摘要
目的基于美国食品药品管理局不良事件报告系统(FAERS)数据库,挖掘托法替布的不良事件信号,为临床安全用药提供参考。方法采用报告比值比法(ROR法)和综合标准法(MHRA法)挖掘FAERS数据库2017年第1季度至2021年第3季度的报告数据。结果获得托法替布ADE报告71849例,涉及ADE 4537种,经筛选后得到280个信号,累及20个系统器官(SOC)。结论不良事件报告人主要为46岁以上人群,以女性居多,所得不良事件信号基本与说明书一致;信号提示托法替布不良事件主要集中在呼吸系统、胸及纵隔疾病,胃肠系统疾病,各类检查,感染及侵染类疾病;说明书记载的5个黑框警告均有相关不良事件信号检出。在使用该药时,除注意患者胆固醇、肝酶变化以外,还应关注患者神经系统疾病及精神状况,并做好相关监护;避免有感染、血栓、肿瘤等风险的患者使用,以保证临床用药的安全。
Objective To mine the signals of adverse drug events(ADE)for Tofacitinib based on the US FDA adverse event reporting system(FAERS)database,and to provide a reference for safe use of drugs in clinic.Methods The reporting odds ratio(ROR)method and the medicines and healthcare products regulatory agency(NHRA)method were used to mine the adverse reaction signals of tofacitinib base on the adverse reaction report data from the FAERS database from the first quarter of 2017 to the third quarter of 2021.Results A total of 71849 cases of tofacitinib ADE were screened,involving 4,537 types of ADEs.After the screening,280 signals were obtained,which involved 20 different system organ classes(SOC).Conclusion The adverse event reporters were mainly people over 46 years old,mostly women,and the adverse event signals are consistent with the instructions.The adverse events of tofacitinib are mainly concentrated in the respiratory,thoracic and procedural complications,gastrointestinal disorders,various examinations,infections and infectious diseases.The 5 black box warnings described in the instructions all have been detected with the related adverse event signals.When using the drug,in addition to paying attention to the patient's cholesterol,and hepatic enzyme changes,attention should also be paid to neurological diseases and mental conditions of patients,thus,relevant monitoring should be done;it was advised to avoid using this drug in patients with the risks of infection,thrombosis,and tumors,etc.,to safely maintain the clinical medication.
作者
刘培尧
鄢荣
游蓝
陈力
黄琳
LIU Peiyao;YAN Rong;YOU Lan;CHEN Li;HUANG Lin(West China School of Public Health and West China Fourth Hospital,Sichuan University,Chengdu 610041,China;Department of Pharmacy/Center for Evidence-based Pharmacy,West China Second Hospital,Sichuan University,Chengdu 610041,China;Key Laboratory of Birth Defects and Related Gynecological Diseases,Ministry of Education,Chengdu 610041,China)
出处
《医药导报》
CAS
北大核心
2023年第6期922-926,共5页
Herald of Medicine
基金
四川省科技计划项目(2019J0R0163)。
关键词
托法替布
美国食品药品管理局不良事件报告系统
不良事件挖掘
报告比值比法
综合标准法
Tofacitinib
FDA adverse event reporting system
Adverse event signal mining
Reporting odds ratio method
Medicines and healthcare products regulatory agency method
