医学信息2025，Vol.38Issue(8)：27-32,6.DOI:10.3969/j.issn.1006-1959.2025.08.005
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
摘要
Abstract
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Key words
Ibrutinib/The Food and Drug Administration Adverse Event Reporting System/Adverse drug event分类
药学引用本文复制引用
李爱国,陈湘磊..基于FAERS数据库进行伊布替尼药物不良事件信号挖掘[J].医学信息,2025,38(8):27-32,6.基金项目
潍坊市卫健委科研项目(编号:WFWSJK-2020-302) （编号:WFWSJK-2020-302）
