基于FAERS数据库的神经激肽-1受体拮抗剂不良事件信号挖掘与分析  

Data-mining and analysis of adverse event signals of neurokinin-1 receptor antagonists based on FAERS database

作　　者：王凤蝶 王静[2,3] 陈力 WANG Feng-die;WANG Jing;CHEN Li(Department of Pharmacy,Meishan Hospital of West China Hospital of Sicuan University/Meishan City People's Hospital,Meishan Sichuan 620010;Department of Pharmacy/Evidence-based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041;Department of Pharmacy,Sichuan Mianyang the 404th Hospital/Mianyang First People's Hospital,Mianyang Sichuan 621000)

机构地区：[1]四川大学华西医院眉山医院/眉山市人民医院药剂科,四川眉山620010 [2]四川大学华西第二医院药学部/循证药学中心,成都610041 [3]四川绵阳四O四医院/绵阳市第一人民医院药学部,四川绵阳621000

出　　处：《中南药学》2023年第12期3337-3344,共8页Central South Pharmacy

基　　金：国家自然科学基金项目(No.82073921);四川省自然科学基金项目(No.2022NSFSC1356)。

摘　　要：目的 通过对神经激肽-1受体拮抗剂(NK-1RA)药品不良事件(ADE)信号挖掘分析,探讨NK-1RA(阿瑞匹坦、福沙匹坦、奈妥匹坦)潜在的不良反应,为临床安全合理用药提供参考。方法 从美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库中提取2014年第一季度至2022年第四季度NK-1RA的ADE报告数据,采用报告比值比(ROR)法和综合标准(MHRA)法对相关报告进行数据挖掘和危险因素分析。结果 三种NK-1RA共获得263个有效ADE信号,其中阿瑞匹坦144个,福沙匹坦98个,奈妥匹坦21个;有效信号共涉及19个系统器官分类(SOC)。阿瑞匹坦与关节沉积、脑病、口腔黏膜变粗糙关联性强,福沙匹坦与注射部位血管炎、输液部位静脉炎、速发严重过敏反应关联性较强,奈妥匹坦则与中性粒细胞减少性结肠炎关联性强。结论 三种NK-1RA的ADE涉及的主要系统器官不同,与各系统器官某些ADE的关联性也不同;发现了说明书收录不全之处,挖掘出多个新的不良反应。建议临床用药时,密切监测患者的不良反应,及时采取措施进行干预。Objective To provide reference for safe and rational drug use,signal mining and analysis of adverse events(ADEs)neurokinin-1 receptor antagonists(NK-1RA)and determine the potential adverse reactions of aprepitant,fosapitant and netopitant.Methods Adverse event reports of NK-1RA from the first quarter of 2014 to the fourth quarter of 2022 were collected from the FAERS database.The reported odds ratio and the comprehensive standard were used for the data mining and risk factor analysis.Results Totally 263 effective ADEs signals were obtained from the three types of NK-1RA,including 144 effective signals of aprepitant,98 effective signals of fosapitant and 21 effective signals of netopitant.These signals involved 19 system organs class.Aprepitant was strongly correlated with joint deposition,encephalopathy and oral mucosal roughness;fosapitant was strongly correlated with injection site vasculitis, infusion site phlebitis and rapid severe allergic reaction;while netopitant was strongly correlated with neutropenic colitis. Conclusion The major systems involved in the three common ADE of NK-1RA vary. The intensity of some adverse events associated with each system also varies. The instructions are not complete, and many new adverse reactions are revealed. Adverse reactions among patients should be closely monitored and timely measures taken.

关 键 词：神经激肽-1受体拮抗剂 比例失衡法 FAERS 药品不良事件 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]