生物等效性试验中常见实验室检查筛选失败原因分析  

Analysis of the Causes of Common Laboratory Screening Failure in Bioequivalence Study

作　　者：王琎 高琳艳 李想 裴彤[1] 胡朝英 张兰[1] WANG Jin;GAO Linyan;LI Xiang;PEI Tong;HU Chaoying;ZHANG Lan(Phase I Clinical Trial Center,Department of Pharmacy,Xuanwu Hospital,Capital Medical University,Beijing 100053,China)

机构地区：[1]首都医科大学宣武医院药学部I期临床研究中心,北京100053

出　　处：《医药导报》2023年第2期284-287,共4页Herald of Medicine

基　　金：国家科技重大专项—重大新药创制(2017ZX09101001-002-044)。

摘　　要：目的分析生物等效性试验中受试者因实验室检查筛选失败的主要原因,为后续试验中可能采取的针对性措施、提高筛选成功率提供参考。方法汇总首都医科大学宣武医院药学部I期临床研究中心已完成的13项生物等效性试验中参加筛选并已采血的1117例健康受试者,对实验室检查不合格的受试者进行分析,归纳不同检查项目筛选失败的主要原因。结果1117例已采血的受试者中,261例因实验室检查筛选失败,占23.4%。其中血生化检查占52.1%,其次为血常规(19.6%)、尿常规(13.7%)、传染病检查(9.2%)、凝血功能(5.4%)、血妊娠检查(占全部采血女性1.8%)。男性受试者最常见筛选失败原因转氨酶、尿酸升高,女性受试者为血小板升高、贫血。结论通过加强健康宣教,改善生活方式,认真体格检查,有助于提高筛选成功率。Objective To analyze the main reasons for the failures of subjects in bioequivalence trials due to laboratory screening,so as to provide ideas for the targeted measures that may be taken in the follow-up test and to improve the success rate of screening.Methods A total of 1117 healthy subjects who participated in the screening and had blood collected were collected from 13 bioequivalence tests completed in the Phase I Clinical Research Center of the Department of Pharmacy of Xuanwu Hospital,and the unqualified subjects were analyzed to summarize the main reasons for the failure of different tests.Results Of 1117 subjects whose blood was collected,261(23.4%)failed in laboratory screening.Among them,blood biochemistry accounted for 52.1%,followed by blood routine(19.6%),urine routine(13.7%),infectious disease examination(9.2%),coagulation function(5.4%),and blood pregnancy examination(accounting for all the women,1.8%).The most common causes for screening failure were elevated transaminase and uric acid in male subjects,and elevated platelet and anemia in female subjects.Conclusion By strengthening health education,improving lifestyle,and careful physical examination,it is helpful to improve the success rate of screening.

关 键 词：生物等效性试验 实验室检查 筛选失败 原因分析 

分 类 号：R969.4[医药卫生—药理学]