目的 基于美国食品药品管理局不良事件报告系统（FAERS）数据库，挖掘德达博妥单抗相关药物不良事件信号，分析其安全性特征，为临床合理用药提供参考。方法 检索FAERS数据库2025年第1～4季度不良药物事件报告，纳入以德达博妥单抗为首要怀疑药物的病例。采用报告比值比（ROR）法进行比例失衡分析，同时对药物不良事件发生时间进行统计分析。结果 共涉及299例，女性占77.93%，死亡结局占28.43%，共挖掘出24个阳性药物不良事件信号。按ROR排序，角膜炎（ROR＝103.76）及口腔黏膜炎（ROR＝73.18）信号强度最高。药物不良事件多发生于给药后60 d内（68.34%），中位发生时间为40 d。结论 德达博妥单抗相关药物不良事件主要集中于口腔黏膜及眼部毒性，呼吸系统不良反应亦需关注，多发生于治疗早期阶段。临床实践中应加强早期监测与预防性干预，以提高用药安全性。

Objective To identify adverse drug event signals associated with datopotamab deruxtecan based on FAERS database, and to analyze its safety profile to provide evidence for rational clinical use. Methods Adverse drug event reports from the FAERS database between the first and fourth quarters of 2025 were retrieved. Cases in which datopotamab deruxtecan was designated as the primary suspected drug were included. Disproportionality analysis was performed using the ROR method. Time-to-onset analysis of adverse drug events was also conducted. Results A total of 299 reports were identified. Females accounted for 77.93% of cases, and death outcomes were reported in 28.43%. Twenty-four positive adverse drug event signals were detected. Based on ROR ranking, keratitis (ROR = 103.76) and stomatitis (ROR = 73.18) showed the strongest signals. Most adverse drug events occurred within 60 days after drug initiation (68.34%), with a median time to onset of 40 days. Conclusion Datopotamab deruxtecan-related adverse drug events were primarily associated with mucosal and ocular toxicities, and respiratory adverse events also warrant attention. Most events occurred in the early treatment period. Early monitoring and preventive interventions should be strengthened in clinical practice to improve medication safety.

R979.1

宿迁市科技项目合同（KY202312）