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，分析盐酸奥扎莫德的不良事件特征，评估其安全性并指导临床合理用药。方法 提取2020年7月—2024年9月FAERS数据库中盐酸奥扎莫德相关不良事件报告，通过描述性统计、报告比值比（ROR）及比例报告比（PRR）进行信号检测，重点按适应证分类（多发性硬化症和溃疡性结肠炎）分析不良事件分布。结果 共纳入7 284例报告，多发性硬化症和溃疡性结肠炎分别占60.88%（3 453例）和22.85%（1 296例）。多发性硬化症患者中，神经系统事件占主导，以多发性硬化复发（ROR＝36.24）和进展型多发性硬化（ROR＝33.58）风险最高，与S1P受体介导的淋巴细胞再分布及中枢免疫调控失衡相关。溃疡性结肠炎患者以胃肠系统事件为主，溃疡性结肠炎恶化（ROR＝12.26）和便血（ROR＝7.81）风险显著，可能反映肠道黏膜屏障破坏与免疫抑制的协同效应。跨适应证共同风险中，黄斑水肿（ROR＝16.22）和心脏扑动（ROR=8.24）需长期监测。结论 盐酸奥扎莫德的不良反应特征因适应证显著分化，多发性硬化症需关注神经免疫事件，溃疡性结肠炎应警惕肠道炎症加重及感染风险，临床需针对适应证优化监测策略，尤其在长期治疗中需强化眼科及心血管评估。

Objective To analyze the adverse event characteristics of ozanimod hydrochloride based on the FAERS database, evaluate its safety, and guide clinical rational drug use. Methods To extract the adverse event reports related to ozanimod hydrochloride from the FAERS database between July 2020 and September 2024. Descriptive statistics, ROR, and PRR were used for signal detection, with a focus on categorizing adverse events by indication (multiple sclerosis and ulcerative colitis). Results A total of 7 284 reports were included, with multiple sclerosis and ulcerative colitis accounting for 60.88% (3 453 cases) and 22.85% (1 296 cases), respectively. In multiple sclerosis patients, neurological events predominated, with the highest risks for multiple sclerosis relapse (ROR = 36.24) and progressive multiple sclerosis (ROR = 33.58), associated with S1P receptor-mediated lymphocyte redistribution and central immune regulation imbalance. In ulcerative colitis patients, gastrointestinal events were most common, with significant risks for worsening of ulcerative colitis (ROR = 12.26) and rectal bleeding (ROR = 7.81), reflecting potential synergistic effects of intestinal mucosal barrier disruption and immune suppression. Across both indications, common risks included macular edema (ROR = 16.22) and cardiac arrhythmia (ROR = 8.24), requiring long-term monitoring. Conclusion The adverse event profiles of ozanimod hydrochloride significantly differ by indication. Multiple sclerosis patients should focus on neurological and immune-related events, while ulcerative colitis patients need to be aware of exacerbated intestinal inflammation and infection risks. Clinical monitoring strategies should be optimized according to the indication, with enhanced ophthalmological and cardiovascular evaluations, especially during long-term treatment.

R971;R975

国家自然科学基金面上项目（82074004）