摘要
首先剖析了新冠肺炎疫情防控中紧急用药与遵循伦理规范之间的冲突情形,论证了超适应证用药所符合的伦理原则,以及确保患者知情同意的重要性;指出新冠肺炎患者的临床紧急救治应得到优先考虑,但疫情中临床试验仍应遵循伦理规范。为获取科学证据,随机对照试验设计并非唯一选择,可选用适应性设计、真实世界研究等,同时进行超适应证用药,以便高效地满足治疗需求。为了更好地平衡满足紧急用药需求与遵循伦理规范之间的关系,建议:明确新发传染病中药物的紧急使用内容和授权机制;加快新冠肺炎临床试验进程要以遵循伦理规范为前提;建设统一的科学信息发布平台,多途径保障公众的知情选择权。
This study analyzes the conflicts between emergency drug use and ethics in the prevention and control of COVID-19.It demonstrates the ethical principles that the use of drugs for unlabeled indications conforms to,and the importance of ensuring informed consent.Clinical emergency treatment of COVID-19 patients should be given priority,but clinical trials in epidemic situations should still follow scientific principles.To obtain scientific evidence,the design of randomized controlled trials is not the only option.Methods such as adaptive design and real-world research can be used.Using drugs for unlabeled indications can efficiently meet treatment needs.To better balance the need for emergency drug use with moral norms,the authors suggest the following:the urgent uses of drugs and authorization mechanisms for emerging infectious diseases should be clarified;accelerations of clinical trials for COVID-19 treatments should be based on compliance with ethical norms;and a unified scientific information publishing platform should be built,to protect the informed choices of the public(in various ways).
作者
李闪闪
张新庆
Li Shanshan;Zhang Xinqing(Department of Marxism,Xi’an Medical University,Xi’an 710021,China;School of Humanities and Social Sciences,Peking Union Medical College,Beijing 100005,China)
关键词
新冠肺炎
超适应证用药
临床试验
紧急救治
伦理规范
COVID-19
using drug for unlabeled indication
clinical trial
emergency treatment
moral norms
