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雌二醇透皮贴剂与倍美力改善绝经后症状的双盲对照研究。

A double-blind comparative study of Estraderm and Premarin in the amelioration of postmenopausal symptoms.

作者信息

Place V A, Powers M, Darley P E, Schenkel L, Good W R

出版信息

Am J Obstet Gynecol. 1985 Aug 15;152(8):1092-9. doi: 10.1016/0002-9378(85)90568-x.

Abstract

Patients whose postmenopausal symptoms were being satisfactorily controlled with conjugated equine estrogens, either 0.625 mg/day (n = 57) or 1.25 mg/day (n = 67), participated in a study that compared the efficacy of these oral regimens with that of 17 beta-estradiol, 0.1 mg/day, administered through intact skin. The study was a multicenter, double-blind, randomized, parallel-group trial during which two thirds of the patients who received each dosage of conjugated equine estrogens were changed to an estradiol transdermal system while the remainder continued with conjugated equine estrogens. A total of 124 patients was included in the analysis of efficacy. The analysis revealed no significant differences between the estradiol transdermal system and conjugated equine estrogens in control of hot flushes or other postmenopausal symptoms and no statistically significant differences between treatment groups in regard to estrogen-related side effects. Minor topical reactions to the transdermal systems were reported during only about 20% of study weeks. Thus, transdermal estradiol, 0.1 mg/day, appears to be equally effective as conjugated equine estrogens, 0.625 or 1.25 mg/day, for controlling postmenopausal symptoms and is well tolerated.

摘要

绝经后症状通过每天服用0.625毫克(n = 57)或1.25毫克(n = 67)的结合马雌激素得到满意控制的患者参与了一项研究,该研究比较了这些口服方案与通过完整皮肤给予的每天0.1毫克17β-雌二醇的疗效。该研究是一项多中心、双盲、随机、平行组试验,在此期间,接受每种剂量结合马雌激素的患者中有三分之二改为使用雌二醇透皮系统,其余患者继续使用结合马雌激素。共有124名患者纳入疗效分析。分析显示,在控制潮热或其他绝经后症状方面,雌二醇透皮系统与结合马雌激素之间无显著差异,在雌激素相关副作用方面,治疗组之间也无统计学显著差异。仅在约20%的研究周内报告了对透皮系统的轻微局部反应。因此,每天0.1毫克的透皮雌二醇在控制绝经后症状方面似乎与每天0.625毫克或1.25毫克的结合马雌激素同样有效,并且耐受性良好。

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