标准化全流程管理在高变异药物生物等效性评价中的应用研究  

Application of Standardized Whole Process Management in Bioequivalence Evaluation of Highly Variable Drugs

作　　者：杨辉[1] 周远大[1] 李娟[1] 陶艺 YANG Hui;ZHOU Yuanda;LI Juan;Tao Yi(Department of Pharmacy,the First Affiliated Hospital of Chongqing Medical University,Chongqing,400016;Phase I clinical trial ward,the First Affiliated Hospital of Chongqing Medical University,Chongqing 400016)

机构地区：[1]重庆医科大学附属第一医院药学部,重庆400016 [2]重庆医科大学附属第一医院Ⅰ期临床试验病房,重庆400016

出　　处：《中国药业》2020年第18期1-4,共4页China Pharmaceuticals

基　　金：重庆市技术创新与应用示范(社会民生类)一般项目[cstc2018jscx-msybX0035];重庆市科卫联合医学科研项目[2018MSXM055]。

摘　　要：目的探讨标准化全流程管理在高变异药物生物等效性评价中的应用价值。方法试验分为研究组与对照组,对照组受试者给予常规病房管理,研究组受试者予标准化全流程管理,计算受试者依从率、方案偏离率、受试者满意度、不良事件发生率。结果研究组方案偏离率为50. 00%,受试者满意度为96. 88%,不良事件发生率为18. 75%,明显优于对照组的75. 00%,75. 00%,43. 75%(P <0. 05);两组受试者依从率相当(P> 0. 05)。结论在高变异药物生物等效性评价中施行标准化全流程管理,可优化Ⅰ期临床试验病房管理流程,提高生物等效性试验的质量,保护受试者权益。Objective To explore the application value of standardized whole process management in bioequivalence evaluation of highly variable drugs. Methods Subjects were divided into a study group and a control group. Both groups were given routine ward management. The study group was given standardized whole process management based on the bioequivalence evaluation of highly variable drugs,and the trial compliance rate,protocol deviation rate,and subject satisfaction,incidence of adverse events were calculated.Results The deviation rate of the study group was 50. 00%,the subject satisfaction rate was 96. 88%,and the incidence of adverse events was 18. 75%,which were all significantly better than 75. 00%,75. 00%,43. 75% of the control group( P < 0. 05);the compliance rate of the two groups was equivalent( P > 0. 05). Conclusion Standardized whole process management applied in the bioequivalence evaluation of highly variable drugs can optimize the management process,improve the quality of bioequivalence test and protect the rights and interests of subjects in phase Ⅰ clinical trial ward.

关 键 词：生物等效性评价 高变异药物 Ⅰ期临床试验 病房管理 标准化全流程管理 

分 类 号：R95[医药卫生—药学]