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 E-vent 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。
Mining of Adverse Reactions Associated with Loperamide Based on FAERS
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 set-tings.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,gastroin-testinal disorders,various examinations,nervous system disorders,and psychiatric disorders,and the ADR with the stron-gest signal strength was arrhythmia.Furthermore,this study also revealed previously unrecorded ADRs such as pulseless e-lectrical 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.
LoperamideThe US Food and Drug Administration Adverse Event Reporting System ( FAERS )Adverse drug eventsSignal mining
万方数据
维普
