目的:血管舒缩症状(VMS)是绝经期间最常见的症状,包括潮热和盗汗。它们对生活质量具有很大的破坏性。Fezolinetant是FDA批准的用于治疗VMS的非激素选择性神经激肽3受体拮抗剂。在这项研究中,我们的目的是评估非唑林坦治疗绝经相关VMS的疗效和安全性.
方法:在2023年9月之前检索数据库,以比较非唑林剂与安慰剂的相关研究。将数据提取成在线形式并使用RevMan(版本5.4.1)进行分析。采用GRADE方法评估有关疗效结果的证据质量。我们纳入了在经历VMS的绝经后妇女中比较非唑林坦与安慰剂的随机对照试验(RCT)。排除标准包括研究,涉及有非唑尼坦禁忌症的参与者或评估其对绝经相关的VMS以外的适应症的疗效的参与者。
结果:这项研究包括6项研究,涉及3301名患者。与安慰剂相比,fezolinetant在第4周和第12周分别降低了VMS发作频率(SMD=-0.64,95%CI[-0.77,-0.5])和(SMD=-0.63,95%CI[-0.72,-0.53]。此外,Fezolinetant分别在第4周和第12周降低了VMS严重程度评分(SMD=-0.59,95CI[-0.77,-0.42])和(SMD=-0.4,95%CI[-0.54,-0.27])。这些降低积极反映在更年期特定生活质量评分上(SMD=-0.46,95CI[-57,-0.34]),(SMD=-0.37,95CI[-0.48,-0.25])分别在第4周和第12周。关于安全分析,fezolinetant显示药物相关TEAE的风险增加(RR=1.47,95CI[1.06,2.04]),严重的TEAE(RR=1.67,95CI[1.09,2.55]),疲劳(RR=4.05,95CI[1.27,12.88]),关节痛(RR=2.83,95CI[1.02,7.8])和ALT或AST>3次(RR=2,95CI[1.12,3.57]),其他安全术语无统计学差异。
结论:Fezolinetant在降低绝经后妇女VMS的频率和严重程度方面已证明有效,改善他们的生活质量。这些发现表明Fezolinetant可以作为管理VMS的激素疗法的可行替代方案。
OBJECTIVE: Vasomotor symptoms (VMS) are the most common symptoms during menopause including hot flushes and night sweats. They are highly disruptive to the quality of life. Fezolinetant is an FDA-approved non-hormonal selective neurokinin3 receptor antagonist for the treatment of VMS. In this study, we aim to assess the efficacy and safety of fezolinetant for VMS associated with menopause.
METHODS: Databases were searched until September 2023 for relevant studies comparing fezolinetant against placebo. Data was extracted into an online form and analyzed using RevMan (Version 5.4.1). The GRADE approach was conducted to evaluate the quality of evidence regarding efficacy outcomes. We included randomized controlled trials (RCTs) comparing fezolinetant to placebo in postmenopausal women experiencing VMS. Exclusion criteria comprised studies involving participants with contraindications to fezolinetant or those evaluating its efficacy for indications other than VMS associated with menopause.
RESULTS: Six studies were included in this study involving 3301 patients. Compared to placebo, fezolinetant reduced the frequency of VMS episodes from baseline (SMD = -0.64, 95 % CI [-0.77, -0.5]) and (SMD = -0.63, 95 % CI [-0.72, -0.53] at weeks 4 and 12 respectively. Additionally, fezolinetant reduced VMS severity score (SMD = -0.59, 95 %CI [-0.77, -0.42]) and (SMD = -0.4, 95 % CI [-0.54, -0.27]) at weeks 4 at 12 respectively. These reductions were positively reflected on Menopause specific quality of life score (SMD = -0.46, 95 %CI [-57, -0.34]), (SMD = -0.37, 95 %CI [-0.48, -0.25]) at weeks 4 and 12 respectively. Regarding safety analysis, fezolinetant showed increased risk for drug-related TEAEs (RR = 1.47, 95 %CI [1.06,2.04]), serious TEAEs (RR = 1.67, 95 %CI [1.09,2.55]), fatigue (RR = 4.05, 95 %CI [1.27,12.88]), arthralgia (RR = 2.83, 95 %CI [1.02,7.8]) and ALT or AST > 3 times (RR = 2, 95 %CI [1.12,3.57]), with no other statistically significant difference regarding other safety terms.
CONCLUSIONS: Fezolinetant has demonstrated efficacy in reducing the frequency and severity of VMS in postmenopausal women, leading to an improvement in their quality of life. These findings suggest that Fezolinetant may serve as a viable alternative to hormonal therapy for managing VMS.