羟氯喹用于医护人员预防 SARS-CoV-2-一项评估有效性和安全性的多中心队列研究。

Hydroxychloroquine for SARS CoV2 Prophylaxis in Healthcare Workers - A Multicentric Cohort Study Assessing Effectiveness and Safety.

机构信息

Department of Pharmacology, Christian Medical College, Ludhiana, Punjab.

Department of Pharmacology and Clinical Pharmacology, Christian Medical College, Vellore, Tamil Nadu.

出版信息

J Assoc Physicians India. 2021 Jun;69(6):11-12.

PMID:34472778

Abstract

UNLABELLED

Background, Objective: We studied the effectiveness and safety of Hydroxychloroquine (HCQ) preexposure prophylaxis against COVID-19 in Healthcare workers (HCWs) previous studies being inconclusive due to small sample and lack of risk stratification Design and setting: Prospective, observational, multicenter cohort study in 44 hospitals in 17 Indian states during May-Sept 2020 Participants: 12089 Consenting Doctors, nurses, ancillary staff likely exposed to COVID-19 patients irrespective of whether taking HCQ preexposure prophylaxis (4257) or not(7826) participated,(in 6 data missing) Measurements: Data was collected on a self administered online questionnaire. Statistical analysis was done on SPSS version 20.

RESULTS

Age above 45 years, diabetes, hypertension, history of COVID contact were independent risk factors for COVID positivity. HCQ intake did not show an independent association. However, when adjusted for other risk factors, HCQ dose as per Government recommendations, 2-3, 4-5 and 6 or more weeks reduced the probability of COVID positivity by 34%, 48%, 72% respectively. COVID free median survival time was higher in non-diabetics, non-hypertensives, persons below 45 years, with no prior exposure to COVID case and those who took HCQ for more than 6 weeks With modeling extent of risk reduction under different scenarios of risk and HCQ intake was 1-65% . Major adverse events reported were GI disorder, palpitation, giddiness and 140 persons discontinued due to adverse events.

LIMITATIONS

Limitation of self reporting by HCWs in online form, minimized by specified options,mandatory fields and telephonic verificationConclusion: The study examined individual risk factors including site variations and found that HCQ 800 mg loading followed by 400 mg weekly, dose for more than 2 weeks, reduced the risk of COVID-19, in HCWs, and is a useful option in low resource settings till vaccines are made accessible to all.

TRIAL REGISTRATION

CTRI/2020/05/025183.

摘要

背景、目的：我们研究了羟氯喹（HCQ）暴露前预防对 COVID-19 的有效性和安全性。由于样本量小且缺乏风险分层，以前的研究结果不一致。

设计和设置

2020 年 5 月至 9 月，在印度 17 个邦的 44 家医院进行了一项前瞻性、观察性、多中心队列研究。研究对象为 12089 名同意参加研究的医生、护士和辅助人员，他们可能接触过 COVID-19 患者，无论是否服用 HCQ 暴露前预防药物（4257 人）或未服用（7826 人）。（6 人数据缺失）

测量

数据通过在线自我管理问卷收集。统计分析使用 SPSS 版本 20 进行。

结果

年龄大于 45 岁、糖尿病、高血压、有 COVID 接触史是 COVID 阳性的独立危险因素。HCQ 摄入与 COVID 阳性无独立关联。然而，当调整其他危险因素后，按政府建议的剂量，2-3、4-5 和 6 周或更长时间的 HCQ 摄入分别降低 COVID 阳性的概率 34%、48%、72%。非糖尿病、非高血压、年龄小于 45 岁、无 COVID 病例接触史和服用 HCQ 超过 6 周的患者 COVID 无感染中位生存时间更高。报告的主要不良事件有胃肠道紊乱、心悸、头晕，有 140 人因不良事件停药。