目的 挖掘沙芬酰胺的藥品不良事件信號，為臨床安全用藥提供參考。方法 基于美國食品藥品管理局（FDA）不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫收集2017年第1季度—2024年第4季度相關的不良反應報告，采用報告比值比（ROR）法和信息成分（IC）法進行數(shù)據(jù)挖掘分析。結果 提取到以沙芬酰胺為首要懷疑藥物的不良反應報告812份，排除非藥品不良反應報告36份，獲取不良反應報告776份，涉及患者270例，其中男性133例，占比49.3%，患者年齡主要集中在65歲以上。共挖掘到51個不良反應信號，涉及14個系統(tǒng)器官分類（SOC），主要包括精神病類、各類神經(jīng)系統(tǒng)疾病、各類損傷、中毒及操作并發(fā)癥，各類檢查和眼器官疾病等。挖掘到藥品說明書未提及的不良反應信號8個，包括躁動、視覺損害、視物模糊、橫紋肌溶解、類天皰瘡、心臟停搏、低血糖和呼吸性堿中毒。沙芬酰胺相關的不良反應多發(fā)生在用藥后的第1個月，占比51.9%。結論 沙芬酰胺用藥期間，尤其第1個月，除關注藥品說明書提及的不良反應外，還應密切關注視覺損害、視物模糊、橫紋肌溶解、類天皰瘡、心臟停搏、低血糖和呼吸性堿中毒等潛在新的不良反應，保障患者的用藥安全。

Objective To explore the adverse event signals of safinamide and provide references for safe clinical drug use. Methods Adverse reaction reports related to safinamide from FAERS database were collected from the first quarter of 2017 to the fourth quarter of 2024. Data mining analysis was performed using the ROR method and IC method. Results A total of 812 adverse reaction reports were extracted with safinamide as the primary suspected drug, excluding 36 non-drug adverse reaction reports. This resulted in 776 adverse reaction reports involving 270 patients, of whom 133 were male, accounting for 49.3%. The majority of patients were aged 65 years and older. A total of 51 adverse event signals were identified, involving 14 SOC, primarily including psychiatric disorders, various neurological diseases, injuries, poisonings, procedural complications, various examination-related issues, and ocular disorders. Eight adverse event signals not mentioned in the product labeling were identified, including agitation, visual impairment, blurred vision, rhabdomyolysis, bullous pemphigoid, cardiac arrest, hypoglycemia, and respiratory alkalosis. Adverse reactions related to safinamide were most common in the first month after medication initiation, accounting for 51.9%. Conclusion During the use of safinamide, especially in the first month, it is important to monitor not only the adverse reactions mentioned in the product labeling but also potential new adverse reactions such as visual impairment, blurred vision, rhabdomyolysis, bullous pemphigoid, cardiac arrest, hypoglycemia, and respiratory alkalosis to ensure patient medication safety.

R971