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瑞德西韦治疗 COVID-19 的安全性和疗效:系统评价和荟萃分析。

Safety and Efficacy of Remdesivir for the Treatment of COVID-19: A Systematic Review and Meta-Analysis.

机构信息

Health Services Management Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.

Health in Disasters and Emergencies Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.

出版信息

J Pharm Pharm Sci. 2021;24:237-245. doi: 10.18433/jpps31870.

Abstract

PURPOSE

To evaluate the safety and efficacy of remdesivir in adult patients with COVID-19.

METHODS

PubMed, Embase, Scopus, Web of Science, Cochrane Library, ClinicalTrials.gov, and medRxiv databases were searched using a search strategy tailored to each database. The Consolidated Standards of Reporting Trials (CONSORT) and Strengthening the reporting of observational studies in epidemiology (STROBE) checklists were used for the studies' qualitative assessment. The outcomes studied were mortality, all adverse events, serious adverse events, and clinical improvement. The quantitative synthesis was conducted using fixed and random effects models in the CMA 2.2. Heterogeneity was tested using the I-squared (I2) measure.

RESULTS

In general, six studies, including five randomized controlled trials and one cohort study were found eligible. Comparison of the findings related to both groups receiving remdesivir (10-day remdesivir group) and placebo/control group showed that remdesivir treatment had no significant effect on mortality at day 14 of the treatment (RR=0.769; 95% CI :0.563-1.050; p=0.098), and all adverse events (RR= 1.078; 95% CI: 0.908-1.279; p= 0.392). However, remdesivir had a significant effect on clinical improvement at day 14 compared to placebo/control (OR= 1.447; 95% CI: 1.005-2.085; p= 0.047) and reduced serious adverse events (RR= 0.736; 95% CI: 0.611-0.887; p= 0.001).

CONCLUSION

Remdesivir has positive effects on clinical improvement, and reduction of the risk of serious adverse events. However, it does not influence the mortality at day 14 of treatment.

摘要

目的

评估瑞德西韦在 COVID-19 成年患者中的安全性和疗效。

方法

使用针对每个数据库定制的搜索策略,在 PubMed、Embase、Scopus、Web of Science、Cochrane 图书馆、ClinicalTrials.gov 和 medRxiv 数据库中进行搜索。使用 CONSORT 和 STROBE 清单对研究进行定性评估。研究的结局指标为死亡率、所有不良事件、严重不良事件和临床改善。使用 CMA 2.2 中的固定和随机效应模型进行定量综合。使用 I 平方(I2)度量来检验异质性。

结果

总体而言,共发现六项符合条件的研究,包括五项随机对照试验和一项队列研究。比较接受瑞德西韦(10 天瑞德西韦组)和安慰剂/对照组的研究结果表明,瑞德西韦治疗对治疗第 14 天的死亡率没有显著影响(RR=0.769;95%CI:0.563-1.050;p=0.098),所有不良事件(RR=1.078;95%CI:0.908-1.279;p=0.392)。然而,与安慰剂/对照组相比,瑞德西韦在治疗第 14 天对临床改善有显著影响(OR=1.447;95%CI:1.005-2.085;p=0.047),并降低严重不良事件的风险(RR=0.736;95%CI:0.611-0.887;p=0.001)。

结论

瑞德西韦对临床改善和降低严重不良事件风险有积极作用。然而,它对治疗第 14 天的死亡率没有影响。

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