目的 分析佐妥昔单抗不良反应发生特点，为临床合理用药提供参考。方法 对2019年1月—2024年12月FAERS数据库中不良反应数据进行回顾性统计分析，确定发生不良反应的主要影响因素。结果 筛选出46例不良反应报告中以71～80岁患者占比最大，主要累及器官/系统有胃肠道系统、血液系统、全身反应和神经系统。结论 佐妥昔单抗作为新靶点治疗药物，临床应用中需加强用药监测，及时识别潜在风险因素，以期减少不良反应的发生，提高临床用药安全性。

Objective To analyze the characteristics of adverse reactions caused by zolbetuximab, so as to provide references for clinical safe and rational use of drugs. Methods A retrospective statistical analysis was conducted on the adverse reaction data in the FAERS database from January 2019 to December 2024 to identify the main influencing factors of adverse reactions. Results Among the adverse reactions reports of 46 patients selected, patients aged 71 — 80 years old account for the largest proportion. The main affected organs/systems include the gastrointestinal system, the hematopoietic system, systemic reactions and the nervous system. Conclusion As a novel targeted therapeutic agent, zolotuzumab should strengthen drug monitoring and identify potential risk factors in clinical application to reduce adverse reactions occurrence and improve clinical drug safety.

R979.1

陕西省卫生健康科研创新能力提升计划平台建设项目（2023PT-10）