目的 挖掘替朗妥昔单抗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中2021年第2季度—2025年第3季度以“替朗妥昔单抗”为首要怀疑药物的不良事件，采用报告比值比法、比例报告比值法、贝叶斯置信传播神经网络和多项伽马泊松缩估计器四种算法进行数据挖掘，利用韦伯分布检验分析发生时间。结果 共纳入255份有效报告，挖掘出23个阳性信号，涉及8个系统器官分类。信号频数排名前5位的是死亡、胸腔积液、皮疹、光敏性反应、水肿。信号强度排名前5位的是光敏性反应、水泡疹、皮肤毒性、细菌性肺炎、心包积液。死亡、脓毒症、水疱、药物不耐受、水泡疹、细菌性肺炎、间质性肺疾病和全血细胞减少症是说明书未提及的新风险信号。不良事件发生中位时间为43 d，呈现出随机失败型曲线特征。结论 在替朗妥昔单抗应用过程中，重点关注以血液学毒性、皮肤毒性和全身毒性为核心的不良事件，警惕说明书未提及的不良事件，并进行早期密集监测与长期全程警戒。

Objective To investigate adverse event signals associated with loncastuximab tesirine in real-world settings, and to provide references for its safe clinical use. Methods Adverse event reports from the FAERS database from the second quarter of 2021 to the third quarter of 2025, in which loncastuximab tesirine was listed as the primary suspected drug were extracted. Data mining was performed using four algorithms: the Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Multi-item Gamma Poisson Shrinker. The time to onset was analyzed using the Weibull distribution test. Results A total of 255 valid reports were included, and 23 positive signals were identified, involving 8 SOC. The top five signals by frequency were death, pleural effusion, rash, photosensitivity reaction, and edema. The top five signals by strength were photosensitivity reaction, vesicular rash, skin toxicity, bacterial pneumonia, and pericardial effusion. Death, sepsis, blister, drug intolerance, vesicular rash, bacterial pneumonia, interstitial lung disease, and pancytopenia were newly identified risk signals not mentioned in the prescribing information. The median time to adverse event onset was 43 days, showing a characteristic random failure pattern curve. Conclusion During the use of loncastuximab tesirine, close attention should be paid to adverse events centered on hematological toxicity, skin toxicity, and systemic toxicity. Vigilance is required for adverse events not mentioned in the prescribing information, with early intensive monitoring and long-term vigilance recommended.

R979.1

南京药学会-常州四药医院药学科研基金资助项目（2024YX001）；江苏省肿瘤医院科技发展基金项目（ZYGL202402）