摘要
目的基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库挖掘与分析评价唑尼沙胺不良事件报告,为该药临床使用安全性提供参考。方法利用报告比值比法(ROR)对FAERS公开数据库中2004年建库至2024年6月30日收集的唑尼沙胺不良事件报告进行信号挖掘并分析患者性别、年龄、上报国家、唑尼沙胺信号强度排名前50位首选术语及报告例数、唑尼沙胺安全警戒信号及累及系统/器官。结果共纳入首要怀疑药物为唑尼沙胺不良事件报告2740例,其中男855例(31.20%),女1108(40.44%),缺失777例(28.36%);年龄主要集中在16~44岁(683例,24.93%);上报不良事件例数最多的国家为美国(1082例,39.49%)。ROR法共挖掘182个唑尼沙胺安全警戒信号,其中说明书中未提及的新的警戒信号72个。共累及14个系统/器官,精神病类信号数最多,为34个,其次分别是神经系统疾病31个、各类检查20个、皮肤及皮下组织类疾病19个、肾和泌尿系统疾病15个。结论对唑尼沙胺安全警戒信号进行挖掘与评价,临床可对应采取相应的干预措施,制定用药监护方案,预防不良事件发生,保障用药安全。
Objective To mine and analyze the adverse event reports of zonisamide based on the US Food and Drug Administration FAERS database,so as to provide reference for the safety of the drug in clinical use.Methods ROR was used to analyze the signal mining of adverse event reports of zonisamide collected in the FAERS public database from the establishment of the database in 2004 to June 30,2024,and the gender,age,reporting country,the top 50 preferred terms of zonisamide signal intensity and the number of reported cases,and the system/organ involved by zonisamide safety warning signal were analyzed.Results A total of 2740 adverse event reports of zonisamide as the first suspected drug were included,including 855 males(31.20%)and 1108 females(40.44%),and 777 missing cases(28.36%).The age was mainly concentrated in 16~44 years old(683 cases,24.93%).The country with the largest number of adverse events reported was the United States(1082 cases,39.49%).ROR method mined 182 safety warning signals of zonisamide,of which 72 were new warning signals that were not mentioned in the instructions.A total of 14 systems/organs were involved,and the number of psychiatric signals was the highest(34),followed by nervous system diseases(31),various types of examination(20),skin and subcutaneous tissue diseases(19),kidney and urinary system diseases(15).Conclusion The mining and evaluation of zonisamide safety warning signals can be used to take corresponding intervention measures,formulate medication monitoring programs,prevent adverse events,and ensure medication safety.
作者
江虹
吴利利
林丽萍
吴遵平
JIANG Hong;WU Lili;LIN Liping;WU Zunping(Department of Pharmacy,the First People′s Hospital of Zunyi,Guizhou Province,Zunyi 563000,China;不详)
出处
《临床合理用药》
2026年第3期21-25,共5页
Chinese Journal of Clinical Rational Drug Use
基金
贵州省合肥市科技合作计划(遵市科合HZ字〔2024〕41号)。
