Department of Obstetrics, Gynecology and Reproductive Sciences, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
Climacteric. 2010 Apr;13(2):132-40. doi: 10.3109/13697130903305627.
To evaluate the effects of the tissue selective estrogen complex (TSEC) pairing bazedoxifene (BZA) with conjugated estrogens (CE) on sexual function and quality of life in postmenopausal women.
In this 12-week, double-blind, placebo-controlled study, postmenopausal, non-hysterectomized women (n = 652) with symptoms of moderate to severe vulvar/vaginal atrophy were randomized to once-daily treatment with BZA 20 mg/CE 0.45 or 0.625 mg, BZA 20 mg, or placebo. The Arizona Sexual Experiences (ASEX) Scale, Menopause-Specific Quality of Life (MENQOL) questionnaire, and Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) were secondary measures used to assess the effects of BZA/CE on sexual function, menopausal symptoms, and satisfaction with treatment, respectively.
At week 12, both BZA/CE doses were associated with significant improvement in ease of lubrication score from baseline compared with placebo (p < 0.05) on the ASEX scale, although there was no difference in the change in total score. The MENQOL questionnaire results at week 12 showed significant improvements in vasomotor function, sexual function and total scores with both BZA/CE doses vs. placebo or BZA 20 mg (p < 0.001). The MS-TSQ results showed that BZA/CE-treated subjects reported significantly greater overall satisfaction with treatment, as well as satisfaction with control of hot flushes during the day and night, effect on quality of sleep, and effect on mood or emotions, compared with subjects treated with placebo or BZA 20 mg (all p < 0.05).
Treatment with BZA/CE for 12 weeks was shown to significantly improve sexual function and quality-of-life measures in symptomatic postmenopausal women.
评估组织选择性雌激素复合物（TSEC）联合巴多昔芬（BZA）与结合雌激素（CE）对绝经后妇女性功能和生活质量的影响。
在这项为期 12 周、双盲、安慰剂对照的研究中，有中度至重度外阴/阴道萎缩症状的绝经后、非子宫切除妇女（n=652）随机接受每日一次 BZA 20mg/CE 0.45 或 0.625mg、BZA 20mg 或安慰剂治疗。亚利桑那州性体验量表（ASEX）、绝经特异性生活质量量表（MENQOL）和绝经症状治疗满意度问卷（MS-TSQ）是评估 BZA/CE 对性功能、绝经症状和治疗满意度影响的次要测量指标。
在第 12 周，与安慰剂相比，两种 BZA/CE 剂量均与 ASEX 量表上润滑容易度评分从基线的显著改善相关（p<0.05），尽管总分的变化没有差异。第 12 周的 MENQOL 问卷结果显示，与安慰剂或 BZA 20mg 相比，两种 BZA/CE 剂量均显著改善了血管舒缩功能、性功能和总分（p<0.001）。MS-TSQ 结果表明，与安慰剂或 BZA 20mg 治疗的受试者相比，BZA/CE 治疗的受试者对治疗的总体满意度以及对白天和夜间潮热的控制、对睡眠质量的影响和对情绪或情绪的影响显著更高（均 p<0.05）。
BZA/CE 治疗 12 周可显著改善有症状绝经后妇女的性功能和生活质量指标。
