基于FAERS数据库对卡马替尼不良事件信号挖掘和用药风险分析  

Signal mining of capmatinib adverse events and drug risk analysis based on the FAERS database

作　　者：王莎 梁伟意 WANG Sha;LIANG Weiyi(Department of Pharmacy,Jiangmen Wuyi Hospital of Traditional Chinese Medicine,Jiangmen 529000,China)

机构地区：[1]江门市五邑中医院药学部,广东江门529000

出　　处：《中国处方药》2025年第5期7-12,共6页Journal of China Prescription Drug

基　　金：2022年度江门市卫生健康局科研项目(22A006)。

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,挖掘卡马替尼不良事件(AE)信号,为患者安全用药提供参考。方法应用报告比值(ROR)法、比例报告比值比(PRR)法、多项伽马泊松分布缩减(MGPS)法和贝叶斯置信递进神经网络(BCPNN)法,分析2020年第2季度~2024年第2季度卡马替尼相关数据的风险信号强度。结果检索到卡马替尼AE报告2050份,发生AE5772例次;AE发生时间中位数为31d;严重AE占比57.56%;阳性信号共涉及26个系统器官分类(SOC),其中位列前3位的分别为全身性疾病及给药部位各种反应、胃肠系统疾病,以及良性、恶性及性质不明的肿瘤;死亡、外周肿胀、疲劳等AE发生频次较高;在发生强度排名前20位的AE中,新的AE占30%(6/20),如声带瘫痪、肝细胞溶解及食管狭窄等。结论应进一步完善卡马替尼用药评估,并加强用药监护,从而切实保障患者的用药安全。Objective Based on the US food and drug administration adverse event reporting system(FAERS)database,to mine capmatinib adverse event(AE)signals and provide a reference for patient safety in medication use.Methods The reporting odds ratio(ROR)method,proportional reporting ratio(PRR)method,multi-item gamma poisson shrinker(MGPS)method,and Bayesian confidence propagation neural network(BCPNN)method were used to detect the data risk signal strength of capmatinib-related data from the second quarter of 2020 to the second quarter of 2024.Results A total of 2050 AE reports of capmatinib were retrieved,with 5772 times.The median occurrence time of AE was 31 days.Serious AE accounted for 57.56%;A total of 26 system organ classifications(SOCs)were involved in positive signals,and the top three were general disorders and administration site conditions,gastrointestinal system diseases,and benign,malignant,and unspecified neoplasms.AEs such as death,peripheral swelling and fatigue occurred more frequently;30%(6/20)of the top 20 AEs were new,such as vocal cord paralysis,hepatic cytolysis and oesophageal stenosis.Conclusion Further improvement of capmatinib medication assessment and enhanced medication monitoring should be implemented to ensure the medication safety of patients.

关 键 词：卡马替尼 不良事件 FAERS数据库 信号挖掘 

分 类 号：R73[医药卫生—肿瘤]