目的 挖掘沙芬酰胺的药品不良事件信号，为临床安全用药提供参考。方法 基于美国食品药品管理局（FDA）不良事件报告系统（FAERS）数据库收集2017年第1季度—2024年第4季度相关的不良反应报告，采用报告比值比（ROR）法和信息成分（IC）法进行数据挖掘分析。结果 提取到以沙芬酰胺为首要怀疑药物的不良反应报告812份，排除非药品不良反应报告36份，获取不良反应报告776份，涉及患者270例，其中男性133例，占比49.3%，患者年龄主要集中在65岁以上。共挖掘到51个不良反应信号，涉及14个系统器官分类（SOC），主要包括精神病类、各类神经系统疾病、各类损伤、中毒及操作并发症，各类检查和眼器官疾病等。挖掘到药品说明书未提及的不良反应信号8个，包括躁动、视觉损害、视物模糊、横纹肌溶解、类天疱疮、心脏停搏、低血糖和呼吸性碱中毒。沙芬酰胺相关的不良反应多发生在用药后的第1个月，占比51.9%。结论 沙芬酰胺用药期间，尤其第1个月，除关注药品说明书提及的不良反应外，还应密切关注视觉损害、视物模糊、横纹肌溶解、类天疱疮、心脏停搏、低血糖和呼吸性碱中毒等潜在新的不良反应，保障患者的用药安全。

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