健康绝经期女性受试者在生物等效性试验中筛选失败原因分析  

Analysis of reasons for failure in screening healthy menopausal female subjects in a bioequivalence trial

作　　者：沈珍 樊莲莲[1] 李慕鹏 甘春燕[1] 申屠建中 SHEN Zhen;FAN Lian-lian;LI MU-peng;GAN Chun-yan;SHENTU Jian-zhong(Phase I Clinical Trial Center,Deyang People’s Hospital,Deyang 618000,Sichuan Province,China;Research Center of Clinical Pharmacy,The First Affiliated Hospital,School of Medicine,Zhejiang University,Hangzhou 310003,Zhejiang Province,China)

机构地区：[1]德阳市人民医院Ⅰ期临床研究中心,四川德阳618000 [2]浙江大学医学院附属第一医院临床研究中心,浙江杭州310003

出　　处：《中国临床药理学杂志》2024年第17期2572-2574,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的探究生物等效性试验健康绝经期女性受试者筛选失败的原因。方法分析一项戊酸雌二醇人体生物等效性试验中185例绝经期女性受试者资料,对筛选失败的原因进行归纳总结。结果筛选失败原因主要包括实验室检查(32.04%)、妇科经阴道彩超(16.57%)、生命体征(14.36%)、胸部电子计算机断层扫描(11.60%)、既往病史/用药史(7.73%)等。结论健康绝经期女性受试者与一般健康受试者相比,筛选失败特点主要是妇科经阴道彩超异常及基础激素水平不符合。Objective To clarify and analyze the reasons for failure in screening healthy menopausal female in a bioequivalence trial.Methods To summarize and clarify the data of 185 healthy menopausal female subjects participating in a bioequivalence trial of estradiol valerate conducted,and summarize the reasons for screening failure.Results The main reasons for screening failure include laboratory tests(32.04%),gynecological transvaginal color Doppler ultrasound(16.57%),vital signs(14.36%),chest computed tomography(CT,11.60%),and medical history/medication history(7.73%).Conclusion Screening failures in healthy menopausal female subjects were characterized mainly by abnormal gynecological transvaginal color Doppler ultrasound and non-compliance with basal hormone levels compared to generally healthy subjects.

关 键 词：戊酸雌二醇 生物等效性试验 健康绝经期女性受试者 受试者筛选 特殊检查 

分 类 号：R97[医药卫生—药品]