Safety of Hydroxychloroquine use for COVID-19 prophylaxis: A questionnaire-based pilot study in healthcare professionals

P. Nadig, V. Reddy, A. Bhambhani, Ravikiran, Satyagama Suvarchala, Supriya Acharya
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Abstract

Hydroxychloroquine (HCQ) was recommended for prophylaxis against SARS-COV-2 for the health care professionals by the Indian Council for Medical Research. We conducted this study to explore the safety of Hydroxychloroquine in health care professionals. A validated questionnaire was circulated electronically to the health care professionals, who were on HCQ as per ICMR recommended regimen. Questions on specific adverse drug reactions (ADRs) were asked along with other details. The participants were requested to upload the baseline and additional electrocardiograms (ECGs) taken during HCQ prophylaxis. Incidence, severity, causality (relatedness to the drug), expectedness, and seriousness of the ADRs were determined as per the standard guidelines. The ECGs were evaluated for the appearance of significant changes. The observations were analyzed through descriptive statistics. The ECG changes were compared using the Students t-test and the association of risk factors with the ADRs was evaluated using logistic regression analysis. ADRs were observed in 58 (46 %) of 126 participants. Gastrointestinal symptoms followed by headache and skin rashes were commonly observed. The ADRs were mostly mild to moderate in the category, non-serious, and possibly related to HCQ. Significant ECG changes were rare. Diabetes, hypertension, and the use of concomitant medication/s were the risk factors. Except for blurred vision, all the ADRs were unexpected in terms of frequency. HCQ causes non-specific ADRs of mild to moderate degrees when used as prophylaxis. Though non-serious, almost all were unexpected. ECG changes are probably not frequent in the absence of a pre-existing disease.
羟氯喹用于COVID-19预防的安全性:一项针对医疗保健专业人员的基于问卷的试点研究
印度医学研究委员会建议卫生保健专业人员使用羟氯喹预防SARS-COV-2。我们进行了这项研究,以探讨羟基氯喹在卫生保健专业人员中的安全性。一份有效的问卷以电子方式分发给按照ICMR推荐方案使用HCQ的卫生保健专业人员。关于特定药物不良反应(adr)的问题以及其他细节。参与者被要求上传基线和额外的心电图(ECGs)在HCQ预防期间。根据标准指南确定adr的发生率、严重程度、因果关系(与药物的相关性)、预期性和严重性。评估心电图是否出现显著变化。观察结果通过描述性统计进行分析。采用学生t检验比较心电图变化,采用logistic回归分析评价危险因素与不良反应的相关性。126名参与者中有58人(46%)出现不良反应。胃肠道症状继发头痛和皮疹。不良反应多为轻度至中度,不严重,可能与HCQ有关。显著的心电图改变罕见。糖尿病、高血压和合用药物是危险因素。除了视力模糊外,所有不良反应的发生频率都出乎意料。HCQ作为预防用药时可引起轻度至中度的非特异性不良反应。虽然不严重,但几乎都是出乎意料的。在没有预先存在疾病的情况下,心电图改变可能不常见。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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