[关键词]
[摘要]
目的 基于美国食品药品监督管理局(FDA)药品不良事件报告系统(FAERS)数据库,挖掘和分析塞利尼索药物不良事件(ADE)信号,为临床安全用药提供参考。方法 采用报告比值比法(ROR)和比例报告比值法(PRR)挖掘2019年3季度—2023年3季度期间塞利尼索ADE报告,利用监管活动医学词典(MedDRA)的首选系统器官分类(SOC)和首选术语(PT)对挖掘的信号进行分类和统计分析。结果 共检索到以塞利尼索为首要怀疑药物的ADE报告4 991例,涉及19 868个PT。经过计算筛选后得到塞利尼索ADE信号118个,涉及16个SOC。塞利尼索ADE信号与已知的相关安全性信息基本一致,ADE主要集中在胃肠系统疾病、全身性疾病及给药部位各种反应、各类检查、代谢及营养类疾病。另外还检出药品说明书未收录的ADE信号53个,如便秘、跌倒、嗜睡和肾功能异常等。结论 基于FAERS的大数据可全面深入分析药品上市后的ADE,提示临床在治疗初期应密切关注塞利尼索胃肠道毒性、血液学毒性以及说明书未提及的风险,并采取预防措施,从而保障临床用药安全。
[Key word]
[Abstract]
Objective To mine the signals of adverse drug events (ADE) for selinexor based on the FAERS database, and to provide a reference for safe use of drugs in clinical. Methods The reported odds ratio (ROR) and proportional reported ratio (PRR) methods were used to mine selinexor adverse event reports between the second quarter of 2019 and the third quarter of 2023, and the mined signals were classified and statistically analyzed using the Medical Dictionary of Regulatory Activities (MedDRA) preferred system organ classification (SOC) and preferred termy (PT). Results A total of 4 991 adverse event reports involving 19 868 PTs with selinexor as the first suspected drug were retrieved. After computational screening, 118 selinexor ADE signals were obtained, involving 16 SOCs. Selinexor ADE signals were basically consistent with the known relevant safety information, and the adverse events were mainly focused on gastrointestinal system diseases, systemic diseases and various reactions at the drug administration site, various types of examinations, metabolic and nutritional diseases. In addition, 53 ADE signals not included in the drug specification were detected, such as constipation, fall, drowsiness, and abnormal renal function. Conclusion FAERS-based big data can provide a comprehensive and in-depth analysis of post-marketing adverse reactions of drugs, suggesting that the clinic should pay close attention to the gastrointestinal toxicity, hematological toxicity and risks not mentioned in the instruction manual of selinexor at the early stage of treatment, and take preventive measures so as to ensure the safety of clinical use.
[中图分类号]
R979.1
[基金项目]
湖北省中医药管理局中医药科研立项项目(ZY2023F075);十堰市科技局引导性科研项目(22Y78)