药物Ⅰ期临床试验中烟碱筛查高阳性率的分析  

Analysis of high positive rate of smoke screening in phase Ⅰ of drug clinical trials

作　　者：张冬林 邓春玲 朱瑜 雷永芳 任秀华[1] 余恒毅 方一念 ZHANG Dong-lin;DENG Chun-ling;ZHU Yu;LEI Yong-fang;REN Xiu-hua;YU Heng- yi;FANG Yi-nian(Department of Pharmacy, Tongfi Hospital, Tongfi Medical College of Huazhong University of Science and Technology, Wuhan HUBEI 430030, China;Department of Pharmacy, Xiangyang City Yicheng Traditional Chinese Medicine Hospital, Yicheng HUBEI 441400, China)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,湖北武汉430030 [2]襄阳市宜城中医院药剂科,湖北宜城441400

出　　处：《中国新药与临床杂志》2017年第12期708-711,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金："十二五"重大新药创制<创新药物研究开发技术平台建设>资助项目(2012ZX09303018001)

摘　　要：目的研究药物Ⅰ期临床试验烟碱筛查(以下简称烟检)高阳性率的相关因素,探讨降低烟检阳性率的有效措施。方法对2016年4月至2016年10月自愿参加某循环系统药物生物等效性试验和某抗肿瘤辅助药物生物等效性试验的227例志愿者,严格按照试验流程对尿液中尼古丁的代谢物可替宁进行定性检测。对于第一次烟检结果阳性(偶尔吸烟或从不吸烟)且愿意继续参加试验的志愿者,在禁烟或避免二手烟3~4 d后进行第二次烟检。结果志愿者第二次烟检阳性率为11.5%,远远低于第一次的66.5%(P<0.001)。结论被动吸烟是烟检阳性的首要因素,禁烟4 d或避免二手烟3 d以上,可有效提高药物Ⅰ期临床试验烟检的合格率,提高筛选效率。AIM To study the related factors about the positive rate of nicotine screening in phase I clinical trials and explore the effective measures to reduce the positive rate. METHODS From April 2016 to October 2016, 227 volunteers in a circulatory system drug bioequivalence test and in a certain anti-tumor auxiliary drug bioequivalence test, were detected strictly in accordance with the test process of qualitative detection of nicotine metabolites cotinine in urine. The volunteers who had a positive result（only occasionally or never smoked） and would like to continue the test were selected and carried out the second smoke detection in a non smoking or avoid second-hand smoke circumstance for 3 to 4 days. RESULTS The positive rate in the second detection was 11.5% which was far lower than the first detection of 66.5%（P 〈0.001）. CONCLUSION The secondhand smoke is the first reason for the positive smoke detection, and non smoking 4 days or avoiding second-hand smoke for more than 3 days can effectively improve the qualification rate of smoke detection in phase I clinical trials and increase the screening efficiency.

关 键 词：临床试验 Ⅰ期 可替宁 被动吸烟 

分 类 号：R954[医药卫生—药学]