Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
Obstet Gynecol. 2024 Mar 1;143(3):393-402. doi: 10.1097/AOG.0000000000005508. Epub 2024 Jan 16.
To evaluate the efficacy and adverse events of fezolinetant for treating vasomotor symptoms (VMS) of menopause.
PubMed/MEDLINE, ClinicalTrials.gov , EMBASE, Cochrane Database, Scopus, and WHO International Clinical Trials Registry Platform were searched through June 2023 for publications and randomized controlled trials on fezolinetant compared with placebo in menopausal women who experienced moderate-to-severe VMS.
Our literature search identified 330 articles, of which five studies with six reports were included in our meta-analysis per our eligibility criteria.
TABULATION, INTEGRATION, AND RESULTS: The risk of bias was evaluated using Cochrane's RoB 2 (Risk of Bias version 2) tool, quality of evidence was graded using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach, and outcome measures data for effect size were pooled in random-effects model and rated. A total of 2,168 participants from five randomized clinical trials (six reports) were included. Fezolinetant significantly lowered VMS frequency, with pooled mean difference of 2.62 (95% CI, 1.84-3.41). The pooled mean difference for fezolinetant compared with placebo for the MENQOL (Menopause-Specific Quality of Life) measure was -0.60 (95% CI, -0.92 to -0.28), and the mean percentage improvement in VMS frequency was 22.51% (95% CI, 15.35-29.67). Fezolinetant was associated with improvement in sleep quality when compared with placebo.
Fezolinetant is effective in lowering moderate-to-severe VMS frequency and sleep disturbances in postmenopausal women.
PROSPERO, CRD42023427616.
评估 fezolinetant 治疗绝经后女性血管舒缩症状（VMS）的疗效和不良反应。
通过 2023 年 6 月在 PubMed/MEDLINE、ClinicalTrials.gov、EMBASE、Cochrane 数据库、Scopus 和世界卫生组织国际临床试验注册平台上搜索，查找 fezolinetant 与安慰剂治疗有中重度 VMS 的绝经后女性的出版物和随机对照试验。
我们的文献检索共识别出 330 篇文章，根据纳入标准，其中 5 项研究的 6 份报告纳入了我们的荟萃分析。
列表、综合和结果：使用 Cochrane 的 RoB 2（风险偏倚版本 2）工具评估偏倚风险，使用 GRADE（推荐评估、制定和评估分级）方法对证据质量进行分级，并使用随机效应模型和评级汇总效应量的结局测量数据。共有来自 5 项随机临床试验（6 份报告）的 2168 名参与者被纳入。Fezolinetant 显著降低 VMS 频率，汇总平均差异为 2.62（95%CI，1.84-3.41）。与安慰剂相比，Fezolinetant 在 MENQOL（绝经特异性生活质量）测量方面的汇总平均差异为-0.60（95%CI，-0.92 至-0.28），VMS 频率的平均改善百分比为 22.51%（95%CI，15.35-29.67）。与安慰剂相比，Fezolinetant 可改善睡眠质量。
Fezolinetant 可有效降低绝经后女性中重度 VMS 频率和睡眠障碍。
PROSPERO，CRD42023427616。
