目的 挖掘和分析塔奎妥单抗上市后的不良事件信号，为临床安全合理用药提供参考。方法 利用OpenVigil数据平台，收集FAERS数据库中塔奎妥单抗2023年8月9日—2025年8月30日的数据，采用报告比值比法（ROR）、比例报告比值法（PRR）、贝叶斯可信传播神经网络法（BCPNN）和多项经验贝斯叶伽马泊松分布缩减法（MGPS）联合挖掘药物不良事件信号。结果 共收集塔奎妥单抗的心血管毒性报告984份，上报国家以美国为主，不良事件信号共73个，共累及25个系统器官分类（SOC），累及的SOC主要分布在皮肤及皮下组织类疾病。发生频次最高不良事件为细胞因子释放综合征，信号强度最高的不良事件为口腔毒性。塔奎妥单抗说明书中未记载的新的可疑不良反应包括燃瘤反应、肿瘤假性进展、共济失调等。结论 基于FAERS数据库挖掘到的塔奎妥单抗相关不良反应，与药品说明书中提到的基本一致，同时也存在部分新发现的可疑不良反应，在临床用药时，需提高警惕，减少用药风险。

Objective To mine and analyze adverse event signals associated with talquetamab post-marketing to provide references for its safe and rational clinical use. Methods Using the OpenVigil data platform, the data of talquetamab in the FAERS database from August 9, 2023 to August 30, 2025 were collected. The adverse drug event signals were jointly mined by using ROR, PRR, BCPNN, and MGPS. Results A total of 984 cardiovascular toxicity reports of talquetamab were collected, with the United States being the main reporting country. There were 73 adverse event signals, involving 25 system and organ classifications (SOCs), and the involved SOCs were mainly distributed in skin and subcutaneous tissue diseases. The adverse event with the highest occurrence frequency was cytokine release syndrome, and the adverse event with the highest signal intensity was oral toxicity. New suspected adverse reactions not recorded in the instructions of talquetamab include tumor-burning reactions, pseudo-tumor progression, ataxia, etc. Conclusion The adverse reactions related to talquetamab mined from the FAERS database are basically consistent with those mentioned in the drug instructions. At the same time, there are also some newly discovered suspicious adverse reactions. When using the drug in clinical practice, vigilance should be heightened to reduce the risk of medication.

R979.1