基于FAERS数据库的加卡奈珠单抗不良事件信号挖掘与分析  

Signal mining and analysis for adverse drug events of galcanezumab based on FAERS database

作　　者：刘姗姗[1] 陈果[1] 刘笑 董玉珍[1] LIU Shanshan;CHEN Guo;LIU Xiao;DONG Yuzhen(Department of Pharmacy,Wuhan University Hospital,Wuhan 430072,China)

机构地区：[1]武汉大学医院药剂科,武汉430072

出　　处：《药物流行病学杂志》2024年第8期860-868,共9页Chinese Journal of Pharmacoepidemiology

摘　　要：目的基于美国食品药品管理局不良事件报告系统(FAERS)数据库挖掘加卡奈珠单抗上市后的药品不良事件(ADE)信号,为临床安全用药提供参考。方法收集FAERS数据库中2018年第3季度至2023年第4季度共22个季度的数据,运用结构化查询语言去除重复数据后,筛选出以加卡奈珠单抗为首要怀疑药物的ADE报告,采用《国际医学用语词典》对ADE报告进行标准化处理与分类,选用报告比值比(ROR)法和信息成分(IC)法进行ADE信号挖掘。结果经筛选后获得ADE信号60个,涉及11个系统/器官分类,主要为全身性疾病及给药部位各种反应。发生频次最多的ADE信号为注射部位各种不适反应,与药品说明书记载的最常见ADE一致。新的ADE信号中发生频次排名前3位的依次为脱发、体重增加和便秘,ROR值和IC值排名前3位的依次为注射部位脓疱、椎动脉夹层和雷诺现象。结论加卡奈珠单抗相关ADE主要涉及全身性疾病及给药部位各种反应,其中椎动脉夹层、雷诺现象为信号强度较高的新的ADE,治疗期间应密切关注患者的疾病进展情况,避免出现严重后果。Objective To mine the adverse drug event(ADE)signals of galcanezumab based on U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)to provide reference for clinical drug safety.Methods The data from the FAERS database from the third quarter of 2018 to the fourth quarter of 2023 were extracted.After data cleaning and standardization,the duplicate data was removed using structured query language,ADE reports with galcanezumab as the main suspected drug were screened.ADE reports were standardized and categorized using the Medical Dictionary for Drug Regulatory Activities.The reporting odds ratio(ROR)method and information component(IC)method were applied for signal detection.Results A total of 60 ADE signals were detected after screening,11 system organ classes were involved,mainly general disorders and administration site conditions.The ADE signals that occurred most frequently were a variety of discomfort reactions at the injection site,consistent with the most common ADEs documented in the drug insert.The top 3 new ADE signals in order of occurrence frequency were alopecia,weight increased and constipation,and in order of ROR and IC values were injection site pustule,vertebral artery dissection and Raynaud's phenomenon.Conclusion ADE related to galcanezumab mainly involve systemic diseases and various reactions at the site of administration,among which vertebral artery dissection and Raynaud's phenomenon are stronger signals and newer ADEs.The patient’s disease progression should be closely monitored during the treatment period to avoid serious consequences.

关 键 词：加卡奈珠单抗 FAERS数据库 药品不良事件 信号挖掘 药物警戒 

分 类 号：R95[医药卫生—药学]