目的 通过FAERS数据库对菲卓替尼进行数据挖掘以指导临床安全用药。方法 收集FAERS数据库中2019年3季度—2025年3季度药物不良反应相关数据，采用ROR、PRR、BCPNN法对菲卓替尼进行数据挖掘。结果 共挖掘到以菲卓替尼为PS的药物不良反应1 336例，男女比为1∶1.11，主要集中在65～85岁，673例严重报告中死亡184例，上报数量最多的国家是美国，占80.9%。同时满足ROR、PRR和BCPNN 3种方法的阳性信号52个，涉及15个系统器官分类（SOC），其中报告数排名前5位的SOC有胃肠系统疾病、全身性疾病及给药部位各种反应、各类检查、血液及淋巴系统疾病，代谢及营养类疾病。信号强度排名前5位的不良反应有维生素B1降低、维生素B1缺乏症、韦尼克脑病、全血细胞计数减少及血小板疾病。未在药品说明书中记载的不良反应有14个。结论 临床应用菲卓替尼时，除关注胃肠道反应、血液系统、韦尼克脑病等说明书上标注的不良反应外，还需要对说明书中未记载的如维生素B1减少、维生素B1缺乏症、血钾升高、血铁降低等等进行监测。

Objective To mine data by using the FAERS database, to guide the safe clinical use of fedratinib. Methods Data were collect on adverse drug reactions related to fedratinib from the third quarter of 2019 to the third quarter of 2025 in the FAERS database, and perform data mining using ROR, PRR and BCPNN methods. Results A total of 1 336 adverse drug reaction reports with fedratinib as the primary suspect (PS) drug were collected. The male-to-female ratio was 1∶1.11, with the majority of cases occurring in patients aged 65～85 years. Among 673 serious reports, 184 fatalities were recorded. The United States contributed the most reports, accounting for 80.9% of the total. Fifty-two positive signals simultaneously satisfied all three methods (ROR, PRR, and BCPNN), spanning 15 SOCs. The top five SOCs by report count were: gastrointestinal disorders, general disorders and administration site conditions, investigations, blood and lymphatic system disorders, and metabolic and nutritional diseases. The top 5 adverse reactions by signal intensity were decreased vitamin B1, vitamin B1 deficiency, Wernicke’s encephalopathy, pancytopenia, and platelet disorders. Fourteen adverse reactions were not described in the drug label. Conclusion Clinical use of fedratinib requires monitoring for known adverse reactions listed in the prescribing information, such as gastrointestinal events, hematological disorders, and Wernicke's encephalopathy. Equal attention should be given to unrecorded reactions, including decreased vitamin B1, thiamine deficiency, hyperkalemia, and hypoferremia.

R973

邯郸市科学技术研究与发展计划项目（24422083079ZC）