基于FAERS分析肌萎缩侧索硬化药物的上市后安全性研究  

Post-marketing safety study of amyotrophic lateral sclerosis therapeutics based on FAERS

作　　者：汪玲[1] 刘林慧 彭惠 李新林 刘茂昌 WANG Ling;LIU Lin-hui;PENG Hui;LI Xin-lin;LIU Mao-chang(Department of Pharmacy,Wuhan Children's Hospital(Wuhan Maternal and Child Healthcare Hospital),Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430016,China)

机构地区：[1]华中科技大学同济医学院附属武汉儿童医院(武汉市妇幼保健院)药学部,武汉430016

出　　处：《中国新药杂志》2025年第3期322-329,共8页Chinese Journal of New Drugs

摘　　要：目的:基于美国FDA不良事件报告系统(FDA adverse event reporting system,FAERS)对肌萎缩侧索硬化(amyotrophic lateral sclerosis,ALS)治疗药物依达拉奉和利鲁唑引起的不良事件(adverse event,AE)进行信号挖掘,为临床药物选择提供参考。方法:选取FAERS数据库自2004年第1季度-2023年第4季度的所有数据,采用报告比值比法(reporting odds ratio,ROR)和多项泊松收缩器法(multi-item gamma poisson shrinker,MGPS)进行信号监测。结果:纳入了以依达拉奉和利鲁唑为首要怀疑药物的AE报告分别为2930和1337份,严重AE中死亡占比最高。依达拉奉和利鲁唑的中位AE发生时间分别为25和44 d,但2种药物所导致的AE在用药后的任一时间均有可能发生。信号监测结果显示2种药物均涉及27个器官系统分类(system organ class,SOC),71个阳性信号。依达拉奉引起的AE主要集中在全身性疾病及给药部位各种反应,而利鲁唑引起的AE与说明书基本一致,临床需要重点关注的AE包括间质性肺疾病、肝功能异常和胰腺炎。结论:本研究提供了ALS治疗药物安全性特征的数据,这将有助于医疗保健专业人员在临床实践中降低依达拉奉和利鲁唑发生AE的风险。Objective:To conduct signal mining of adverse events caused by amyotrophic lateral sclerosis(ALS)therapeutic drugs,edaravone and riluzole,based on FDA adverse event reporting system(FAERS)to provide reference for clinical drug selection.Methods:All data from the FAERS database from the first quarter of 2004 to the fourth quarter of 2023 were selected for signal monitoring using repotting odds ratio and multi-item gamma Poisson shrinker methods.Results:A total of 2930 and 1337 adverse event reports with edaravone and riluzole as the primary suspected drugs were included,respectively,and death had the highest proportion among the serious adverse events.The median occurrence time of adverse events was 25 and 44 days for edaravone and riluzole,respectively,but the adverse events due to both drugs could occur at any time after dosing.Signal monitoring results showed that both drugs were involved in 27 system organ classes and 71 positive signals.The adverse events caused by edaravone were mainly concentrated at general disorders and administration site effects,whereas those caused by riluzole were essentially the same as those in the labelling,and the adverse events to which the clinic need to pay close attention included interstitial lung disease,abnormalities in hepatic function,and pancreatitis.Conclusion:This study provides data on the safety profile of ALS therapeutic drugs,which will help healthcare professionals reduce the risk of adverse events with edaravone and riluzole in clinical practice.

关 键 词：依达拉奉 利鲁唑 美国FDA不良事件报告系统 肌萎缩侧索硬化症 安全性 数据挖掘 

分 类 号：R969.3[医药卫生—药理学]