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康复期血浆治疗 COVID-19 的疗效与安全性:一项系统评价与荟萃分析

Efficacy and Safety of Convalescent Plasma for COVID-19: A Systematic Review and Meta-analysis.

作者信息

Prasad Manya, Seth Tulika, Elavarasi Arunmozhimaran

机构信息

Department of Community Medicine, NDMC Medical College and Hindu Rao Hospital, New Delhi, India.

Department of Clinical Hematology, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Indian J Hematol Blood Transfus. 2021 Jul;37(3):347-365. doi: 10.1007/s12288-021-01417-w. Epub 2021 Mar 16.

Abstract

UNLABELLED

Convalescent plasma is currently being used in the treatment of COVID-19. Recommendations regarding use convalescent plasma in COVID-19 requires systematic summaries of available evidence. We searched the databases Medline, Embase, Cochrane CENTRAL, Epistomonikos, Medrxiv and Biorxiv. Title/abstract screening, full text screening and data abstraction were carried out in duplicate by two reviewers. Pooled effect sizes and 95% confidence intervals were calculated using random effects meta-analysis. GRADE tool was used to rate the certainty of evidence. Twenty two studies were found eligible for inclusion: nine randomized controlled trials and thirteen cohort studies. Low certainty evidence from eight RCTs showed inconclusive effects of convalescent plasma on mortality at 28 days (OR 0.85, 95% CI 0.61 to 1.18). Low certainty evidence from thirteen cohort studies showed a reduction in mortality at 28 days (OR 0.66, 95% CI 0.53 to 0.82). The pooled OR for clinical improvement was 1.07 (95% CI 0.86 to 1.34) representing low certainty evidence. Evidence from three RCTs showed inconclusive effect of CP on the need for mechanical ventilation (OR 1.20, 95% CI 0.72 to 1.98). Four cohort studies reporting unadjusted estimates suggested a reduction in the need for mechanical ventilation with convalescent plasma (OR 0.80 95% CI 0.71 to 0.91, low certainty). Pooled estimates from 2 RCTs showed inconclusive effects of convalescent plasma on the proportion of patients with nondetectable levels of virus in nasopharyngeal specimens on day 3 (OR 3.62, 95% CI 0.43, 30.49, very low-quality evidence). The present review reports uncertain estimates on the efficacy of convalescent plasma in the treatment of COVID-19. There is low certainty evidence of a possible reduction in mortality and mechanical ventilation, a faster viral clearance and the absence of any serious adverse events. However, its efficacy for these outcomes requires evidence from good quality and adequately powered randomized controlled trials.

SUPPLEMENTARY INFORMATION

The online version contains supplementary material available at 10.1007/s12288-021-01417-w.

摘要

未标注

恢复期血浆目前正用于治疗新型冠状病毒肺炎(COVID-19)。关于在COVID-19中使用恢复期血浆的建议需要对现有证据进行系统总结。我们检索了Medline、Embase、Cochrane CENTRAL、Epistomonikos、Medrxiv和Biorxiv数据库。两名评审员独立进行标题/摘要筛选、全文筛选和数据提取。使用随机效应荟萃分析计算合并效应量和95%置信区间。采用GRADE工具对证据的确定性进行评级。发现22项研究符合纳入标准:9项随机对照试验和13项队列研究。来自8项随机对照试验的低确定性证据表明,恢复期血浆对28天死亡率的影响尚无定论(比值比[OR]为0.85,95%置信区间为0.61至1.18)。来自13项队列研究的低确定性证据表明,28天死亡率有所降低(OR为0.66,95%置信区间为从0.53至0.82)。临床改善的合并OR为1.07(95%置信区间为0.86至1.34),代表低确定性证据。来自3项随机对照试验的证据表明,恢复期血浆对机械通气需求的影响尚无定论(OR为1.20,95%置信区间为0.72至1.98)。四项报告未经调整估计值的队列研究表明,恢复期血浆可降低机械通气需求(OR为0.80,95%置信区间为0.71至0.91,低确定性)。来自2项随机对照试验的合并估计值表明,恢复期血浆对第3天鼻咽标本中病毒检测不到水平的患者比例的影响尚无定论(OR为3.62,95%置信区间为0.43至30.49,极低质量证据)。本综述报告了恢复期血浆治疗COVID-19疗效的不确定估计值。有低确定性证据表明死亡率和机械通气可能降低、病毒清除更快且无任何严重不良事件。然而,其对这些结局的疗效需要高质量且有足够样本量的随机对照试验提供证据。

补充信息

在线版本包含可在10.1007/s12288-021-01417-w获取的补充材料。

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