在生物等效性研究中健康受试者的医疗风险及其防范策略  

Medical Risks and Control Strategies for Healthy Subjects in Bioequivalence Studies

作　　者：刘剑锋[1] 钟平 朱文玲 罗茜 章秀锦[2] LIU Jianfeng;ZHONG Ping;ZHU Wenling;LUO Xi;ZHANG Xiujin(Department of Pulmonary Medicine,the First Affiliated Hospital of Xiamen University,Xiamen,Fujian 361022,China;BE/Phase I Clinical Trial Center,the First Affiliated Hospital of Xiamen University,Xiamen,Fujian 361022,China)

机构地区：[1]厦门大学附属第一医院肺科,福建厦门361022 [2]厦门大学附属第一医院BE/I期临床试验研究中心,福建厦门361022

出　　处：《药学与临床研究》2021年第2期127-130,共4页Pharmaceutical and Clinical Research

摘　　要：目的:探讨生物等效性研究中健康受试者发生风险的可能来源并提出相应的风险防范策略。方法:回顾性分析本研究中心2017年3月至2019年6月生物等效性研究中发生的严重不良事件和重要不良事件,通过查询原始病历,分析不良事件的来源、转归、与研究药物的关系,找出医疗风险关键点。结果:在32项生物等效性研究中,共发生5例严重不良事件和2例重要不良事件。具体来源分类如下:①与药物不良反应有关:1例急性肾损伤;②与受试者筛选有关:1例癫痫、1例水痘、1例泌尿系统结石;③与试验步骤有关:1例急性阑尾炎;④妊娠事件:2例早孕并流产。上述受试者经及时正确的诊治后均痊愈,其中与受试药物的关联性为无关3例,可能无关2例,可能有关1例,很可能有关1例。结论:在生物等效性研究中,受试者的风险主要来源于药物不良反应、受试者筛选不严谨、临床试验步骤不当以及意外妊娠。充分的知情、完善的方案设计和预案、科学严谨的受试者筛选体系、规范个体化的操作和及时正确的诊治是防范风险的最佳策略。Objective:To explore the sources of risks for healthy subjects in bioequivalence studies and propose corresponding risk control strategies.Methods:We tried to find out the key points of medical risks through the query of the original medical records and the analysis of adverse events on their sources,outcomes and relationships with tested drugs in a retrospective study of serious and significant adverse events in bioequivalence studies from March 2017 to June 2019.Results:Five serious and two significant adverse events occurred in 32 bioequivalence studies.Specific categories were as follows:a)One case of acute kidney injury was related to adverse drug reaction,b)One case of epilepsy,one case of chickenpox and one case of urinary calculi were related to healthy subjects screening,c)One case of acute appendicitis was related to trial procedure,d)Two cases of early pregnancy and miscarriage were defined as pregnancy events.All the above subjects were cured after timely and correct treatment,among which the association with the tested drugs was irrelevant in 3 cases,possibly irrelevant in 2 cases,possibly related in 1 case and probably related in 1 case.Conclusions:There were still some risks for healthy subjects in the bioequivalence studies,and the main sources of risks come from adverse drug reactions,unprecise subject screening,improper clinical trial procedures and unintended pregnancies.The best strategy for risk control include fully informed,perfect protocol design,scientific and rigorous subject screening,standardized and individualized manipulation and timely and correct diagnosis and treatment.

关 键 词：生物等效性研究 健康受试者 不良事件 风险控制 

分 类 号：R969.1[医药卫生—药理学] R969.4[医药卫生—药学]