Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials.
Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials.
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DOI：
10.1186/s12879-021-06829-7
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发表时间：
2021-11-20
影响因子：
3.7
通讯作者：
Hemkens LG
中科院分区：
文献类型：
--
作者：
Axfors C;Janiaud P;Schmitt AM;Van't Hooft J;Smith ER;Haber NA;Abayomi A;Abduljalil M;Abdulrahman A;Acosta-Ampudia Y;Aguilar-Guisado M;Al-Beidh F;Alejandria MM;Alfonso RN;Ali M;AlQahtani M;AlZamrooni A;Anaya JM;Ang MAC;Aomar IF;Argumanis LE;Averyanov A;Baklaushev VP;Balionis O;Benfield T;Berry S;Birocco N;Bonifacio LB;Bowen AC;Bown A;Cabello-Gutierrez C;Camacho B;Camacho-Ortiz A;Campbell-Lee S;Cao DH;Cardesa A;Carnate JM;Castillo GJJ;Cavallo R;Chowdhury FR;Chowdhury FUH;Ciccone G;Cingolani A;Climacosa FMM;Compernolle V;Cortez CFN;Costa Neto A;D'Antico S;Daly J;Danielle F;Davis JS;De Rosa FG;Denholm JT;Denkinger CM;Desmecht D;Díaz-Coronado JC;Díaz Ponce-Medrano JA;Donneau AF;Dumagay TE;Dunachie S;Dungog CC;Erinoso O;Escasa IMS;Estcourt LJ;Evans A;Evasan ALM;Fareli CJ;Fernandez-Sanchez V;Galassi C;Gallo JE;Garcia PJ;Garcia PL;Garcia JA;Garigliany M;Garza-Gonzalez E;Gauiran DTV;Gaviria García PA;Giron-Gonzalez JA;Gómez-Almaguer D;Gordon AC;Gothot A;Grass Guaqueta JS;Green C;Grimaldi D;Hammond NE;Harvala H;Heralde FM;Herrick J;Higgins AM;Hills TE;Hines J;Holm K;Hoque A;Hoste E;Ignacio JM;Ivanov AV;Janssen M;Jennings JH;Jha V;King RAN;Kjeldsen-Kragh J;Klenerman P;Kotecha A;Krapp F;Labanca L;Laing E;Landin-Olsson M;Laterre PF;Lim LL;Lim J;Ljungquist O;Llaca-Díaz JM;López-Robles C;López-Cárdenas S;Lopez-Plaza I;Lucero JAC;Lundgren M;Macías J;Maganito SC;Malundo AFG;Manrique RD;Manzini PM;Marcos M;Marquez I;Martínez-Marcos FJ;Mata AM;McArthur CJ;McQuilten ZK;McVerry BJ;Menon DK;Meyfroidt G;Mirasol MAL;Misset B;Molton JS;Mondragon AV;Monsalve DM;Moradi Choghakabodi P;Morpeth SC;Mouncey PR;Moutschen M;Müller-Tidow C;Murphy E;Najdovski T;Nichol AD;Nielsen H;Novak RM;O'Sullivan MVN;Olalla J;Osibogun A;Osikomaiya B;Oyonarte S;Pardo-Oviedo JM;Patel MC;Paterson DL;Peña-Perez CA;Perez-Calatayud AA;Pérez-Alba E;Perkina A;Perry N;Pouladzadeh M;Poyato I;Price DJ;Quero AKH;Rahman MM;Rahman MS;Ramesh M;Ramírez-Santana C;Rasmussen M;Rees MA;Rego E;Roberts JA;Roberts DJ;Rodríguez Y;Rodríguez-Baño J;Rogers BA;Rojas M;Romero A;Rowan KM;Saccona F;Safdarian M;Santos MCM;Sasadeusz J;Scozzari G;Shankar-Hari M;Sharma G;Snelling T;Soto A;Tagayuna PY;Tang A;Tatem G;Teofili L;Tong SYC;Turgeon AF;Veloso JD;Venkatesh B;Ventura-Enriquez Y;Webb SA;Wiese L;Wikén C;Wood EM;Yusubalieva GM;Zacharowski K;Zarychanski R;Khanna N;Moher D;Goodman SN;Ioannidis JPA;Hemkens LG
恢复期血浆已被广泛用于治疗新冠肺炎，并在许多随机临床试验中进行调查，但只有少数试验的结果是公开的。这项研究的目的是使用所有可用的随机临床试验的数据，包括未发表的和正在进行的试验(开放科学框架，https://doi.org/10.17605/OSF.IO/GEHFX).)，评估与安慰剂或不治疗相比，恢复期血浆治疗的益处以及新冠肺炎患者的全原因死亡率在这项协作性的系统回顾和荟萃分析中，临床试验注册中心(ClinicalTrials.gov，世卫组织国际临床试验注册平台)、Cochrane新冠肺炎注册中心、LOVE数据库和PubMed被搜索到2021年4月8日。通过电子邮件联系了在2021年3月1日之前注册的试验的调查人员，这些试验没有公布结果。符合条件的是正在进行的、已停止的和已完成的随机临床试验，这些试验将新冠肺炎患者的恢复期血浆与安慰剂或不治疗进行比较，无论设定或治疗时间表如何。汇总的死亡率数据从出版物中提取或由未发表试验的研究人员提供，并使用Hartung-Knapp-Sidik-Jonkman随机效应模型进行组合。我们调查了未发表的试验对总体证据的贡献。33项试验共纳入16477名患者(20项未发表的3190名患者，13项已发表的13287名患者)。32项试验只招募住院患者(包括3名只有重症监护病房患者)。在29/33个试验中，偏倚风险较低。在接受恢复期血浆治疗的8495名患者中，1997名死亡(23%)，而7982名对照组患者中，1952名死亡(24%)。全因死亡率的综合风险比为0.97(95%可信区间：0.92；1.02)，研究间的异质性并非不可能(I2 = 为0%)。回收试验占Meta分析权重的69.8%，未发表证据占25.3%。新冠肺炎患者的恢复期血浆治疗并未降低全因死亡率。这些结果提供了强有力的证据，证明新冠肺炎患者的恢复期血浆治疗不应该在随机试验之外使用。从试验调查人员之间的协作中合成证据可以为证据生成和患者护理中的证据应用提供信息。网上版载有补充材料，可在10.1186/s12879-021-06829-7查阅。
Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care. The online version contains supplementary material available at 10.1186/s12879-021-06829-7.
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影响因子：
3.9
作者：
Abubakar AR;Sani IH;Godman B;Kumar S;Islam S;Jahan I;Haque M
通讯作者：
Haque M
影响因子：
15.8
作者：
Juul, Sophie;Nielsen, Emil Eik;Jakobsen, Janus Christian
通讯作者：
Jakobsen, Janus Christian
DOI：
10.17816/clinpract35168
发表时间：
2020-01-01
期刊：
Journal of Clinical Practice
影响因子：
--
作者：
Baklaushev, Vladimir P.;Averyanov, Alexander V.;Troitsky, Alexander V.
通讯作者：
Troitsky, Alexander V.
影响因子：
2.9
作者：
Budhai, Alexandra;Wu, Annie A.;Shaz, Beth H.
通讯作者：
Shaz, Beth H.
影响因子：
105.7
作者：
Higgins, JPT;Thompson, SG;Altman, DG
通讯作者：
Altman, DG