格卡瑞韦/哌仑他韦和索磷布韦/维帕他韦上市后不良反应信号挖掘与分析  

Excavation and analysis of ADR signals of GLE/PIB and SOF/VEL after marketing

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

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

出　　处：《中国医院药学杂志》2022年第4期426-430,共5页Chinese Journal of Hospital Pharmacy

基　　金：成都市医学科研课题(编号:2020114);中国药学会科技开发中心科普项目(编号:CME2021KPYJ00104)。

摘　　要：目的:通过对泛基因型直接抗丙型肝炎病毒复方制剂格卡瑞韦/哌仑他韦(GLE/PIB)及索磷布韦/维帕他韦(SOF/VEL)药品不良事件(ADE)信号的挖掘和分析,为临床安全合理使用两药提供参考。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GLE/PIB及SOF/VEL 2018年第1季度至2020年第4季度在治疗丙型肝炎过程中发生的药品不良事件报告数据进行挖掘及分析。结果:最终得到GLE/PIB有效信号134个,SOF/VEL有效信号168个,主要集中在胃肠道系统疾病、全身性疾病及给药部位各种反应等方面,其中有61个重叠信号。结论:基于两者ADE信号分析比较,对2种药物安全性差异有了进一步认识,能更好地为临床药物选择提供参考。OBJECTIVE To provide reference for clinic safe and rational drug use through mining and analysis the adverse drug reaction(ADE)signals of the direct anti-hepatitis C virus compound preparations of pan-geneotypes glecaprevir/pibrentasvir(GLE/PIB)and sofosbuvir/velpatasvir(SOF/VEL).METHODS The methods of reporting odds ratio(ROR)and the medicines and health care products regulatory agency(MHRA)were used to analyze the data of adverse occurred during the treatment of hepatitis C which reported from the first quarter of 2018 to the fourth quarter of 2020 of the united states FDA adverse event reporting system(FAERS).RESULTS Totally 134 signals of GLE/PIB and 168 signals of SOF/VEL were obtained through the methods, mainly focusing on diseases of the gastrointestinal system and hepatobiliary, systemic diseases, and various reactions at the site of administration, etc.61 signals were overlapped.CONCLUSION The differences of safety between the two drugs have been further understood and references for clinical drug selection were obtained through the analysis and comparison of the ADE signals.

关 键 词：格卡瑞韦/哌仑他韦 索磷布韦/格卡瑞韦 药品不良事件 信号挖掘 

分 类 号：R97[医药卫生—药品]