低剂量雌二醇治疗日本绝经期妇女的更年期症状：一项随机对照试验。

Low-dose estradiol for climacteric symptoms in Japanese women: a randomized, controlled trial.

机构信息

Aiseikai-Yamashina-Hospital, Kyoto, Japan.

出版信息

Climacteric. 2009 Aug;12(4):319-28. doi: 10.1080/13697130802657888.

DOI:10.1080/13697130802657888

PMID:19330598

Abstract

OBJECTIVES

To investigate two different doses of oral estradiol to reduce the number of hot flushes in Japanese women with climacteric symptoms.

METHODS

Women (n = 211) aged 40-64 years who had experienced natural menopause or bilateral oophorectomy, with > or = three moderate/severe hot flushes per day in the week before study, were randomized to receive micronized estradiol (E2) 0.5 or 1.0 mg or placebo once daily for 8 weeks. The primary efficacy endpoint was percentage change in mean daily number of hot flushes over 7 days from baseline to final examination.

RESULTS

Percentage change in mean daily number of hot flushes at final examination was similar for E2 0.5 mg and E2 1.0 mg (-79.58 +/- 28.29% vs. -82.49 +/- 25.31%, p = 0.555) but was significantly lower with placebo (-57.89 +/- 34.15%, p < 0.001 vs. E2, both doses). There was no significant difference in number of treatment-related adverse events occurring in the E2 0.5 and 1.0 mg groups (25% and 36.6%, respectively). The higher E2 dose showed more pronounced effects on symptom severity.

CONCLUSIONS

The dose of 0.5 mg/day was effective as the oral E2 starting dose for treatment of hot flushes in Japanese women.

摘要

目的

研究两种不同剂量的口服雌二醇对减少有更年期症状的日本女性热潮红次数的作用。

方法

年龄在 40-64 岁之间、经历自然绝经或双侧卵巢切除术、在研究前一周内每天有>或=3 次中度/重度热潮红的女性（n=211），随机接受微粒化雌二醇（E2）0.5 或 1.0mg 或安慰剂，每日一次，共 8 周。主要疗效终点为从基线到最终检查的 7 天内平均每日热潮红次数的变化百分比。

结果

最终检查时平均每日热潮红次数的变化百分比，E2 0.5mg 和 E2 1.0mg 组相似（分别为-79.58 +/- 28.29%和-82.49 +/- 25.31%，p=0.555），但安慰剂组明显较低（-57.89 +/- 34.15%，p<0.001 与 E2 两组相比）。E2 0.5 和 1.0mg 组发生的与治疗相关的不良事件数量无显著差异（分别为 25%和 36.6%）。较高的 E2 剂量对症状严重程度有更明显的影响。