“恢复期血浆治疗”在新冠肺炎治疗中的伦理思考  

Ethical Thinking of “Convalescent Plasma Therapy” in the Treatment of COVID-19

作　　者：马文兵[1,2] 程锴 陈延绅 郑巧伟 禚映辰[1] 卢晓云 封卫毅[1] MA Wenbing;CHENG Kai;CHEN Yanshen;ZHENG Qiaowei;ZHUO Yingchen;LU Xiaoyun;FENG Weiyi(Clinical Pharmacy,Pharmaceutical Department,the First Affiliated Hospital of Xi'an Jiaotong University,Xi’an 710061,China;School of Life Science and Technology, Xi'an Jiaotong University, Xi'an 710049, China)

机构地区：[1]西安交通大学第一附属医院药学部临床药学室,陕西西安710061 [2]西安交通大学生命科学与技术学院,陕西西安710049

出　　处：《中国医学伦理学》2021年第5期593-598,共6页Chinese Medical Ethics

基　　金：国家自然科学基金面上项目“基于人工智能的小鼠肿瘤节拍/自适应化疗疗效预测模型的建立与研究”(81972814);陕西自然科学基金一般项目-社会发展领域“肠道G-菌通过TLR4信号通路调控MDSCs介导肿瘤抵抗环磷酰胺的机制研究”(2021SF-130)。

摘　　要：新型冠状病毒肺炎疫情的暴发,在缺乏特效治疗以及疫苗的安全、有效性未明确的前提下,“恢复期血浆治疗”一度被认为是新冠肺炎潜在的治疗方案。然而“恢复期血浆治疗”临床研究大多只是研究初步阶段,安全性和有效性仍需要验证,风险和受益可能并存。同样“恢复期血浆治疗”临床研究存在伦理审查、患者知情同意等伦理学问题。研究“恢复期血浆治疗”临床研究的现状与伦理学问题,并提出相应的应对措施,有助于规范疫情下临床研究,确保研究质量以及临床安全性。The outbreak of COVID-19, at present, in the absence of specific treatment and the safety and effectiveness of the vaccine is not clear, “convalescent plasma therapy” has been considered as a potential treatment for COVID-19. However, the clinical study of “convalescent plasma therapy” is only at the initial stage of research, and its safety and effectiveness still need to be verified, so risks and benefits may coexist. Similarly, the clinical research of “convalescent plasma therapy” faces ethical issues such as ethical review and informed consent of patients and so on. This paper discussed the present situation and ethical problems of clinical research on “convalescent plasma therapy”,and put forward corresponding countermeasures, which is helpful to standardize clinical research under epidemic situation and ensure the quality and clinical safety.

关 键 词：恢复期血浆疗法 新冠肺炎 医学伦理 临床研究 

分 类 号：R-052[医药卫生]