基于FAERS的瑞派替尼和舒尼替尼不良事件信号挖掘  

Signal Mining of Adverse Events Induced by Ripretinib and Sunitinib Based on FAERS

作　　者：庞培杰 贾映东[1] 刘天宇[1] 周海萍 PANG Peijie;JIA Yingdong;LIU Tianyu;ZHOU Haiping(Suining Central Hospital,Suining,Sichuan,China 629000;Yibin Second People's Hospital,Yibin,Sichuan,China 644000)

机构地区：[1]四川省遂宁市中心医院,四川遂宁629000 [2]四川省宜宾市第二人民医院,四川宜宾644000

出　　处：《中国药业》2025年第2期114-118,共5页China Pharmaceuticals

基　　金：四川省医学会医学科研青年创新课题[Q18046]。

摘　　要：目的 为临床安全使用瑞派替尼和舒尼替尼提供参考。方法 提取美国食品和药物管理局不良事件报告系统(FAERS)中2020年5月1日至2023年9月10日以瑞派替尼为首要怀疑药物,以及2014年5月1日至2023年9月10日以舒尼替尼为首要怀疑药物的药品不良事件(ADE)报告,采用OpenVigil 2.1在线工具进行数据挖掘;采用报告比值比(ROR)法和贝叶斯置信区间递进神经网络(ROR)法进行联合检验;筛选后获得ADE报告发生频次及信号强度排名前20的ADE信号。利用监管活动医学词典(MedDRA)25.1中的首选语(PT)和系统器官分类(SOC)对ADE信号进行编码和分类,分析ADE信号发生特点。结果 初步获得ADE报告7 154份,18 062份。信息齐全患者中,两药ADE信号涉及患者均以男性(51.89%,61.69%)、老年人(14.91%,55.87%)多见,且均主要为北美洲(95.97%,35.90%)上报,严重ADE结局均以住院(含住院时间延长)报告数最多(22.20%,23.93%)。筛选后共纳入瑞派替尼ADE报告2 567份,获得108个PT,涉及19个SOC,ADE信号主要集中于皮肤及皮下组织类疾病(25.09%);舒尼替尼ADE报告9 228份,获得287个PT,涉及21个SOC,ADE信号主要集中于全身性疾病及给药部位各种反应(25.42%)。两药均检出药品说明书中收载的常见不良反应信号,但部分ADE信号(如瑞派替尼的疾病进展、肌痉挛、皮肤角化症等7个及舒尼替尼的死亡、疾病进展、脱水)未见于药品说明书;两药ADE报告频次排名前20位的PT有8个相同,信号强度排名前20的仅2个。结论 瑞派替尼和舒尼替尼ADE信号具有差异性,临床用药时应根据患者实际情况个体化给药,提高用药安全性;临床医师在用药期间还应关注药品说明书未提及的ADE。Objective To provide a reference for the safe clinical use of ripretinib and sunitinib.Methods The adverse drug event(ADE)reports with ripretinib as the primary suspected drug from May 1,2020 to September 10,2023 and the ADE reports with sunitinib as the primary suspected drug from May 1,2014 to September 10,2023 were extracted from the FDA′s Adverse Event Reporting System(FAERS),and the OpenVigil 2.1 online tool was used for data mining.The ADE signals were mined by the reporting odds ratio(ROR)and Bayesian confidence propagation neural network(BCPNN)methods.After screening,the top 20 ADE signals in terms of frequency and signal intensity in ADE reports were obtained.The ADE signals were encoded and classified by the preferred term(PT)and system organ classification(SOC)in Medical Dictionary for Regulatory Activities(MedDRA 25.1),and the characteristics of ADE signals were analyzed.Results A total of 7154,18062 ADE reports were obtained preliminarily with ripretinib,sunitinib as the primary suspected drugs respectively.Relevant data of the patients with complete information showed that the ADE signals of ripretinib and sunitinib involved more males(51.89%,61.69%)and elderly(14.91%,55.87%),and both mainly reported by North America(95.97%,35.90%);the reported severe ADE outcomes were mostly hospitalization(containing prolonged hospitalization time,22.20%,23.93%).After screening,2567 ripretinib-related ADE reports were included,108 PTs and 19 SOCs were involved,and the ADE signals were mainly skin and subcutaneous tissue diseases(25.09%);9228 sunitinib-related ADE reports were included,287 PTs and 21 SOCs were involved,and the ADE signals were mainly systemic diseases and various reactions at the site of administration(25.42%).Common adverse reactions recorded in the two drug instructions were both detected,but some[seven of ripretinib(such as disease progression,muscle spasms,skin keratosis),and three of sunitinib(death,disease progression,and dehydration)]were not recorded in the drug instructions.There were ei

关 键 词：瑞派替尼 舒尼替尼 美国食品和药物管理局不良事件报告系统 药品不良事件 数据挖掘 

分 类 号：R969.3[医药卫生—药理学]