Farma-Cros Ibérica, SL, C/ Castilla-La Mancha 7, Pol. Ind. Camporrosso, 02520 Chinchilla de Montearagón, Albacete, Spain.
Maturitas. 2012 Aug;72(4):353-8. doi: 10.1016/j.maturitas.2012.05.007. Epub 2012 Jun 9.
Topical estrogen therapy is recommended for the treatment of vaginal atrophy. This study was designed to compare the uterotrophic effects of a new estrogen vaginal formulation (0.005% estriol vaginal gel) and other existing topical treatments (Ovestinon(®) and Colpotrofin(®)).
Each one of the studied formulations was administered intravaginally to groups of ovariectomized rats with cytologically confirmed vaginal atrophy. The doses were adjusted by animal weight according to human dosage. After daily treatment for 14days, the animals were sacrificed and their vaginas and uteri removed. All uteri were weighted. Uteri and vaginas were fixed for histological evaluation.
All three active formulations proved to be very effective in the cytological reversal of vaginal atrophy. However, they differ in their effects in the uteri. Ovestinon(®) and Colpotrofin(®) produced a significant increase in uterine weight, myometrial and endometrial thickness as well as histological modifications in the endometrium suggestive of estrogenic activity. Conversely, animals treated with 0.005% estriol vaginal gel, did not show significant weight increase or any other macroscopical or microcospical modifications of the uteri, an effect comparable to placebo.
There are significant differences in the uterotrophic effect of three different topical estrogen formulations as tested in a rat model of vaginal postmenopausal atrophy. While the three formulations were equally effective in reversing vaginal atrophy, only the newly developed ultra-low dose 0.005% estriol vaginal gel has proved to lack any significant estrogenic effect on the uterus.
局部雌激素治疗被推荐用于治疗阴道萎缩。本研究旨在比较一种新的雌激素阴道制剂（0.005%雌三醇阴道凝胶）和其他现有局部治疗方法（Ovestinon®和 Colpotrofin®）的子宫促生长作用。
用细胞学证实患有阴道萎缩的去卵巢大鼠阴道内给予研究的每种制剂。剂量根据动物体重按人体剂量调整。每日治疗 14 天后，处死动物并取出阴道和子宫。所有子宫称重。子宫和阴道固定用于组织学评估。
所有三种活性制剂均被证明在阴道萎缩的细胞学逆转中非常有效。然而，它们在子宫中的作用不同。Ovestinon®和 Colpotrofin®导致子宫重量、子宫肌层和子宫内膜厚度以及子宫内膜的组织学改变显著增加，提示具有雌激素活性。相反，用 0.005%雌三醇阴道凝胶治疗的动物没有显示出子宫重量的显著增加或任何其他宏观或微观改变，其效果与安慰剂相当。
在阴道绝经后萎缩的大鼠模型中测试了三种不同局部雌激素制剂的子宫促生长作用，存在显著差异。虽然三种制剂在逆转阴道萎缩方面同样有效，但只有新开发的超低剂量 0.005%雌三醇阴道凝胶被证明对子宫没有任何明显的雌激素作用。
