基于美国FAERS数据库和欧洲DME清单的恩扎卢胺/阿帕他胺ADE信号的挖掘与分析  

Mining and Analysis of Adverse Drug Events Signals of Enzalutamide and Apalutamide Based on the US FAERS Database and the European DME List

作　　者：苏辉 蒋婷婷 张妮 刘耀 SU Hui;JIANG Tingting;ZHANG Ni;LIU Yao(Department of Pharmacy,Daping Hospital,Army Medical University,Chongqing 400042,China)

机构地区：[1]陆军军医大学大坪医院药剂科,重庆400042

出　　处：《药学与临床研究》2025年第1期26-30,共5页Pharmaceutical and Clinical Research

基　　金：重庆市临床药学重点专科建设项目;2021年重庆市中青年医学高端人才培养项目;创新药物上市后临床研究科研专项(WKZX2023CX210006)。

摘　　要：目的:挖掘和分析恩扎卢胺和阿帕他胺上市后相关药品不良事件(ADE),为临床安全用药提供参考。方法:检索美国食品药品监督管理局不良事件报告系统数据库中药品上市至2023年第2季度收录恩扎卢胺和阿帕他胺为首要怀疑药物的ADE报告,采用报告比值比法和比例报告比值比法挖掘潜在的风险信号,重点分析两药上报频数前30位的ADE及指定医疗事件(DME)。结果:获得恩扎卢胺和阿帕他胺的ADE报告分别为36 989份和5555份。本研究发现两药说明书未收录的ADE,其中,恩扎卢胺包含腹部不适、吞咽困难、骨转移等;阿帕他胺涉及心力衰竭、大脑出血等。同时,阿帕他胺检出了7个DME,其中,全身剥脱性皮炎、肺纤维化、粒细胞缺乏症未在药品说明书中提及。结论:两药安全性有较大差异,临床使用恩扎卢胺应重点关注胃肠系统、骨骼相关ADE,阿帕他胺重点关注皮肤、心血管类疾病及呼吸系统相关ADE。Objective:To provide reference for safe and rational drug use in clinic by mining and analysis of adverse drug event(ADE)signals of enzalutamide and apalutamide.Methods:Data of ADE reports related to enzalutamide and apalutamide as the primary suspects from drug launch date to the second quarter of 2023 were collected from the US FDA adverse event reporting system.This study used reporting odds ratio(ROR)and proportional reporting ratio(PRR)to comprehensively analyze potential ADE,and analyzed the top 30 ADE and designated medical event(DME)signals reported by the two drugs.Results:A total of 36989 and 5555 ADE reports were collected about enzalutamide and apaluta-mide,respectively.This study discovered ADEs for the two drugs not mentioned in their drug instructions.Among them,enzalutamide included abdominal discomfort,dysphagia,metastases to bone,etc;apalutamide included cardiac failure,cerebral haemorrhage,etc.Meanwhile,7 DMEs were detected for apatamide,and dermatitis exfoliative generalised,pulmonary fibrosis and agranulocytosis were not mentioned in its drug instruction.Conclusion:There is a significant difference in the safety of the two drugs.In clinical use,enzalutamide should be paid special attention on ADEs related to gastrointestinal disorders and disorders of musculoskeletal and connective tissues;while apatamide should be paid special attention on ADEs related to skin,cardiovascular diseases and respiratory system.

关 键 词：FAERS 恩扎卢胺 阿帕他胺 药品不良事件 信号挖掘 比例失衡法 指定医疗事件 

分 类 号：R979.1[医药卫生—药品]