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羟氯喹预防 COVID-19 的疗效和安全性:随机试验的系统评价和荟萃分析。

The efficacy and safety of hydroxychloroquine for COVID-19 prophylaxis: A systematic review and meta-analysis of randomized trials.

机构信息

Department of Medicine, McMaster University, Hamilton, Canada.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

出版信息

PLoS One. 2021 Jan 6;16(1):e0244778. doi: 10.1371/journal.pone.0244778. eCollection 2021.

DOI:10.1371/journal.pone.0244778
PMID:33406138
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7787432/
Abstract

BACKGROUND

Populations such as healthcare workers (HCW) that are unable to practice physical distancing are at high risk of acquiring Coronavirus disease-2019 (COVID-19). In these cases pharmacological prophylaxis would be a solution to reduce severe acute respiratory syndrome coronavirus-2 (SARS CoV-2) transmission. Hydroxychloroquine has in vitro antiviral properties against SARS CoV-2. We therefore sought to determine the efficacy and safety of hydroxychloroquine as prophylaxis for COVID-19.

METHODS AND FINDINGS

We electronically searched EMBASE, MEDLINE, the Cochrane COVID-19 Register of Controlled Trials, Epistemonikos COVID-19, clinicaltrials.gov, and the World Health Organization International Clinical Trials Registry Platform up to September 28th, 2020 for randomized controlled trials (RCTs). We calculated pooled relative risks (RRs) for dichotomous outcomes with the corresponding 95% confidence intervals (CIs) using a random-effect model. We identified four RCTs (n = 4921) that met our eligibility criteria. The use of hydroxychloroquine, compared to placebo, did not reduce the risks of developing COVID-19 (RR 0.82, 95% CI 0.65 to 1.04, moderate certainty), hospitalization (RR 0.72, 95% CI 0.34 to 1.50, moderate certainty), or mortality (RR 3.26, 95% CI 0.13 to 79.74, low certainty), however, hydroxychloroquine use increased the risk of adverse events (RR 2.76, 95% CI 1.38 to 5.55, moderate certainty).

CONCLUSION

Although pharmacologic prophylaxis is an attractive preventive strategy against COVID-19, the current body of evidence failed to show clinical benefit for prophylactic hydroxychloroquine and showed a higher risk of adverse events when compared to placebo or no prophylaxis.

摘要

背景

无法保持身体距离的人群,如医护人员,感染 2019 年冠状病毒病(COVID-19)的风险很高。在这种情况下,药物预防将是减少严重急性呼吸综合征冠状病毒-2(SARS-CoV-2)传播的一种解决方案。羟氯喹具有体外抗 SARS-CoV-2 的抗病毒特性。因此,我们试图确定羟氯喹作为 COVID-19 预防药物的疗效和安全性。

方法和发现

我们通过电子检索 EMBASE、MEDLINE、Cochrane COVID-19 对照试验登记处、Epistemonikos COVID-19、clinicaltrials.gov 和世界卫生组织国际临床试验注册平台,截至 2020 年 9 月 28 日,检索了随机对照试验(RCTs)。我们使用随机效应模型计算了二分类结局的合并相对风险(RR)及其相应的 95%置信区间(CI)。我们确定了四项符合我们入选标准的 RCT(n=4921)。与安慰剂相比,使用羟氯喹并未降低发生 COVID-19(RR 0.82,95%CI 0.65 至 1.04,中等确定性)、住院(RR 0.72,95%CI 0.34 至 1.50,中等确定性)或死亡率(RR 3.26,95%CI 0.13 至 79.74,低确定性)的风险,但是,羟氯喹的使用增加了不良事件的风险(RR 2.76,95%CI 1.38 至 5.55,中等确定性)。

结论

虽然药物预防是预防 COVID-19 的一种有吸引力的策略,但目前的证据没有显示预防性羟氯喹有临床益处,与安慰剂或不预防相比,羟氯喹的使用风险更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9cc/7787432/705adff60824/pone.0244778.g006.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9cc/7787432/705adff60824/pone.0244778.g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9cc/7787432/38f6706dbb68/pone.0244778.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9cc/7787432/30600a21d388/pone.0244778.g002.jpg
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