目的 挖掘并分析瑞波替尼的药品不良事件信号，为临床安全用药提供参考。方法 分析美国食品药品管理局不良事件报告系统（FAERS）数据库2024年第1季度至2025年度第4季度瑞波替尼不良事件数据，采用报告比值比法（ROR）、比例报告比值比法（PRR）、贝叶斯置信区间神经网络传播法（BCPNN）及多项伽马-泊松压缩估计法（MGPS）进行信号挖掘。结果 共获得目标药物瑞波替尼不良事件报告522份，涉及目标人群192例。符合4种检测方法的不良事件阳性信号15个，对应112份不良反应报告。信号强度前5位的不良反应依次为味觉障碍、运动功能障碍、共济失调、口腔感觉减退、神经毒性。不良事件主要集中于各类神经系统疾病，有明确时间记录的不良反应发生在用药后30 d内。结论 瑞波替尼的安全性风险以神经系统毒性为核心特征，部分严重信号（如共济失调、神经系统病变）在现有说明书中提示不足；临床使用时应重点关注用药初期（前30 d）的神经系统症状，监测必要时调整给药方案，以保障用药安全。

Objective To explore and analyze the signals for repotrectinib adverse drug events, so as to provide reference for the safe drug use in clinical practice. Methods The date of repotrectinib adverse drug events from FAERS were analyzed, and the time period was from the first quarter of 2024 to the fourth quarter of 2025. The signals were mined by means of ROR, PRR, BCPNN, and MGPS. Results A total of 522 adverse drug events reports of repotrectinib were obtained, involving 192 target individuals. There were 15 positive signals for adverse events across the 4 detection methods, corresponding to 112 adverse reaction reports. The top 5 adverse drug event signals were taste disorder, motor dysfunction, ataxia, hypoaesthesia oral, and neurotoxicity. Adverse drug event signals were mainly concentrated in various nervous system diseases. Adverse reactions with clear time records occurred within 30 days after the medication was administered. Conclusion The safety risk of repotrectinib is characterized by core nervous system toxicity, and some severe signals (such as ataxia and nervous system disorder) are insufficiently prompted in the existing package insert. Clinicians should focus on monitoring nervous system symptoms in the early stage of medication (first 30 days), and adjust the dosage regimen if necessary to ensure medication safety.

R979.1

宿迁市第一人民医院科研专项项目（KY202312）