基于美国FAERS数据库的地拉罗司不良事件信号挖掘与分析  

Detection and analysis of signals of adverse events induced by deferasirox based on FAERS

作　　者：钟红 陈红 张玄羿 邓慧远 罗相林 万杰 孔文强 ZHONG Hong;CHEN Hong;ZHANG Xuanyi;DENG Huiyuan;LUO Xianglin;WAN Jie;KONG Wenqiang(Department of Pharmacy,the First People’s Hospital of Zigong City,Zigong Sichuan 643000 China;Department of Pharmacy,Gongjing TCM Hospital of Zigong City,Zigong Sichuan 643000 China;Department of Information,the First People’s Hospital of Zigong City,Zigong Sichuan 643000 China)

机构地区：[1]自贡市第一人民医院药剂科,四川自贡643000 [2]自贡市贡井区中医医院药剂科,四川自贡643000 [3]自贡市第一人民医院信息科,四川自贡643000

出　　处：《中国药物警戒》2024年第8期931-935,共5页Chinese Journal of Pharmacovigilance

基　　金：四川省自贡市卫健委项目(22yb063)。

摘　　要：目的挖掘地拉罗司不良事件(AE)风险信号,为临床安全用药提供参考。方法提取美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库中地拉罗司从2005年11月1日上市至2023年9月30日的AE报告,按《监管活动医学词典》(MedDRA)系统-器官分类(SOC)和首选术语(PT)进行分类,采用报告比值法(ROR)和信息成分法(IC),挖掘并分析可疑风险信号。结果共检索到以地拉罗司为首要怀疑的AE报告19657份,男女比例为1.04∶1,患者年龄集中在18~85岁(7948份,40.43%)。检测到地拉罗司AE信号870个,累及20个SOC。报告数前20位的PT中,说明书未记载的可疑阳性信号有4个,主要集中在感染及侵染类疾病(2个)及全身性疾病及给药部位各种反应(2个)。结论临床应用地拉罗司时,除关注药品说明书收录的不良反应外,还应密切关注其致感染、脑血管意外、便秘、过敏性心肌炎等风险,保障患者用药安全。Objective To provide reference for clinical safe medication by exploring adverse event reports of deferasirox.Methods The adverse event(AE)reports of deferasirox collected between November 2005 and September 2023 were retrieved from FAERS database,and classified according to the system organ class(SOC)and preferred term(PT).Suspicious risk signals were mined and analyzed using the reporting odds ratio(ROR)and information component(IC)method.Results A total of 19657 AEs related to deferasirox as the primary suspect were reported.The male-tofemale ratio was 1.04:1 and the age mainly ranged from 18 to 85 years old(7948 cases,40.43%).A total of 870 AE signals were detected,involving 20 SOC.Among the top 20 PTs of reports,4 positive signals were not mentioned in drug instructions,including infections,infestations(2 signals),general disorders and administration site conditions(2 signals).Conclusion In clinical use of deferasirox,clinicians should be alert not only to adverse reactions,but to the risk of infection,cerebrovascular accidents,constipation and hypersensitivity myocarditis so as to ensure the safety of medication for patients.

关 键 词：地拉罗司 FDA不良事件报告系统 不良事件 信号挖掘 报告比值法 信息成分法 感染及侵染类疾病 全身性疾病 给药部位各种反应 

分 类 号：R973[医药卫生—药品] R994.11[医药卫生—药学]