目的 挖掘匹妥布替尼的不良反应信号，为临床安全用药提供参考。方法 收集美国食品药品管理局（FDA）不良事件报告系统（FAERS）数据库中2023年第1季度—2025年第4季度匹妥布替尼的药品不良事件报告，采用报告比值比（ROR）法和贝叶斯置信传播神经网络（BCPNN）法进行数据挖掘，使用韦伯分布检验评估不良反应的发生规律。结果 共挖掘到以匹妥布替尼为首要怀疑药物的不良事件报告379例，男性占比50.13%，年龄主要集中在≥75岁（25.33%），报告国家主要是美国，报告数逐年上升。阳性信号21个，涉及9个系统器官分类；排名前6位的首选术语依次为淋巴细胞增多症、淋巴细胞计数升高、白细胞计数升高、血尿酸升高、恶性肿瘤进展、肿瘤溶解综合征；挖掘出10个新的不良事件及欧盟重要医疗事件清单中收录的7个重要不良事件；未识别肝损伤风险信号；不良事件多发生在用药后30 d内。结论 匹妥布替尼的整体安全性较高，但第1个月内应加强临床监测。

Objective To explore the adverse reaction signals of pirtobrutinib in order to provide reference for clinicians to use drugs safely. Methods Adverse drug event reports related to pirtobrutinib from the first quarter of 2023 to the fourth quarter of 2025 were retrieved from FAERS. The ROR and BCPNN methods were comprehensively used to mine drug adverse reaction signals. The Weibull distribution test was used to evaluate the onset time of adverse events. Results A total of 379 adverse drug event reports with pirtobrutinib as the primary suspected drug were obtained. The patients were mainly male (50.13%), aged ≥75 years (25.33%). The majority of reports came from the United States and the number of reports showed an increasing annual trend. A total of 21 positive signals of adverse drug events were detected, involving 9 system organ classes. The top 6 preferred terms are lymphocytosis, elevated lymphocyte count, elevated white blood cell count, elevated blood uric acid, progression of malignant tumor, tumor lysis syndrome. 10 new adverse drug events were identified and 7 important adverse drug events included in the EU's important medical event list were also discovered. Risk signals of liver injury were not identified. Adverse drug events mostly occurred within 30 days after medication. Conclusion The overall safety of pirtobrutinib is relatively high, but it is necessary to strengthen clinical monitoring within the first month.

R973

重庆市科卫联合医学科研青年项目(2025QNXM044)