in bringing about coordinated chromatin conformational changes to activate genes present in associated chromosomal domains. Fluorescence immuno-localization studies employing specific anti-BmBBP antibodies revealed its presence in the follicle cells and in the ooplasm, as well as the nucleus of different developmental stages of oocytes

Prescription pattern of patients admitted in the intensive care unit of a tertiary care hospital in Puducherry, India: a cross sectional study

Background: Patients with varied demographic characteristics, admission criteria and heterogeneous group are admitted to medical Intensive Care Unit (ICU) and are usually associated with co-morbid illnesses. Instituting rational pharmacotherapy is the need of the hour for saving the life of critically-ill patients while irrational drug use may be life threatening. Drug use patterns and prescribing behaviour are the essential tools to measure drug use in health care facilities.Methods: A record based, cross-sectional, observational study was done at medical ICU, IGMC and RI, Puducherry after obtaining IEC approval. Systemic random sampling was followed and data was collected for a period of one year. Data were analysed based on demographic characteristics, prescribing pattern and WHO drug use indicators.Results: The data of 151 patients were analysed. Mean age of the patients admitted in ICU was 52.9±17.7 years. Percentage of male patients (57.6) admitted in ICU were more when compared to female patients (42.4). Infective etiology was the most common factor for ICU admission followed by cardiac disorders. Diabetes mellitus and hypertension were the most common co-morbidities. The average length of stay in ICU was 4.11±2.99 days. Duration of stay in ICU ranged from 1-5 days (78.8% patients) to 15-20 days (0.1% patients). On an average 10.6±4.3 drugs were prescribed for each patient. Percentage of drugs prescribed by generic name was 45.8%. Majority of the drugs (87.4%) were from essential medicine list. Antibiotics in the prescription was 13.8% and 44.4% of drugs were administered in parenteral route. The prescription was complete in 145 case sheets (96%). Majority of the patients (68.9%) were discharged with improvement in the condition for which they were admitted.Conclusions: This drug utilization study has highlighted the strengths and shortcomings of the prescription pattern of patients who were admitted in the critical care setup. The information derived from this research work will be transmitted to the stakeholders for implementing the modifications wherever applicable for the betterment of the patient and the community