USC Keck School of Medicine, Atherosclerosis Research Unit, 2250 Alcazar Street, CSC132, Los Angeles, CA 90033, USA.
Stroke. 2011 Nov;42(11):3168-75. doi: 10.1161/STROKEAHA.111.620831. Epub 2011 Sep 8.
Although epidemiological and experimental studies suggest that dietary intake of soy may be cardioprotective, use of isoflavone soy protein (ISP) supplementation as a primary preventive therapy remains unexplored. We determined whether ISP reduces subclinical atherosclerosis assessed as carotid artery intima-media thickness progression.
In a double-blind, placebo-controlled trial, 350 postmenopausal women 45 to 92 years of age without diabetes and cardiovascular disease were randomized to 2 evenly divided daily doses of 25 g soy protein containing 91 mg aglycon isoflavone equivalents or placebo for 2.7 years.
Overall, mean (95% CI) carotid artery intima-media thickness progression rate was 4.77 (3.39-6.16) μm/year in the ISP group and 5.68 (4.30-7.06) μm/year in the placebo group. Although carotid artery intima-media thickness progression was reduced on average by 16% in the ISP group relative to the placebo group, this treatment effect was not statistically significant (P=0.36). Among the subgroup of women who were randomized within 5 years of menopause, ISP participants had on average a 68% lower carotid artery intima-media thickness progression rate than placebo participants 2.16 (-1.10 to 5.43) versus 6.79 (3.56-10.01) μm/year (P=0.05). ISP supplementation had a null effect on women who were >5 years beyond menopause when randomized. There were no major adverse events from ISP supplementation.
ISP supplementation did not significantly reduce subclinical atherosclerosis progression in postmenopausal women. Subgroup analysis suggests that ISP supplementation may reduce subclinical atherosclerosis in healthy young (median age, 53 years) women at low-risk for cardiovascular disease who were <5 years postmenopausal. These first trial results of their kind warrant further investigation.
尽管流行病学和实验研究表明，食用大豆可能对心脏有保护作用，但使用异黄酮大豆蛋白（ISP）补充剂作为主要预防治疗方法仍未得到探索。我们确定 ISP 是否可以减少作为亚临床动脉粥样硬化评估的颈动脉内膜中层厚度进展。
在一项双盲、安慰剂对照试验中，350 名年龄在 45 至 92 岁之间、无糖尿病和心血管疾病的绝经后妇女被随机分为两组，每天服用 2 次 25 克含有 91 毫克糖苷异黄酮当量的大豆蛋白或安慰剂，为期 2.7 年。
总体而言，ISP 组的颈动脉内膜中层厚度进展率的平均值（95%置信区间）为 4.77（3.39-6.16）μm/年，安慰剂组为 5.68（4.30-7.06）μm/年。尽管与安慰剂组相比，ISP 组的颈动脉内膜中层厚度进展平均减少了 16%，但这种治疗效果在统计学上并不显著（P=0.36）。在绝经后 5 年内随机分组的女性亚组中，与安慰剂组相比，ISP 组的颈动脉内膜中层厚度进展率平均降低了 68%，为 2.16（-1.10 至 5.43）μm/年，而安慰剂组为 6.79（3.56-10.01）μm/年（P=0.05）。当随机分组时，绝经后超过 5 年的女性服用 ISP 补充剂没有效果。服用 ISP 补充剂没有出现重大不良事件。
ISP 补充剂并未显著降低绝经后妇女的亚临床动脉粥样硬化进展。亚组分析表明，在心血管疾病风险低、绝经后<5 年、中位年龄为 53 岁的健康年轻女性中，ISP 补充剂可能会减少亚临床动脉粥样硬化。这些同类试验的首次结果值得进一步研究。
