Indian Institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, Gurgaon, Haryana, India; Department of Health Research Methods, Evidence and Impact (Ye, Loeb, Fang, Tadayon Najafabadi, Xiao, Couban, Guyatt), McMaster University, Hamilton, Ont.; Guangzhou University of Chinese Medicine (Fang), Guangzhou, Guangdong, China; West China School of Nursing and West China Hospital (Xiao), Sichuan University, Chengdu, Sichuan, China; Department of Medicine (Bégin), Université de Montréal, Que.
CMAJ. 2020 Jul 6;192(27):E745-E755. doi: 10.1503/cmaj.200642. Epub 2020 May 22.
The safety and efficacy of convalescent plasma in severe coronavirus disease 2019 (COVID-19) remain uncertain. To support a guideline on COVID-19 management, we conducted a systematic review and meta-analysis of convalescent plasma in COVID-19 and other severe respiratory viral infections.
In March 2020, we searched international and Chinese biomedical literature databases, clinical trial registries and prepublication sources for randomized controlled trials (RCTs) and nonrandomized studies comparing patients receiving and not receiving convalescent plasma. We included patients with acute coronavirus, influenza and Ebola virus infections. We conducted a meta-analysis using random-effects models and assessed the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.
Of 1099 unique records, 6 studies were eligible, and none of these included patients with COVID-19. One nonrandomized study ( = 40) on convalescent plasma in severe acute respiratory syndrome coronavirus (SARS-CoV) provided uninformative results regarding mortality (relative risk [RR] 0.10, 95% confidence interval [CI] CI 0.01 to 1.70). Pooled estimates from 4 RCTs on influenza ( = 572) showed no convincing effects on deaths (4 RCTs, RR 0.94, 95% CI 0.49 to 1.81), complete recovery (2 RCTs, odds ratio 1.04, 95% CI 0.69 to 1.64) or length of stay (3 RCTs, mean difference -1.62, 95% CI -3.82 to 0.58, d). The quality of evidence was very low for all efficacy outcomes. Convalescent plasma caused few or no serious adverse events in influenza RCTs (RR 0.85, 95% CI 0.56 to 1.29, low-quality evidence).
Studies of non-COVID-19 severe respiratory viral infections provide indirect, very low-quality evidence that raises the possibility that convalescent plasma has minimal or no benefit in the treatment of COVID-19 and low-quality evidence that it does not cause serious adverse events.
在严重的 2019 年冠状病毒病(COVID-19)中,恢复期血浆的安全性和疗效仍不确定。为了支持 COVID-19 管理指南,我们对 COVID-19 和其他严重呼吸道病毒感染的恢复期血浆进行了系统评价和荟萃分析。
2020 年 3 月,我们检索了国际和中国生物医学文献数据库、临床试验注册处和预发表来源,以查找比较接受和不接受恢复期血浆的患者的随机对照试验(RCT)和非随机研究。我们纳入了急性冠状病毒、流感和埃博拉病毒感染的患者。我们使用随机效应模型进行荟萃分析,并使用推荐评估、制定和评估(GRADE)方法评估证据质量。
在 1099 条独特记录中,有 6 项研究符合条件,但没有一项研究包括 COVID-19 患者。一项关于严重急性呼吸综合征冠状病毒(SARS-CoV)恢复期血浆的非随机研究( = 40),关于死亡率的结果无信息(相对风险[RR]0.10,95%置信区间[CI]0.01 至 1.70)。4 项关于流感的 RCT( = 572)的汇总估计值显示,在死亡(4 项 RCT,RR 0.94,95%CI 0.49 至 1.81)、完全康复(2 项 RCT,优势比 1.04,95%CI 0.69 至 1.64)或住院时间(3 项 RCT,平均差-1.62,95%CI-3.82 至 0.58,d)方面没有令人信服的效果。所有疗效结局的证据质量均为极低。在流感 RCT 中,恢复期血浆引起的严重不良事件很少或没有(RR 0.85,95%CI 0.56 至 1.29,低质量证据)。
非 COVID-19 严重呼吸道病毒感染的研究提供了间接的、极低质量的证据,表明恢复期血浆在治疗 COVID-19 方面可能几乎没有益处,并且可能没有高质量证据表明其不会引起严重不良事件。