布罗达单抗上市后安全警戒信号的挖掘与评价  

Mining and evaluation of the safe warning signals induced by Brodalumab in post-marketing experience

作　　者：彭媛[1,2] 陈晗 李锐 杨明 刘福[1] Peng Yuan;Chen Han;Li Rui;Yang Ming;Liu Fu(Department of Pharmacy,the Affiliated Hospital of North Sichuan Medical College,Sichuan Nanchong 637000,China;School of Pharmacy,North Sichuan Medical College,Sichuan Nanchong 637100,China)

机构地区：[1]川北医学院附属医院药剂科,四川南充637000 [2]川北医学院药学院,四川南充637100

出　　处：《遵义医科大学学报》2023年第4期409-414,共6页Journal of Zunyi Medical University

基　　金：南充市社科研究十三五规划项目(NO:NC2020B047)。

摘　　要：目的挖掘和评价布罗达单抗上市后的安全警戒信号。方法采用ROR法对美国不良事件报告系统进行布罗达单抗的安全警戒信号挖掘。结果纳入美国不良事件报告系统2016年第一季度至2022年第一季度的数据,得到首要怀疑布罗达单抗的不良反应报告4431例,安全警戒信号206个,主要集中在皮肤和皮下组织病症、感染和传染病症、肌肉骨骼和结缔组织病症。结论通过对布罗达单抗进行上市后安全警戒信号的挖掘与评价可为临床用药提供参考。Objective To mine and evaluate the safe warning signals induced by brodalumab in post-marketing experience and to provide reference for rational drug use in clinical practices.Methods Report the odds ratio(ROR)method was used to mine the safe warning signals induced by brodalumab from the American FDA adverse event reporting system(FAERS).Results A total of 4431 Adverse Drug Reaction(ADR)reports involving brodalumab as the primary suspected drugs were included in FAERS from quarterⅠof 2016 to quarterⅠof 2022,the corresponding number of safe warning signals were 206,which mainly involve skin and subcutaneous tissue disorders,infections and infestations and musculoskeletal and connective tissue disorders.Conclusion The ROR method could provide reference for clinical drug use through mining and evaluating the safe warning signals induced by brodalumab in post-marketing experience.

关 键 词：抗白细胞介素-17抗体 布罗达单抗 不良反应 信号挖掘 药物警戒 

分 类 号：R986[医药卫生—药品]