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瑞德西韦治疗成人 COVID-19:美国医师学会实践要点的实时系统综述。

Remdesivir for Adults With COVID-19 : A Living Systematic Review for American College of Physicians Practice Points.

机构信息

Minneapolis VA Evidence Synthesis Program, Center for Care Delivery and Outcomes Research, and University of Minnesota School of Medicine, Minneapolis, Minnesota (T.J.W.).

Minneapolis VA Section of Infectious Diseases and University of Minnesota School of Medicine, Minneapolis, Minnesota (A.S.K.).

出版信息

Ann Intern Med. 2021 Feb;174(2):209-220. doi: 10.7326/M20-5752. Epub 2020 Oct 5.

Abstract

BACKGROUND

Few treatments exist for coronavirus disease 2019 (COVID-19).

PURPOSE

To evaluate the effectiveness and harms of remdesivir for COVID-19.

DATA SOURCES

Several databases, tables of contents of journals, and U.S. Food and Drug Administration and company websites were searched from 1 January through 31 August 2020.

STUDY SELECTION

English-language, randomized trials of remdesivir treatments for adults with suspected or confirmed COVID-19. New evidence will be incorporated using living review methods.

DATA EXTRACTION

Single-reviewer abstraction and risk-of-bias assessment verified by a second reviewer; GRADE (Grading of Recommendations Assessment, Development and Evaluation) methods used for certainty-of-evidence assessments.

DATA SYNTHESIS

Four randomized trials were included. In adults with severe COVID-19, remdesivir compared with placebo probably improves recovery by a large amount (absolute risk difference [ARD] range, 7% to 10%) and may result in a small reduction in mortality (ARD range, -4% to 1%) and a shorter time to recovery or clinical improvement. Remdesivir may have little to no effect on hospital length of stay. Remdesivir probably reduces serious adverse events by a moderate amount (ARD range, -6% to -8%). Compared with a 10-day remdesivir course, a 5-day course may reduce mortality, increase recovery or clinical improvement by small to moderate amounts, reduce time to recovery, and reduce serious adverse events among hospitalized patients not requiring mechanical ventilation. Recovery due to remdesivir may not vary by age, sex, symptom duration, or disease severity.

LIMITATIONS

Low-certainty evidence with few published trials, including 1 preliminary report and 2 open-label trials. Trials excluded pregnant women and adults with severe kidney or liver disease.

CONCLUSION

In hospitalized adults with COVID-19, remdesivir probably improves recovery and reduces serious adverse events and may reduce mortality and time to clinical improvement. For adults not receiving mechanical ventilation or extracorporeal membrane oxygenation, a 5-day course of remdesivir may provide similar benefits to and fewer harms than a 10-day course.

PRIMARY FUNDING SOURCE

U.S. Department of Veterans Affairs, Veterans Health Administration Office of Research and Development, Health Services Research and Development Service, and Evidence Synthesis Program.

摘要

背景

针对 2019 年冠状病毒病(COVID-19),目前的治疗方法寥寥无几。

目的

评估瑞德西韦治疗 COVID-19 的效果和危害。

资料来源

从 2020 年 1 月 1 日至 8 月 31 日,检索了多个数据库、期刊目录以及美国食品和药物管理局和公司网站。

研究选择

针对疑似或确诊 COVID-19 的成年患者,采用瑞德西韦治疗的英文随机试验。将采用实时审查方法纳入新证据。

资料提取

单 reviewer 提取和由另一位 reviewer 验证的偏倚风险评估;采用 GRADE(推荐评估、制定与评价)方法评估证据确定性。

资料综合

共纳入 4 项随机试验。在患有严重 COVID-19 的成年患者中,与安慰剂相比,瑞德西韦可能会显著改善恢复(绝对风险差异范围为 7%至 10%),并且可能会略微降低死亡率(绝对风险差异范围为-4%至 1%)和缩短恢复或临床改善的时间。瑞德西韦对住院时间可能影响不大。瑞德西韦可能会适度减少严重不良事件(绝对风险差异范围为-6%至-8%)。与 10 天疗程的瑞德西韦相比,5 天疗程可能会适度减少死亡率,增加恢复或临床改善程度,缩短恢复时间,并减少不需要机械通气的住院患者的严重不良事件。瑞德西韦的疗效可能不会因年龄、性别、症状持续时间或疾病严重程度而有所差异。

局限性

低确定性证据,试验数量较少,包括 1 份初步报告和 2 份开放标签试验。试验排除了孕妇和患有严重肾脏或肝脏疾病的成年人。

结论

在患有 COVID-19 的住院成年患者中,瑞德西韦可能会改善恢复情况,减少严重不良事件,并且可能会降低死亡率和临床改善时间。对于未接受机械通气或体外膜肺氧合的成年人,5 天疗程的瑞德西韦可能与 10 天疗程具有相似的疗效,并且危害更小。

主要资金来源

美国退伍军人事务部,退伍军人卫生管理局研究与发展办公室,卫生服务研究与发展服务处,以及证据综合计划。

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