基于FAERS数据库格卡瑞韦/哌仑他韦不良事件信号挖掘与分析  

Adverse drug events signals of glecaprevir/pibrentasvir based on the FAERS database

作　　者：陈玲[1] 伏箫燕 钟薇[1] 黄佳 陈力[2,3,4] CHEN Ling;FU Xiao-yan;ZHONG Wei;HUANG Jia;CHEN Li(Department of Pharmacy,Xindu People’s Hospital,Chengdu 610500;Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041;Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041;Key Laboratory of Birth Defects and Related Diseases of Women and Children(Sichuan University),Ministry of Education,Chengdu 610041)

机构地区：[1]成都市新都区人民医院药剂科,成都610500 [2]四川大学华西第二医院药学部,成都610041 [3]四川大学华西第二医院循证药学中心,成都610041 [4]出生缺陷与相关妇儿疾病教育部重点实验室,成都610041

出　　处：《中南药学》2021年第11期2354-2359,共6页Central South Pharmacy

基　　金：成都市医学科研课题(No.2020114);中国药学会科技开发中心科普项目(No.CME2021KPYJ00104)。

摘　　要：目的挖掘和分析格卡瑞韦/哌仑他韦的药品不良事件(ADE)信号,为临床安全合理用药提供依据。方法采用比值失衡法中的报告比值比法(ROR)和综合标准法(MHRA)对美国FDA不良事件报告系统(FAERS)中格卡瑞韦/哌仑他韦2018年第一季度至2020年第四季度的ADE报告进行数据挖掘及分析,检测阈值为报告数大于3且ROR的95%置信区间(CI)下限大于1的ADE,并对ADE采用国际医学用语词典(MedDRA)的首选系统器官分类(SOC)和首选术语(PT)进行统计和分类,选取ADE报告数和信号强度排名前50位的PT进行分析。结果收集到8923例ADE报告,得到信号134个,主要集中在胃肠道系统疾病、肝胆系统疾病、各类检查以及皮肤及皮下组织类疾病等方面。结论本次研究利用ROR及MHRA挖掘出格卡瑞韦/哌仑他韦的不良反应信号,深入了解该药品的安全性特征及潜在风险,为临床用药提供参考。Objective To provide reference for rational drug use through mining and analysis the adverse drug events(ADE)signals of glecaprevir/pibrentasvir.Methods The methods of reporting odds ratio(ROR)and medicines and healthcare products regulatory agency(MHRA)were used to analyze the data from the first quarter of 2018 to the fourth quarter of 2020 of the united states FDA adverse event reporting system(FAERS).ADE with more than 3 reports and the lower limit of 95%confidence interval(CI)of ROR greater than 1 was defined as a positive signal.ADEs were counted and classified with the preferred system organ class(SOC)and preferred term(PT)of Medical Dictionary for Regulatory Activities(MedDRA).The PTs of top 50 ADE reports and signal strength were analyzed.Results Totally 8923 ADE reports were collected,and 134 signals of glecaprevir/pibrentasvir were obtained,mainly involving on diseases of the gastrointestinal and hepatobiliary system,medical examinations,skin and subcutaneous tissue diseases,etc.Conclusion The characteristics,and potential risks of geckarivir/pirentavir are obtained ROR and MHRA methods.

关 键 词：格卡瑞韦/哌仑他韦 药品不良事件 信号挖掘 比例失衡法 

分 类 号：R969.3[医药卫生—药理学]