目的 基于美国食品药品管理局不良事件报告系统（FAERS）数据库挖掘尼卡利单抗上市后报告的不良事件信号，为其临床用药提供参考。方法 调取FAERS数据库2025年第2季度—2026年第2季度与尼卡利单抗有关的报告，提取以尼卡利单抗为首要怀疑药物的病例。采用报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯置信传播神经网络（BCPNN）及多项伽马泊松收缩（MGPS）法进行信号检测，并同步统计不良事件的发生时间。结果 共纳入以尼卡利单抗为首要怀疑药物的报告240例，其中女性104例，占比43.33%。4种方法合计检出阳性信号52个，其中4种方法同时判定为阳性的信号17个。剔除疾病本身、疗效、产品及暴露类等非不良事件术语后，最终保留9个不良事件信号进入分析。临床较为关注的信号包括带状疱疹、外周水肿、流行性感冒、无菌性脑膜炎及输注相关反应等，主要集中在感染、水肿及输注相关反应。在可计算发生时间的30例报告中，23例（76.67%）记录的事件发生于用药后30 d以内，中位发生时间为10 d；因时间信息缺失较多，该结果的代表性有限。结论 尼卡利单抗不良事件报告涉及感染、外周水肿及输注相关反应。部分潜在信号的报告数较少，其临床意义及与药物的因果关联仍需进一步验证。

Objective To mine post-marketing adverse drug event signals of nipocalimab from the FAERS database, and provide reference for its clinical use. Methods Adverse drug event reports of nipocalimab from the FAERS database between the second quarter of 2025 and the second quarter of 2026 were retrieved, and cases in which nipocalimab was designated as the primary suspect drug were extracted. Disproportionality analysis was performed using the ROR, PRR, BCPNN, and MGPS methods, and the time to onset of adverse drug events was analyzed simultaneously. Results A total of 240 reports with nipocalimab as the primary suspect drug were included, of which 104 (43.33%) involved female patients. The four methods jointly detected 52 positive signals, among which 17 were positive by all four methods. After excluding non-adverse drug event terms such as the disease itself, efficacy, product, and exposure-related terms, 9 adverse drug event signals were finally retained for analysis. Signals of greater clinical concern included herpes zoster, peripheral oedema, influenza, aseptic meningitis, and infusion-related reaction, most of which were concentrated in infection, oedema, and infusion-related reactions. Among the 30 reports with calculable time to onset, 23 (76.67%) occurred within 30 days after drug administration, with a median time to onset of 10 days, however, the representativeness of this result is limited owing to missing time information.Conclusion The adverse event reports of nipocalimab involve infections, peripheral edema and infusion-related reactions. The number of reports for some potential signals is relatively low, and their clinical significance and causal relationship with the drug still need to be further verified.

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