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莫努匹拉韦治疗非住院和住院COVID-19患者的临床疗效和安全性:一项随机对照试验的系统评价和荟萃分析

Clinical efficacy and safety of molnupiravir for nonhospitalized and hospitalized patients with COVID-19: A systematic review and meta-analysis of randomized control trials.

作者信息

Huang Po-Yu, Liu Ting-Hui, Wu Jheng-Yan, Tsai Ya-Wen, Lai Chih-Cheng

机构信息

Department of Internal Medicine, Chi Mei Medical Center, Tainan City, Taiwan.

Department of General Medicine, Chi Mei Medical Center, Tainan, Taiwan.

出版信息

J Med Virol. 2023 Mar;95(3):e28621. doi: 10.1002/jmv.28621.

Abstract

The efficacy of molnupiravir in treating patients with coronavirus disease 2019 (COVID-19) has been inconsistent across randomized controlled trials (RCTs). Thus, this meta-analysis was conducted to clarify the literature. A literature search of electronic databases-PubMed, Embase, and Cochrane Library-was performed to identify relevant articles published up to December 31, 2022. Only RCTs that investigated the clinical efficacy and safety of molnupiravir for patients with COVID-19 were included. The primary outcome was all-cause mortality at 28-30 days. This pooled analysis of nine RCTs did not reveal a significant difference in all-cause mortality between molnupiravir and control groups (risk ratio [RR], 0.43; 95% confidence interval [CI], 0.10-1.77) for overall patients. However, the risks of mortality and hospitalization were lower in the molnupiravir group than in the control group (mortality: RR, 0.28; 95% CI, 0.10-0.79; hospitalization: RR, 0.67; 95% CI, 0.45-0.99) among nonhospitalized patients. In addition, molnupiravir use was associated with a borderline higher virological eradication rate relative to the control (RR, 1.05; 95% CI, 1.00-1.11). Finally, no significant difference in adverse event risk was discovered between the groups (RR, 0.98; 95% CI, 0.89-1.08). The findings reveal the clinical benefits of molnupiravir for nonhospitalized patients with COVID-19. However, molnupiravir may not improve the clinical outcomes of hospitalized patients. These findings support the recommended use of molnupiravir for treating nonhospitalized patients with COVID-19 but not for hospitalized patients.

摘要

莫努匹拉韦治疗2019冠状病毒病(COVID-19)患者的疗效在随机对照试验(RCT)中一直不一致。因此,进行了这项荟萃分析以阐明相关文献。对电子数据库——PubMed、Embase和Cochrane图书馆进行了文献检索,以识别截至2022年12月31日发表的相关文章。仅纳入了研究莫努匹拉韦对COVID-19患者临床疗效和安全性的随机对照试验。主要结局是28至30天的全因死亡率。对9项随机对照试验的这项汇总分析未发现莫努匹拉韦组和对照组在总体患者全因死亡率上有显著差异(风险比[RR],0.43;95%置信区间[CI],0.10 - 1.77)。然而,在非住院患者中,莫努匹拉韦组的死亡和住院风险低于对照组(死亡率:RR,0.28;95% CI,0.10 - 0.79;住院率:RR,0.67;95% CI,0.45 - 0.99)。此外,相对于对照组,使用莫努匹拉韦的病毒学清除率略高(RR,1.05;95% CI,1.00 - 1.11)。最后,两组之间不良事件风险未发现显著差异(RR,0.98;95% CI,0.89 - 1.08)。研究结果揭示了莫努匹拉韦对非住院COVID-19患者的临床益处。然而,莫努匹拉韦可能无法改善住院患者的临床结局。这些研究结果支持推荐使用莫努匹拉韦治疗非住院COVID-19患者,而非住院患者。

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