目的 通過對(duì)唑尼沙胺不良事件的信號(hào)挖掘，為癲癇患者臨床安全用藥提供參考。方法 使用比例失衡法對(duì)美國美國食品藥品管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）中唑尼沙胺的不良事件進(jìn)行數(shù)據(jù)挖掘。結(jié)果 提取以唑尼沙胺作為首要懷疑藥物的不良事件10 038例，共涉及3 292名患者。采用比例失衡法共檢測(cè)到不良事件信號(hào)260個(gè)，累及27個(gè)系統(tǒng)和器官（SOC），并挖掘出12個(gè)說明書中未收錄的新的不良事件，尤其是代謝性酸中毒和高血氨腦病值得注意。結(jié)論 癲癇患者使用唑尼沙胺時(shí)，應(yīng)密切監(jiān)測(cè)患者不良事件，盡早發(fā)現(xiàn)用藥風(fēng)險(xiǎn)，保證臨床合理用藥。

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