目的 挖掘仑卡奈单抗的药品不良事件信号，为合理用药提供参考。方法 通过美国食品药品监督管理局不良事件报告系统（FAERS）和世界卫生组织药品不良反应报告数据库（WHO-VigiAccess）收集2023年第1季度—2024年第4季度的仑卡奈单抗相关不良事件报告，利用比例失衡法中的报告比值比（ROR）法和比例报告比值（PRR）法进行数据统计并分析。结果 在FAERS数据库和WHO-VigiAccess数据库分别涉及25、23种系统器官分类（SOC），主要为各类神经系统疾病、全身性疾病及给药部位各种反应、精神病类。在FAERS数据库中，报告例数排名靠前的不良事件信号涉及头痛、淀粉样蛋白相关性影像异常水肿/渗出型、淀粉样蛋白相关性影像异常微出血和血铁质沉积型、寒战和疲劳；而WHO-VigiAccess数据库则为头痛、寒战、疲劳、淀粉样蛋白相关性影像异常水肿/渗出型和输液相关反应。2个数据库中信号强度排名靠前的不良事件信号均涉及淀粉样蛋白相关性影像异常、淀粉样蛋白相关性影像异常微出血和血铁质沉积型、淀粉样蛋白相关性影像异常水肿/渗出型、中枢神经系统表面铁沉积症和大脑微出血等首选术语。FAERS数据库显示，大多数病例发生不良事件是在给药第1个月内。结论 在使用仑卡奈单抗时，应重点关注老年女性和长期用药患者，并要警惕感染、缺血性卒中等罕见的不良事件。同时也应加强临床用药监护，降低不良事件对患者预后以及生活质量的影响。

Objective To provide reference for rational drug use through mining adverse drug event signals associated of lecanemab. Methods To collect adverse drug event reports of lecanemab from Q1 2023 to Q4 2024 in FAERS and WHO-VigiAccess databases. Data mining was performed using ROR and PRR methods in the proportional imbalance method. Results The FAERS database and WHO-VigiAccess database involved 25 and 23 SOC, respectively, mainly for various neurological diseases, systemic diseases, reactions at the drug administration site, and psychosis. In the FAERS database, the adverse drug event signals with the highest number of reported cases were related to headache, amyloid-associated imaging abnormality oedema/exudative type, amyloid-associated imaging abnormality microhaemorrhagic and haemoferritic type, chills, and fatigue, while in the WHO-VigiAccess database, they were headache, chills, fatigue, amyloid-associated imaging abnormality oedema/exudative type, and infusion-associated reactions. The top-ranked adverse drug event signals in both databases in terms of signal intensity were related to the preferred terms of amyloid-associated imaging abnormality, amyloid-associated imaging abnormality microhaemorrhagic and haemoferritic type, amyloid-associated imaging abnormality oedema/exudative type, central nervous system surface iron deposition disorders, and microhaemorrhages in the brain. The FAERS database showed that the occurrence of adverse drug event in most of the cases occurred within the first month of administration. Conclsion When using lencanumab, focus should be placed on elderly women and patients on long-term use of the drug, and be vigilant for rare adverse drug events such as infections, ischaemic stroke, etc. Clinical monitoring of the use of the drug should also be strengthened to reduce the impact of the adverse drug event on the patient’s prognosis as well as quality of life.

R971

山东省自然科学基金联合基金资助项目（ZR2022LSW016）；潍坊市卫生健康委员会科研项目（WFWSJK-2024-072）