目的 對卡度尼利單抗臨床應用情況和安全性進行評價，為臨床合理使用提供參考。方法 回顧性調查中國科學院合肥腫瘤醫(yī)院2023年6月—2024年3月使用卡度尼利單抗的病例資料，統(tǒng)計患者的基本信息、用藥信息及藥品不良反應等。同時依據(jù)藥品說明書、權威診療規(guī)范和臨床診療指南進行用藥評價和安全性分析。結果 35例患者使用卡度尼利單抗，共用藥117例次，臨床應用覆蓋10個癌種，符合藥品說明書和特殊情況下的藥物合理使用22例（62.86%），超用法用量用藥34例（97.14%）；藥品不良反應（ADR）發(fā)生率為51.43%，免疫相關的ADR主要表現(xiàn)為內分泌毒性（8.57%）、皮膚毒性（5.71%）、肌肉骨骼毒性（2.86%）等。結論 真實世界中卡度尼利單抗臨床不合理應用情況較普遍。建議醫(yī)療機構應基于現(xiàn)有循證醫(yī)學證據(jù)，加強藥品超說明書用藥管理，同時關注免疫相關不良反應，藥學部門應加大醫(yī)囑審核力度，共同保障患者的用藥安全及臨床獲益。

Objective To evaluate the rationality and safety of cadonilimab, and provide references for clinical application. Methods The cases treated with cadonilimab from June 2023 to March 2024 in Hefei Cancer Hospital, Chinese Academy of Sciences, were retrospectively investigated, and the patients’ basic information, medication information, and adverse drug reactions were statistically analyzed. Simultaneously the rationality and safety were analyzed based on drug instructions and clinical practice guidelines. Results A total of 35 patients were treated with cadonilimab for 117 times. The clinical application covered 10 types of cancer, and 22 cases（62.86%） were used in accordance with the drug instructions and rational use of off-label, and 34 cases（97.14%） were off-label used on dosage; The incidence of adverse drug reactions（ADRs） was 51.43%, and immune related adverse events（irAEs） mainly manifested as endocrine toxicity（8.57%）, skin toxicity（5.71%）, and musculoskeletal toxicity（2.86%）. Conclusion There were widespread of irrational use of cadonilimab in the real world. It is suggested that the management of off-label drug use based on available evidence should be strengthen by the medical institutions, while paying attention to immune-related adverse events. Pharmaceutical departments should increase the review of medical orders to jointly ensure the safety and clinical benefits of patients’ medication.

R979.1