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CRETA 研究中采用 Cervantes 量表评估外阴阴道萎缩疗法对绝经后妇女生活质量的影响。

Impact of vulvovaginal atrophy therapies on postmenopausal women's quality of life in the CRETA study measured by the Cervantes scale.

机构信息

Department of Obstetrics and Gynecology, Palacios Institute of Women's Health, Madrid, Spain.

Department of Obstetrics and Gynecology, Teknon Clinic, Barcelona, Spain.

出版信息

Maturitas. 2023 Jun;172:46-51. doi: 10.1016/j.maturitas.2023.03.007. Epub 2023 Mar 30.

Abstract

OBJECTIVE

To assess the correlation of different vulvovaginal atrophy therapeutic options with the quality of life of postmenopausal women.

STUDY DESIGN

The CRETA study is a descriptive, observational, cross-sectional, multicenter study designed to measure, besides treatment satisfaction and adherence, the quality of life of postmenopausal women diagnosed with vulvovaginal atrophy in 29 hospitals and centers across Spain.

MAIN OUTCOME MEASURES

The study enrolled postmenopausal women currently receiving treatment with vaginal moisturizers, local estrogen therapy or ospemifene. Clinical features and treatment perceptions were collected by self-report questionnaire and quality of life was evaluated using the Cervantes scale.

RESULTS

Among the 752 women included, the ospemifene cohort showed a statistically significant lower global score (44.9 ± 21.7) on the Cervantes scale (and therefore, a better quality of life) than the cohorts treated with moisturizers (52.5 ± 21.6, p = 0.003) or local estrogen therapy (49.2 ± 23.8, p = 0.0473). In the analysis by domains, ospemifene-treated women showed statistically significant better scores in menopause & health and psychological status than moisturizers-treated women (p < 0.05). In the domains of sexuality and couple relations, the score for the quality of life of the ospemifene cohort was statistically significantly better than the scores in either of the cohorts treated with moisturizers (p < 0.001) or local estrogen therapy (p < 0.05).

CONCLUSIONS

Postmenopausal women diagnosed with vulvovaginal atrophy and treated with ospemifene have better quality of life than women treated with vaginal moisturizers or local estrogen therapy. The improvement observed with ospemifene is more remarkable in those aspects related to sex life and couple relations. CLINCIALTRIALS.

GOV NUMBER

NCT04607707.

摘要

目的

评估不同外阴阴道萎缩治疗选择与绝经后妇女生活质量的相关性。

研究设计

CRETA 研究是一项描述性、观察性、横断面、多中心研究,旨在衡量西班牙 29 家医院和中心诊断为外阴阴道萎缩的绝经后妇女的生活质量,除了治疗满意度和依从性外。

主要观察指标

该研究纳入了目前正在接受阴道保湿剂、局部雌激素治疗或 ospemifene 治疗的绝经后妇女。通过自我报告问卷收集临床特征和治疗认知,使用 Cervantes 量表评估生活质量。

结果

在纳入的 752 名妇女中,ospemifene 组在 Cervantes 量表上的总体评分(44.9±21.7)明显低于使用保湿剂(52.5±21.6,p=0.003)或局部雌激素治疗(49.2±23.8,p=0.0473)的队列,提示 ospemifene 组的生活质量更好。在各领域分析中,ospemifene 治疗组在绝经和健康以及心理状态方面的评分明显优于保湿剂治疗组(p<0.05)。在性生活和夫妻关系方面,ospemifene 组的生活质量评分明显优于使用保湿剂(p<0.001)或局部雌激素治疗(p<0.05)的队列。

结论

诊断为外阴阴道萎缩并接受 ospemifene 治疗的绝经后妇女的生活质量优于接受阴道保湿剂或局部雌激素治疗的妇女。与 ospemifene 相关的改善在与性生活和夫妻关系相关的方面更为显著。临床试验.gov 编号:NCT04607707。

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