【摘要】 目的 探讨广泛期小细胞肺癌患者使用免疫检查点抑制剂（ICIs）发生免疫相关不良事件（irAEs）的临床特征及影响因素。方法 利用中国医院药物警戒系统回顾性收集我院2023年1月1日至5月31日使用ICIs的130例广泛期小细胞肺癌患者的资料，记录所有患者治疗期间irAEs的发生情况及激素使用情况。采用多因素Logistic回归模型分析影响irAEs发生的因素。结果 纳入的130例患者中，有32例患者发生了38例次irAEs，发生率为24.6%，严重程度为1～3级；以皮肤症状（8.4%）最为常见，且集中发生在治疗的第1个周期；5例患者发生多器官系统irAEs。发生irAEs患者的激素使用不合理率为23.1%（甲状腺功能异常患者除外）。神经元特异性烯醇化酶（NSE）为影响irAEs发生的独立因素（P<0.05）。结论 ICIs所致的irAEs发生率较高，可累及全身各个器官系统，以皮肤症状发生最早；NSE是影响irAEs发生的独立因素，可一定程度预测irAEs的发生风险。更多还原

【Abstract】 OBJECTIVE To explore the clinical characteristics and influencing factors of immune-related adverse events(irAEs) in patients with extensive-stage small cell lung cancer(SCLC) treated with immune checkpoint inhibitors(ICIs).METHODS The data from 130 patients with extensive-stage SCLC treated with ICIs at our hospital from January 1, 2023, to May 31, 2023 was collected retrospectively using the Chinese Hospital Pharmacovigilance System. The occurrence of irAEs and the use of corticosteroids during treatment for all patients were recorded. A multifactorial Logistic regression model was used to analyze the influencing factors for the occurrence of irAEs. RESULTS Among the 130 patients included, 32 patients experienced 38 episodes of irAEs, with an incidence rate of 24.6% and severity of degree 1-3. Skin symptoms were the most common(8.4%) and predominantly occurred in the first cycle of treatment. Five patients developed irAEs involving multiple organ systems. The irrational use rate of corticosteroids in patients with irAEs was 23.1%(excluding patients with thyroid dysfunction). Neuron specific enolase(NSE) was a independent factor influencing the occurrence of irAEs(P<0.05). CONCLUSIONS The incidence of irAEs caused by ICIs remains relatively high and can involve various organ systems throughout the body, with skin symptoms occurring earliest. NSE is an independent influencing factor for the occurrence of irAEs, and could predict the risk of irAEs to a certain extent.更多还原