一项多中心、随机、开放、对照试验，旨在评估红丽来阴道乳膏和倍美力阴道乳膏对中国绝经后女性不同亚组绝经泌尿生殖综合征的疗效。

A multicenter, randomized, open, controlled trial to evaluate the efficacy of Honglilai Vaginal Cream and Premarin Vaginal Cream for Genitourinary Syndrome of Menopause in different subgroups of Chinese postmenopausal women.

作者信息

Yang Mukun, Lin Shouqing, Zheng Shurong, Sun Aijun, Bian Meilu, Li Shilan, Liu Jianli, Hu Lina, Hui Ning, Zhong Jing, Hou Hongchun, Yue Tianfu, Gao Xiaoli, Bai Wenpei

机构信息

Beijing Shijitan Hospital, Capital Medical University, Beijing, China.

Peking Union Medical College Hospital, Beijing, China.

出版信息

Gynecol Endocrinol. 2022 Oct;38(10):861-867. doi: 10.1080/09513590.2022.2118710. Epub 2022 Sep 6.

DOI:10.1080/09513590.2022.2118710

PMID:36067791

Abstract

AIM

In a randomized, multicenter, open, controlled trial, we compared the effects of Honglilai Vaginal Cream and Premarin Vaginal Cream in different age subgroups and menopausal year subgroups (trial registration numbers: 02003L00493).

METHODS

Postmenopausal women with Genitourinary Syndrome of Menopause (GSM) were divided into Honglilai group ( = 319) and Premarin group ( = 116), while subgroups were divided according to their different characteristics of age and menopausal years. Honglilai Vaginal Cream (0.625 mg/g) or Premarin Vaginal Cream (0.625 mg/g) once daily for 3 weeks.

RESULTS

In the subgroup of participates >60 years, there were no significant differences of Vaginal Cell Maturation Index (VMI) between the two groups after treatment ( = .171). In the subgroup of 50-59 years, the VMI of Honglilai group was significantly lower than Premarin group (Honglilai group: 74.37 ± 22.76; Premarin group: 80.06 ± 16.15; = .02). There were no significant differences of Vaginal symptom scores between Honglilai group and Premarin group in every sub-group ( > .05).

CONCLUSIONS

Honglilai Vaginal Cream had comparable efficacy with Premarin Vaginal Cream in Chinese women older than 60 years.

摘要

目的

在一项随机、多中心、开放、对照试验中，我们比较了红丽来阴道乳膏和倍美力阴道乳膏在不同年龄亚组和绝经年限亚组中的效果（试验注册号：02003L00493）。

方法

将患有绝经后泌尿生殖综合征（GSM）的绝经后女性分为红丽来组（n = 319）和倍美力组（n = 116），同时根据年龄和绝经年限的不同特征进行亚组划分。红丽来阴道乳膏（0.625mg/g）或倍美力阴道乳膏（0.625mg/g），每日一次，共3周。

结果

在年龄>60岁的参与者亚组中，治疗后两组的阴道细胞成熟指数（VMI）无显著差异（P = 0.171）。在50 - 59岁的亚组中，红丽来组的VMI显著低于倍美力组（红丽来组：74.37±22.76；倍美力组：80.06±16.15；P = 0.02）。各亚组中红丽来组和倍美力组的阴道症状评分无显著差异（P>0.05）。