临床试验尿液成瘾药物筛查探讨

Discussion of urine addictive drugs Screening in clinical trials

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.