目的 挖掘肽受体放射性核素治疗药物镥[¹⁷⁷Lu]氧奥曲肽在真实世界中的不良事件信号，为临床安全用药提供参考。方法 提取美国食品药品管理局不良事件报告系统数据库（FAERS）中2017年第4季度—2026年第1季度以“镥[¹⁷⁷Lu]氧奥曲肽”为首要怀疑药物的不良事件，采用报告比值比法（ROR）、比例报告比值法（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项伽马泊松缩估计器（MGPS）4种检测方法进行数据挖掘，并采用韦伯分布检验分析不良事件的发生时间特征。结果 共纳入5 274份有效报告，挖掘出128个阳性信号，经二次筛选剔除无效及不相关不良事件后得到85个有效信号，分布于13个系统器官分类。信号频数排序前10位的是全身状况恶化、死亡、血小板计数降低、实验室检查异常、血小板减少症、腹痛、贫血、腹水、白细胞计数降低、血红蛋白降低。信号强度排序前10位的是类癌性心脏病、类癌危象、类癌综合征、血嗜铬粒蛋白A升高、5-羟基吲哚乙酸升高、辐射暴露、单核细胞百分比升高、全身状况恶化、血清五羟色胺升高和骨髓浸润。不良事件发生的中位时间为77.50 d，韦伯分布分析呈现出早期失效型曲线特征。结论 临床应用镥[¹⁷⁷Lu]氧奥曲肽期间，需重点关注血液系统毒性、胃肠道反应及肾功能相关风险，警惕说明书未提及的不良事件信号，强化用药前风险评估与治疗期间动态监测。

Objective To identify adverse drug events signals of lutetium[¹⁷⁷Lu] oxodotreotide in the real-world setting, and to provide evidence for its clinical safety. Methods Adverse drug events reports with “lutetium[¹⁷⁷Lu] oxodotreotide” as the primary suspected drug were extracted from the FAERS database from Q4 2017 to Q1 2026. Four disproportionality analysis methods, including ROR, PRR, BCPNN, and MGPS were employed for signal detection. The time-to-onset characteristics of adverse drug events were further analyzed using Weibull distribution. Results A total of 5 274 reports were included, and 146 positive signals were identified. After secondary screening to exclude invalid and irrelevant adverse drug events, 85 valid signals remained, involving 13 system organ classes. The top 10 signals by frequency were general condition aggravated, death, platelet count decreased, abnormal laboratory tests, thrombocytopenia, abdominal pain, anemia, ascites, white blood cell count decreased, and hemoglobin decreased. The top 10 signals by signal strength were carcinoid heart disease, carcinoid crisis, carcinoid syndrome, elevated serum chromogranin A, elevated 5-hydroxyindoleacetic acid, radiation exposure, elevated monocyte percentage, deteriorating general condition, elevated serum serotonin, and bone marrow infiltration. The median time to onset was 77.5 days, and Weibull analysis indicated an early failure-type hazard pattern. Conclusion During treatment with lutetium[¹⁷⁷Lu] oxodotreotide, particular attention should be paid to hematological toxicity, gastrointestinal reactions, and renal function-related risks. Clinicians should also remain vigilant for adverse drug events signals not listed in the drug label and strengthen pre-treatment risk assessment and dynamic monitoring during therapy.

R979.1

江苏省肿瘤医院科技发展基金项目（ZYGL202502）