[摘 要] 以免疫检查点抑制剂（ICI）为主的免疫治疗在激活T细胞、解除免疫抑制的同时可诱发免疫相关不良反应（irAE）。随 着ICI在实体瘤中的广泛应用，irAE已成为临床常见问题，严重影响免疫治疗持续获益和患者生活质量。因此，应用ICI前需进行 患者基线评估，如对有自身免疫性疾病、器官移植、病毒感染等特殊人群评估获益与风险。同时，irAE的预测及早期识别很重要， 应结合临床因素，如基础性疾病、既往用药及治疗史；宿主因素，如肠道菌群及特定基因多态性；以及生物标志物，包括肿瘤突变 负荷、炎症指标、自身抗体等综合预测irAE。此外，irAE的早期症状，如乏力、咳嗽、胆红素升高、转氨酶升高等需要与感染、肿瘤 进展、非ICI相关的不良反应鉴别。irAE属于排除性诊断，还需借助影像、病理及多学科会诊等手段鉴别。积极开展irAE的机制 研究及前瞻性临床试验有助于推动irAE的精准预测与治疗发展。

[Abstract] Immune checkpoint inhibitors (ICIs) based immunotherapy can induce immune-related adverse events (irAEs) while activating T cells and relieving immunosuppression. With the wide application of ICIs in solid tumors, irAEs has become a common clinical issue, seriously affecting the continuous benefits of immunotherapy and quality of life of patients. Therefore, a baseline assessment of patients is required before applying ICIs, such as evaluating the benefits and risks for special groups like those with autoimmune diseases, organ transplants, and viral infections. Meanwhile, the prediction and early identification of irAEs are paramount. Integrating various factors is essential for this purpose, including clinical factors such as underlying diseases and treatment history, host factors like intestinal flora and genetic polymorphisms, and biomarkers including tumor mutational burden, inflammatory indicators, and autoantibodies. In addition, the early symptoms of irAEs, such as fatigue, cough, and elevated bilirubin and transaminase levels, need to be differentiated from infections, tumor progression and adverse events caused by non-ICI interventions. irAE is an exclusion diagnosis and still requires the use of imaging, pathological and multidisciplinary consultation for differentiation. Mechanism research on irAE and prospective clinical trials should be conducted to promote the development precise prediction and treatment of irAE.

国家自然科学基金面上资助项目（No.81572875）；山东省自然科学基金面上资助项目（No.ZR202102190539）；CSCO领航肿瘤研究基 金资助项目（No.Y-2019AZMS-0440）