Soy Isoflavones for Reducing Bone Loss Study: effects of a 3-year trial on hormones, adverse events, and endometrial thickness in postmenopausal women.
Soy Isoflavones for Reducing Bone Loss Study: effects of a 3-year trial on hormones, adverse events, and endometrial thickness in postmenopausal women.
复制标题
DOI：
10.1097/gme.0000000000000280
复制
发表时间：
2015-02
期刊：
影响因子：
--
通讯作者：
Kurzer MS
中科院分区：
文献类型：
--
作者：
Alekel DL;Genschel U;Koehler KJ;Hofmann H;Van Loan MD;Beer BS;Hanson LN;Peterson CT;Kurzer MS
评估绝经后妇女服用大豆异黄酮片（3 年）的整体安全性和潜在的子宫内膜刺激作用。考虑激素浓度和其他假设的调节因素，确定顺从女性的子宫内膜厚度对治疗的反应。我们将健康绝经后女性（45.8-65.0 岁）随机分配到安慰剂对照组或在两个部位接受两剂（80 或 120 毫克/天）大豆异黄酮组。我们使用意向治疗 (N=224) 和依从性 (>95%；N=208) 分析来评估循环激素浓度、不良事件和子宫内膜厚度（通过经阴道超声）。子宫内膜厚度中位值 (mm) 从基线下降到 36 个月。组间治疗差异的非参数方差分析显示，任何时间点的绝对子宫内膜厚度（或百分比变化）均无差异（卡方 p 值范围为 0.12-0.69），任何时间点的循环激素也无差异。与 120 毫克/天组相比，80 毫克/天组的泌尿生殖系统不良事件数量较多 (p=0.005)，而其他系统则没有显示治疗效果。该模型预测顺从女性在不同时间点的子宫内膜厚度对治疗的反应（使用自然对数）是显着的（p<0.0001），表明雌激素暴露（p=0.0013）、血浆17β-雌二醇（p=0.0086）和酒精摄入（p=0.023）对反应有显着贡献。 80 (p=0.57) 和 120 (p=0.43) mg/天的剂量均不会随时间推移对子宫内膜厚度产生影响。我们的随机对照试验验证了绝经后女性服用大豆异黄酮片的长期整体安全性，她们表现出良好的依从性。我们没有发现三年期间治疗对子宫内膜厚度、不良事件或循环激素浓度（尤其是甲状腺功能）有影响的证据。
To assess the overall safety and potential endometrial stimulation of soy isoflavone tablets consumed (3-year) by postmenopausal women. To determine the endometrial thickness response-to-treatment among compliant women, taking into account hormone concentrations and other hypothesized modifying factors. We randomized healthy postmenopausal women (45.8–65.0 years) to placebo control or two doses (80 or 120 mg/day) of soy isoflavones at two sites. We used intent-to-treat (N=224) and compliant (>95%; N=208) analyses to assess circulating hormone concentrations, adverse events, and endometrial thickness (via transvaginal ultrasound). Median values for endometrial thickness (mm) declined from baseline through 36 mo. Nonparametric ANOVA for treatment differences among groups showed no differences in absolute (or percentage change) endometrial thickness at any time point (Chi-Square p-values ranged from 0.12–0.69), nor in circulating hormones at any time point. A greater number of adverse events for the genitourinary system (p=0.005) was noted in the 80 compared to 120 mg/day group, whereas other systems showed no treatment effects. The model predicting the endometrial thickness response-(using natural logarithm)-to-treatment with compliant women across time points was significant (p<0.0001), indicating that estrogen exposure (p=0.0013), plasma 17 β-estradiol (p=0.0086), and alcohol intake (p=0.023) contributed significantly to the response. Neither the 80 (p=0.57) nor 120 (p=0.43) mg/day dose exerted an effect on endometrial thickness across time. Our RCT verified the long-term overall safety of consuming soy isoflavone tablets by postmenopausal women who displayed excellent compliance. We found no evidence of a treatment effect on endometrial thickness, adverse events, or circulating hormone concentrations, most notably thyroid function, during a three year period.