目的 通過(guò)對(duì)抗癲癇藥物左乙拉西坦不良事件（ADE）信號(hào)的挖掘分析，以期為臨床安全合理用藥提供參考。方法 采用比例失衡法中的報(bào)告比值比法（ROR）和綜合標(biāo)準(zhǔn)法（MHRA）對(duì)2017年1季度至2021年3季度美國(guó)食品藥品監(jiān)督管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）中左乙拉西坦的ADE報(bào)告進(jìn)行數(shù)據(jù)挖掘及分析。結(jié)果 分析處理數(shù)據(jù)后共得到622個(gè)有效信號(hào)，涉及24個(gè)系統(tǒng)器官，主要集中在各類(lèi)神經(jīng)系統(tǒng)疾病、精神病類(lèi)、妊娠期及產(chǎn)褥期及圍產(chǎn)期狀況等方面，發(fā)現(xiàn)說(shuō)明書(shū)中未出現(xiàn)的信號(hào)累及器官系統(tǒng)有6個(gè)。結(jié)論 基于FAERS數(shù)據(jù)庫(kù)對(duì)左乙拉西坦ADE信號(hào)挖掘可促進(jìn)左乙拉西坦的安全、合理使用。

Objective To provide reference for clinical safe and rational drug use through mining and analysis of adverse drug event (ADE) signals of levetiracetam. Methods The reporting odds ratio (ROR) method and the Medicines and healthcare products regulatory agency (MHRA) method were used to mine and analyze the ADE reports of levetiracetam which included 19 quarter from the first quarter of 2017 to third quarter of 2021 of FDA adverse events reporting system (FAERS). Results A total of 622 valid signals were obtained, involving 24 system organs, mainly focusing on nervous system disorders, psychiatric disorders, pregnancy, puerperium and perinatal conditions, and 6 organ systems that did not appear in the instruction. Conclusion Signal mining of levetiracetam ADE based on FAERS database can promote safe and rational use of levetiracetam.

四川省科技廳項(xiàng)目（2019JDR0163）；四川省教育廳項(xiàng)目（16ZA0290）