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恢复期血浆治疗 COVID-19:临床试验和真实世界证据的荟萃分析。

CONVALESCENT plasma for COVID-19: A meta-analysis of clinical trials and real-world evidence.

机构信息

Division of Clinical Immunology and Transfusion Science, Department of Medical Technology, School of Allied Health Sciences, University of Phayao, Phayao, Thailand.

Unit of Excellence in Integrative Molecular Biomedicine, School of Allied Health Sciences, University of Phayao, Phayao, Thailand.

出版信息

Eur J Clin Invest. 2021 Nov;51(11):e13663. doi: 10.1111/eci.13663. Epub 2021 Aug 18.

Abstract

BACKGROUND

There is still a lack of consensus on the efficacy of convalescent plasma (CP) treatment in COVID-19 patients. We performed a systematic review and meta-analysis to investigate the efficacy of CP vs standard treatment/non-CP on clinical outcomes in COVID-19 patients.

METHODS

Cochrane Library, PubMed, EMBASE and ClinicalTrials.gov were searched from December 2019 to 16 July 2021, for data from clinical trials and observational studies. The primary outcome was all-cause mortality. Risk estimates were pooled using a random-effect model. Risk of bias was assessed by Cochrane Risk of Bias tool for clinical trials and Newcastle-Ottawa Scale for observational studies.

RESULTS

In total, 18 peer-reviewed clinical trials, 3 preprints and 26 observational studies met the inclusion criteria. In the meta-analysis of 18 peer-reviewed trials, CP use had a 31% reduced risk of all-cause mortality compared with standard treatment use (pooled risk ratio [RR] = 0.69, 95% confidence interval [CI]: 0.56-0.86, P = .001, I  = 50.1%). Based on severity and region, CP treatment significantly reduced risk of all-cause mortality in patients with severe and critical disease and studies conducted in Asia, pooled RR = 0.61, 95% CI: 0.47-0.81, P = .001, I  = 0.0%; pooled RR = 0.67, 95% CI: 0.49-0.92, P = .013, I  = 0.0%; and pooled RR = 0.62, 95% CI: 0.48-0.80, P < .001, I  = 20.3%, respectively. The meta-analysis of observational studies showed the similar results to the clinical trials.

CONCLUSIONS

Convalescent plasma use was associated with reduced risk of all-cause mortality in severe or critical COVID-19 patients. However, the findings were limited with a moderate degree of heterogeneity. Further studies with well-designed and larger sample size are needed.

摘要

背景

关于恢复期血浆(CP)治疗 COVID-19 患者的疗效,目前仍缺乏共识。我们进行了一项系统评价和荟萃分析,以调查 CP 与标准治疗/非 CP 对 COVID-19 患者临床结局的影响。

方法

从 2019 年 12 月至 2021 年 7 月 16 日,我们检索了 Cochrane 图书馆、PubMed、EMBASE 和 ClinicalTrials.gov 以获取临床试验和观察性研究的数据。主要结局为全因死亡率。使用随机效应模型汇总风险估计值。通过 Cochrane 偏倚风险工具评估临床试验的偏倚风险,通过 Newcastle-Ottawa 量表评估观察性研究的偏倚风险。

结果

共有 18 项已发表的临床试验、3 项预印本和 26 项观察性研究符合纳入标准。在对 18 项已发表试验的荟萃分析中,CP 治疗组与标准治疗组相比,全因死亡率的风险降低了 31%(合并风险比 [RR] = 0.69,95%置信区间 [CI]:0.56-0.86,P =.001,I² = 50.1%)。基于严重程度和地区,CP 治疗在严重和危重症患者中显著降低了全因死亡率风险,且在亚洲进行的研究中,RR = 0.61,95%CI:0.47-0.81,P =.001,I² = 0.0%;RR = 0.67,95%CI:0.49-0.92,P =.013,I² = 0.0%;RR = 0.62,95%CI:0.48-0.80,P <.001,I² = 20.3%。观察性研究的荟萃分析结果与临床试验相似。

结论

CP 治疗与严重或危重新冠肺炎患者的全因死亡率降低相关。然而,由于存在中度异质性,研究结果受到限制。需要进一步开展设计良好且样本量更大的研究。

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