目的 基于美国食品药品管理局（FDA）药物不良事件报告系统（FAERS）中的不良事件报告，分析与达可替尼相关的药物不良事件信号，为医务人员制定药物治疗方案提供参考。方法 收集2018年第3季度—2025年第2季度的FAERS数据库中以达可替尼为首要怀疑的报告。采用报告比值比法和贝叶斯置信区间递进神经网络法进行信号检测和分析。结果 共收集947份达可替尼报告，挖掘到75个信号，涉及18个系统/器官分类。其中女性患者（47.4%）占比高于男性患者（40.6%）；年龄主要分布在65岁以上（30.4%）；累及的系统/器官分类主要包括类检查、全身性疾病及给药部位各种反应和肝胆系统疾病；报告例次排名前5位的信号为死亡、恶性肿瘤进展、高血压、肝功能异常和皮疹；信号强度排名前5位的信号为血降钙素升高、乳糜胸、三碘甲状腺原氨酸减低、肺脓肿和血磷升高。发现新的不良事件主要有高血压、腹水、血小板减少症、胸腔积液、心电图QT间期延长、水肿、血降钙素升高等。达可替尼相关不良事件发生时间中位数为28.5 d，大部分患者发生在用药后的第1个月内。结论 基于FAERS数据库挖掘的达可替尼药物不良事件信号与药品说明书大部分相符，医务人员需关注患者胃肠道症状和肝功能指标变化。

Objective To analyze the adverse drug event signals related to dacomitinib based on the adverse event reports in the FAERS, and to provide a reference for medical staff to formulate drug treatment plans. Methods Reports of dacomitinib as the primary suspect in the FAERS database from Q3 2018 to Q2 2025 were collected. The reporting odds ratio method and Bayesian confidence propagation neural network method were used for signal detection and analysis. Results A total of 947 reports of dacomitinib were collected, and 75 signals were excavated involving 18 system-organ class. Among them, female patients (47.4%) accounted for a higher proportion than male patients (40.5%). The age was mainly distributed over 65 years old (30.4%). The system-organ class involved mainly included similar examinations, systemic diseases and various reactions at the site of administration, and hepatobiliary system diseases. The top 5 signals in the reported cases were death, malignant tumor progression, hypertension, abnormal liver function, and rash. The top 5 signals in signal intensity were elevated hemocalcitonin, chylothorax, decreased triiodothyronine, lung abscess, and elevated blood phosphorus. New adverse events were mainly found to include hypertension, ascites, thrombocytopenia, pleural effusion, prolonged QT interval on electrocardiogram, edema, and elevated blood calcitonin. The median time to dacomitinib-related adverse events was 28.5 d, and most patients occurred within the first month after treatment. Conclusion The adverse event signals of dacomitinib based on the FAERS database are mostly consistent with the drug instructions, and medical staff should pay attention to the changes in gastrointestinal symptoms and liver function indicators of patients.

R979.1

南通市卫生健康委员会科研课题（QN2022058）