University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, NatalRN, Brazil, University Potiguar, Post-graduation Program in Biotechnology, Laboratory of Nanotechnology, Natal/RN, Brazil.
Federal University of Ceará, Department of Analytical Chemistry, Group of Advanced Biomaterial in Chemistry (GQMAT), FortalezaCE, Brazil, Federal University of Ceará, Department of Analytical Chemistry, Group of Advanced Biomaterial in Chemistry (GQMAT), Fortaleza/CE, Brazil.
Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.
To determine the safety and efficacy of a transdermal nanostructured formulation of progesterone (10%) combined with estriol (0.1%) + estradiol (0.25%) for relieving postmenopausal symptoms.
A total of 66 postmenopausal Brazilian women with climacteric symptoms of natural menopause received transdermal nanostructured formulations of progesterone and estrogens in the forearm daily for 60 months to mimic the normal ovarian secretory pattern. Confocal Raman spectroscopy of hormones in skin layers was performed. Clinical parameters, serum concentrations of estradiol and follicle-stimulating hormone, blood pressure, BI-RADS classification from bilateral mammography, and symptomatic relief were compared between baseline and 60 months post-treatment. Clinicaltrials.gov: NCT02033512.
An improvement in climacteric symptoms was reported in 92.5% of women evaluated before and after 60 months of treatment. The serum concentrations of estradiol and follicle-stimulating hormone changed significantly (p<0.05) after treatment; the values of serum follicle-stimulating hormone decreased after 60 months from 82.04±4.9 to 57.12±4.1 IU/mL. A bilateral mammography assessment of the breasts revealed normal results in all women. No adverse health-related events were attributed to this hormone replacement therapy protocol.
The nanostructured formulation is safe and effective in re-establishing optimal serum levels of estradiol and follicle-stimulating hormone and relieving the symptoms of menopause. This transdermal hormone replacement therapy may alleviate climacteric symptoms in postmenopausal women.
确定经皮纳米结构孕酮（10%）与雌三醇（0.1%）+雌二醇（0.25%）联合治疗缓解绝经后症状的安全性和有效性。
66 名有自然绝经后绝经期症状的巴西绝经后妇女，在前臂每天接受经皮纳米结构孕酮和雌激素治疗 60 个月，以模拟正常卵巢分泌模式。对激素在皮肤层中的共焦拉曼光谱进行了分析。比较了治疗前和治疗后 60 个月时的临床参数、雌二醇和卵泡刺激素的血清浓度、血压、双侧乳房的 BI-RADS 分类以及症状缓解情况。Clinicaltrials.gov：NCT02033512。
在 92.5%接受评估的妇女中，治疗前和治疗后 60 个月的绝经期症状均有改善。治疗后雌二醇和卵泡刺激素的血清浓度明显变化（p<0.05）；治疗 60 个月后，血清卵泡刺激素从 82.04±4.9 降至 57.12±4.1 IU/ml。对所有妇女的双侧乳房进行了乳房 X 线摄影评估，结果均正常。没有任何与健康相关的不良事件归因于这种激素替代疗法方案。
该纳米结构制剂在重新建立雌二醇和卵泡刺激素的最佳血清水平和缓解更年期症状方面是安全有效的。这种经皮激素替代疗法可能会缓解绝经后妇女的更年期症状。
