目的 挖掘维替索妥尤单抗的不良事件信号，为临床安全用药提供依据。方法 从美国食品药品管理局不良事件报告系统数据库（FAERS）收集2021年第3季度—2025年第1季度的报告数据，筛选以维替索妥尤单抗为首要怀疑药物的报告。采用报告比值比（ROR）法和贝叶斯可信区间递进神经网络（BCPNN）法进行不良事件信号挖掘。用国际医学用语词典（MedDRA）首选系统器官分类（SOC）和首选术语（PT）对ADE进行分类统计。结果 共纳入以维替索妥尤单抗为首要怀疑药物的不良事件报告556份，患者以女性为主（74.46%），适应证为宫颈癌最多（28.42%），严重报告占51.08%，主要上报国家为美国（89.39%）。采用ROR法和BCPNN共检出48个信号，涉及18个SOC。信号强度前5位的不良事件信号为眼球黏连、眼毒性、点状角膜炎、外周运动神经病变和被截获的用药错误。说明书未记载的不良事件包括贫血、发热性中性粒细胞减少、白内障和低钾血症。结论 维替索妥尤单抗的不良事件与说明书基本相符，眼器官不良事件信号强且发生率高，值得临床关注和警惕。

Objective To mine adverse drug event signals of tisotumab vedotin to provide a basis for safe use in clinical practice. Methods To collect reported data from the third quarter of 2021 to the first quarter of 2025 by FAERS database, screen reports with tisotumab vedotin as the primary suspect drug. The adverse drug event signals were detected by ROR and BCPNN methods. The SOC and PT in the MedDRA were used for classification statistics and descriptive analysis. Results A total of 556 adverse drug event reports with tisotumab vedotin as the primary suspected drug were included, with female patients being the majority (74.46%), the main indication was cervical cancer (28.42%), the severe adverse drug event account 51.08%, and the main reporting country was the United States (89.39%). A total of 48 positive PT signals were detected simultaneously by ROR and BCPNN methods, involving 18 SOCs. The top five adverse drug event signals in terms of signals strength were symblepharon, ocular toxicity, punctate keratitis, peripheral motor neuropathy and intercepted medication error. The adverse drug event not recorded in the drug included anemia, febrile neutropenia, cataract and hypokalemia. Conclusion The adverse drug event induced by tisotumab vedotin were generally consistent with those in the drug instruction, the intensity and frequency of ocular signals are high which require clinical attention and timely intervention.

R979.1

上海市黄浦区科研项目（HLQ202303）；上海市长宁区妇幼保健院科研启动基金项目（2023Y-10）