目的 检索和挖掘镥[¹⁷⁷Lu]特昔维匹肽不良事件信号，为其临床安全用药提供参考。方法 从FAERS数据库检索镥[¹⁷⁷Lu]特昔维匹肽为首要怀疑药物的不良事件报告，检索范围为2004年第1季度—2025年第4季度，并采用报告比值比法（ROR）、比例报告比值法（PRR）、贝叶斯置信区间神经传播网络法（BCPNN）和多重伽马–泊松收缩估计法（MGPS），对可疑的不良事件信号进行挖掘。按发生频数和信号强度对挖掘到的不良事件信号进行排序，并用首选术语（PT）对其进行分类与统计。结果 共挖掘到镥[¹⁷⁷Lu]特昔维匹肽为首要怀疑药物的不良事件报告11 396例，其中女性20例（0.18%），男性1 868例（16.39%），不良事件报告主要上报国家为美国。共检测出57个阳性信号，涉及10个SOC。发生频率前10位的不良事件信号为实验室检查异常、贫血、血小板计数降低、血小板减少症、血红蛋白降低、口干、全血细胞减少症、全血细胞计数减少、血液检查异常及性欲丧失。信号强度前10的不良事件信号为血液学检测异常、实验室检查异常、骨髓浸润、脊髓感染、燃瘤反应、唾液分泌不足、放射性损伤、全血细胞计数减少、性欲丧失、肾肌酐清除率降低。性欲丧失和脊髓感染在说明书中没有记录。结论 镥[¹⁷⁷Lu]特昔维匹肽的不良事件与说明书基本相符，性欲丧失和脊髓感染为新发现的不良事件，值得临床关注与警惕。

Objective To retrieve and mine adverse drug event signals of lutetium [¹⁷⁷Lu] texaphyrin to provide a reference for clinical safety. Methods Adverse event risk reports of lutetium [¹⁷⁷Lu] texaphyrin as the primary suspected drug were retrieved from the FAERS database from Q1 2004 to Q4 2025. Signal detection for suspected adverse events was conducted using the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multiplicative gamma-poisson shrinkage. The adverse drug event signals were ranked by occurrence frequency and signal strength, and classified and counted using PT. Results A total of 11 396 adverse drug event reports were identified. 20 cases (0.18%) were female, 1 868 cases (16.39%) were male, the majority of reports were submitted from the United States. Fifty-seven positive signals were detected, covering 10 system organ classes. The top 10 most frequent adverse drug events signals were: abnormal laboratory tests, anemia, decreased platelet count, thrombocytopenia, decreased hemoglobin, dry mouth, pancytopenia, decreased complete blood cell count, abnormal blood test, and loss of libido. The top 10 adverse drug events signals by signal strength were hematological test abnormality, abnormal laboratory tests, bone marrow infiltration, spinal cord infection, tumor flare reaction, hyposalivation, radiation injury, decreased complete blood cell count, loss of libido, and decreased renal creatinine clearance. Loss of libido and spinal cord infection were not documented in the drug labeling. Conclusion Adverse drug event of lutetium [¹⁷⁷Lu] texaphyrin is generally consistent with the labeling. Loss of libido and spinal cord infection are newly identified adverse drug events, which warrant clinical attention and vigilance.

R979.1;R983