Fezolinetant：停經後中至重度熱潮紅之非荷爾蒙療法新選擇

Fezolinetant: A Novel Non-Hormone Treatment for Moderate to Severe Hot Flashes Caused by Menopause

10.6168/FJCP.202401_32(1).0001

王建贏(Jian-Ying Wang)；陳一瑄(I-Hsuan Chen)；韓立瑄(Li-Shiuan Han)；劉亮妤(Liang-Yu Liu)；李銘嘉(Ming-Chia Lee)

fezolinetant ； 神經激肽3 ； 熱潮紅 ； 非荷爾蒙治療 ； fezolinetant ； neurokinin 3 ； hot flashes ； non-hormonal therapy

臺灣臨床藥學雜誌

32卷1期（2024 / 01 / 31）

1 - 9

繁體中文;英文

本研究旨在回顧fezolinetant，一種新型神經激肽3受體拮抗劑，在兩項關鍵三期試驗中顯示治療停經婦女熱潮紅等血管舒縮症狀方面的療效與安全性。結果顯示，相較於基線，與安慰劑相比服用fezolinetant 45 mg後在第4週及12週均顯著降低熱潮紅的日頻次（第4週：[SKYLIGHT 1試驗：-2.1次／日，p < 0.001；SKYLIGHT 2試驗：-1.8次／日，p < 0.001]；第12週：[SKYLIGHT 1試驗：-2.6次／日，p < 0.001；SKYLIGHT 2試驗：-2.5次日，p < 0.001]）及嚴重程度（第4週：[SKYLIGHT 1試驗：-0.2，p = 0.002；SKYLIGHT 2試驗：-0.3，p < 0.001]；第12週：[SKYLIGHT 1試驗：-0.2，p = 0.007；SKYLIGHT 2試驗：-0.3，p < 0.001]）且耐受性良好，試驗期間最常發生的不良反應是頭痛（3-6%）。基於在臨床試驗中顯示出的益處，fezolinetant於2023年5月獲得美國食品藥物管理局的批准。作為一個非荷爾蒙治療選擇，fezolinetant的臨床應用潛力極大，對於優化停經後婦女的中至重度熱潮紅治療方案具有重要的臨床意義。

This study aims to review fezolinetant, a novel neurokinin 3 receptor antagonist, for its efficacy and safety in treating vasomotor symptoms such as hot flashes in menopausal women as demonstrated in two pivotal phase III trials. The results showed that compared to baseline, the daily frequency of hot flashes was significantly reduced after taking 45mg of fezolinetant compared to placebo at both week 4 and week 12 (week 4: [SKYLIGHT 1 trial: -2.1 times/day, p < 0.001; SKYLIGHT 2 trial: -1.8 times/day, p < 0.001]; week 12: [SKYLIGHT 1 trial: -2.6 times/day, p < 0.001; SKYLIGHT 2 trial: -2.5 times/day, p < 0.001]) as well as severity (week 4: [SKYLIGHT 1 trial: -0.2, p = 0.002; SKYLIGHT 2 trial: -0.3, p < 0.001]; week 12: [SKYLIGHT 1 trial: -0.2, p = 0.007; SKYLIGHT 2 trial: -0.3, p < 0.001]). The treatment was well-tolerated, with headache being the most commonly reported side effect (3-6%). Based on the benefits demonstrated in clinical trials, fezolinetant received approval from the U.S. Food and Drug Administration in May 2023. As a non-hormonal treatment option, fezolinetant holds great potential for clinical application, offering significant clinical relevance in optimizing treatment regimens for moderate to severe hot flashes caused by menopause.