0.005%雌三醇阴道凝胶对外阴阴道萎缩症状和体征的早期影响。

Early Effect of 0.005% Estriol Vaginal Gel on Symptoms and Signs of Vulvovaginal Atrophy.

作者信息

Lázaro-Carrasco de la Fuente Jesús, Cuerva González Marcos, González Rodríguez Silvia, Delgado Marín Juan Luis, Cuevas Castillo Carmen, Nieto Magro Concepción

机构信息

Obstetrics and Gynecology Unit, Arpa Medica Clinic, Ramón y Cajal University Hospital and University of Alcalá, Madrid, Spain.

Department of Obstetrics and Gynecology, San Francisco de Asís University Hospital, La Paz University Hospital, and Alfonso X El Sabio University, Madrid, Spain.

出版信息

J Menopausal Med. 2022 Aug;28(2):60-69. doi: 10.6118/jmm.21038.

OBJECTIVES

This study aims to assess the effect of ultralow dose 0.005% estriol vaginal gel in women with genitourinary syndrome of menopause (GSM).

METHODS

In this prospective and multicenter single-arm study, efficacy was assessed by the evaluation of the epithelial maturation value (MV), vaginal pH, symptoms and signs of vulvovaginal atrophy. Tolerability, acceptability, and the effect on intimate relationships were also evaluated.

RESULTS

We included 35 postmenopausal women with moderate-to-severe vaginal dryness. The most bothering symptom reported was vaginal dryness. The mean increase in the MV after 7 and 14 days of treatment were 22.1 ( < 0.001) and 39.9 ( < 0.001) points, with an increase in the superficial cells of 17.7 percentage points (pp) (95% confidence interval [CI], 7.9-27.4; < 0.001) and 41.4 pp (95% CI, 28.2-54.6; < 0.001) observed at the timepoints. Additionally, the pH decreased by 0.6 ± 0.7 (mean ± SD) at 7 days ( < 0.0001) and by 1.1± 0.8 at 14 days ( < 0.0001) from a baseline mean value of 6.3 ± 0.8. The severity of vaginal dryness (range, 0 [none] to 3 [severe]) was significantly reduced by a mean of 1.4 points ( < 0.0001) at 7 days and 2 points ( < 0.0001) at 14 days.

CONCLUSIONS

Ultralow dose 0.005% estriol vaginal gel produced a rapid improvement of most relevant symptoms and signs of GSM. This clinically meaningful response was observed from the initial days of treatment, confirming a fast onset and a progressive action.

目的

本研究旨在评估超低剂量0.005%雌三醇阴道凝胶对绝经后泌尿生殖综合征（GSM）女性的疗效。

方法

在这项前瞻性多中心单臂研究中，通过评估上皮成熟值（MV）、阴道pH值、外阴阴道萎缩的症状和体征来评估疗效。还评估了耐受性、可接受性以及对亲密关系的影响。

结果

我们纳入了35名有中度至重度阴道干燥的绝经后女性。报告的最困扰症状是阴道干燥。治疗7天和14天后MV的平均增加分别为22.1（<0.001）和39.9（<0.001）分，在这些时间点观察到表层细胞增加了17.7个百分点（pp）（95%置信区间[CI]，7.9 - 27.4；<0.001）和41.4 pp（95% CI，28.2 - 54.6；<0.001）。此外，pH值从基线平均值6.3±0.8在7天时下降了0.6±0.7（平均值±标准差）（<0.0001），在14天时下降了1.1±0.8（<0.0001）。阴道干燥的严重程度（范围为0[无]至3[严重]）在7天时平均显著降低了1.4分（<0.0001），在14天时降低了2分（<0.0001）。