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COVID-19 治疗中使用恢复期血浆输注的疗效和安全性:随机对照试验的更新系统评价和荟萃分析。

Efficacy and Safety of COVID-19 Treatment Using Convalescent Plasma Transfusion: Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.

机构信息

Department of BioNano Technology, Gachon University, 1342 Seongnam-Daero, Sujeong-Gu, Seongnam-si 13120, Gyeonggi-Do, Korea.

Department of Industrial and Environmental Engineering, Graduate School of Environment, Gachon University, 1342 Seongnam-Daero, Sujeong-Gu, Seongnam-si 13120, Gyeonggi-Do, Korea.

出版信息

Int J Environ Res Public Health. 2022 Aug 25;19(17):10622. doi: 10.3390/ijerph191710622.

DOI:10.3390/ijerph191710622
PMID:36078338
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9518594/
Abstract

This study investigated the efficacy and safety of convalescent plasma (CP) transfusion against the coronavirus disease 2019 (COVID-19) via a systematic review and meta-analysis of randomized controlled trials (RCTs). A total of 5467 articles obtained from electronic databases were assessed; however, only 34 RCTs were eligible after manually screening and eliminating unnecessary studies. The beneficial effect was addressed by assessing the risk ratio (RR) and standardized mean differences (SMDs) of the meta-analysis. It was demonstrated that CP therapy is not effective in improving clinical outcomes, including reducing mortality with an RR of 0.88 [0.76; 1.03] (I = 68% and = 0.10) and length of hospitalization with SMD of -0.47 [-0.95; 0.00] (I = 99% and = 0.05). Subgroup analysis provided strong evidence that CP transfusion does not significantly reduce all-cause mortality compared to standard of care (SOC) with an RR of 1.01 [0.99; 1.03] (I = 70% and = 0.33). In addition, CP was found to be safe for and well-tolerated by COVID-19 patients as was the SOC in healthcare settings. Overall, the results suggest that CP should not be applied outside of randomized trials because of less benefit in improving clinical outcomes for COVID-19 treatment.

摘要

本研究通过对随机对照试验(RCT)的系统评价和荟萃分析,调查了恢复期血浆(CP)输注治疗 2019 年冠状病毒病(COVID-19)的疗效和安全性。从电子数据库中评估了总共 5467 篇文章,但经过手动筛选和排除不必要的研究后,只有 34 项 RCT 符合入选标准。通过评估荟萃分析的风险比(RR)和标准化均数差(SMD)来评估有益效果。结果表明,CP 治疗并不能有效改善临床结局,包括降低死亡率的 RR 为 0.88 [0.76;1.03](I = 68%, = 0.10)和住院时间的 SMD 为-0.47 [-0.95;0.00](I = 99%, = 0.05)。亚组分析提供了强有力的证据,表明与标准治疗(SOC)相比,CP 输注并不能显著降低全因死亡率,RR 为 1.01 [0.99;1.03](I = 70%, = 0.33)。此外,CP 在医疗保健环境中对 COVID-19 患者是安全且耐受良好的,与 SOC 一样。总体而言,结果表明 CP 不应该在 RCT 之外使用,因为它对改善 COVID-19 治疗的临床结局没有更多益处。

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本文引用的文献

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Reinforcement of the Standard Therapy with Two Infusions of Convalescent Plasma for Patients with COVID-19: A Randomized Clinical Trial.采用两次输注康复期血浆强化标准治疗对 COVID-19 患者的疗效:一项随机临床试验
J Clin Med. 2022 May 27;11(11):3039. doi: 10.3390/jcm11113039.
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Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial).恢复期血浆疗法治疗 COVID-19 患者的疗效:一项随机对照试验(COPLA-II 试验)。
BMJ Open. 2022 Apr 6;12(4):e055189. doi: 10.1136/bmjopen-2021-055189.
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Convalescent plasma in the treatment of moderate to severe COVID-19 pneumonia: a randomized controlled trial (PROTECT-Patient Trial).
恢复期血浆治疗中重度 COVID-19 肺炎:一项随机对照试验(PROTECT-Patient 试验)。
Sci Rep. 2022 Feb 15;12(1):2552. doi: 10.1038/s41598-022-06221-8.
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High-titre methylene blue-treated convalescent plasma as an early treatment for outpatients with COVID-19: a randomised, placebo-controlled trial.高滴度亚甲蓝处理的恢复期血浆作为 COVID-19 门诊患者的早期治疗:一项随机、安慰剂对照试验。
Lancet Respir Med. 2022 Mar;10(3):278-288. doi: 10.1016/S2213-2600(21)00545-2. Epub 2022 Feb 9.
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A phase 2 single center open label randomised control trial for convalescent plasma therapy in patients with severe COVID-19.一项针对重症 COVID-19 患者恢复期血浆疗法的 2 期单中心开放标签随机对照试验。
Nat Commun. 2022 Jan 19;13(1):383. doi: 10.1038/s41467-022-28064-7.
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Effect of convalescent plasma as complementary treatment in patients with moderate COVID-19 infection.恢复期血浆作为补充治疗对中度 COVID-19 感染患者的影响。
Transfus Med. 2022 Apr;32(2):153-161. doi: 10.1111/tme.12851. Epub 2022 Jan 9.
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Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients: A Randomized Clinical Trial.COVID-19 恢复期血浆治疗住院患者的疗效和安全性:一项随机临床试验。
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Convalescence plasma treatment of COVID-19: results from a prematurely terminated randomized controlled open-label study in Southern Sweden.恢复期血浆治疗 COVID-19:瑞典南部一项提前终止的随机对照开放性标签研究结果。
BMC Res Notes. 2021 Dec 4;14(1):440. doi: 10.1186/s13104-021-05847-7.
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Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial.高滴度恢复期血浆对 COVID-19 肺炎住院患者进展为严重呼吸衰竭或死亡的影响:一项随机临床试验。
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