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评估瑞德西韦治疗新型冠状病毒肺炎疗效、有效性和安全性的临床研究:一项范围综述

Clinical studies assessing the efficacy, effectiveness and safety of remdesivir in management of COVID-19: A scoping review.

作者信息

Pimentel Juan, Laurie Cassandra, Cockcroft Anne, Andersson Neil

机构信息

CIET-PRAM, Department of Family Medicine, McGill University, Montreal, Canada.

Departamento de Medicina Familiar y Salud Pública, Facultad de Medicina, Universidad de La Sabana, Chía, Colombia.

出版信息

Br J Clin Pharmacol. 2021 Jul;87(7):2663-2684. doi: 10.1111/bcp.14677. Epub 2020 Dec 15.

Abstract

AIMS

Remdesivir is 1 of the repurposed drugs under investigation to treat patients with COVID-19. Clinicians and decision-makers need a summary of the most recent evidence. This scoping review maps the evidence on the efficacy, effectiveness and safety of remdesivir for patients with COVID-19, up to 14 September 2020.

METHODS

Our scoping review searched Pubmed, Embase (Ovid), Scopus and 17 primary trial registries for empirical publications or active registered clinical trials for data on the efficacy, effectiveness, or safety of remdesivir for COVID-19 or SARS-CoV-2. We conducted a narrative synthesis of the included publications.

RESULTS

Seventeen empirical studies and 23 clinical trial registrations (n = 40) accumulated 46 508 participants. We found 4 published randomized-controlled trials accumulating 2293 patients. Two trials reported shorter median recovery time and better clinical status among patients who received remdesivir compared with the control groups. Observational studies report an association between remdesivir treatment and decreased mortality, as well as increased survival. The most common adverse reaction was hepatic impairment, although the trials reported a similar proportion of adverse events in the intervention and control groups.

CONCLUSION

Remdesivir might shorten the time to clinical improvement among hospitalized adults with severe COVID-19. Trial data report a similar proportion of adverse events in treated and control groups. The results of the 23 registered active trials, including more than 30 000 participants, will shed light on the efficacy and safety of the antiviral. The findings of the remaining clinical trials expected to report results in 2020 will allow a quantitative synthesis of available evidence.

摘要

目的

瑞德西韦是正在研究用于治疗2019冠状病毒病(COVID-19)患者的一种重新利用的药物。临床医生和决策者需要最新证据的总结。本综述绘制了截至2020年9月14日瑞德西韦治疗COVID-19患者的疗效、有效性和安全性的证据。

方法

我们的综述检索了PubMed、Embase(Ovid)、Scopus和17个主要试验注册库,以获取关于瑞德西韦治疗COVID-19或严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的疗效、有效性或安全性的实证出版物或正在进行的注册临床试验。我们对纳入的出版物进行了叙述性综合分析。

结果

17项实证研究和23项临床试验注册(n = 40)共纳入46508名参与者。我们发现4项已发表的随机对照试验共纳入2293名患者。两项试验报告称,与对照组相比,接受瑞德西韦治疗的患者中位恢复时间更短,临床状况更好。观察性研究报告了瑞德西韦治疗与死亡率降低以及生存率提高之间的关联。最常见的不良反应是肝功能损害,尽管试验报告干预组和对照组的不良事件比例相似。

结论

瑞德西韦可能会缩短住院的重症COVID-19成年患者临床改善的时间。试验数据报告治疗组和对照组的不良事件比例相似。23项正在进行的注册试验(包括30000多名参与者)的结果将阐明这种抗病毒药物的疗效和安全性。预计2020年报告结果的其余临床试验的结果将有助于对现有证据进行定量综合分析。

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