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《COVID-19 单克隆抗体治疗的疗效和安全性:随机临床试验的系统评价和荟萃分析》。

The Efficacy and Safety of Monoclonal Antibody Treatments Against COVID-19: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

机构信息

Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia.

出版信息

Acta Med Indones. 2023 Jul;55(3):243-254.

Abstract

BACKGROUND

The use of monoclonal antibody as the proposed treatment of COVID-19 showed different results in various prior studies, and Efficacy remains open in literature. This study aimed to comprehensively determine the effect of monoclonal antibodies on clinical, laboratory, and safety outcomes in COVID-19 patients.

METHODS

Sixteen RCTs were analyzed in this meta-analysis using RevMan 5.4 to measure the pooled estimates of risk ratios (RRs) and standardized mean differences (SMDs) with 95% CIs.

RESULTS

The pooled effect of Monoclonal antibodies demonstrated efficacy on mortality risk reduction (RR=0,89 (95%CI 0.82-0.96), I2=13%, fixed-effect), Tocilizumab also show efficacy on mortality risk reduction for severe-critical disease (RR=0.90 (95%CI 0.83-0.97), I2=12%, fixed-effect)), need for mechanical ventilation (RR=0.76 (95%CI 0.62-0.94), I2=42%, random-effects), and hospital discharge (RR=1.07 (95%CI 1.00-1.14), I2=60%, random-effects). Bamlanivimab monotherapy did not reduce viral load (SMD=-0.07 (95%CI -0.21-0.07), I2=44%, fixed-effect). Monoclonal antibodies did not differ from placebo/standard therapy for hospital discharge at day 28-30 (RR=1.05 (95%CI 0.99-1.12), I2=71%, random-effects) and safety (RR=1.04 (95%CI 0.76-1.43), I2=54%, random-effects).

CONCLUSION

Tocilizumab should be used for severe to critical COVID-19 because it is not harmful and can improve mortality risk, mechanical ventilation, and hospital discharge. Bamlanivimab-Etesevimab and REGN-COV2 reduced viral load in mild-moderate outpatients.

摘要

背景

单克隆抗体作为 COVID-19 的拟议治疗方法在先前的各项研究中结果不同,疗效在文献中仍存在争议。本研究旨在全面确定单克隆抗体对 COVID-19 患者临床、实验室和安全性结局的影响。

方法

本荟萃分析使用 RevMan 5.4 分析了 16 项 RCT,以测量风险比(RR)和标准化均数差(SMD)的合并估计值,置信区间为 95%。

结果

单克隆抗体的汇总效应显示在降低死亡率风险方面有效(RR=0.89(95%CI 0.82-0.96),I2=13%,固定效应),托珠单抗在降低重症-危重症死亡率方面也有效(RR=0.90(95%CI 0.83-0.97),I2=12%,固定效应)),需要机械通气(RR=0.76(95%CI 0.62-0.94),I2=42%,随机效应)和出院(RR=1.07(95%CI 1.00-1.14),I2=60%,随机效应)。巴伦珠单抗单药治疗并不能降低病毒载量(SMD=-0.07(95%CI -0.21-0.07),I2=44%,固定效应)。单克隆抗体与安慰剂/标准治疗在 28-30 天的出院率(RR=1.05(95%CI 0.99-1.12),I2=71%,随机效应)和安全性(RR=1.04(95%CI 0.76-1.43),I2=54%,随机效应)方面没有差异。

结论

托珠单抗应用于重症至危重症 COVID-19,因为它没有危害,可以提高死亡率风险、机械通气和出院率。巴伦珠单抗-埃特司韦单抗和 REGN-COV2 降低了轻度至中度门诊患者的病毒载量。

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