生物等效性试验健康受试者筛选失败原因分析及对策  

Analysis of the Reasons for the Failure of Screening Healthy Subjects in the Bioequivalence Test and the Countermeasures

作　　者：苏健芬 郭理宁 谭玉英 徐佐恒 杨辉 张文洁 SU Jianfen;GUO Lining;TAN Yuying;XU Zuoheng;YANG Hui;ZHANG Wenjie(Central Hospital of Panyu District,Guangzhou,Guangdong 511400,China;Guangzhou,Jinan University,Guangzhou,Guangdong 511486,China)

机构地区：[1]广州市番禺区中心医院,广东广州511400 [2]暨南大学,广东广州511486

出　　处：《今日药学》2021年第10期792-796,共5页Pharmacy Today

基　　金：广州市民生科技攻关计划项目(201803010036);广州市民生科技攻关计划项目(201903010016)。

摘　　要：目的分析某中心仿制药生物等效性试验中,受试者筛选失败的原因,并针对原因探讨提高筛选成功率的对策。方法分析某中心仿制药生物等效性试验的1456例健康受试者筛选过程,对筛选失败的原因进行归纳总结。针对原因和影响因素,制定对策提高筛选成功率。结果与受试者筛选失败有关的因素包括身份鉴定、既往史、体格检查、身高体质量测量、生命体征测量、实验室检查和依从性等,其中实验室检查不合格,占34.40%;生命体征测量不合格,占14.15%;既往史询问和身高体质量测量也各占11.23%和9.40%。干预措施实施后,生物等效性试验中问诊、BMI/体质量、生命体征、尿酸等筛选项筛选成功率有所提高,总体筛选成功率明显提高。结论实验室检查不合格、生命体征测量不合格、既往史不合格、身高体质量不合格是受试者筛选失败的主要原因。可从规范受试者来源、加强教育、数据库查重,强化单独知情同意过程,制定科学的正常值参考范围等方面提高受试者的筛选成功率。OBJECTIVE To analyze the reasons for the failure of screening in the process of bioequivalence test of generic drugs in a center,and to explore and formulate countermeasures to improve the success rate of screening.METHODS The screening process of 1456 cases of healthy volunteers who participated in the bioequivalence test of generic drugs in a center were analyzed and summarize the reasons of screening failure.In view of the causes and influencing factors,practical countermeasures were formulated to improve the success rate of screening.RESULTS The factors that may be related to the failure of screening included identification,previous history inquiry,physical examination,height and weight measurement,vital signs measurement,laboratory examination and compliance.The laboratory examination failure accounted for 34.40%of the total screening population.The vital signs measurement failure accounted for 14.15%.The failure of previous history inquiry and height weight measurement also accounted for 11.23%and 9.40%respectively.After the implementation of the intervention measures,the success rate of some screening items such as weight/BMI,vital signs,uric acid were improved,and the overall screening success rate was significantly improved.CONCLUSION The main reasons for failure of subjects screening are the unqualified laboratory examination,the unqualified vital signs measurement,the unqualified previous history inquiry and height weight measurement.The success rate of screening can be improved by standardizing the source of objects,strengthening the education before screening,making use of the commercialized online database of subjects,strengthening the process of individual informed assent,formulating the scientific and reasonable reference range of normal values.

关 键 词：生物等效性试验 健康受试者 筛选 对策 

分 类 号：R969.1[医药卫生—药理学]