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莫努匹韦治疗成人轻或中度 COVID-19:随机对照试验的系统评价和荟萃分析。

Molnupiravir for treatment of adults with mild or moderate COVID-19: a systematic review and meta-analysis of randomized controlled trials.

机构信息

Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

The First Clinical Medical College of Lanzhou University, Lanzhou, China; Department of Radiology, The First Hospital of Lanzhou University, Lanzhou, China.

出版信息

Clin Microbiol Infect. 2023 Aug;29(8):979-999. doi: 10.1016/j.cmi.2023.04.014. Epub 2023 Apr 20.

Abstract

BACKGROUND

The effects of molnupiravir in treating patients with non-severe COVID-19 remain uncertain.

OBJECTIVES

To evaluate the efficacy and safety of molnupiravir in adult patients with mild or moderate COVID-19.

DATA SOURCES

PubMed, Embase, CENTRAL, Web of Science, and WHO COVID-19 database up to 27 December 2022.

STUDY ELIGIBILITY CRITERIA

Randomized controlled trials with no language restrictions.

PARTICIPANTS

Adults with mild or moderate COVID-19.

INTERVENTIONS

Molnupiravir against standard care or placebo.

ASSESSMENT OF RISK OF BIAS

We used a revision of RoB-2 criteria.

METHODS OF DATA SYNTHESIS

Outcomes were mortality, hospital admission, viral clearance, time to viral clearance, time to symptom resolution or clinical improvement, any adverse events, and serious adverse events. We performed DerSimonian-Laird random-effects meta-analyses to summarize the evidence and evaluated the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach.

RESULTS

Nine randomized controlled trials enrolling 30 472 patients proved eligible. Majority of patients were outpatients, with a mean age ranging from 35 to 56.6 years. In adult patients with mild or moderate COVID-19, molnupiravir probably reduces mortality (relative risk [RR], 0.43; 95% CI, 0.20-0.94; risk difference [RD], 0.1% fewer; moderate certainty) and the risk of hospital admission (RR, 0.67; 95% CI, 0.45-0.99; RD, 1.4% fewer; moderate certainty) and may reduce time to viral clearance (mean difference, -1.81 days; 95% CI, -3.31 to -0.31; low certainty) and time to symptom resolution or clinical improvement (mean difference, -2.39 days; 95% CI, -3.71 to -1.07; low certainty). Molnupiravir probably increases the rate of viral clearance (RR, 3.47; 95% CI, 2.43-4.96; RD 16.1% more; moderate certainty) at 7 days (±3 days) and likely does not increase serious adverse events (RR, 0.84; 95% CI, 0.61-1.15; RD 0.1% fewer; moderate certainty).

CONCLUSIONS

In adult patients with mild or moderate COVID-19, molnupiravir likely reduces mortality and risk of hospital admission probably without increasing serious adverse events.

摘要

背景

莫努匹韦治疗非重症 COVID-19 患者的效果仍不确定。

目的

评估莫努匹韦在轻症或中度 COVID-19 成年患者中的疗效和安全性。

资料来源

PubMed、Embase、CENTRAL、Web of Science 和世卫组织 COVID-19 数据库,截至 2022 年 12 月 27 日。

研究入选标准

无语言限制的随机对照试验。

研究对象

轻症或中度 COVID-19 成人患者。

干预措施

莫努匹韦对比标准治疗或安慰剂。

偏倚风险评估

我们使用了 RoB-2 标准的修订版。

资料综合方法

结局指标为死亡率、住院、病毒清除、病毒清除时间、症状缓解或临床改善时间、任何不良事件和严重不良事件。我们采用 DerSimonian-Laird 随机效应荟萃分析来总结证据,并使用推荐评估、制定与评价(GRADE)方法评估证据质量。

结果

纳入的 9 项随机对照试验共纳入 30472 例患者,证明符合纳入标准。大多数患者为门诊患者,平均年龄 35-56.6 岁。在轻症或中度 COVID-19 成年患者中,莫努匹韦可能降低死亡率(相对风险 [RR],0.43;95%置信区间 [CI],0.20-0.94;风险差异 [RD],减少 0.1%;中等级别)和住院风险(RR,0.67;95% CI,0.45-0.99;RD,减少 1.4%;中等级别),并可能缩短病毒清除时间(平均差,-1.81 天;95% CI,-3.31 至-0.31;低等级别)和症状缓解或临床改善时间(平均差,-2.39 天;95% CI,-3.71 至-1.07;低等级别)。莫努匹韦可能增加 7 天(±3 天)时的病毒清除率(RR,3.47;95% CI,2.43-4.96;RD,增加 16.1%;中等级别),且可能不会增加严重不良事件(RR,0.84;95% CI,0.61-1.15;RD,减少 0.1%;中等级别)。

结论

在轻症或中度 COVID-19 成年患者中,莫努匹韦可能降低死亡率和住院风险,且可能不会增加严重不良事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7024/10116122/eb441f9dfd15/gr1_lrg.jpg

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