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 (n = 319) and Premarin group (n = 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 (p = .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; p = .02). There were no significant differences of Vaginal symptom scores between Honglilai group and Premarin group in every sub-group (p > .05).
Conclusions
Honglilai Vaginal Cream had comparable efficacy with Premarin Vaginal Cream in Chinese women older than 60 years.
摘要
目的
采用随机、多中心、开放、对照的方法, 比较不同年龄亚组和绝经年限亚组(试验注册号:02003100493)应用红丽来和倍美力阴道乳膏的疗效。
方法
将绝经后女性生殖道综合征(GSM)患者分为红丽来组(319例)和倍美力组(116例), 并根据年龄和绝经年限分为不同亚组。红丽来阴道乳膏(0.625 mg/g)或倍美力阴道乳膏(0.625 mg/g)每日1次, 疗程3周。
结果
在年龄>60岁的受试者中, 两组治疗后阴道细胞成熟指数(VMI)差异无统计学意义(P=.171)。在50∼59岁亚组中, 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)。在各个亚组中, 红丽来组与倍美力组的阴道症状评分差异无统计学意义(p>0.05)。
结论
红丽来阴道乳膏与倍美力阴道乳膏对中国60岁以上女性的疗效相当。
Acknowledgments
Thanks to professor Shouqing Lin for her contributions as the leader of this multi-center study.
Disclosure statement
No potential conflict of interest was reported by the authors.