Effectiveness of pegylated erythropoietin in renal anaemia patients on dialysis-a multicentre, cross-sectional, observational outcome study

Background: Low dose of pegylated erythropoietin (PegEPO) is better than conventional erythropoietin stimulating agents (ESAs) in improving hyporesponsiveness and maintaining stable haemoglobin (Hb) levels in renal anaemic patients undergoing hemodialysis. This real-world study aimed to assess effectiveness and safety of low-dose PegEPO (30 µg/0.3 mL), administered at different time-points in renal anaemia patients on dialysis. Methods: HEMEPEG (HEMoglobin outcomE with PegEPO) was a multicentre, retrospective, cross-sectional, observational study of renal anaemia patients receiving PegEPO up to 3 months. The study assessed an increase in Hb, patients achieving Hb 10-12 g/dl, and Hb increase by ≥1 and ≥2 g/dl. Results: Data from 223 out of 273 patients from 19 Indian centers were analyzed. PegEPO was administered weekly to 132 patients (59.19%), with 38.64% being diabetic and 77.27% previously treated with ESAs. Ten day dosing was given to 91 patients (40.81%), including 46.15% diabetic patients and 72.53% previously treated with ESAs. A Significant (p<0.0001) increase in mean Hb levels from baseline to day 30, 60 and 90 were observed for both studied groups, with a target Hb of 10-12 g/dl achieved in 51.08% and 52.85% of patients in the respective groups after 3 months. An increase in Hb by ≥1 and ≥2 g/dl were observed in weekly (68.67% and 45.78%) and 10-day group (77.14% and 50.00%) patients, respectively. Conclusions: PegEPO (30 µg/0.3 mL) was effective treatment of renal anaemia and diabetic chronic kidney disease (CKD) patients on dialysis when administered weekly or every 10 days over a 3-month treatment period

Evaluation of Adverse Drug Reactions in a Tertiary Care Hospital in Kolkata, West Bengal: An Observational, Cross-sectional Study

Background:In the present world, drugs are inevitable to cure diseases. However, these drugs are reported to cause unwanted complications to the patients.Adverse drug reactions (ADRs) are considered as one of the leading causes of morbidity and mortality, identified globally. Thus, vigilance of these adverse effects is essential in order to reduce patient suffering. Present study thus aimed to collect reports and to evaluate on adverse drug events from patients attending a tertiary care hospital in Kolkata.Materials &Method: This is a cross-sectional, observational study conducted for a period of six months at R.G. Kar Medical College and Hospital, West Bengal, India providing tertiary level of healthcare to the community. Data were collected from both outpatient and inpatient departments. Collected datawere evaluated on the basis of different parameters like demographic features of patients, drugs responsible for the adverse effects, symptoms of the adverse effects and causality assessment based on WHO-UMC and Naranjo assessment scale.Results: Out of the 100 reports collected on adverse drug reactions, 55% of the patients were female and 45% male. The mean age of the patients was 47 years. Anti-neoplastic and immunomodulating agents was responsible for maximum number (41.78%) of ADR cases. Using the WHO-causality assessment scale, 67% of ADRs were found to be probably drug-related and 33% of the ADRs were possible.Based on the Naranjo-causality assessment scale, 43% ADRs were found to be definite,45% probable and 12% possible.Conclusion:Monitoring of ADRs is thus essential to create awareness in the society and to optimize therapy by increasing patient compliance

Antimicrobial Prophylaxis in Lower Uterine Segment Caesarean Section: A Prospective Observational Data-based Study

Introduction: Any major surgery like lower uterine Caesarean Section (CS) can be hazardous due to postoperative nosocomial infection. Pregnant mothers are at greater risk during such surgical intervention as compared to vaginal delivery. Prophylactic antibiotic administration is a standard practice across the globe to prevent such anticipated postoperative infection. Aim: To evaluate the prophylactic antimicrobial use with regards to the choice of antimicrobials, dose, route, timing and duration, any possible Adverse Drug Reaction (ADR) as well as to assess the frequency of the postoperative morbidity due to infection (if any). Materials and Methods: A prospective observational data-based study was conducted in the Department of Pharmacology in collaboration with Department of Obstetrics and Gynaecology, Burdwan Medical College and Hospital, Burdwan, West Bengal, India, from February 2016 to October 2017. Study was conducted on 1944 pregnant women of reproductive age group planned or scheduled for elective/emergency lower segment CS, but otherwise healthy and received prophylactic antimicrobials for the surgery. They were prospectively observed regarding the treatment they received with focus on antimicrobial agents from the period of antimicrobial prophylaxis during their stay at hospital to till their discharge. Demographic data, vital signs, indication of CS, postoperative infections and ADR if any were recorded in predesigned proforma. The study population was divided into two groups: group A included 995 mothers, who received ceftriaxone sodium (1 g intravenously) and metronidazole (15 mg/kg) infusion and group B included 949 mothers, who received ampicillin (2 g intravenously), metronidazole (15 mg/kg) infusion and injection gentamycin (5 mg/kg) for 0.5 hour before initiation of CS. The data were statistically analysed by standard statistical software Microsoft Excel 2010 and Statistical Package for the Social Sciences (SPSS) sotware version 27.0 (SPSS Inc., Chicago, IL, USA) expressed as mean and standard deviation and percentage. Independent t- test and Chi-square test were used for analysis. Results: The mean age of group A was 22.36±3.07 years and group B was 22.76±2.47 years. Endomyometritis was documented in 4 (0.4%) from group A and 2 (0.21%) from the group B. Wound infection was present in 3 (0.3%) for group A and five (0.5%) for the group B. Infection related complications like chest infection seen in 7 (0.7%) for group A and in 3 (0.31%) for group B and urinary tract infection was noticed in 6 (0.6%) for group A and 5 (0.52%) for group B. Any incidence of maternal mortality was not evident among the two study groups and statistically insignificant ADR like vomiting and maculopapular rash (p-value=0.324) was observed in both the study groups with the use of above-mentioned antimicrobial therapy. Conclusion: Prophylactic use of ceftriaxone plus metronidazole and combination of triple antimicrobial therapy of ampicillin, metronidazole, and gentamycin therapy at the usual standard dose were commonly used antimicrobials at the present set up and they are safe and equally effective in decreasing considerably the incidence of post caesarean maternal infection thereby reducing their morbidity and mortality