基于FAERS数据库的左乙拉西坦不良事件信号挖掘与分析  

Data mining and analysis of adverse drug events signals for levetiracetam based on FAERS database

作　　者：王新茗 王凤玲 黄玲[1] 李燕[1] 蒋婷[1] 郑玲利[1] 陈力[2,3,4] WANG Xinming;WANG Fengling;HUANG Ling;LI Yan;JIANG Ting;ZHENG Lingli;CHEN Li(Department of Pharmacy,The First Affiliated Hospital of Chengdu Medical College,Chengdu 610500,China;Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Ministry of Education,West China Second University Hospital,Sichuan University,Chengdu 610041,China)

机构地区：[1]成都医学院第一附属医院药学部,四川成都610500 [2]四川大学华西第二医院药学部,四川成都610041 [3]四川大学华西第二医院循证药学中心,四川成都610041 [4]四川大学华西第二医院出生缺陷与相关妇儿疾病教育部重点实验室,四川成都610041

出　　处：《药物评价研究》2023年第1期146-152,共7页Drug Evaluation Research

基　　金：四川省科技厅项目(2019JDR0163);四川省教育厅项目(16ZA0290)。

摘　　要：目的 通过对抗癫痫药物左乙拉西坦不良事件(ADE)信号的挖掘分析,以期为临床安全合理用药提供参考。方法采用比例失衡法中的报告比值比法(ROR)和综合标准法(MHRA)对2017年1季度至2021年3季度美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)中左乙拉西坦的ADE报告进行数据挖掘及分析。结果 分析处理数据后共得到622个有效信号,涉及24个系统器官,主要集中在各类神经系统疾病、精神病类、妊娠期及产褥期及围产期状况等方面,发现说明书中未出现的信号累及器官系统有6个。结论 基于FAERS数据库对左乙拉西坦ADE信号挖掘可促进左乙拉西坦的安全、合理使用。Objective To provide reference for clinical safe and rational drug use through mining and analysis of adverse drug event(ADE) signals of levetiracetam. Methods The reporting odds ratio(ROR) method and the Medicines and healthcare products regulatory agency(MHRA) method were used to mine and analyze the ADE reports of levetiracetam which included 19 quarter from the first quarter of 2017 to third quarter of 2021 of FDA adverse events reporting system(FAERS). Results A total of 622 valid signals were obtained, involving 24 system organs, mainly focusing on nervous system disorders, psychiatric disorders, pregnancy,puerperium and perinatal conditions, and 6 organ systems that did not appear in the instruction. Conclusion Signal mining of levetiracetam ADE based on FAERS database can promote safe and rational use of levetiracetam.

关 键 词：左乙拉西坦 比例失衡法 药品不良事件 FDA不良事件报告系统 抗癫痫药物 

分 类 号：R971[医药卫生—药品]