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心血管危险因素与雌孕激素联合替代疗法:一项关于醋酸诺美孕酮和雌二醇的安慰剂对照研究。

Cardiovascular risk factors and combined estrogen-progestin replacement therapy: a placebo-controlled study with nomegestrol acetate and estradiol.

作者信息

Conard J, Basdevant A, Thomas J L, Ochsenbein E, Denis C, Guyene T T, Degrelle H

机构信息

Department of Hemostasis, Hotel-Dieu, Paris, France.

出版信息

Fertil Steril. 1995 Nov;64(5):957-62. doi: 10.1016/s0015-0282(16)57909-6.

DOI:10.1016/s0015-0282(16)57909-6
PMID:7589641
Abstract

OBJECTIVE

To assess the effects of oral E2 replacement therapy combined with nomegestrol acetate, a 19-norprogesterone derivative, on cardiovascular risk factors.

DESIGN

A double-blind randomized prospective study comparing the effect of a placebo and two oral E2-nomegestrol acetate combinations (1 mg-2.5 mg and 1.5 mg-3.75 mg) over a three-cycle trial.

SETTING

Department of Internal Medicine and Nutrition, Hotel-Dieu, Paris, France.

PATIENTS

Fifty-seven nonhysterectomized women with natural menopause.

MAIN OUTCOME MEASURES

Blood pressure, renin substrate, glucose, total cholesterol, high-density and low-density lipoprotein cholesterol, triglycerides, apoproteins A1 and B, lipoprotein(a), antithrombin III, fibrinogen, plasminogen, prothrombin fragment 1 + 2, protein C, and total and free protein S.

RESULTS

Both treatments significantly reduced menopausal complaints, total cholesterol, low-density lipoprotein cholesterol and lipoprotein(a). Treatment with the 1.5 mg-3.75 mg combination resulted in a significant increase in apolipoprotein A1. No significant change were observed in other parameters.

CONCLUSIONS

Sequentially combined with oral E2 in hormone replacement therapy, nomegestrol acetate had favorable effects on plasma lipids and lipoproteins. This nonandrogenic progestin decreased lipoprotein(a) levels as observed previously with medroxyprogesterone acetate combined with conjugated equine estrogens.

摘要

目的

评估口服雌激素(E2)替代疗法联合19-去甲孕酮衍生物醋酸诺美孕酮对心血管危险因素的影响。

设计

一项双盲随机前瞻性研究,比较安慰剂与两种口服E2-醋酸诺美孕酮组合(1毫克 - 2.5毫克和1.5毫克 - 3.75毫克)在三个周期试验中的效果。

地点

法国巴黎迪厄医院内科与营养科。

患者

57名自然绝经且未行子宫切除术的女性。

主要观察指标

血压、肾素底物、血糖、总胆固醇、高密度和低密度脂蛋白胆固醇、甘油三酯、载脂蛋白A1和B、脂蛋白(a)、抗凝血酶III、纤维蛋白原、纤溶酶原、凝血酶原片段1 + 2、蛋白C以及总蛋白S和游离蛋白S。

结果

两种治疗均显著减轻绝经相关症状,降低总胆固醇、低密度脂蛋白胆固醇和脂蛋白(a)。1.5毫克 - 3.75毫克组合治疗使载脂蛋白A1显著升高。其他参数未见显著变化。

结论

在激素替代疗法中,醋酸诺美孕酮与口服E2序贯联合使用,对血脂和脂蛋白有良好影响。这种非雄激素类孕激素可降低脂蛋白(a)水平,这与之前观察到的醋酸甲羟孕酮联合结合马雌激素的效果相同。

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