ESTROGEN AND PROGESTIN IN HEART DISEASE

本拨款建议是对RFA 87-HL-06-H的回应 绝经后雌激素/孕激素干预。 在这本书中， 建议使用随机， 前瞻性、三因素析因、可能双盲研究 设计 需要解决的问题是雌激素的使用（目前与 不存在）、给药途径（口服与透皮）、剂量 (low与高水平相比）和与抗肿瘤药物联合治疗 （出席与缺席）。 将在基线时对患者进行研究， 每隔6个月进行一次为期3年的治疗。 终点为 评估的是内分泌（血清雌二醇，雌酮，硫酸雌酮， 和醋酸甲羟孕酮水平），心血管（胸部 疼痛问卷、静息心电图、运动应激心电图，以及 铊造影术），脂质（循环总胆固醇， 甘油三酯、LDL、HDL、HDL 2/HDL 3亚组分、Apo B、E、A- 1、A-2和Apo E表型）、凝血（血浆纤维蛋白原， 因子VII、抗凝血酶III活性、纤维蛋白原D-二聚体、纤维蛋白 降解产物、纤维蛋白肽A和高分子量 纤维蛋白原）、高血压（红细胞阳离子转运、血浆肾素 活性，正常和高分子量的肾素底物，和 醛固酮），骨骼（血清钙，磷酸盐，肌酐，中- 段PTH，25（OH）和1，25（OH）维生素D，碱性 磷酸酶和骨钙素;尿钙，羟脯氨酸和 双光子测量腰椎和股骨颈骨量 吸收测定法），子宫内膜（标准组织学评估， 计算机化数字成像和雌激素受体定位）， 胆囊（超声）和乳房（体格检查和 乳房X线照相术）。 这些研究将全面评估激素的影响 在被认为与心脏病有关的终点进行替代， 以及这种形式的其他拟议的好处和风险， 疗法

This grant proposal is in response to RFA 87-HL-06-H Postmenopausal Estrogen/Progestin Interventions. In it we propose to study 150 postmenopausal patients using a randomized, prospective, three-way factorial, possibly doubled blind study design. Issues to be addressed are estrogen usage (present versus absent), route of administration (oral versus transdermal), dosage (low versus high) and combination therapy with a progestin (present versus absent). Patients will be studied at baseline and at 6-month intervals for 3 years on therapy. End points to be assessed are endocrine (serum estradiol, estrone, estrone sulfate, and medroxyprogesterone acetate levels), cardiovascular (chest pain questionnaire, resting EKG, exercise stress EKG, and thallium scintigraphy), lipids (circulating total cholesterol, triglycerides, LDL, HDL, HDL2/HDL3 subfractions, Apo B, E, A- 1, A-2, and Apo E phenotyping), coagulation (plasma fibrinogen, factor VII, antithrombin III activity, fibrinogen D-dimer, fibrin degradation products, fibrinopeptide A, and high molecular weight fibrinogen), hypertension (red cell cation transport, plasma renin activity, normal and high molecular weight renin substrate, and aldosterone), skeleton (serum calcium, phosphate, creatinine, mid- segment PTH, 25(OH) and 1,25(OH) vitamin D, alkaline phosphatase, and osteocalcin; urinary calcium, hydroxyproline and creatinine; and lumbar and femoral neck bone mass by dual photon absorptiometry), endometrium (standard histological assessment, computerized digital imaging and estrogen receptor localization), gallbladder (ultrasound) and breast (physical examination and mammography). These studies will comprehensively assess the impact of hormone replacement on end points believed to be related to heart disease, as well as other proposed benefits and risks of this form of therapy.