临床试验尿液成瘾药物筛查探讨  

Discussion of urine addictive drugs Screening in clinical trials

作　　者：刘雄飞 许俊羽[1] 赵侠[1,2] 周颖 崔一民[1] 

机构地区：[1]北京大学第一医院药剂科,北京100034 [2]中国药科大学基础医学与临床药学院,南京211198

出　　处：《中国临床药理学杂志》2018年第3期371-374,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家自然科学基金资助项目(81373487)

摘　　要：尿液成瘾药物筛查是目前药物Ⅰ期临床试验和生物等效性试验纳入健康受试者的关键操作之一,也是保证受试者的安全、试验结果准确可靠的必要措施之一。虽然《化学药物临床药代动力学研究技术指导原则》等指南提出临床试验需要筛查成瘾药物,但都未明确指出尿液成瘾药物筛查的品种以及在临床试验中的意义。本文根据北京大学第一医院药物Ⅰ期临床试验研究室近几年开展的项目中尿液成瘾药物筛查品种以及筛查结果,分析与探讨尿液滥用药物筛查在临床试验中的必要性及重要意义。Urine addictive drugs screening is one of the key operations for drug Ⅰ phase clinical trials and bioequivalence tests in subject recruitment; It is also one of the necessary measures to ensure the safety of subjects and the accuracy and reliability of clinical trial results.However,the current clinical trial guidelines do not clearly indicate the significance of Urine drug screening in clinical trials. This article is based on screening of addictive drugs in the Peking university first hospital Ⅰ phase clinical trial Unit in recent years,to illustrate the necessity of drug screening in clinical trials.

关 键 词：临床试验 成瘾性药物 药物不良反应 药物相互作用 

分 类 号：R97[医药卫生—药品]