COVID-19康复者恢复期血浆采集和使用

Collection and Use of Convalescent Plasma from Recovery of COVID-19 Patient

严重急性呼吸系统综合征冠状病毒2型(SARS-CoV-2)导致的新型冠状病毒肺炎(COVID-19),引发全球性健康危机。目前,尚无针对COVID-19患者有效的治疗方法,而康复者恢复期血浆(convalescent plasma,CP)含有针对感染病原体的中和抗体。感染患者输注CP是一种被动抗体疗法,最早可追溯到20世纪,之前CP已用于其他呼吸道感染的爆发,SARS-CoV-1和MERS患者使用CP的证据表明是安全的。采供血机构根据国家和地方性指南,制定COVID-19 CP工作流程、说明各个步骤,包括对CP献血者资格评估、招募、知情同意、献血前筛查、抗体检测、采集、病毒检测、制备、储存、发放、输注、疗效评估,以便最大化CP捐献者和受血者安全性。同时也需要关注输注CP的潜在风险,包括抗体依赖性增强(antibody-dependent enhancement,ADE)、过敏性输血反应、发热反应、输血相关急性肺损伤(transfusion-related acute lung injury,TRALI)、输血相关循环超负荷(transfusion-associated circulation overload,TACO)。在大量混杂因素的复杂治疗环境中,随机对照试验(randomized controlled trial,RCT)是确定COVID-19 CP临床治疗疗效和安全性的最有效方法。

Novel coronavirus pneumonia(COVID-19)caused by Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2)has spurred a global health crisis.To date,there is no effective therapy for COVID-19 patients.Convalescent plasma from recovered infection patient contains neutralizing antibodies against the same infection.Transfusion convalescent plasma to infected patients is a form of passive antibody therapy,can be traced back as early as the 20th century.The CP has been used in outbreaks of other respiratory infections.Available evidence from use of convalescent plasma in SARS-CoV-1 and MERS patients suggested that CP was safe.Blood establishment should develop COVID-19 CP workflow according to national and local guidelines,to illustrate the individual steps that need to be undertaken,including assessment of CP donor eligibility,informed consent,recruitment,pre-donation screening,antibody testing,collections,processing,virus testing,storage,distribution,transfusion of CP and assessment of efficacy,in order to maximize safety of CP donors and recipients.At the same time,we also need to pay attention to the potential risks of CP transfusion,including:antibodymediated enhancement(ADE),allergic transfusion reactions,febrile reactions,transfusion-related acute lung injury(TRALI),transfusion-associated cardiac overload(TACO).In a complex nursing environment with a large number of confounding factors,Randomized Controlled Trial(RCT)is the most effective and efficient strategy to determine the efficacy and safety of COVID-19 CP clinical therapy.