瑞士巴塞尔大学医院Lars G. Hemkens团队研究了COVID-19患者恢复期血浆治疗与临床结局的相关性。2021年2月26日，该研究发表在《美国医学会杂志》上。

恢复期血浆是治疗COVID-19的一种策略。

为了在同行评审和预印本出版物或随机临床试验（RCT）新闻稿中，评估恢复期血浆治疗与安慰剂或标准治疗的临床结局，研究组从PubMed、Cochrane COVID-19试验注册中心等大型数据库中检索至2021年1月29日的随机临床试验，提取相关临床结果、试验特征和患者特征的数据。主要分析仅包括同行评审的随机对照试验出版物，而次要分析包括所有公开的随机对照试验数据（同行评审的出版物、预印本和新闻稿）。主要结局包括全因死亡率、住院时间、临床改善、临床恶化、机械通气使用和严重不良事件。

共有1060例患者来自4个同行评审的随机对照试验，10?722例患者来自6个其他公开的随机对照试验。在4项同行评审的随机对照试验中，恢复期血浆全因死亡的总风险比为0.93，绝对风险差为−1.21%，由于不精确，证据的确定性较低。在所有10项随机对照试验中，总风险比为1.02，由于纳入了未发表的数据，证据具有中等的确定性。在同行评审的随机对照试验中，住院时间的总风险比为1.17，机械通气的总风险比为0.76，由于两种结果的不精确性，证据的确定性很低。关于临床改善、临床恶化和严重不良事件的有限数据均显示无显著差异。

研究结果表明，与安慰剂或标准治疗相比，恢复期血浆治疗与全因死亡率的降低或对其他临床结果的任何益处均无显著相关性。全因死亡的证据确定性为低至中度，其他结果的证据确定性为低度。

附：英文原文

Title: Association of Convalescent Plasma Treatment With Clinical Outcomes in Patients With COVID-19: A Systematic Review and Meta-analysis

Author: Perrine Janiaud, Cathrine Axfors, Andreas M. Schmitt, Viktoria Gloy, Fahim Ebrahimi, Matthias Hepprich, Emily R. Smith, Noah A. Haber, Nina Khanna, David Moher, Steven N. Goodman, John P. A. Ioannidis, Lars G. Hemkens

Issue&Volume: 2021-02-26

Abstract:

Importance  Convalescent plasma is a proposed treatment for COVID-19.

Objective  To assess clinical outcomes with convalescent plasma treatment vs placebo or standard of care in peer-reviewed and preprint publications or press releases of randomized clinical trials (RCTs).

Data Sources  PubMed, the Cochrane COVID-19 trial registry, and the Living Overview of Evidence platform were searched until January 29, 2021.

Study Selection  The RCTs selected compared any type of convalescent plasma vs placebo or standard of care for patients with confirmed or suspected COVID-19 in any treatment setting.

Data Extraction and Synthesis  Two reviewers independently extracted data on relevant clinical outcomes, trial characteristics, and patient characteristics and used the Cochrane Risk of Bias Assessment Tool. The primary analysis included peer-reviewed publications of RCTs only, whereas the secondary analysis included all publicly available RCT data (peer-reviewed publications, preprints, and press releases). Inverse variance–weighted meta-analyses were conducted to summarize the treatment effects. The certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation.

Main Outcomes and Measures  All-cause mortality, length of hospital stay, clinical improvement, clinical deterioration, mechanical ventilation use, and serious adverse events.

Results  A total of 1060 patients from 4 peer-reviewed RCTs and 10722 patients from 6 other publicly available RCTs were included. The summary risk ratio (RR) for all-cause mortality with convalescent plasma in the 4 peer-reviewed RCTs was 0.93 (95% CI, 0.63 to 1.38), the absolute risk difference was 1.21% (95% CI, 5.29% to 2.88%), and there was low certainty of the evidence due to imprecision. Across all 10 RCTs, the summary RR was 1.02 (95% CI, 0.92 to 1.12) and there was moderate certainty of the evidence due to inclusion of unpublished data. Among the peer-reviewed RCTs, the summary hazard ratio was 1.17 (95% CI, 0.07 to 20.34) for length of hospital stay, the summary RR was 0.76 (95% CI, 0.20 to 2.87) for mechanical ventilation use (the absolute risk difference for mechanical ventilation use was 2.56% [95% CI, 13.16% to 8.05%]), and there was low certainty of the evidence due to imprecision for both outcomes. Limited data on clinical improvement, clinical deterioration, and serious adverse events showed no significant differences.

Conclusions and Relevance  Treatment with convalescent plasma compared with placebo or standard of care was not significantly associated with a decrease in all-cause mortality or with any benefit for other clinical outcomes. The certainty of the evidence was low to moderate for all-cause mortality and low for other outcomes.

DOI: 10.1001/jama.2021.2747

Source: https://jamanetwork.com/journals/jama/fullarticle/2777060