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一项低剂量激素疗法治疗绝经后无阻塞性冠状动脉疾病女性心肌缺血的随机对照试验:美国国立卫生研究院/国立心肺血液研究所赞助的女性缺血综合征评估(WISE)的结果。

A randomized controlled trial of low-dose hormone therapy on myocardial ischemia in postmenopausal women with no obstructive coronary artery disease: results from the National Institutes of Health/National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE).

机构信息

Division of Cardiology, Department of Medicine, Cedars-Sinai Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.

出版信息

Am Heart J. 2010 Jun;159(6):987.e1-7. doi: 10.1016/j.ahj.2010.03.024.

DOI:10.1016/j.ahj.2010.03.024
PMID:20569710
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2918903/
Abstract

BACKGROUND

Compared with men, women have more evidence of myocardial ischemia with no obstructive coronary artery disease. Although low endogenous estrogen levels are associated with endothelial dysfunction, the role of low-dose hormone therapy has not been fully evaluated. We postulate that a 12-week duration of low-dose hormone replacement therapy is associated with myocardial ischemia and endothelial dysfunction.

METHODS AND RESULTS

Using a multicenter, randomized, placebo-controlled design, subjects were randomized to receive either 1 mg norethindrone/10 microg ethinyl estradiol or placebo for 12 weeks. Chest pain and menopausal symptoms, cardiac magnetic resonance spectroscopy, brachial artery reactivity, exercise stress testing, and psychosocial questionnaires were evaluated at baseline and exit. Recruitment was closed prematurely because of failure to recruit after publication of the Women's Health Initiative hormone trial. Of the 35 women who completed the study, there was less frequent chest pain in the treatment group compared with the placebo group (P = .02) at exit. Women taking 1 mg norethindrone/10 microg ethinyl estradiol also had significantly fewer hot flashes/night sweats (P = .003), less avoidance of intimacy (P = .05), and borderline differences in sexual desire and vaginal dryness (P = .06). There were no differences in magnetic resonance spectroscopy, brachial artery reactivity, compliance, or reported adverse events between the groups.

CONCLUSIONS

These data suggest that low-dose hormone therapy improved chest pain symptoms, menopausal symptoms, and quality of life, but did not improve ischemia or endothelial dysfunction. Given that it was not possible to enroll the prespecified sample size, these results should not be considered definitive.

摘要

背景

与男性相比,女性有更多证据表明存在非阻塞性冠状动脉疾病的心肌缺血。虽然低内源性雌激素水平与内皮功能障碍有关,但低剂量激素治疗的作用尚未得到充分评估。我们假设,低剂量激素替代疗法持续 12 周与心肌缺血和内皮功能障碍有关。

方法和结果

采用多中心、随机、安慰剂对照设计,将受试者随机分为接受 1 毫克炔诺酮/10 微克乙炔雌二醇或安慰剂治疗 12 周。在基线和退出时评估胸痛和绝经症状、心脏磁共振波谱、肱动脉反应性、运动应激测试和社会心理问卷。由于妇女健康倡议激素试验公布后未能招募到患者,提前关闭了招募。在完成研究的 35 名女性中,治疗组在退出时的胸痛频率明显低于安慰剂组(P=0.02)。服用 1 毫克炔诺酮/10 微克乙炔雌二醇的女性也明显减少了热潮红/盗汗(P=0.003)、回避亲密(P=0.05),性欲和阴道干燥方面也有边界差异(P=0.06)。两组之间磁共振波谱、肱动脉反应性、顺应性或报告的不良事件均无差异。

结论

这些数据表明,低剂量激素治疗可改善胸痛症状、绝经症状和生活质量,但不能改善缺血或内皮功能障碍。由于无法招募到规定的样本量,这些结果不应被认为是确定的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2618/2918903/36de8c2d6d8f/nihms191106f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2618/2918903/50b9531d8075/nihms191106f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2618/2918903/36de8c2d6d8f/nihms191106f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2618/2918903/50b9531d8075/nihms191106f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2618/2918903/36de8c2d6d8f/nihms191106f2.jpg

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