Lima Sonia M Rolim Rosa, Yamada Silvia Saito, Reis Benedito Fabiano, Postigo Sostenes, Galvão da Silva Maria Antonieta L, Aoki Tsutomu
Department of Gynecology and Obstetrics, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil.
Department of Gynecology and Obstetrics, Santa Casa of Sao Paulo Medical School, Sao Paulo, Brazil; Department of Gynecology and Obstetrics, Vale do Sapucaí University, Pouso Alegre, Minas Gerais, Brazil.
Maturitas. 2013 Mar;74(3):252-8. doi: 10.1016/j.maturitas.2012.11.012. Epub 2013 Jan 9.
To assess efficacy and tolerability of a isoflavone (Glycine max L. Merr.) vaginal gel to the treatment of vaginal atrophy in postmenopausal women.
The double-blind, randomized, placebo-controlled, clinical trial. Ninety women were treated for 12 weeks with isoflavone vaginal gel 4% (1g/day) and a placebo gel and conjugated equine estrogen cream (0.3mg/day). After 4 and 12 weeks, the vaginal atrophy symptoms were classified at none, mild, moderate and severe and the vaginal cytology were taken to determine the maturation value. The endometrial safety (by transvaginal ultrasonography) was evaluated through at screening and the end of the trial.
Isoflavone vaginal gel appears to be effective for relief of vaginal dryness and dyspareunia symptoms and an increase in the intermediate and superficial cells was noted. These results were similar to the effects with use of conjugated equine estrogens and superior to placebo gel. No changes in endometrial thickness, sera FSH and estradiol levels were observed at study endpoint.
Glycine max (L.) Merr. at 4% vaginal gel on a daily basis in postmenopausal women led to improvements in vaginal atrophy symptoms and a significant increase in cell maturation values. Isoflavones proved good treatment options for relief of vulvovaginal symptoms especially in women who do not wish to use hormonal therapy or have contra-indications for this treatment.
评估一种异黄酮（大豆）阴道凝胶治疗绝经后妇女阴道萎缩的疗效和耐受性。
双盲、随机、安慰剂对照临床试验。90名女性分别接受4%异黄酮阴道凝胶（1克/天）、安慰剂凝胶和结合马雌激素乳膏（0.3毫克/天）治疗12周。在4周和12周后，将阴道萎缩症状分为无、轻度、中度和重度，并进行阴道细胞学检查以确定成熟值。通过经阴道超声在筛查时和试验结束时评估子宫内膜安全性。
异黄酮阴道凝胶似乎对缓解阴道干燥和性交困难症状有效，且观察到中层和表层细胞增加。这些结果与使用结合马雌激素的效果相似，且优于安慰剂凝胶。在研究终点未观察到子宫内膜厚度、血清促卵泡生成素和雌二醇水平的变化。
绝经后妇女每天使用4%大豆阴道凝胶可改善阴道萎缩症状，并显著提高细胞成熟值。异黄酮被证明是缓解外阴阴道症状的良好治疗选择，尤其是对于那些不希望使用激素疗法或有该治疗禁忌症的女性。
