生物等效性试验不良反应/事件分析及风险管理  

Adverse Reactions/Events Analysis and Risk Management of Bioequivalence Trial

作　　者：苏健芬 曾美娟 胡建楣 徐佐恒 古文钊 杨辉 SU Jianfen;ZENG Meijuan;HU Jianmei;XU Zuoheng;GU Wenzhao;YANG Hui(Guangzhou Panyu Central Hospital,Guangzhou,Guagndong 511400,China;College of Pharmacy,Guangdong Medical University,Dongguan,Guangdong 523808,China)

机构地区：[1]广州市番禺区中心医院,广东广州511400 [2]广东医科大学药学院,广东东莞523808

出　　处：《今日药学》2021年第9期716-720,共5页Pharmacy Today

基　　金：广州市科技局民生科技攻关计划项目(201903010016)。

摘　　要：目的收集某药物临床试验中心2018年3月~2019年10月完成的仿制药生物等效性(bioequivalency, BE)正式试验项目信息,按不同分类方法统计不良反应/事件(adverse drug reaction, ADR/adverse event, AE)的发生率,分析BE试验AE的影响因素,并针对安全性风险因素提出对策。方法分析该中心的23项仿制药BE数据,统计AE在不同人体系统、严重程度、给药周期、药物种类、与药物相关性、性别、季节、给药组、给药途径、住院天数的分布情况,基于AE的起源探讨BE试验风险管理措施。结果纳入的1 275例受试者中,AE总体发生率为39.92%。出现的AE大多程度较轻,Ⅰ级占95.76%。口服药物和注射药物AE发生率分别为40.03%和37.50%,AE的发生与给药途径无明显相关。春、夏、冬季发生率高而秋季发生率最低。不同住院天数与AE的发生相关,发生率随住院天数增加而增加。结论应在BE试验过程针对各阶段的风险因素进行有指向性的管控,加强对风险的管理,降低AE发生率,从而增加药物临床试验安全性。OBJECTIVE To collect the formal pilot project information of generic drugs bioequivalence from March 2018 to October 2019 in a drug clinical trial center, analyze the incidence of adverse drug reaction(ADR) and adverse event(AE) in medical records according to different classification methods, analyze the influencing factors of AE in BEtrial, and put forward the corresponding countermeasures for the risk factors of safety in BE trial. METHODS The data of 23 generic BE clinical trials in the center were analyzed. The distribution of AE in different human systems, severity, administration phases, drug types, drug correlation, gender, seasons, administration groups, route of administration and length of stay were analyzed. Based on the origin of AE,the risk management measures of BE trial were discussed. RESULTS Among the 1 275 subjects, the overall incidence of AE was 39.92%. Most of the AE were mild, grade I were accounted for 95.76%. The incidence of oral administration and injection were 40.03% and 37.50% respectively. There was no significant correlation between the occurrence of AE and route of administration. The occurrence rate of AE was higher in spring, summer and winter than in autumn. The incidence of AE increased with the increase of hospitalization days. CONCLUSION In the process of bioequivalence trila, the risk factors in each stage should be controlled directly to strengthen the risk management and reduce the incidence of adverse events, so as to increase the safety of drug clinical trials.

关 键 词：生物等效性 不良反应/事件 影响因素 风险管理 对策 

分 类 号：R969.4[医药卫生—药理学]