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恢复期血浆治疗 COVID-19 患者的疗效:一项随机对照临床试验的系统评价和荟萃分析。

The efficiency of convalescent plasma in COVID-19 patients: A systematic review and meta-analysis of randomized controlled clinical trials.

机构信息

Department of Respiratory and Critical Care Medicine, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.

出版信息

Front Immunol. 2022 Jul 28;13:964398. doi: 10.3389/fimmu.2022.964398. eCollection 2022.

Abstract

UNLABELLED

The objective of this study was to assess whether convalescent plasma therapy could offer survival advantages for patients with novel coronavirus disease 2019 (COVID-19). An electronic search of Pubmed, Web of Science, Embase, Cochrane library and MedRxiv was performed from January 1st, 2020 to April 1st, 2022. We included studies containing patients with COVID-19 and treated with CCP. Data were independently extracted by two reviewers and synthesized with a random-effect analysis model. The primary outcome was 28-d mortality. Secondary outcomes included length of hospital stay, ventilation-free days, 14-d mortality, improvements of symptoms, progression of diseases and requirements of mechanical ventilation. Safety outcomes included the incidence of all adverse events (AEs) and serious adverse events (SAEs). The Cochrane risk-of-bias assessment tool 2.0 was used to assess the potential risk of bias in eligible studies. The heterogeneity of results was assessed by I^2 test and Q statistic test. The possibility of publication bias was assessed by conducting Begg and Egger test. GRADE (Grading of Recommendations Assessment, Development and Evaluation) method were used for quality of evidence. This study had been registered on PROSPERO, CRD42021273608. 32 RCTs comprising 21478 patients with Covid-19 were included. Compared to the control group, COVID-19 patients receiving CCP were not associated with significantly reduced 28-d mortality (CCP 20.0% vs control 20.8%; risk ratio 0.94; 95% CI 0.87-1.02; p = 0.16; I² = 8%). For all secondary outcomes, there were no significant differences between CCP group and control group. The incidence of AEs (26.9% vs 19.4%,; risk ratio 1.14; 95% CI 0.99-01.31; p = 0.06; I² = 38%) and SAEs (16.3% vs 13.5%; risk ratio 1.03; 95% CI 0.87-1.20; p = 0.76; I² = 42%) tended to be higher in the CCP group compared to the control group, while the differences did not reach statistical significance. In all, CCP therapy was not related to significantly improved 28-d mortality or symptoms recovery, and should not be viewed as a routine treatment for COVID-19 patients.

TRIAL REGISTRATION NUMBER

CRD42021273608. Registration on February 28, 2022.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/, Identifier CRD42022313265.

摘要

目的

评估恢复期血浆疗法是否可为新型冠状病毒病 2019(COVID-19)患者提供生存优势。

方法

从 2020 年 1 月 1 日至 2022 年 4 月 1 日,我们对 Pubmed、Web of Science、Embase、Cochrane 图书馆和 MedRxiv 进行了电子检索。我们纳入了包含 COVID-19 患者并接受 CCP 治疗的研究。由两名评审员独立提取数据,并采用随机效应分析模型进行综合。主要结局为 28 天死亡率。次要结局包括住院时间、无通气天数、14 天死亡率、症状改善、疾病进展和机械通气需求。安全性结局包括所有不良事件(AE)和严重不良事件(SAE)的发生率。采用 Cochrane 偏倚风险评估工具 2.0 评估合格研究的潜在偏倚风险。通过 I^2 检验和 Q 统计检验评估结果的异质性。采用 Begg 和 Egger 检验评估发表偏倚的可能性。使用 GRADE(推荐评估、制定与评价)方法评估证据质量。本研究已在 PROSPERO 上注册,注册号为 CRD42021273608。

结果

共纳入 32 项 RCT,包含 21478 例 COVID-19 患者。与对照组相比,接受 CCP 的 COVID-19 患者的 28 天死亡率无显著降低(CCP 20.0%vs 对照组 20.8%;风险比 0.94;95%CI 0.87-1.02;p=0.16;I²=8%)。对于所有次要结局,CCP 组与对照组之间均无显著差异。CCP 组的 AE(26.9%vs 19.4%;风险比 1.14;95%CI 0.99-01.31;p=0.06;I²=38%)和 SAE(16.3%vs 13.5%;风险比 1.03;95%CI 0.87-1.20;p=0.76;I²=42%)发生率较对照组偏高,但差异无统计学意义。总之,CCP 治疗与 28 天死亡率或症状恢复的显著改善无关,不应视为 COVID-19 患者的常规治疗。

注册信息

CRD42021273608。注册日期:2022 年 2 月 28 日。

系统综述注册

https://www.crd.york.ac.uk/prospero/,注册号:CRD42022313265。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47f9/9366612/c0b032714800/fimmu-13-964398-g001.jpg

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