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氯喹、羟氯喹与2019冠状病毒病:疗效与安全性的系统评价及叙述性综合分析

Chloroquine, hydroxychloroquine, and COVID-19: Systematic review and narrative synthesis of efficacy and safety.

作者信息

Takla Michael, Jeevaratnam Kamalan

机构信息

Faculty of Health and Medical Science, University of Surrey, Guildford GU2 7AL, United Kingdom.

出版信息

Saudi Pharm J. 2020 Dec;28(12):1760-1776. doi: 10.1016/j.jsps.2020.11.003. Epub 2020 Nov 13.

Abstract

The COVID-19 pandemic has required clinicians to urgently identify new treatment options or the re-purposing of existing drugs. Of particular interest are chloroquine (CQ) and hydroxychloroquine (HCQ). The aims of this systematic review are to systematically identify and collate 24 studies describing the use of CQ and HCQ in human clinical trials and to provide a detailed synthesis of evidence of its efficacy and safety. Of clinical trials, 100% showed no significant difference in the probability of viral transmission or clearance in prophylaxis or therapy, respectively, compared to the control group. Among observational studies employing an endpoint specific to efficacy, 58% concurred with the finding of no significant difference in the attainment of outcomes. Three-fifths of clinical trials and half of observational studies examining an indicator unique to drug safety discovered a higher probability of adverse events in those treated patients suspected of, and diagnosed with, COVID-19. Of the total papers focusing on cardiac side-effects, 44% found a greater incidence of QTc prolongation and/or arrhythmias, 44% found no evidence of a significant difference, and 11% mixed results. The strongest available evidence points towards the inefficacy of CQ and HCQ in prophylaxis or in the treatment of hospitalised COVID-19 patients.

摘要

新冠疫情要求临床医生紧急确定新的治疗方案或对现有药物进行重新利用。特别受关注的是氯喹(CQ)和羟氯喹(HCQ)。本系统评价的目的是系统识别和整理24项描述CQ和HCQ在人体临床试验中使用情况的研究,并对其疗效和安全性证据进行详细综合分析。在临床试验中,100%的研究表明,与对照组相比,在预防或治疗中病毒传播或清除的概率分别无显著差异。在采用特定疗效终点的观察性研究中,58%的研究结果与未发现结局有显著差异的结果一致。在检查药物安全性特有指标的临床试验中,五分之三以及观察性研究的一半发现,在疑似或确诊新冠的患者中,接受治疗的患者出现不良事件的概率更高。在关注心脏副作用的所有论文中,44%发现QTc延长和/或心律失常的发生率更高,44%未发现有显著差异的证据,11%的结果不一。现有最有力的证据表明,CQ和HCQ对预防或治疗住院新冠患者无效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5417/7783222/fd54037fa8c6/gr1.jpg

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