Lundström E, Bygdeson M, Svane G, Azavedo E, von Schoultz B
Department of Obstetrics, Karolinska University Hospital, Stockhom, Sweden.
Climacteric. 2007 Jun;10(3):249-56. doi: 10.1080/13697130701385805.
To compare the effects of two different ultra-low doses of continuous combined hormone therapy and placebo on mammographic breast density in postmenopausal women.
A subpopulation of 255 postmenopausal women from the CHOICE trial were randomly assigned to 0.5 mg 17beta-estradiol (E2) + 0.25 mg norethisterone acetate (NETA), 0.5 mg E2 + 0.1 mg NETA, or placebo. Women using hormone replacement therapy (HRT) up to 2 months prior to the study were excluded; 154 women fulfilled the inclusion criteria. Mammograms were performed at baseline and after 6 months. Breast density was evaluated by visual classification scales and a computer-assisted digitized technique.
No significant differences were detected between the active treatment groups and the placebo group in the digitized quantification. The mean baseline values for density around 20% were unchanged after 6 months. Also, visual classifications showed no increase in breast density in any study group.
In contrast to currently available bleed-free regimens, the new ultra-low-dose combination of 0.5 mg E2 and 0.1 mg NETA seems to have very little or even a neutral effect on the breast. Both digitized quantification and visual assessment of breast density were unchanged after 6 months. Larger prospective studies should be performed to confirm this new finding.
比较两种不同超低剂量连续联合激素疗法与安慰剂对绝经后女性乳房X线密度的影响。
从CHOICE试验的绝经后女性亚组中随机选取255名女性，将其分为服用0.5毫克17β-雌二醇（E2）+0.25毫克醋酸炔诺酮（NETA）组、0.5毫克E2+0.1毫克NETA组或安慰剂组。排除在研究前2个月内使用过激素替代疗法（HRT）的女性；154名女性符合纳入标准。在基线期和6个月后进行乳房X线检查。通过视觉分类量表和计算机辅助数字化技术评估乳房密度。
在数字化定量分析中，活性治疗组与安慰剂组之间未检测到显著差异。6个月后，密度的平均基线值约20%未发生变化。此外，视觉分类显示任何研究组的乳房密度均未增加。
与目前可用的无出血方案不同，新的0.5毫克E2和0.1毫克NETA超低剂量组合似乎对乳房影响极小甚至呈中性作用。6个月后，乳房密度的数字化定量分析和视觉评估均未改变。应开展更大规模的前瞻性研究以证实这一新发现。
