RANDOMIZED TRIAL OF ESTROGEN-ATHEROSCLEROSIS REGRESSION

冠心病(CHD)已成为 60岁以上妇女死亡。关于脂类的知识- 降低或其他可能有助于预防的干预措施 冠状动脉进展或导致冠状动脉退行性变 绝经后妇女的动脉粥样硬化本质上是 根本不存在。血浆效应的随机试验 降低冠心病患者的胆固醇并不包括女性。 检验这种联系的观察性流行病学研究 绝经后妇女雌激素使用与冠心病之间的关系 报告的结果相互矛盾。 这项拟议研究的意义在于，它将提供一个 为妇女试验提供了基础，并可能为 绝经后高脂蛋白血症的合理治疗 女人。这项研究的结果将在几个方面具有意义 领域：a)这项研究将确定是否以及在多大程度上 雌激素替代治疗减少冠状动脉粥样硬化 在雌激素缺乏的绝经后猴子中 降胆固醇饮食；b)结果将使我们能够确定 是否以及在多大程度上添加了黄体酮(普罗维拉) 对雌激素替代疗法的任何益处都会减弱 雌激素替代疗法的效果；亚组分析 根据预随机数据，另外两个问题将 答：c)荷尔蒙疗法对 高密度脂蛋白亚类和低密度脂蛋白分子量，都是已知的 与动脉粥样硬化病变有关？最后，d)什么是 血浆性激素结合水平与性激素水平的关系 球蛋白与冠状动脉粥样硬化程度？ 这项研究是我们意识到的第一次努力 在非人类试验中使用随机试验的方法 灵长类种群对冠状动脉粥样硬化的评估 干预。此外，它是对美国国立卫生研究院赞助的 绝经后雌激素/孕激素干预研究 其设计目的是确定不同 雌激素/孕激素制剂对冠心病和骨质疏松风险的影响 因素和其他因素，以及它们的安全性。

Coronary heart disease (CHD) has become the leading cause of death among women beyond age 60. Knowledge about lipid- lowering or other interventions that may be useful in preventing progression or causing regression of coronary artery atherosclerosis among postmenopausal women is essentially nonexistent. Randomized trails of the effect of plasma cholesterol lowering on CHD have not included women. Observational epidemiologic studies examining the association between estrogen use and CHD in postmenopausal women have reported contradictory results. The significance of this proposed study is that it will provide a foundation for trials in women and may provide a basis for the rational management of hyperlipoproteinemic postmenopausal women. The results of this study will have significance in several areas: a) the study will determine whether and to what extent estrogen replacement decreases coronary artery atherosclerosis among estrogen-deficient postmenopausal monkeys on a cholesterol lowering diet; b) the results will allow us to determine whether and to what extent the addition of a progestin (Provera) to the estrogen replacement therapy will diminish any beneficial effect of estrogen replacement therapy; in subgroup analyses based on the prerandomization data, two additional questions will be answered: c) What is the effect of hormonal therapy on the HDL subclasses and the LDL molecular weight, all known to be associated with atherosclerotic lesions? and finally, d) What is the relationship between the plasma levels of sex hormone binding globulin and the degree of coronary atherosclerosis? The study represents the first effort that we are aware of to utilize the methodology of a randomized trial in a nonhuman primate population to evaluate a coronary atherosclerosis intervention. Moreover, it is a complement to the NIH-sponsored PEPI (Postmenopausal Estrogen/Progestin Interventions) study which is designed to determine the effect of different estrogen/progestin preparations on CHD and osteoporosis risk factors and other factors, as well as their safety.