Franchini Massimo, Corsini Fabiana, Focosi Daniele, Cruciani Mario
Department of Hematology and Transfusion Medicine, Carlo Poma Hospital, 46100 Mantua, Italy.
Santorso Hospital, AULSS7 Pedemontana, 36061 Vicenza, Italy.
Diagnostics (Basel). 2021 Sep 11;11(9):1663. doi: 10.3390/diagnostics11091663.
Convalescent plasma (CP) from patients recovered from COVID-19 is one of the most studied anti-viral therapies against SARS-COV-2 infection. The aim of this study is to summarize the evidence from the available systematic reviews on the efficacy and safety of CP in COVID-19 through an overview of the published systematic reviews (SRs). A systematic literature search was conducted up to August 2021 in Embase, PubMed, Web of Science, Cochrane and Medrxiv databases to identify systematic reviews focusing on CP use in COVID-19. Two review authors independently evaluated reviews for inclusion, extracted data and assessed quality of evidence using AMSTAR (A Measurement Tool to Assess Reviews) and GRADE tools. The following outcomes were analyzed: mortality, viral clearance, clinical improvement, length of hospital stay, adverse reactions. In addition, where possible, subgroup analyses were performed according to study design (e.g., RCTs vs. non-RCTs), CP neutralizing antibody titer and timing of administration, and disease severity. The methodological quality of included studies was assessed using the checklist for systematic reviews AMSTAR-2 and the GRADE assessment. Overall, 29 SRs met the inclusion criteria based on 53 unique primary studies (17 RCT and 36 non-RCT). Limitations to the methodological quality of reviews most commonly related to absence of a protocol (11/29) and funding sources of primary studies (27/29). Of the 89 analyses on which GRADE judgements were made, effect estimates were judged to be of high/moderate certainty in four analyses, moderate in 38, low in 38, very low in nine. Despite the variability in the certainty of the evidence, mostly related to the risk of bias and inconsistency, the results of this umbrella review highlight a mortality reduction in CP over standard therapy when administered early and at high titer, without increased adverse reactions.
从新冠肺炎康复患者体内获取的恢复期血浆（CP）是针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染研究最多的抗病毒疗法之一。本研究的目的是通过对已发表的系统评价（SRs）进行概述，总结现有关于CP治疗新冠肺炎有效性和安全性的系统评价中的证据。截至2021年8月，在Embase、PubMed、Web of Science、Cochrane和Medrxiv数据库中进行了系统的文献检索，以识别关注CP在新冠肺炎中应用的系统评价。两位综述作者独立评估纳入的综述，提取数据，并使用AMSTAR（一种评估综述的测量工具）和GRADE工具评估证据质量。分析了以下结果：死亡率、病毒清除率、临床改善情况、住院时间、不良反应。此外，在可能的情况下，根据研究设计（如随机对照试验与非随机对照试验）、CP中和抗体滴度和给药时间以及疾病严重程度进行亚组分析。使用系统评价AMSTAR-2清单和GRADE评估对纳入研究的方法学质量进行评估。总体而言，基于53项独特的原始研究（17项随机对照试验和36项非随机对照试验），29项SRs符合纳入标准。综述方法学质量的局限性最常见于缺乏方案（11/29）和原始研究的资金来源（27/29）。在进行GRADE判断的89项分析中，四项分析的效应估计被判定为高/中度确定性，38项为中度，38项为低度，九项为极低度。尽管证据的确定性存在差异，这主要与偏倚风险和不一致性有关，但本伞状综述的结果强调，早期且高滴度给予CP比标准治疗可降低死亡率，且不会增加不良反应。
