目的 对卡度尼利单抗临床应用情况和安全性进行评价，为临床合理使用提供参考。方法 回顾性调查中国科学院合肥肿瘤医院2023年6月—2024年3月使用卡度尼利单抗的病例资料，统计患者的基本信息、用药信息及药品不良反应等。同时依据药品说明书、权威诊疗规范和临床诊疗指南进行用药评价和安全性分析。结果 35例患者使用卡度尼利单抗，共用药117例次，临床应用覆盖10个癌种，符合药品说明书和特殊情况下的药物合理使用22例（62.86%），超用法用量用药34例（97.14%）；药品不良反应（ADR）发生率为51.43%，免疫相关的ADR主要表现为内分泌毒性（8.57%）、皮肤毒性（5.71%）、肌肉骨骼毒性（2.86%）等。结论 真实世界中卡度尼利单抗临床不合理应用情况较普遍。建议医疗机构应基于现有循证医学证据，加强药品超说明书用药管理，同时关注免疫相关不良反应，药学部门应加大医嘱审核力度，共同保障患者的用药安全及临床获益。

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