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新型冠状病毒肺炎康复者恢复期血浆制备及临床应用的监管考量

Regulatory consideration on preparation and clinical use of COVID-19 convalescent plasma.

作者信息

Yılmaz Soner, Ertuğrul Örüç Nigar, Özcebe Osman İlhami, Azap Alpay, Çetin Ahmet Türker, Yenicesu İdil, Öztürk Abdullah, Gündüz Mehmet, Tekin Ahmet

机构信息

Regional Blood Center, University of Health Sciences Gülhane Training and Research Hospital, Ankara, Turkey.

Department of Transfusion Services, Health Sciences University Dıskapı Yıldırım Beyazıt, Training and Research Hospital, Ankara, Turkey.

出版信息

Transfus Apher Sci. 2020 Oct;59(5):102846. doi: 10.1016/j.transci.2020.102846. Epub 2020 Jun 4.

Abstract

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease (COVID-19), spreading from Wuhan to worldwide has been emerged since December 2019. Although scientists and researchers have been racing to develop specific therapeutic agents or vaccines against SARS-CoV-2 since the identification of the agent, either a drug or a vaccine has not been approved to treat or to prevent COVID-19 up to date. On the base of historical experiences, Convalescent Plasma (CP), a passive antibody therapy, has been evaluated as a hopeful and potential therapeutic option since the beginning of the COVID-19 outbreak. Immune plasma had been used previously for the treatment of H1N1 influenza virus, SARS-CoV-1 and MERS-CoV epidemics successfully. In this scope competent authorities are responsible to set up certain principles and criteria for the collection and clinical use of COVID-19 Convalescent Plasma (CCP). This document has been prepared to aid both for the convalescent plasma suppliers and the clinicians. The first part encompasses the supply of CCP and the second part lead the clinical use of CCP for the treatment of patients with severe COVID-19 infection. Turkish Ministry of Health developed a guide on collection and clinical use of CCP and created a web-based monitoring system to follow-up the patients treated with convalescent plasma in universal. This follow-up process is thought to be crucial for the creation and development of current and future treatment modalities. This guide would be a pathfinder for clinicians and/or institutions those eager to conduct CCP treatment more effectively.

摘要

严重急性呼吸综合征冠状病毒2(SARS-CoV-2)是冠状病毒病(COVID-19)的病原体,自2019年12月以来已从武汉传播至全球。尽管自该病原体被识别以来,科学家和研究人员一直在竞相研发针对SARS-CoV-2的特定治疗药物或疫苗,但截至目前,尚无药物或疫苗被批准用于治疗或预防COVID-19。基于历史经验,自COVID-19疫情爆发之初,恢复期血浆(CP)这种被动抗体疗法就被评估为一种有希望且有潜力的治疗选择。免疫血浆此前已成功用于治疗H1N1流感病毒、SARS-CoV-1和MERS-CoV疫情。在此范围内,主管当局有责任为COVID-19恢复期血浆(CCP)的采集和临床使用制定某些原则和标准。本文件旨在帮助恢复期血浆供应商和临床医生。第一部分涵盖CCP的供应,第二部分指导CCP在治疗重症COVID-19感染患者中的临床使用。土耳其卫生部制定了一份关于CCP采集和临床使用的指南,并创建了一个基于网络的监测系统,以全面跟踪接受恢复期血浆治疗的患者。这一跟踪过程被认为对于当前和未来治疗方式的创建和发展至关重要。本指南将为渴望更有效开展CCP治疗的临床医生和/或机构提供指引。

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Effectiveness of convalescent plasma therapy in severe COVID-19 patients.恢复期血浆疗法治疗重症 COVID-19 患者的疗效。
Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.

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