目的 评价并分析阿得贝利单抗临床使用合理性和用药安全性，为临床规范应用和管理提供参考。方法 收集2024年4月—2025年10月中国科学院合肥肿瘤医院患者使用阿得贝利单抗的所有病历资料，统计整理患者的基本情况、用药信息以及发生免疫相关不良反应（irAEs）等数据进行临床用药合理性评价与安全性分析。结果 共纳入32例患者，在2024年4月—2025年10月期间阿得贝利单抗共使用126个周期，均为1 200 mg iv，临床应用共涉及7个瘤种，符合药品说明书适应证的有19例，无适应证用药的有13例，联合用药不适宜的有24例。阿得贝利单抗irAEs发生率为78.13%，严重不良反应发生率为18.75%，主要为血液毒性、消化系统症状和全身症状等，不良反应影响因素分析显示irAEs在阿得贝利单抗治疗1～2周期和3周期及以上的发生率具有统计学意义。结论 阿得贝利单抗在真实世界临床使用过程中存在无适应证用药、用法用量不适宜等不合理应用情况，建议医疗机构应加强免疫检查点抑制剂合理用药管理，临床医师注重规范用药和irAEs安全性监测，药学部门严格审方和处方点评要求，共同保障患者用药合理安全。

Objective To evaluate and analyze the rationality and safety of adebrelimab in clinical use, providing a reference for standard clinical application and management. Methods All medical records of patients treated with adebrelimab at Hefei Cancer Hospital, Chinese Academy of Sciences from April 2024 to October 2025 were collected. Patient demographics, medication information, and data on the occurrence of adverse drug reactions were statistically analyzed for clinical medication rationality evaluation and safety analysis. Results A total of 32 patients were included. From April 2024 to October 2025, adebrelimab was used for 126 cycles, all administered as 1 200 mg iv. Clinical application involved seven different tumor types. Usage was compliant with the drug label indications in 19 cases, while 13 cases involved off-label use. Inappropriate combination therapy was identified in 24 cases. The incidence of immune related adverse events (irAEs) to adebrelimab was 78.13%, with the incidence of serious irAEs being 18.75%. The main irAEs were hematologic toxicity, digestive system symptoms, and systemic symptoms. Univariate analysis showed a statistically significant difference in the incidence of irAEs between the adebelimumab treatment with 1—2 cycles and 3 or more cycles. Conclusion In real-world clinical practice, adebelimumab exhibits inappropriate usage, including off-label use and inappropriate dosage or administration. It is recommended that healthcare institutions strengthen the comprehensive medication management of immune checkpoint inhibitors. Clinical physicians should emphasize standardized medication practices and safety monitoring of irAEs, while pharmacy departments must enforce strict prescription review and medication evaluation requirements. Together, these efforts will ensure rational and safe medication use for patients.

R965

安徽省卫生健康科研项目（AHWJ2023BAa20074）