Adverse events associated with Covishield vaccination among healthcare workers in a tertiary hospital in South India.

Background: Vaccination is the most important prophylactic measure taken to curb COVID-19 pandemics. This study was undertaken to throw light on the safety of Covishield vaccine among health care workers (HCWs) and to assess the co-variates associated with incidence of adverse events. Methods: This prospective observational study was conducted in a tertiary care center in South India as part of the HCW vaccination drive. All consenting HCWs who received the first dose of Covishield vaccine and developed ADRs were included in this study. After vaccination, all beneficiaries were monitored for AEFI for a period of half an hour and later followed up through telephone and google survey forms on day 2 and day 7 of vaccination. The data was subsequently collated into spreadsheet format and analyzed. Results: The study included 1264 consenting healthcare workers who were predominantly youth, aged 15-24 years (n = 583, 46 %) and with a female preponderance of 76 % (n = 960). Past history of COVID-19 infections was reported among 4.6 % (58) of the study population. Postvaccination symptoms were majorly reported during the first (40 %) and second day (44 %) after vaccination with a high prevalence of both local (n = 1083, 85 %) and systemic symptoms (n = 1065, 84 %). The mean duration of symptoms was observed to be 1.4 ± 0.81 days post vaccination. Symptoms were observed significantly high among females (76.7 %, p = 0.013). The prevalence of systemic (88 % vs 80 %) (p < 0.001) and allergic symptoms (7 % vs 3 %; p = 0.03) were observed to be significantly high among respondents with <25 years of age. The systemic and allergic symptoms following vaccination were reported to be low among healthcare workers who had a previous history of COVID-19 infection. Conclusion: COVID vaccination has been observed to be safe and well tolerated with more systemic symptoms reported among younger age group and females.

A prospective, randomized study: Evaluation of the effect of rosuvastatin in patients with chronic obstructive pulmonary disease and pulmonary hypertension.

OBJECTIVES: Statins by their anti-inflammatory and endothelial stabilizing effect can be beneficial in patients with chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). The present study was done to evaluate the effect of rosuvastatin on pulmonary functions and quality of life (QOL) in patients with concomitant COPD and PH. MATERIALS AND METHODS: It was a prospective, randomized, double-blind, placebo-controlled, study conducted in patients with COPD and PH. A total of sixty patients were assigned to receive either rosuvastatin 10 mg or placebo once a day in addition to their conventional treatment for 12 weeks. Routine blood investigations, pulmonary functions, echocardiogram, exercise capacity, and QOL using a questionnaire were assessed at the baseline and after 12 weeks. RESULTS: In patients of rosuvastatin group, there was a statistically significant increase in peak expiratory flow rate (PEFR) (P = 0.04) but no significant change in other pulmonary functions: Forced vital capacity (FVC), forced expiratory volume at 1 s (FVC, FEV1, FEV1/FVC), and echocardiogram parameters. There was a significant increase in 6-min walk test (6-min walk distance) (P = 0.03) at the end of 12 weeks. On comparing with placebo, rosuvastatin showed a significant reduction (P = 0.045) in COPD exacerbations while adverse effects did not differ. CONCLUSION: Statins have a favorable effect on patients with COPD and PH regarding the improvement in PEFR, COPD exacerbations, and exercise capacity. Such effects can be beneficial in these patients and more so in patients with concomitant coronary artery disease or hyperlipidemia where long-term benefits of statins have been established.

Acebrophylline-induced angioedema.

A 53-year-old woman visited her physician complaining of acute breathlessness and productive cough. Her medications included budesonide and formoterol for asthma, fixed-dose combination aspirin 150 mg + clopidogrel 75 mg + atorvastatin 20 mg for ischemic heart disease. History revealed that she had allergic rhinitis and was hypersensitive to penicillins. The patient was prescribed acebrophylline (ABP). Six hours after ABP therapy she presented with generalized urticarial lesions, swelling of hands, feet, lips and face, suggestive of angioedema. ABP was stopped immediately, and the patient was treated symptomatically. This case was categorized as probable as per standard causality assessment scale.

Assessment of adverse drug reactions to antituberculosis regimen in a tertiary care hospital

Background: Adverse drug reactions are common with multidrug therapy in tuberculosis, if detected early can improve patient compliance and prevent emergence of resistance.Methods: A prospective observational study as a part of Pharmacovigilance Program under Central Drugs Standard Control Organisation was conducted in Kasturba hospital, Manipal to collect adverse drug reactions (ADR). Data of patients reported with antitubercular treatment (ATT) related ADRs from September 2012 to August 2013 was evaluated for patient demography, type of tuberculosis, ATT regimen, organ/ system affected and time of onset of ADR. ADRs were then subjected to causality assessment as per WHO scale.Results: A total of 65 ADRs were reported in 60 patients during the study period, of which 46.7% were in males and 53.3% in females. 85% of ADRs were reported in patients with pulmonary tuberculosis. 77% of ADRs were observed with daily regimen. Common ADRs were hepatitis (40%), gastritis (15%), skin reactions (15%), peripheral neuropathy (14%), gout (6%) and nephritis (3%). Median duration for the onset of ADR was 31 days each for hepatitis, gout, nephritis and 20, 11, 9 days for gastritis, peripheral neuropathy and skin reactions respectively. As per causality assessment, 80% of ADRs were assigned “possible”, 11% “probable” and 9% “certain”. As per severity scale 27.7% of ADR were severe, 36.9% were moderate.Conclusions: Early detection and management of ADRs is vital for the success of ATT and patient adherence.

A prospective study on the effect of topical lidocaine gel versus drops on ocular pain in manual small incision cataract surgery

Background: Cataract is globally acknowledged leading cause of blindness. This study was undertaken to compare the effects of Lidocaine 4% drops with 2% gel on intra operative and post-operative pain in patients who underwent manual small incision cataract surgery.Methods: It was a single Centre, one-surgeon, prospective, comparison study. Patients enrolled for surgeries were divided into Group A: Lidocaine 4% drops 1 ml was instilled in the conjunctival sac 5 minutes before surgery and Group B: Lidocaine 2% gel 2ml was applied. Endpoints evaluated were ocular pain of patient during and after surgery.Results: A total of 60 patients underwent MSICS, out of which 30 each received drops and gel. Mean intraoperative pain VAS score was 2.26±0.69 for gel group and 5.13±1.13 for drops group (p*<0.001) Mean post-operative pain VAS score was 0.26±0.69 in gel group and 1.13±1.13 in drops group (p*=0.002).Conclusions: Compared to drops, Lidocaine gel has reduced intraoperative and post-operative pain.

A study on the effect of topical lidocaine gel versus drops on surgeon抯 comfort during manual small incision cataract surgery

Background: Cataract is a frequent surgical procedure performed worldwide. The study compared lidocaine 4% drops with 2% gel on surgeon抯 comfort, need for supplemental anaesthesia and duration of surgery in patients who underwent manual small incision cataract surgery.Methods: This was a Prospective, Comparison study conducted at a Single centre by multiple surgeons. Patients enrolled for surgeries were divided into Group A: Lidocaine 4% drops 1ml was instilled in the conjunctival sac 5 minutes before surgery and Group B: Lidocaine 2% gel 2ml was applied. Endpoints evaluated were surgeon抯 comfort, need for supplemental anesthesia and duration of surgery.Results: The mean duration of surgery for gel was 20�minutes as compared to 29�minutes with drops (p*- value<0.001). 26 (87%) patients in gel did not require any supplemental anesthesia as compared to 3 (10%) patients in drops. Peribulbar supplementation was required for 20 (67%) patients in drops as compared to 1 (3%) patient in gel (p*- value<0.001). 26 (87%) patients in gel were operated comfortably by the surgeon as compared to 2 (6%) patients in drops. Mild to Moderate discomfort was experienced by the surgeon in operating 27 (90%) patients in drops as compared to 3(10%) patients in gel (p*- value<0.001).Conclusions: The surgeons were more comfortable using gel with least requirement of supplemental anaesthesia and faster completion compared to drops.