Ferrari Augusto
Gynecology and Obstetrics Department, San Raffaele Hospital, Milano, Italy.
J Obstet Gynaecol Res. 2009 Dec;35(6):1083-90. doi: 10.1111/j.1447-0756.2009.01058.x.
The aim of the present study was to assess the efficacy and safety of a standardized compound based on an extract of soy phytoestrogens, with high doses of isoflavones in the management of menopausal hot flushes.
A total of 180 women aged 40-65 years with a minimum of five moderate-to-severe hot flushes in the last 7 days at baseline and absence of menstruation for at least 6 months participated in a 12-week prospective, randomized, double-blind, placebo-controlled multicenter trial. After a 2-week run-in period, women received one tablet a day of 80 mg isoflavones (corresponding to 60 mg of genistein) or a matching placebo.
The mean daily number of moderate-to-severe hot flushes decreased in both study groups, but the reduction was greater in the isoflavones arm at 6 (36.2%) and 12 weeks (41.2%) than in the placebo arm (24.0% at 6 weeks, 29.3% at 12 weeks), with a difference of 1.1 (95% CI [-2.0 to -0.06]) (P = 0.038) at 6 weeks and 1.1 (95% CI [-2.05 to -0.15]) (P = 0.023) at 12 weeks. Similar findings were obtained for hot flushes of any intensity. The Kupperman index decreased in both study groups. Relief of hot flushes was greater when time to menopause was >or=12 months and in cases of BMI >or=27 kg/m(2).
In daily practice conditions, high doses of isoflavones, particularly genistein, can be used for the management of hot flushes in postmenopausal women not treated with hormone replacement therapy due to their superior efficacy to placebo and very good safety profile.
本研究旨在评估一种基于大豆植物雌激素提取物且含有高剂量异黄酮的标准化化合物在治疗绝经后潮热方面的疗效和安全性。
共有180名年龄在40 - 65岁之间的女性参与了一项为期12周的前瞻性、随机、双盲、安慰剂对照多中心试验。这些女性在基线时过去7天内至少有5次中度至重度潮热，且停经至少6个月。经过2周的导入期后，女性们每天服用一片80毫克异黄酮（相当于60毫克染料木黄酮）或匹配的安慰剂。
两个研究组中，中度至重度潮热的平均每日发作次数均有所减少，但异黄酮组在6周（减少36.2%）和12周（减少41.2%）时的减少幅度大于安慰剂组（6周时减少24.0%，12周时减少29.3%），6周时差异为1.1（95%可信区间[-2.0至-0.06]）（P = 0.038），12周时差异为1.1（95%可信区间[-2.05至-0.15]）（P = 0.023）。对于任何强度的潮热也有类似发现。两个研究组的库珀曼指数均有所下降。绝经时间≥12个月以及体重指数≥27 kg/m²的情况下，潮热缓解更为明显。
在日常实践中，高剂量异黄酮，尤其是染料木黄酮，因其疗效优于安慰剂且安全性良好，可用于未接受激素替代疗法的绝经后女性潮热的治疗。
