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美国食品药品监督管理局批准非甾体选择性 ER 降解剂 fezolinetant(Veozah):对其治疗绝经后血管舒缩症状的疗效和安全性的关键性评估,呼吁开展前瞻性研究。

FDA approved fezolinetant (Veozah): a critical evaluation of its efficacy and safety for menopausal vasomotor symptoms, calling for prospective research.

机构信息

Department of Internal Medicine, Ziauddin University, Karachi, Pakistan.

Department of Internal Medicine, Jinnah Sindh Medical University, Karachi, Pakistan.

出版信息

Arch Womens Ment Health. 2024 Dec;27(6):943-946. doi: 10.1007/s00737-024-01456-y. Epub 2024 Mar 13.

Abstract

Women going through menopause frequently experience vasomotor symptoms such as hot flashes, night sweats, and sleep disturbances, significantly influencing their quality of life. Hormonal therapy has been demonstrated to be beneficial in treating VMS. However, due to specific restrictions, it is not recommended for every woman. Fezolinetant, a neurokinin 3 antagonist and non-hormonal treatment for severe to moderate VMS, functions by inhibiting neuronal impulses originating from the hypothalamic thermoregulatory center. Current Skylight 2 and 4 trials statistically demonstrate the safety and acceptability of fezolinetant, with relatively few adverse effects reported. Fezolinetant has been shown great potential for treating menopausal-related VMS, supporting its further advancement. However, further investigation is required to thoroughly evaluate its safety, effectiveness, and its impact on sleep patterns.

摘要

处于绝经期的女性常经历血管舒缩症状,如热潮红、盗汗和睡眠障碍,显著影响其生活质量。激素治疗已被证明对 VMS 有益。但是,由于特定的限制,并非推荐给每位女性。非激素药物费佐利奈坦是一种神经激肽 3 拮抗剂,用于治疗严重至中度 VMS,通过抑制源自下丘脑体温调节中枢的神经元冲动起作用。目前的 Skylight 2 和 4 试验在统计学上证明了费佐利奈坦的安全性和可接受性,报告的不良反应相对较少。费佐利奈坦在治疗与绝经相关的 VMS 方面显示出巨大的潜力,支持其进一步发展。但是,需要进一步研究来全面评估其安全性、有效性及其对睡眠模式的影响。

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