基于FAERS的曲美替尼相关神经系统不良事件信号挖掘研究

Data Mining and Analysis of Trametinib Related Adverse Events of Nervous System Based on FAERS

摘要: 目的：基于FAERS对曲美替尼(TRA)相关神经系统不良事件(ADE)进行信号挖掘，探索ADE的发生特点，TRA与ADE的相关性及TRA发生神经系统相关ADE的高危因素，期望为临床安全应用TRA提供参考。方法：提取FAERS 2017年第一季度至2022年第四季度共24个季度的TRA相关神经系统ADE报告数据，利用报告比值比(ROR)法和综合标准(MHRA)法进行数据分析。结果共获得TRA报告数4392个，其中TRA相关神经系统ADE报告数86个，有信号的PT共15个,可分为7个高危组语(HLGT)。报告数居前3位的PT依次是惊厥发作、晕厥、困倦；信号强度居前3位的PT依次为中枢神经系统疾病、轻偏瘫、脑积水。药品说明书中未收录的PT有15个。结论：需重视TRA相关神经系统不良事件的风险，尤其是外周神经系统和脑积水，有神经系统相关基础疾病的患者需加强监护，保障用药安全。

Abstract: Objective: To provide a reference for clinical administration of trametinib (TRA), we mine the TRA-related adverse event (ADE) of respiratory system based on the FAERS and explore the characteristics of ADE occurrence, the correlation strength between ADE and TRA and the risk factors of TRA-related ADE of nervous system. Methods: We use reporting odds ratio (ROR) methods and healthcare products regulatory agency (MHRA) methods to mine the TRA-related ADE of nervous system based on the adverse reaction report data of 24 quarters from the first quarter of 2017 to the fourth quarter of 2022 extracted from the FAERS. Results: Totally 4 392 TRA-related reports were obtained, 86ADE of nervous system were reported. There were 15 PT with signal, which could be divided into 7 high level group term (HLGT). The top 3 reported PT were seizure, syncope, sleepy. The top 3 PT with the highest signal intensity were central nervous system lesion, hemiparesis and hydrocephalus. There were 15 PT that were not included in the drug instructions. Conclusions: Need to attach importance to TRA related nervous system the risk of ADE, especially the peripheral neuropathy and hydrocephalus, patients with underlying diseases related to the nervous system need to be closely monitored to ensure the safety of medication.