Estrogen in the prevention of atherosclerosis - A randomized, double-blind, placebo-controlled trial
Estrogen in the prevention of atherosclerosis - A randomized, double-blind, placebo-controlled trial
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DOI：
10.7326/0003-4819-135-11-200112040-00005
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发表时间：
2001-12-04
影响因子：
39.2
通讯作者：
Azen, SP
中科院分区：
文献类型：
--
作者：
Hodis, HN;Mack, WJ;Azen, SP
背景资料：尽管观察性研究表明雌激素替代疗法（ERT）可降低绝经后妇女的心血管发病率和死亡率，但在健康绝经后妇女中使用非对抗性ERT预防冠心病的作用尚未得到证实。目的：确定非对抗性ERT对无心血管疾病的健康绝经后妇女亚临床动脉粥样硬化进展的影响。设计：随机、双盲、安慰剂对照试验。设置：大学诊所。患者：222名绝经后妇女，年龄≥ 45岁，既往无心血管疾病，低密度脂蛋白胆固醇水平≥ 3.37 mmol/L（大于或等于130 mg/dL）。干预：无对抗的微粉化17 β-雌二醇（1 mg/d）或安慰剂。所有妇女都接受了饮食咨询。如果女性的低密度脂蛋白胆固醇水平超过4.15 mmol/L，则接受降脂药物治疗（160 mg/dL）。测量：在基线和2年试验期间每6个月获得的计算机图像处理的B型超声图中右侧远端颈总动脉远壁的内膜-中层厚度的变化率。在多变量混合效应模型中，在至少有一次颈动脉内膜中层厚度随访测量的女性中（n = 199），服用非对抗性雌二醇的患者亚临床动脉粥样硬化的平均进展率低于服用安慰剂的患者（-0.0017 mm/y vs. 0.0036 mm/y）;平均进展率之间的安慰剂-雌二醇差异为0.0053 mm/y（95% CI，0.0001 - 0.0105 mm/y）（P = 0.046）。在未接受降脂药物治疗的女性中（n = 77），安慰剂-雌二醇组平均进展率的差异为0.0147 mm/y（CI，0.0055 - 0.0240）（P = 0.002）。雌二醇和安慰剂接受者之间平均进展率没有差异，接受降脂药物治疗（n = 122）（P > 0.2）。结论：总体而言，健康绝经后妇女接受无对抗性ERT联合17 β-雌二醇治疗的亚临床动脉粥样硬化的平均进展率比服用安慰剂的妇女慢。亚临床动脉粥样硬化进展的减少见于未服用降脂药物的女性，而服用这些药物的女性则不然。
Background: Although observational studies suggest that estrogen replacement therapy (ERT) reduces cardiovascular morbidity and mortality in postmenopausal women, use of unopposed ERT for prevention of coronary heart disease in healthy postmenopausal women remains untested.Objective: To determine the effects of unopposed ERT on the progression of subclinical atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease.Design: Randomized, double-blind, placebo-controlled trial.Setting: University-based clinic.Patients: 222 postmenopausal women 45 years of age or older without preexisting cardiovascular disease and with low-density lipoprotein cholesterol levels of 3.37 mmol/L or greater (greater than or equal to 130 mg/dL).Intervention: unopposed micronized 17 beta -estradiol (1 mg/d) or placebo. All women received dietary counseling. Women received lipid-lowering medication if their low-density lipoprotein cholesterol level exceeded 4.15 mmol/L (160 mg/dL).Measurements: The rate of change in intima-media thickness of the right distal common carotid artery far wall in computer image processed B-mode ultrasonograms obtained at baseline and every 6 months during the 2-year trial.Results: In a multivariable mixed-effects model, among women who had at least one follow-up measurement of carotid intima-media thickness (n = 199), the average rate of progression of subclinical atherosclerosis was lower in those taking unopposed estradiol than in those taking placebo (-0.0017 mm/y vs. 0.0036 mm/y); the placebo-estradiol difference between average progression rates was 0.0053 mm/y (95% Cl, 0.0001 to 0.0105 mm/y) (P = 0.046). Among women who did not receive lipid-lowering medication (n = 77), the placebo-estradiol difference between average rates of progression was 0.0147 mm/y (Cl, 0.0055 to 0.0240) (P = 0.002). Average rates of progression did not differ between estradiol and placebo recipients who took lipid-lowering medication (n = 122) (P > 0.2).Conclusions: overall, the average rate of progression of subclinical atherosclerosis was slower in healthy postmenopausal women taking unopposed ERT with 17 beta -estradiol than in women taking placebo. Reduction In the progression of subclinical atherosclerosis was seen in women who did not take lipid-lowering medication but not in those who took these medications.