基于FAERS数据库的瑞派替尼不良事件信号挖掘与分析  

Mining and analysis of adverse event signals of ripretinib based on FAERS database

作　　者：骆云霞 李魏嶙[1] 陈新玉[1] 徐华敏 何满娥 吕亚玲[1] 谢家冰[1] LUO Yunxia;LI Weilin;CHEN Xinyu;XU Huamin;HE Man’e;LÜYaling;XIE Jiabing(Chenzhou Third People’s Hospital,Chenzhou 423000,China)

机构地区：[1]郴州市第三人民医院,湖南郴州423000

出　　处：《现代药物与临床》2024年第10期2671-2675,共5页Drugs & Clinic

基　　金：郴州市科技发展计划项目(ZDYF2020228)。

摘　　要：目的利用美国FAERS数据库挖掘瑞派替尼上市后的药品不良事件信号,旨在评估其上市后在真实世界中的安全性并为临床用药提供参考。方法提取FAERS数据库2020年第2季度—2024年第2季度的数据,经过数据清洗和标准化处理,挖掘出以瑞派替尼为主要怀疑药物的不良事件报告。并采用ROR、PRR、BCPNN法联合筛选其不良事件风险信号。结果收集到以瑞派替尼为首要怀疑药物的不良事件报告共11469份,涉及患者3250例,男性患者的构成比高于女性患者(54.28%vs 43.63%)。挖掘出相关不良事件风险信号131个,报告数排名前5位的不良事件分别疲劳、脱发、死亡、疾病进展、进展性肿瘤。而说明书中未收载的药品不良反应信号报告数前5位为毛发结构异常、肝转移、牙龈出血、发声困难、血钾降低。结论瑞派替尼在临床应用中虽存在潜在不良反应信号,但基于FAERS数据库的数据挖掘分析显示,其整体安全性仍处于可接受范围。然而,瑞派替尼可能引发的频发不良反应及说明书中未记载的不良反应,如肝转移、肝肿瘤等需要引起关注。因此,临床药师和医生应高度关注这些风险,制定并实施有效的预防和管理措施,以确保瑞派替尼临床使用的安全性和有效性。Objective FAERS database was used to mine adverse drug event signals of ripretinib after marketing in order to evaluate its safety in the real world after marketing and provide reference for clinical use.Methods The data from the second quarter of 2020 to the second quarter of 2024 in the FAERS database were extracted,cleaned,and standardized.Adverse drug event reports with ripretinib as the main suspected drug were screened.The ROR,PRR,and BCPNN methods were used to jointly mine adverse drug event signals.Results A total of 11469 adverse drug event reports with ripretinib as the primary suspected drug were collected,involving 3250 patients,and the proportion of male patients was higher than that of female patients(54.28%vs 43.63%).A total of 131 risk signals related to adverse drug event were excavated,and the top 5 adverse drug event s were fatigue,alopecia,death,disease progression,and progressive tumors.The top 5 adverse drug reaction signals not included in the instructions were abnormal hair structure,liver metastasis,bleeding gums,dysphonia,and decreased serum potassium.Conclusion Although ripretinib exhibits potential adverse drug event signals in clinical applications,the overall safety analysis based on the FAERS database suggests that it remains within an acceptable range.However,the frequent adverse reactions that may be caused by ripretinib and adverse reactions not recorded in the label,such as liver metastases and liver tumors,need to be of concern.Therefore,clinical pharmacists and physicians should pay close attention to these risks and develop and implement effective prevention and management measures to ensure the safety and efficacy of ripretinib in clinical use.

关 键 词：瑞派替尼 上市后安全性评价 信号挖掘 不良事件 疲劳 脱发 毛发结构异常 肝转移 

分 类 号：R979.1[医药卫生—药品]