基于FAERS数据库进行伊布替尼药物不良事件信号挖掘  

Adverse Drug Event Signals Mining of Ibrutinib Based on FAERS Database

作　　者：李爱国[1] 陈湘磊[2] LI Aiguo;CHEN Xianglei(Department of Blood Transfusion,Yidu Central Hospital of Weifang,Qingzhou 262500,Shandong,China;Department of Hematology,Yidu Central Hospital of Weifang,Qingzhou 262500,Shandong,China)

机构地区：[1]潍坊市益都中心医院输血科,山东青州262500 [2]潍坊市益都中心医院血液科,山东青州262500

出　　处：《医学信息》2025年第8期27-32,共6页Journal of Medical Information

基　　金：潍坊市卫健委科研项目(编号:WFWSJK-2020-302)。

摘　　要：目的 利用美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)挖掘伊布替尼药物不良事件(ADE)信号,为临床合理用药提供参考。方法 调取FAERS中2014年第一季度至2023年第一季度的伊布替尼数据,采用报告比值比法和贝叶斯可信区间递进神经网络法进行信号挖掘,分析其ADE发生情况。结果 共检测到58 380份以伊布替尼为首要怀疑药物的ADE报告,伊布替尼不良反应的中位发生时间为143 d,主要发生在用药治疗的早期,ADE上报呈逐年上升趋势。ADE信号为580个,涉及到25个系统器官分类(SOC)。结论 在真实世界中,伊布替尼存在药品说明书以外的ADE,应提高对此类ADE发生的警惕性,更好地保障患者用药安全。Objective To explore the adverse drug event(ADE) signals of ibutinib by using the Food and Drug Administration(FDA) Adverse Event Reporting System(FAERS),and to provide reference for clinical rational drug use.Methods The data of ibutinib from the first quarter of 2014 to the first quarter of 2023 in FAERS were collected.The reporting odds ratio method and Bayesian confidence interval progressive neural network method were used for signal mining to analyze the occurrence of ADE.Results A total of 58 380 reports of adverse events with ibutinib as the primary suspected drug were detected.The median occurrence time of adverse reactions of ibutinib was 143 days,mainly in the early stage of drug treatment,and ADE reporting showed an increasing trend year by year.ADE signals were 580,involving 25 system organ classification(SOC).Conclusion In the real world,ibrutinib has adverse events other than drug labels,and vigilance for such adverse events should be improved to better ensure the safety of patients.

关 键 词：伊布替尼 美国食品药品监督管理局不良事件报告系统 药物不良事件 

分 类 号：R979.1[医药卫生—药品]