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托珠单抗治疗重症和危重症 COVID-19 的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of Tocilizumab in severe and critical COVID-19: A Systematic Review and Meta-Analysis.

机构信息

Department of Pharmacoeconomics and Pharma Management, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Department of Pharmacoeconomics and Pharma Management, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Expert Rev Clin Immunol. 2021 May;17(5):499-511. doi: 10.1080/1744666X.2021.1908128. Epub 2021 Apr 7.

Abstract

OBJECTIVES

Currently published papers and clinical guidelines regarding the effects of tocilizumab in severe and critical COVID-19 are contradictory. The aim of this meta-analysis was to combine the results of clinical studies of different designs to investigate the efficacy and safety of tocilizumab in severely-to-critically ill COVID-19 patients.

METHODS

A systematic search was performed in PubMed, Embase, CENTRAL, ClinicalTrials.gov, Scopus, and preprint servers up to 26 December 2020. Since a substantial heterogeneity was expected, a random-effects model was applied to calculate the pooled effect size (ES) and 95% confidence interval (CI) for each study outcome.

RESULTS

Forty-five comparative studies involving 13,189 patients and 28 single-arm studies involving 1,770 patients were analyzed. The risk of mortality (RR of 0.76 [95%CI 0.65 to 0.89], P < 0.01) and intubation (RR of 0.48 [95%CI 0.24 to 0.97], P = 0.04) were lower in tocilizumab patients compared with controls. We did not find any significant difference in secondary infections, length of hospital stay, hospital discharge before day 14, and ICU admission between groups.

CONCLUSION

Tocilizumab can improve clinical outcomes and reduce mortality rates in severe to critical COVID-19 patients. Large-scale randomized controlled trials are still required to improve the statistical power of meta-analysis.

摘要

目的

目前关于托珠单抗治疗严重和危重新冠肺炎的影响的已发表论文和临床指南存在矛盾。本荟萃分析的目的是结合不同设计的临床研究结果,调查托珠单抗治疗重症至危重症 COVID-19 患者的疗效和安全性。

方法

系统检索了 PubMed、Embase、CENTRAL、ClinicalTrials.gov、Scopus 和预印本服务器,检索时间截至 2020 年 12 月 26 日。由于预计存在很大的异质性,因此应用随机效应模型计算每个研究结局的汇总效应量(ES)和 95%置信区间(CI)。

结果

分析了 45 项涉及 13189 例患者的对照研究和 28 项涉及 1770 例患者的单臂研究。与对照组相比,托珠单抗组患者的死亡率(RR 为 0.76 [95%CI 0.65 至 0.89],P < 0.01)和插管率(RR 为 0.48 [95%CI 0.24 至 0.97],P = 0.04)较低。两组间次要感染、住院时间、住院 14 天前出院和 ICU 入院率无显著差异。

结论

托珠单抗可改善重症至危重症 COVID-19 患者的临床结局并降低死亡率。仍需要大规模随机对照试验来提高荟萃分析的统计学效能。

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