Department of Radiation Oncology, Clinical Research Centre, Advanced Centre for Treatment Research & Education in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Navi Mumbai, India.
Clinical Research Secretariat, Clinical Research Centre, Advanced Centre for Treatment Research & Education in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute (HBNI), Navi Mumbai, India.
Transfus Med. 2021 Dec;31(6):409-420. doi: 10.1111/tme.12803. Epub 2021 Jun 29.
Despite scientific advances, there is no effective medical therapy for coronavirus disease 2019 (COVID-19). This systematic review and meta-analysis aimed to evaluate the safety and efficacy of convalescent plasma therapy in COVID-19.
This review was carried out in accordance with Cochrane methodology including risk of bias assessment and grading of the quality of evidence. Only prospective clinical trials randomly assigning COVID-19 patients to convalescent plasma plus standard of care therapy (test arm) versus placebo/standard of care (control arm) were included. Two reviewers independently read each preprint/publication and extracted relevant data from individual studies. Data were pooled using the random-effects model and expressed as risk ratio (RR) with 95% confidence interval (CI).
A total of 13 206 patients from 12 randomised controlled trials were included. There was no significant difference in clinical improvement rate (RR = 1.00, 95% CI: 0.98-1.02, p = 0.96) or time to clinical improvement (median difference of 1.08 days with 95% CI ranging from -0.15 to +2.30 days) between convalescent plasma versus placebo/standard of care therapy. The use of convalescent plasma was not associated with significantly reduced risk of death (RR = 0.81, 95% CI: 0.65-1.02, p = 0.08). Reassuringly, overall incidence of infusion-related serious adverse events was low (3.25%) and not significantly different (RR = 1.14, 95% CI: 0.93-1.40, p = 0.22) for convalescent plasma transfusion compared to placebo/standard of care therapy.
There is low to moderate certainty evidence that the addition of convalescent plasma to current standard of care therapy is generally safe but, does not result in any significant clinical benefit or reduction of mortality in COVID-19.
尽管科学取得了进步，但针对 2019 年冠状病毒病（COVID-19）仍没有有效的医学疗法。本系统评价和荟萃分析旨在评估恢复期血浆疗法在 COVID-19 中的安全性和疗效。
本综述按照 Cochrane 方法进行，包括偏倚风险评估和证据质量分级。仅纳入将 COVID-19 患者随机分配至恢复期血浆加标准治疗（试验组）与安慰剂/标准治疗（对照组）的前瞻性临床试验。两位审查员独立阅读每份预印本/出版物，并从各个研究中提取相关数据。使用随机效应模型对数据进行汇总，并以风险比（RR）和 95%置信区间（CI）表示。
共有来自 12 项随机对照试验的 13206 例患者纳入研究。在临床改善率（RR=1.00，95%CI：0.98-1.02，p=0.96）或临床改善时间（中位数差值为 1.08 天，95%CI 范围为-0.15 至+2.30 天）方面，恢复期血浆与安慰剂/标准治疗之间没有显著差异。与安慰剂/标准治疗相比，使用恢复期血浆并未显著降低死亡风险（RR=0.81，95%CI：0.65-1.02，p=0.08）。令人欣慰的是，输注相关严重不良事件的总发生率较低（3.25%），且与安慰剂/标准治疗相比无显著差异（RR=1.14，95%CI：0.93-1.40，p=0.22）。
低至中度确定性证据表明，将恢复期血浆加入当前标准治疗方案一般是安全的，但不会给 COVID-19 患者带来任何显著的临床获益或降低死亡率。
