性别因素对生物等效性试验受试者筛选的影响  

The Influence of Gender Factors on Subjects Screening in Bioequivalence Test

作　　者：何云山 周建军[1,2] 彭利兰 邹鸿立 彭国茳[1,2] 李牛秀[2] HE Yunshan;ZHOU Jianjun;PENG Lilan;ZOU Hongli;PENG Guojiang;LI Niuxiu(Office of Drug Clinical Trial Institutions,the Affiliated Hospital of Xiangnan University,Chenzhou 423000,China;Phase I Clinical Trial Research Laboratory,the Affiliated Hospital of Xiangnan University,Chenzhou 423000,China)

机构地区：[1]湘南学院附属医院药物临床试验机构办公室,郴州423000 [2]湘南学院附属医院I期临床试验研究室,郴州423000

出　　处：《医药导报》2025年第5期834-839,共6页Herald of Medicine

基　　金：湖南省卫健委一般课题(B202313018285);湖南省自然科学基金资助项目(2024JJ7526);湘南学院、湘南学院附属医院联合课题(2021XJ82)。

摘　　要：目的探讨生物等效性研究中性别因素在受试者筛选中的影响,为提高后续试验中受试者筛选成功率提供参考。方法采用回顾性研究,汇总湘南学院附属医院I期临床试验研究室2021年7月—2023年7月开展的生物等效性研究中健康受试者筛选情况信息,统计各项目筛选时受试者在不同环节筛选失败例次,分析性别因素对受试者筛选的影响。结果共纳入生物等效性研究32项,涉及受试者2794例,其中男1816例,女978例。男性在生命体征和身体质量指数(BMI)异常方面比例较高,女性在心电图异常和主动退出方面比例较高。男性合格率低于女性(40.0%vs.45.8%,P<0.05)。主成分分析(PCA)结果表明,男性数据分布较分散,女性数据分布集中,二者可明显区分。二元logistic回归分析显示,男性与女性在实验室检查筛败和BMI方面差异有统计学意义(P<0.05)。进一步分析显示男性在血生化、尿常规、凝血功能、输血4项的筛败率高于女性,但血常规筛败率低于女性。结论性别是生物等效性研究筛选环节中的重要影响因素,纳入适当性别比例的受试者有助于提高入组速度,降低临床试验的成本。Objective To explore the impact of gender factors in participant selection during bioequivalence studies,and to provide insights for improving the screening success rate in subsequent trials.Methods A retrospective study was conducted to summarize the screening information of healthy subjects in the bioequivalence study conducted in the Phase I Clinical Trial Laboratory of the Affiliated Hospital of Xiangnan University from July 2021 to July 2023.The number of failed screening cases in different stages of screening for each project was counted,and the influence of gender factors on subject screening was analyzed.Results A total of 32 bioequivalence studies involving 2794 subjects,including 1816 males and 978 females,were included in the study.The proportion of males was higher in vital signs and BMI abnormalities,and the proportion of females was higher in ECG abnormalities and active withdrawal,and the pass rate was lower in males than in females(40.0%vs.45.8%),and the existence of the two was statistically significant(P<0.05).The results of PCA showed that the distribution of data in males was more dispersed,and the distribution of data in females was centralized,and the two could be clearly differentiated.Binary logistic regression analysis showed significant differences between males and females in laboratory test screening failures and BMI(P<0.05).Further analysis showed that the screening failure rates of blood biochemistry,urine routine,coagulation function and blood transfusion were higher in males than in females,but the screening failure rates of blood routine were lower than those of females.Conclusions Gender is an important influencing factor in the screening process of bioequivalence studies.Including subjects with appropriate gender ratios can help improve enrollment speed and reduce clinical trial costs.

关 键 词：生物等效性研究 受试者 性别差异 原因分析 

分 类 号：R969[医药卫生—药理学]