摘要
目的:挖掘美国FDA不良事件报告系统(FAERS)数据库中特泊替尼不良事件信号,为临床安全用药提供参考。方法:检索2021第一季度—2025年第一季度以特泊替尼为首要怀疑药物的不良事件报告,采用报告比值比法、英国药品和保健品管理局综合标准法、多项式伽马泊松分布缩减法、贝叶斯可信区间递进神经网络法4种方法进行信号挖掘;并按性别、年龄进行亚组分析。结果:共纳入报告1226份,患者439例(女性52.4%、老年76.3%),挖掘到信号39个,涉及14个系统器官分类。前五位不良事件均收录于说明书,包括水肿、腹泻、疲劳、肾功能损害和恶心。6个新的信号包括味觉障碍、呼吸衰竭、耳聋、尿潴留、气胸和心包积液。亚组分析显示,男性发生间质性肺疾病及体液潴留的风险高于女性(P<0.05),老年人水肿发生风险显著高于65岁以下人群(P<0.05)。结论:用药期间除关注特泊替尼常见的不良事件外,还需密切关注其潜在新的不良事件,以保障患者的用药安全。
Objective:To mine adverse event signals of tepotinib in the US FDA Adverse Event Reporting System(FAERS)database,providing references for clinical safe medication.Methods:Adverse event reports with tepotinib as the primary suspected drug from Q12021 to Q12025 were retrieved.Signal detection was performed using four methods:the reporting odds ratio,the Medicines and Healthcare Products Regulatory Agency comprehensive criteria method,the multi-item gamma poisson shrinker,and the Bayesian confidence propagation.Subgroup analyses were conducted by gender and age.Results:A total of 1226 reports involving 439 patients(52.4%female,76.3%elderly)were included.A total of 39 signals were identified,involving 14 system organ classes.The top five adverse events were all recorded in the package inserts,including edema,diarrhea,fatigue,renal impairment and nausea.Six new signals were discovered,including dysgeusia,respiratory failure,deafness,urinary retention,pneumothorax and pericardial effusion.Subgroup analysis showed that males had a higher risk of interstitial lung disease and fluid retention than females(P<0.05),and the risk of edema in the elderly was significantly higher than in people under 65 years old(P<0.05).Conclusion:In addition to monitoring common adverse events of tepotinib,close attention should be paid to potential new adverse events to ensure patients'safety.
作者
姜月平
李杨
JIANG Yueping;LI Yang(Department of Pharmacy,Gaochun Traditional Chinese Medicine Hospital,Nanjing 211300,China;Department of Pharmacy,Nanjing Hospital Affiliated to Nanjing Medical University/Nanjing First Hospital,Nanjing 210006,China)
出处
《药学与临床研究》
2026年第1期58-61,共4页
Pharmaceutical and Clinical Research
