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恢复期血浆治疗 2019 冠状病毒病(COVID-19):临床试验设计的考虑因素。

Convalescent plasma to treat coronavirus disease 2019 (COVID-19): considerations for clinical trial design.

机构信息

Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, New York, USA.

出版信息

Transfusion. 2020 Jun;60(6):1123-1127. doi: 10.1111/trf.15843. Epub 2020 May 12.

DOI:10.1111/trf.15843
PMID:32374891
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7267607/
Abstract

Case series studying convalescent plasma use in the treatment of COVID-19 have been promising, but additional, high-quality studies are needed to determine the efficacy of the treatment when applied for prophylaxis, for early phases of illness, and for severe illness. Previous studies of convalescent plasma in treating other viral diseases have identified factors to consider when designing treatment protocols, including timing of administration relative to onset of illness, timing of donation relative to resolution of symptoms, severity of illness of the donor, pretransfusion serology of the recipient, and antibody titers of the donor. There are many clinical trials studying treatment of, and prophylaxis against, COVID-19 using convalescent plasma. In addition to clinical trials, the FDA also allows treatment through two other pathways: the "Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19" protocol, and emergency investigational new drug applications. The FDA also provides criteria for donation of convalescent plasma.

摘要

关于恢复期血浆治疗 COVID-19 的病例研究结果令人鼓舞,但仍需要更多高质量的研究来确定该疗法在预防、疾病早期和重症患者中的疗效。之前关于恢复期血浆治疗其他病毒疾病的研究已经确定了在设计治疗方案时需要考虑的因素,包括相对于疾病发作的给药时间、相对于症状缓解的献血时间、供者疾病的严重程度、受者输血前血清学情况以及供者的抗体滴度。目前有许多临床试验正在研究恢复期血浆治疗 COVID-19 和预防 COVID-19 的效果。除了临床试验外,FDA 还允许通过另外两种途径使用恢复期血浆治疗:“COVID-19 治疗用恢复期血浆扩大获取”方案,以及紧急调查性新药申请。FDA 还为恢复期血浆的捐献提供了标准。

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