基于FAERS数据库的洛哌丁胺药物不良反应信号挖掘  

Mining of Adverse Reactions Associated with Loperamide Based on FAERS

作　　者：袁媛 李秀梅 李铭扬 YUAN Yuan;LI Xiu-mei;LI Ming-yang(Department of Gastroenterology,Xiangyang No.1 People′s Hospital,Hubei U-niversity of Medicine,Xiangyang,Hubei 441000,China;Department of Cardiology,Xiangyang No.1 People′s Hospital,Hubei U-niversity of Medicine,Xiangyang,Hubei 441000,China)

机构地区：[1]湖北医药学院附属襄阳市第一人民医院消化内科,湖北襄阳441000 [2]湖北医药学院附属襄阳市第一人民医院心血管内科,湖北襄阳441000

出　　处：《湖北医药学院学报》2024年第6期602-606,共5页Journal of Hubei University of Medicine

摘　　要：目的:基于FAERS数据库对洛哌丁胺的药物不良事件进行信号挖掘,为临床安全用药提供参考。方法:收集2004年至2023年美国食品药品监督管理局不良事件报告系统(US Food and Drug Administration Adverse Event Reporting System,FAERS)中所上报的数据,采用比例失衡法对数据库中相关数据进行信号挖掘。结果:本研究共挖掘出1563例上报信息,除外原发疾病相关及与药物无关的不良反应(adverse drug reactions,ADRs)后,共发现127个新的阳性信号,累及17个器官系统分类(system organ classes,SOC)。上报数前5位的SOC分别为心脏器官疾病、胃肠系统疾病、各类检查、各类神经系统疾病、精神病类,其中信号强度最高的ADRs为心律失常发作。另外,本研究还发现了无脉性电活动、传导障碍、膀胱扩张、急性胰腺炎等说明书中未明确记载的ADRs。结论:临床用药中除了需关注已明确的ADRs外,还应注意心脏器官疾病、胃肠系统疾病、各类神经系统疾病、精神病类等新发现的阳性信号。Objective To explore the adverse drug reactions(ADRs)associated with loperamide based on the US Food and Drug Administration Adverse Event Reporting System(FAERS),to provide guidance for safe medication in real-world settings.Methods The ADR data in the FAERS between 2004 and 2023 were collected,and disproportionality analysis was conducted to identify relevant information within the database.Results A total of 1563 cases were identified in this study.After excluding the ADRs related to primary diseases and the adverse reaction irrelevant to drugs,we discovered 127 new positive signals involving 17 system organ classes(SOCs).The top five SOCs reported included cardiac disorders,gastrointestinal disorders,various examinations,nervous system disorders,and psychiatric disorders,and the ADR with the strongest signal strength was arrhythmia.Furthermore,this study also revealed previously unrecorded ADRs such as pulseless electrical activity,conduction disorders,bladder distension,and acute pancreatitis.Conclusion In clinical practice,it is important to consider the known ADRs associated with loperamide as well as the newly discovered positive signals including cardiac disorders,gastrointestinal disorders,nervous system disorders,and psychiatric disorders.

关 键 词：洛哌丁胺 美国食品药品监督管理局不良事件报告系统 药物不良反应 信号挖掘 

分 类 号：R95[医药卫生—药学]