目的 基于FAERS数据库挖掘和分析多奈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 采用报告比值比法（ROR）和比例报告比值比法（PRR）从美国食品药品管理局（FDA）不良事件报告系统（FAERS）中收集多奈单抗2024年第3季度—2025年第4季度的不良事件数据。结果 共收集到多奈单抗为首要怀疑药物的不良事件报告共1 522份，上报国家以美国为主（88.30%）。共挖掘出不良事件信号共149个，共累及18个系统器官分类（SOC），累及的SOC主要分布在各类神经系统疾病。信号强度排名前5位的不良事件信号涉及淀粉样蛋白相关成像异常（ARIA）、淀粉样蛋白相关性影像异常水肿/渗出型（ARIA-E）、大脑微出血、淀粉样蛋白相关性影像异常微出血和血铁质沉积型（ARIA-H）和海马萎缩。多奈单抗说明书中未记载的新的可疑不良反应包括海马萎缩、脑血管缺血性疾病与磁共振成像异常等。结论 多奈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 Based on the FAERS database, To analysis adverse event signals of donanemab after its market launch, in order to provide reference for clinical safe and rational drug use. Methods The event data of donanemab from the third quarter of 2024 to the fourth quarter of 2025 were collected from the FAERS using the ROR and PRR. Results A total of 1 522 adverse event reports of donanemab as the primary suspected drug were collected. The reporting countries were mainly the United States (88.30%). A total of 149 adverse event signals were identified, involving 18 system organ classifications (SOCs). The affected SOC mainly distributed in various neurological diseases. The top 5 ranked adverse event signals in terms of intensity included amyloid-related imaging abnormalities (ARIA), amyloid-related imaging abnormality edema/exudative type (ARIA-E), cerebral microbleeds, amyloid-related imaging abnormality microbleeds and iron deposition type (ARIA-H), and hippocampal atrophy, etc. The new suspected adverse reactions not recorded in the donanemab instructions include hippocampal atrophy, cerebrovascular ischemic diseases and magnetic resonance imaging abnormalities, etc. Conclusions The adverse reactions related to donanemab 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.

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