目的 基于美国食品药品管理局（FDA）不良事件报告系统（FAERS）挖掘拉那利尤单抗在真实世界应用中的不良事件风险信号，为临床安全合理用药提供参考。方法 检索并筛选FAERS数据库中2018年第1季度—2025年第4季度上报的拉那利尤单抗相关的不良事件报告。通过报告比值比（ROR）、多项伽马泊松缩减法（MGPS）等4种比例失衡算法开展信号检测，并分析人群特征及不良事件发生时间，以Weibull模型评估时间依赖性。结果 共纳入2 857例报告，女性占70.0%，18～64岁占46.6%，美国来源占87.8%。Weibull拟合发现尺度参数α为272.02，形状参数β为1.16（95% CI：1.09～1.24），提示“耗损型”时间模式。4种算法共得到142个阳性PT，累及27个SOC。频数排名前30位的阳性信号主要为注射部位反应、体质量变化及感染等相关不良事件。此外，基于IC₀₂₅的信号强度分析显示，“静脉通路不良”为的IC₀₂₅为3.66，为中等信号强度。结论 拉那利尤单抗真实世界安全性总体与已知风险一致，但仍可能存在需进一步验证的潜在新信号（如体质量改变、肾结石及自身免疫相关事件），建议长期随访中加强体质量及代谢指标监测，并关注泌尿系统相关症状。

Objective To evaluate the real-world safety profile of lanadelumab by mining adverse drug event signals from the FAERS database, providing evidence for clinical risk management and rational drug use. Methods Lanadelumab-associated adverse drug event reports submitted to FAERS from Q1 2018 to Q4 2025 were retrieved and screened. Signal detection was performed using four disproportionality methods, including ROR and MGPS. Demographic characteristics and time-to-onset were analyzed, and a Weibull model was fitted to evaluate time-dependent patterns. Results A total of 2 857 reports were included, with females accounting for 70.0%, patients aged 18 to 64 years for 46.6%, and reports originating from the United States for 87.8%. The Weibull distribution fitting revealed a scale parameter (α) of 272.02 and a shape parameter (β) of 1.16 (95% CI: 1.09 — 1.24), indicating a “wear-out failure” time profile. A total of 142 consistent positive PTs were identified across the four algorithms, involving 27 SOCs. The top 30 positive signals ranked by frequency were primarily associated with injection site reactions, weight changes, and infections. Furthermore, signal strength analysis based on IC₀₂₅ demonstrated that “poor venous access” had an IC₀₂₅ of 3.66, presenting as a strong signal. Conclusion The real-world safety profile of lanadelumab is generally consistent with known risks. However, potential novel signals requiring further confirmation (such as weight changes, nephrolithiasis, and autoimmune-related events). Long-term follow-up should include monitoring of body weight and metabolic parameters, with attention to urinary tract related symptoms.

R973

苏州市科技公关计划（医疗卫生创新） 项目（SYWD2025251）