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
沈珍 1樊莲莲 1李慕鹏 1甘春燕 1申屠建中2
作者信息
- 1. 德阳市人民医院Ⅰ期临床研究中心,四川德阳 618000
- 2. 德阳市人民医院Ⅰ期临床研究中心,四川德阳 618000;浙江大学医学院附属第一医院临床研究中心,浙江杭州 310003
- 折叠
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.
Abstract
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Key words
estradiol valerate/bioequivalence trial/healthy menopausal female subjects/subjects screening/special examination引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据