Dando Toni M, Perry Caroline M
Adis International Inc., Yardley, Pennsylvania, USA.
Treat Endocrinol. 2004;3(5):319-24. doi: 10.2165/00024677-200403050-00005.
Hormone replacement therapy with continuous 17 beta-estradiol/levonorgestrel (estradiol/levonorgestrel), administered once weekly as a transdermal system, has shown efficacy in the treatment of vasomotor symptoms associated with menopause. Transdermal estradiol/levonorgestrel (4.4/2.74 and 4.5/3.75mg) significantly reduced the mean weekly (primary endpoint) and daily number of hot flashes (flushes) compared with placebo in a 12-week, randomized, double-blind trial in postmenopausal women (both of the dosages used are higher than the approved dosage). The same endpoints were also numerically reduced from baseline by estradiol/levonorgestrel (4.4/1.39 [approved dosage], 4.4/2.74, and 4.5/3.75mg), as well as 17 beta-estradiol (estradiol) in a substudy of a 12-month randomized trial in postmenopausal women; however, there were no significant between-group differences. Estradiol/levonorgestrel also reduced the mean daily maximal severity of hot flashes. In the 12-week study, mean daily hot flash severity improved from severe to mild for estradiol/levonorgestrel recipients, but remained moderately severe for placebo recipients. None of the recipients of estradiol/levonorgestrel 4.4/1.39mg and 12.8% of women treated with estradiol developed endometrial hyperplasia (primary endpoint) in a large, 12-month, randomized, double-blind trial in postmenopausal women. Over 12 months, estradiol/levonorgestrel and estradiol significantly improved mean quality-of-life total scores (women's health questionnaire) from baseline; there were no significant between-group differences. The estradiol/levonorgestrel transdermal system was generally well tolerated. In two trials, application-site reactions were common in all treatment groups (estradiol/levonorgestrel, estradiol, and placebo).
采用连续17β-雌二醇/左炔诺孕酮（雌二醇/左炔诺孕酮）进行激素替代疗法，通过经皮系统每周给药一次，已显示出对治疗与绝经相关的血管舒缩症状有效。在一项针对绝经后女性的12周随机双盲试验中，与安慰剂相比，经皮雌二醇/左炔诺孕酮（4.4/2.74和4.5/3.75毫克）显著降低了每周平均（主要终点）潮热（潮红）次数和每日潮热次数（两种使用剂量均高于批准剂量）。在一项针对绝经后女性的12个月随机试验的子研究中，雌二醇/左炔诺孕酮（4.4/1.39[批准剂量]、4.4/2.74和4.5/3.75毫克）以及17β-雌二醇（雌二醇）也使相同终点指标较基线数值有所降低；然而，组间差异不显著。雌二醇/左炔诺孕酮还降低了潮热的每日平均最大严重程度。在12周研究中，接受雌二醇/左炔诺孕酮治疗者的潮热严重程度从重度改善为轻度，而安慰剂组仍为中度严重。在一项针对绝经后女性的大型12个月随机双盲试验中，接受4.4/1.39毫克雌二醇/左炔诺孕酮治疗者和12.8%接受雌二醇治疗的女性均未发生子宫内膜增生（主要终点）。在12个月期间，雌二醇/左炔诺孕酮和雌二醇均使平均生活质量总分（女性健康问卷）较基线显著改善；组间差异不显著。经皮雌二醇/左炔诺孕酮系统总体耐受性良好。在两项试验中，所有治疗组（雌二醇/左炔诺孕酮、雌二醇和安慰剂）均常见应用部位反应。
