目的 通过美国食品药品管理局不良事件报告系统（FAERS）数据库对佩米替尼相关的药品不良事件进行信号挖掘，以期为临床安全用药提供依据。方法 收集FAERS数据库中2020年第2季度—2026年第1季度与佩米替尼相关不良事件报告，使用报告比值比法（ROR）、比例报告比值（PRR）、贝叶斯置信度递进神经网络（BCPNN）以及多项伽玛泊松分布缩减法（MGPS）进行数据挖掘。结果 本研究共收集到688份佩米替尼相关不良事件报告，不良事件的结局主要为住院或住院时间延长和死亡。获得不良事件阳性信号54个，共涉及8个系统器官分类（SOC）。报告数量排名前5位的不良事件为脱发、高磷酸血症、便秘、食欲减退和口腔黏膜炎。信号强度排名前5位的不良事件依次为指甲毒性、皮肤钙化、高磷酸血症、倒睫、和血磷升高。挖掘到部分不良事件未被药品说明书提及，如食欲减退、脱水、钙化防御症、皮肤钙化、血钙升高、钙质沉着、液体摄入下降等。佩米替尼相关不良事件的中位发生时间为61 d，50.00%病例发生在用药后的前2个月内。结论 使用佩米替尼治疗过程中，除监测常见的不良事件外，还需加强监测潜在的不良事件，尤其在用药后的前2个月内。

Objective To mine adverse drug event signals related to pemigatinib using the FAERS database, in order to provide evidence for clinical medication safety. Methods Adverse drug events reports related to pemigatinib from the FAERS database between the second quarter of 2020 and the first quarter of 2026 were collected. Data mining was performed using ROR, PRR, BCPNN, and MGPS methods. Results A total of 688 adverse drug events reports related to pemigatinib were collected. The main outcomes of these adverse drug events were hospitalization or prolonged hospitalization and death. A total of 54 positive adverse drug events signals were identified, involving eight SOCs. The top five adverse drug events by report frequency were alopecia, hyperphosphatemia, constipation, anorexia, and mucositis. The top five adverse drug events by signal strength were nail toxicity, skin calcification, hyperphosphatemia, trichiasis, and elevated blood phosphate levels. Some adverse drug events not mentioned in the drug's label were also identified, such as anorexia, dehydration, calciphylaxis, skin calcification, hypercalcemia, calcium deposits and reduced fluid intake. The median onset time for pemigatinib-related adverse drug events was 61 days, with 50.00% of cases occurring within the first two months of treatment. Conclusion In addition to monitoring common adverse drug events, potential adverse events, especially those occurring within the first two months of treatment, should also be closely monitored during pemigatinib therapy.

盐城市卫生健康委员会科研项目（YK2024118）