基于OpenFDA数据库对拉莫三嗪不良事件的信号挖掘与分析  

Signal Detection and Analysis of Lamotrigine Adverse Events Based on the OpenFDA Database

作　　者：范北辰 朱秀清[2] 温耀祺 戴丽静 陈玉清[2] 温预关[2] FAN Beichen;ZHU Xiuqing;WEN Yaoqi;DAI Lijing;CHEN Yuqing;WEN Yuguan;Zhongshan(College of Dalian Medical University,Dalian,Liaoning 116085,China;The Affiliated Brain Hospital,Guangzhou Medical University,Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China,Guangzhou Medical University,Guangzhou,Guangdong 510370,China)

机构地区：[1]大连医科大学中山学院,辽宁大连116085 [2]广州医科大学附属脑科医院药学部广东省神经科学疾病研究重点实验室神经致病基因和离子通道教育部重点实验室,广东广州510370

出　　处：《今日药学》2025年第2期103-107,共5页Pharmacy Today

基　　金：广东省药学会科学研究基金(2024A34);广东省医院协会药学科研专项基金(2022YXKY11);广州市医学重点学科(2025-2027)。

摘　　要：目的基于美国食品药品监督管理局公共数据开放项目(OpenFDA)数据库对拉莫三嗪的不良事件进行分析,为临床安全合理用药提供参考。方法利用OpenFDA数据库检索拉莫三嗪自2004年至今的不良事件报告,采用报告比值比法(ROR)和经验贝叶斯几何平均数(EBGM)进行信号挖掘。按药物不良事件术语集的首选术语(PT)和系统器官分类(SOC)对报告例数居前100位不良事件的风险信号进行统计和分析。结果共检索到拉莫三嗪相关不良事件报告113567份,挖掘到涉及5类SOC的48项有效信号,其中20项为药品说明书中未记录的不良反应信号。结论通过OpenFDA对拉莫三嗪的不良事件进行数据挖掘,有助于发现潜在的不良反应风险信号,应对药品说明书未提及的不良反应引起重视,为临床合理用药提供参考依据。OBJECTIVE Based on the OpenFDA database,this study analyzed adverse events related to lamotrigine to provide references for clinical safety and rational drug use.METHODS Adverse event reports of lamotrigine from 2004 to the present were retrieved from the U.S.Food and Drug Administration's public data access project(OpenFDA)database.Signal detection was performed using the reporting odds ratio(ROR)and empirical Bayes geometric mean(EBGM)methods.The top 100 adverse events with the highest reporting counts were statistically analyzed based on the preferred terms(PT)and System Organ Class(SOC)of the Medical Dictionary for Regulatory Activities.RESULTS A total of 113567 lamotrigine-related adverse event reports were retrieved,revealing 48 significant signals across five SOC categories,including 20 signals representing adverse reactions not previously documented in the drug label.CONCLUSION Data mining of lamotrigine adverse events through OpenFDA facilitates the identification of potential adverse reaction risk signals.It highlights adverse reactions not mentioned in the drug label,providing references for clinical rational drug use and ensuring patient medication safety.

关 键 词：拉莫三嗪 不良事件 OpenFDA 信号挖掘 

分 类 号：R969[医药卫生—药理学]