Dupont A, Dupont P, Cusan L, Tremblay M, Rioux J, Cloutier D, Mailloux J, De Lignières B, Gutkowska J, Boucher H
Department of Molecular Endocrinology, CHUL Research Center, Quebec, Canada.
Maturitas. 1991 Oct;13(4):297-311. doi: 10.1016/0378-5122(91)90238-l.
Sixty-three healthy post-menopausal women participated in the study aimed at determining the efficiency of percutaneous administration of estradiol (E2) giving physiological plasma levels of the estrogen to provide an efficient relief of climacteric and urogenital symptoms. Among these women, 31 had previous hysterectomy and were randomly allocated to one of the two estrogen replacement therapies while, similarly, the 32 women having an uterus were randomly divided between two groups who received in addition to estrogens, micronized oral progesterone. As estrogen, women received either E2 by percutaneous administration (Oestrogel) or oral conjugated estrogens (Premarin). With Oestrogel, serum E2 and estrone levels were within those seen during premenopause and showed a ratio close to 1.0. Climacteric symptoms were reduced or eliminated similarly in all groups. No changes was noticed on the concentration of serum angiotensinogen with Oestrogel therapy while a 2.5-fold increase was found in women receiving Premarin. As indicated by the 24-week endometrial biopsy, the progestational response induced by oral progesterone at the dose used was sufficient in twenty out of thirty-two women to cause endometrial atrophy, thus suggesting the need for higher amounts of micronized progesterone in a proportion of women. The present data also indicate that Oestrogel provides efficient relief of climacteric and urogenital symptoms without exerting any detectable effect on hepatic function while maintaining the ratio of serum E2/E1 at the physiological value of 1.0.
63名健康的绝经后女性参与了这项研究,该研究旨在确定经皮给予雌二醇(E2)以达到生理血浆水平的雌激素,从而有效缓解更年期和泌尿生殖系统症状的效果。在这些女性中,31名曾接受过子宫切除术,她们被随机分配至两种雌激素替代疗法之一;同样地,32名有子宫的女性被随机分为两组,除雌激素外,这两组还接受了微粒化口服孕激素治疗。作为雌激素,女性要么接受经皮给予的E2(欧适可凝胶),要么接受口服结合雌激素(倍美力)。使用欧适可凝胶时,血清E2和雌酮水平处于绝经前水平,且二者比例接近1.0。所有组的更年期症状均有类似程度的减轻或消除。使用欧适可凝胶治疗时,血清血管紧张素原浓度未发生变化,而接受倍美力治疗的女性血清血管紧张素原浓度升高了2.5倍。24周的子宫内膜活检结果表明,在所使用的剂量下,口服孕激素在32名女性中的20名中诱导的孕激素反应足以导致子宫内膜萎缩,因此提示部分女性需要更高剂量的微粒化孕激素。目前的数据还表明,欧适可凝胶可有效缓解更年期和泌尿生殖系统症状,在将血清E2/E1比值维持在生理值1.0的同时,对肝功能未产生任何可检测到的影响。