基于放射性同位素标记药物临床试验的伦理学思考  

Ethical thinking on radioisotope-labeled drug clinical trials

作　　者：徐溢涛[1] 缪丽燕[1] 朱雪松[1] 张华[1] XU Yi-tao;MIAO Li-yan;ZHU Xue-song;ZHANG Hua(The First Affiliated Hospital of Soochow University,Suzhou JIANGSU 215006,China)

机构地区：[1]苏州大学附属第一医院,江苏苏州215006

出　　处：《中国新药与临床杂志》2020年第7期401-404,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家科技重大专项-重大新药创制(2017ZX09304021)。

摘　　要：开展基于放射性同位素标记技术的药物临床试验,揭示药物在人体内代谢的过程,已经成为新药研发过程中的重要环节,但放射性同位素具有不断释放特征射线的放射风险而存在着相应的伦理挑战。本文从放射性同位素标记药物临床试验研究方案的科学性、研究的放射风险及知情同意书等多个角度,阐述同位素标记的必要性、受试者和研究人员与环境的放射风险及相关知情告知要素等伦理审查要点。The clinical trials of drugs based on radioisotope label technology which reveals the process of drug metabolism in the human body has become an important link in the development of new drugs, but radioisotope has the radiation risk of continuously releasing characteristic rays and corresponding ethical challenges. This article analyzed and summarized the ethical review points including isotope labeling necessity, the radiation risks of subjects, researches and the research environment, and relevant informed factors of clinical trials from various perspectives such as scientific design of radioisotope-labeled drugs research protocols, radiation risks, and informed consent.

关 键 词：放射性同位素 同位素标记 临床试验 伦理学委员会 研究 

分 类 号：R-052[医药卫生]