神经激肽-3 受体拮抗剂治疗更年期血管运动症状的系统综述。

IF 2.8 3区 医学 Q1 OBSTETRICS & GYNECOLOGY
Nicole E Cieri-Hutcherson, Elaine K Marji, Timothy C Hutcherson
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引用次数: 0

摘要

重要性:血管运动症状(VMS)影响着许多绝经后患者的睡眠和生活质量:本系统性综述研究了已获批准和正在开发的神经激肽-3 受体拮抗剂对绝经后血管运动症状患者的安全性和有效性:使用检索词和神经激肽-3 受体拮抗剂、elinzanetant、fezolinetant 和 osanetant 的排列组合对 MEDLINE、EMBASE 和 International Pharmaceutical Abstracts 进行了检索。纳入标准包括:关于非索内坦、艾林扎内坦或奥沙内坦疗效或安全性的报告;女性参与者的研究;英文完整记录;主要文献。仅有摘要的记录被排除在外。对提取的数据进行综合,以便对报告的研究特征、疗效结果和安全事件进行比较。通过用于随机研究的 Cochrane Risk of Bias 2 工具对符合条件的记录进行了偏倚风险评估,并使用了建议分级评估、开发和评价系统。本研究既未获得资助,也未注册:搜索共返回 191 条记录,经重复筛选后有 186 条记录入选。符合纳入标准的有六项随机对照试验(RCT),其中四项报告的是非索内坦,两项报告的是艾林扎内坦。有一条记录是对非唑烷酮随机对照试验的事后分析。另有一项研究是在数据库搜索之外发现的。与安慰剂相比,三项非唑来奈特 RCT 研究表明,在第 4 周和第 12 周,VMS 频率/严重程度降低,更年期特定生活质量评分提高,睡眠质量改善,且未出现严重不良事件。两项关于艾林扎尼坦的研究也显示,VMS 的频率和严重程度有所改善。所有 8 项记录都通过治疗引发的不良事件评估了安全性;最常见的不良事件是 COVID-19、头痛、嗜睡和胃肠道。每份评估记录的偏倚风险都很低。根据建议分级评估、发展和评价系统,证据具有很强的确定性:由于有高质量的证据支持非索内酯和艾林扎内酯的疗效,对于寻求非激素治疗VMS的女性来说,这两种药物可能是一种不良反应轻微的有效选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Systematic review of neurokinin-3 receptor antagonists for the management of vasomotor symptoms of menopause.

Importance: Vasomotor symptoms (VMS) affect many postmenopausal persons and impact sleep and quality of life.

Objective: This systematic review examines the literature describing the safety and efficacy of neurokinin-3 receptor antagonists approved and in development for postmenopausal persons with VMS.

Evidence review: A search of MEDLINE, EMBASE, and International Pharmaceutical Abstracts was conducted using the search terms and permutations of neurokinin-3 receptor antagonist, elinzanetant, fezolinetant, and osanetant. Inclusion criteria of reporting on efficacy or safety of fezolinetant, elinzanetant, or osanetant; studies in participants identifying as female; full record in English; and primary literature were applied. Abstract-only records were excluded. Extracted data were synthesized to allow comparison of reported study characteristics, efficacy outcomes, and safety events. Eligible records were evaluated for risk of bias via the Cochrane Risk of Bias 2 tool for randomized studies and the Grading of Recommendations Assessment, Development and Evaluation system was used. This study was neither funded nor registered.

Findings: The search returned 191 records; 186 were screened after deduplication. Inclusion criteria were met by six randomized controlled trials (RCT), four reported on fezolinetant, and two reported on elinzanetant. One record was a post hoc analysis of a fezolinetant RCT. An additional study was identified outside the database search. Three fezolinetant RCT demonstrated a reduction in VMS frequency/severity, improvement in Menopause-Specific Quality of Life scores, and improvement in sleep quality at weeks 4 and 12 compared with placebo without serious adverse events. The two RCT on elinzanetant also showed improvements in VMS frequency and severity. All eight records evaluated safety through treatment-emergent adverse events; the most common adverse events were COVID-19, headache, somnolence, and gastrointestinal. Each record evaluated had a low risk of bias. There is a strong certainty of evidence as per the Grading of Recommendations Assessment, Development and Evaluation system.

Conclusions and relevance: Because of the high-quality evidence supporting the efficacy of fezolinetant and elinzanetant, these agents may be an effective option with mild adverse events for women seeking nonhormone treatment of VMS.

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来源期刊
CiteScore
5.40
自引率
7.40%
发文量
330
审稿时长
3-8 weeks
期刊介绍: ​Menopause, published monthly, provides a forum for new research, applied basic science, and clinical guidelines on all aspects of menopause. The scope and usefulness of the journal extend beyond gynecology, encompassing many varied biomedical areas, including internal medicine, family practice, medical subspecialties such as cardiology and geriatrics, epidemiology, pathology, sociology, psychology, anthropology, and pharmacology. This forum is essential to help integrate these areas, highlight needs for future research, and enhance health care.
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