目的 通過挖掘萊博雷生不良反應風險信號，以期促進臨床安全合理用藥。方法 下載美國食品藥品監(jiān)督管理局不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫中萊博雷生2019年1月—2024年12月數(shù)據(jù)，采用報告比值比（ROR）和比例報告比值比（PRR）2種公式法檢測萊博雷生不良事件信號。結(jié)果 共檢測到以萊博雷生為首要懷疑藥物的不良事件信號為1 249次，涉及目標人群為656例。其中女性356例（54.27%）多于男性237例（36.13%），45歲以上患者共計127例（19.36%）。陽性不良事件信號種類主要系統(tǒng)器官分類（SOC）為神經(jīng)系統(tǒng)疾病、精神病類、全身性疾病及給藥部位各種反應等。按陽性信號頻數(shù)排名靠前的不良反應為藥物無效、睡眠性癱瘓、嗜睡等。按陽性信號強度排名靠前的為睡眠性癱瘓、猝倒癥、睡驚癥等。結(jié)論 以上不良反應信號和風險提出了警示作用，為合理使用萊博雷生提供了參考依據(jù)。

Objective To mining the risk signal of adverse reaction of lemborexant, to promote the safe and rational clinical drug use. Methods Download lemborexant adverse event in FAERS database from January 2019 to December 2024 to detect lemborexant adverse event signals by using ROR and PRR. Results A total of 1 249 adverse reaction signal events were detected with lemborexant as the primary suspected drug, involving a target population of 656 cases. Among them, there were 356 females (54.27%) and 237 males (36.13%), with 127 patients aged 45 and above (19.36%). Types of positive adverse reaction signals were detected, with the main SOC being nervous system disorders, psychiatric disorders, and general disorders, and administration site conditions. The top adverse reactions ranked by the frequency of positive signals were drug inefficacy, sleep paralysis, lethargy, etc. Sleep paralysis, cataplexy and sleep fright were the top ones according to the positive signal intensity. Conclusion Above adverse reaction signals and risks put forward a warning effect, and provided a reference basis for rational use of lemborexant.

R971