目的 通过对唑尼沙胺不良事件的信号挖掘，为癫痫患者临床安全用药提供参考。方法 使用比例失衡法对美国美国食品药品管理局（FDA）不良事件报告系统（FAERS）中唑尼沙胺的不良事件进行数据挖掘。结果 提取以唑尼沙胺作为首要怀疑药物的不良事件10 038例，共涉及3 292名患者。采用比例失衡法共检测到不良事件信号260个，累及27个系统和器官（SOC），并挖掘出12个说明书中未收录的新的不良事件，尤其是代谢性酸中毒和高血氨脑病值得注意。结论 癫痫患者使用唑尼沙胺时，应密切监测患者不良事件，尽早发现用药风险，保证临床合理用药。

Objective To provide a reference for the safe clinical use of drugs in epilepsy patients through signal mining of zonisamide adverse events. Methods Data mining of zonisamide adverse events in the FDA Adverse Event Reporting System (FAERS) using the proportional imbalance method. Results 10 038 Adverse events with zonisamide as the first suspected drug were extracted, involving a total of 3 292 patients. A total of 260 adverse event signals were detected using the proportional imbalance method, involving 27 systems and organs (SOC), and 12 new adverse events not included in the specification were mined. Conclusion When zonisamide is used in patients with epilepsy, patients should be closely monitored for adverse events to detect medication risks as early as possible and ensure rational clinical use.

R971