Gupta Pratima, Ozel Begüm, Stanczyk Frank Z, Felix Juan C, Mishell Daniel R
Departments of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Menopause. 2008 Jan-Feb;15(1):94-7. doi: 10.1097/gme.0b013e318148b98b.
To compare serum 17beta-estradiol (E2), estrone (E1), estrone sulfate, follicle-stimulating hormone, luteinizing hormone, sex hormone-binding globulin, vaginal pH, and the vaginal maturation indices in women using a low-dose transdermal patch releasing 14 microg of E2 per day and a vaginal ring releasing 7.5 microg of E2 per day.
Twenty-four postmenopausal women were randomly assigned to either the patch (n = 12) or the ring (n = 12) for a 12-week study period. Serum E2, E1, estrone sulfate, follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin were measured by immunoassay at baseline and 6 and 12 weeks. Vaginal pH was determined at baseline and 6 and 12 weeks. Vaginal cytologic examinations for vaginal maturation index were done at baseline and 12 weeks.
Twenty women completed the study. The patch significantly increased serum E1 and E2 levels at 6 and 12 weeks (P < 0.01); there was no significant increase in serum E1 and E2 levels with the ring. Both the patch and the ring significantly reduced vaginal pH at 6 (P < 0.001) and 12 (P < 0.001) weeks and significantly reduced the percentage of vaginal parabasal cells at 12 weeks with no significant difference between the two groups. Both preparations increased the proportion of superficial cells; the increase was significant only with the patch (P = 0.04).
A transdermal E2 skin patch releasing 14 microg of E2 per day had an effect on vaginal pH and vaginal maturation indices similar to that of a vaginal E2 ring releasing 7.5 microg of E2 per day. Therefore, this patch is likely to relieve symptoms of vulvovaginal atrophy.
比较使用每日释放14微克雌二醇的低剂量透皮贴剂和每日释放7.5微克雌二醇的阴道环的女性的血清17β - 雌二醇(E2)、雌酮(E1)、硫酸雌酮、促卵泡激素、促黄体生成素、性激素结合球蛋白、阴道pH值以及阴道成熟指数。
24名绝经后女性被随机分配至贴剂组(n = 12)或阴道环组(n = 12),进行为期12周的研究。在基线、第6周和第12周时,通过免疫测定法测量血清E2、E1、硫酸雌酮、促卵泡激素、促黄体生成素和性激素结合球蛋白。在基线、第6周和第12周时测定阴道pH值。在基线和第12周时进行阴道细胞学检查以确定阴道成熟指数。
20名女性完成了研究。贴剂在第6周和第12周时显著提高了血清E1和E2水平(P < 0.01);阴道环组血清E1和E2水平无显著升高。贴剂和阴道环在第6周(P < 0.001)和第12周(P < 0.001)时均显著降低了阴道pH值,且在第12周时均显著降低了阴道基底旁细胞百分比,两组之间无显著差异。两种制剂均增加了表层细胞比例;仅贴剂的增加具有显著性(P = 0.04)。
每日释放14微克雌二醇的透皮E2贴剂对阴道pH值和阴道成熟指数的影响与每日释放7.5微克雌二醇的阴道E2环相似。因此,这种贴剂可能缓解外阴阴道萎缩症状。