目的 分析佐妥昔單抗不良反應(yīng)發(fā)生特點，為臨床合理用藥提供參考。方法 對2019年1月—2024年12月FAERS數(shù)據(jù)庫中不良反應(yīng)數(shù)據(jù)進(jìn)行回顧性統(tǒng)計分析，確定發(fā)生不良反應(yīng)的主要影響因素。結(jié)果 篩選出46例不良反應(yīng)報告中以71～80歲患者占比最大，主要累及器官/系統(tǒng)有胃腸道系統(tǒng)、血液系統(tǒng)、全身反應(yīng)和神經(jīng)系統(tǒng)。結(jié)論 佐妥昔單抗作為新靶點治療藥物，臨床應(yīng)用中需加強(qiáng)用藥監(jiān)測，及時識別潛在風(fēng)險因素，以期減少不良反應(yīng)的發(fā)生，提高臨床用藥安全性。

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

陜西省衛(wèi)生健康科研創(chuàng)新能力提升計劃平臺建設(shè)項目（2023PT-10）