目的 基于美國食品藥品管理局不良事件報告系統(tǒng)（FAERS）數據庫，分析鹽酸奧扎莫德的不良事件特征，評估其安全性并指導臨床合理用藥。方法 提取2020年7月—2024年9月FAERS數據庫中鹽酸奧扎莫德相關不良事件報告，通過描述性統(tǒng)計、報告比值比（ROR）及比例報告比（PRR）進行信號檢測，重點按適應證分類（多發(fā)性硬化癥和潰瘍性結腸炎）分析不良事件分布。結果 共納入7 284例報告，多發(fā)性硬化癥和潰瘍性結腸炎分別占60.88%（3 453例）和22.85%（1 296例）。多發(fā)性硬化癥患者中，神經系統(tǒng)事件占主導，以多發(fā)性硬化復發(fā)（ROR＝36.24）和進展型多發(fā)性硬化（ROR＝33.58）風險最高，與S1P受體介導的淋巴細胞再分布及中樞免疫調控失衡相關。潰瘍性結腸炎患者以胃腸系統(tǒng)事件為主，潰瘍性結腸炎惡化（ROR＝12.26）和便血（ROR＝7.81）風險顯著，可能反映腸道黏膜屏障破壞與免疫抑制的協(xié)同效應?？邕m應證共同風險中，黃斑水腫（ROR＝16.22）和心臟撲動（ROR=8.24）需長期監(jiān)測。結論 鹽酸奧扎莫德的不良反應特征因適應證顯著分化，多發(fā)性硬化癥需關注神經免疫事件，潰瘍性結腸炎應警惕腸道炎癥加重及感染風險，臨床需針對適應證優(yōu)化監(jiān)測策略，尤其在長期治療中需強化眼科及心血管評估。

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

國家自然科學基金面上項目（82074004）