A multicenter, prospective, randomized, double-blind, placebo-controlled study to investigate the efficacy of a continuous-combined hormone therapy preparation containing 1mg estradiol valerate/2mg dienogest on hot flushes in postmenopausal women.
A multicenter, prospective, randomized, double-blind, placebo-controlled study to investigate the efficacy of a continuous-combined hormone therapy preparation containing 1mg estradiol valerate/2mg dienogest on hot flushes in postmenopausal women.
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DOI：
10.1016/j.maturitas.2007.08.004
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发表时间：
2007-10
期刊：
影响因子：
4.9
通讯作者：
J. Endrikat;T. Graeser;U. Mellinger;K. Ertan;Cornelia Holz
中科院分区：
文献类型：
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作者：
J. Endrikat;T. Graeser;U. Mellinger;K. Ertan;Cornelia Holz
为了评估雌激素减少，连续联合激素治疗制剂（HT）的影响，含1 mg戊酸雌二醇（1 EV）和2 mg地诺孕素（2DNG）的数量上的中度和重度潮热。METHODS本研究比较了口服连续联合HT的影响，含1 mg EV和2 mg DNG（1 EV/2DNG）与安慰剂。计划的治疗持续时间为12周。数据来自324名绝经后妇女。主要疗效变量为每周中度和重度潮热平均次数的个体相对变化。治疗第5-12周与治疗前2周相比，1 EV/2DNG组中度和重度潮热减少了80.8±30.9%，安慰剂组减少了41.5±39.4%。该差异具有统计学显著性（p<0.0001; Wilcoxon秩和检验）。1 EV/2DNG组所有类型潮热（轻度+中度+重度）的发生率降低75.2±30.2%，安慰剂组降低35.3±37.0%。在非直肠切除女性亚组中，在84天的治疗参考期内，暴露于1 EV/2DNG导致出血2.4±6.2天，而安慰剂组为0.3±1.3天。1 EV/2DNG的安全性特征与安慰剂非常相似。结论：与安慰剂相比，1 mg EV和2 mg DNG连续联合HT制剂可显著减少中度和重度潮热（p<0.0001）。因此，这种低雌激素制剂是治疗HT的有效和安全的选择。
OBJECTIVESTo evaluate the effects of an estrogen-reduced, continuous-combined hormone therapy preparation (HT) containing 1mg estradiol valerate (1EV) and 2mg dienogest (2DNG) on the number of moderate and severe hot flushes.METHODSThis study compared the effects of an oral continuous-combined HT containing 1mg EV and 2mg DNG (1EV/2DNG) with those of placebo. The planned treatment duration was 12 weeks. Data were obtained from 324 postmenopausal women. The primary efficacy variable was the individual relative change of the mean number of moderate and severe hot flushes per week. Weeks 5–12 of treatment were compared with the 2 weeks preceding the treatment phase.RESULTSModerate and severe hot flushes were reduced by 80.8±30.9% in the 1EV/2DNG group and by 41.5±39.4% in the placebo group. This difference was statistically significant (p<0.0001; Wilcoxon's rank sum test). The incidence of all types of hot flushes (mild+moderate+severe) was reduced by 75.2±30.2% under 1EV/2DNG and by 35.3±37.0% under placebo. In the subset of non-hysterectomized women, exposure to 1EV/2DNG led to 2.4±6.2 days with bleeding in the reference period of 84 days of treatment, versus 0.3±1.3 days in the placebo group. The safety profile of 1EV/2DNG was very similar to that of placebo.CONCLUSIONSContinuous-combined HT preparation with 1mg EV and 2mg DNG induced a significant reduction of moderate and severe hot flushes compared to placebo (p<0.0001). Thus, this low-estrogen preparation is an effective and safe option for HT.