摘要
目的采用美国食品药品监督管理局不良事件报告系统(FAERS)数据库和WHO-VigiAccess数据库挖掘莫达非尼的不良反应(ADR)信号,为临床安全用药提供参考。方法使用Openvigil 2.1数据平台和VigiAccess数据库提取自建立来所有与莫达非尼相关的不良事件(AE)报告,采用报告比值比法(ROR)、比例报告比值比法(PRR)进行数据挖掘。结果从FAERS和VigiAccess数据库分别收集莫达非尼ADR报告7424和5989份。女性和18~64岁的个体更有可能发生AE。报告频次较多的是头痛、嗜睡、失眠、抑郁。报告强度较高的有先天性斜颈、牵连观念、猝倒症。与说明书比较发现,孕产妇在妊娠过程中的暴露、激越、先天性斜颈等27个ADR信号未被提及。结论莫达非尼在真实世界中发生的ADR与说明书多数一致,但也有新的ADR被发现,临床使用中应特别关注。
Objective To explore the adverse drug reaction(ADR)signals of modafinil using the US Food and Drug Ad-ministration Adverse Event Reporting System(FAERS)database and WHO-VigiAccess database,so as to provide references for clinical safe drug use.Methods Openvigil 2.1 data platform and VigiAccess database were used to extract the reports of all ad-verse events related to modafinil,and the reported odds ratio method(ROR)and proportional reporting odds ratio method(PRR)were used for data mining.Results 7424 and 5989 ADR reports of modafinil were collected from FAERS and VigiAccess databases,respectively.Women and individuals aged 18~64 years were more likely to have adverse events.Headache,lethar-gy,insomnia and depression are frequently reported.Reports with high intensity include congenital torticollis,associative think-ing,and cataplexy.Compared with the instructions,it was found that 27 adverse reaction signals such as maternal exposure dur-ing pregnancy,agitation and congenital torticollis were not mentioned.Conclusion Most of the ADR of modafinil in the real world is consistent with the instructions,but there are also new ADR found,which should be paid special attention to in clinical use.
作者
于淼
董秋菊
YU Miao;DONG Qiuju(College of Pharmacy,Jinzhou Medical University,Jinzhou Liaoning 121001,China)
出处
《天津药学》
2025年第7期868-873,共6页
Tianjin Pharmacy
