目的 基于FAERS数据库对罗泽利昔珠单抗的不良事件进行信号挖掘与分析，以期为临床安全用药提供参考。方法 收集FAERS数据库中2023年第2季度—2025年第2季度以罗泽利昔珠单抗为主要怀疑药品的不良事件数据，使用报告比值比法和贝叶斯置信区间神经网络传播法挖掘其不良事件信号。结果 共检索到以罗泽利昔珠单抗为主要怀疑药物的不良事件报告294份，其中严重不良事件占比48.0%。除药品说明书常见的不良事件如头痛、恶心和腹泻外，获得13个不良事件信号，其中包括肌痛、颈痛和带状疱疹3个新信号。罗泽利昔珠单抗77.8%的不良事件发生在用药后的第1个月。结论 罗泽利昔珠单抗用药期间除监测常见的不良事件外，也应加强对潜在新的不良事件的监护，尤其在用药的第1个月。

Objective To mine and analysis of adverse events of Rozanolixizumab based on the FAERS database, to provide a reference for safe clinical medication. Methods Adverse event data for Rozanolixizumab as the primary suspected drug were collected from the FAERS database from the second quarter of 2023 to the second quarter of 2025. The reporting odds ratio method and Bayesian confidence interval neural network propagation method were used to mine adverse event signals. Results A total of 294 adverse event reports with Rozanolixizumab as the main suspected drug were retrieved, among which serious adverse events accounted for 48.0%. In addition to the common adverse events in the drug instructions such as headache, nausea and diarrhea, 13 adverse event signals were obtained, including three new signals, myalgia, neck pain, and herpes zoster. 77.8% of the adverse events of rozeliximab occurred in the first month after medication.Conclusion During the administration of Rozanolixizumab, in addition to monitoring common adverse events, it is also necessary to strengthen the monitoring of potential new adverse events, especially in the first month of medication.

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