POSTMENOPAUSAL ESTROGEN/PROGESTIN INTERVENTION TRIAL

绝经后雌激素/孕激素干预试验

• 批准号: 3553209
• 负责人: VALERY T MILLER
• 金额: $ 19.42万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-09-30 至 1994-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3553209
• 关键词: blood pressure; clinical trials; combination chemotherapy; cooperative study; disease /disorder proneness /risk; estrogens; female; fibrinogen; heart disorder; hormone therapy; human subject; human therapy evaluation; insulin; medroxyprogesterone; osteoporosis; postmenopause; progestins

Coronary artery disease (CAD) and osteoporosis are two primary medical problems in post menopausal women. While estrogen/progestogen replacement therapy is recommended for prevention of bone loss, estrogens and progestogens have important and often opposing effects on a number of CAD risk factors. We propose a comprehensive and integrated three year evaluation of the effects of nine different treatment strategies on bone mass retention, endometrial status, gallstone formation and a number of CAD risk factors, as compared with a group of comparable controls. Experimental groups will include three estrogen only groups (hysterectomized women only), and six estrogen/progestogen groups to evaluate effects of dosage, mode of administration, type of progestogen and timing of hormonal administration on these parameters. The study will not only establish the effects on CAD risk factors including lipoprotein (VLDL, LDL, HDL and HDL subfractions, HDL2/3) and apolipoprotein (apoA-I, A-II, B) levels, fasting and post-challenge glucose levels, a number of coagulation parameters including indicators of coagulation, fibrinolysis and platelet aggregation, and blood pressure, but also on potentially important changes in the composition of lipoproteins. We will additionally examine effects on the density distribution of LDL particles and on levels and composition of LDL in subgroups of the study population. The results of the proposed studies will provide information to allow an informed decision on defining which strategy provides optimal protection against bone loss and endometrial hyperplasia, but minimal alteration of the beneficial cardiovascular effects of estrogen.

冠状动脉疾病(CAD)和骨质疏松是两种主要的疾病 绝经后妇女的医疗问题。而当 建议使用雌激素/孕激素替代疗法治疗 预防骨质流失，雌激素和孕激素有 对许多CAD风险的重要且经常相反的影响 各种因素。 我们提出了一项全面和综合的三年评估 九种不同治疗策略对骨量的影响 内膜滞留、子宫内膜状况、胆结石形成和一些 与一组可比的冠心病危险因素进行比较 控制。试验组将只包括三种雌激素 两组(仅限子宫切除妇女)和六个 雌激素/孕激素组疗效评价的剂量、方式 给药时间、孕激素类型和激素使用时机 对这些参数的管理。 这项研究不仅将确立对冠心病风险因素的影响 包括脂蛋白(极低密度脂蛋白、低密度脂蛋白、高密度脂蛋白和高密度脂蛋白亚组分， HDL2/3)和载脂蛋白(apoA-I、A-II、B)水平，空腹和 挑战后血糖水平、一些凝血参数 包括凝血、纤溶和血小板指标 聚集，和血压，但也对潜在的重要 脂蛋白组成的变化。我们还会另外 检测对低密度脂蛋白颗粒密度分布的影响 不同亚组低密度脂蛋白水平和组成的研究 人口。拟议研究的结果将提供 信息，以便在知情的情况下作出决定 策略提供最佳的骨丢失保护和 子宫内膜增生症，但有益于微小的改变 雌激素的心血管效应。