KEEPS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 Keep将是一项随机、双盲、前瞻性、多中心的雌激素替代疗法临床试验，适用于年龄在40-55岁的年轻、健康的围绝经期妇女。八个中心中的每个中心将招募90名患者，总共720名患者参加试验。在符合资格标准后，女性将被随机分为三组，分别接受结合雌激素(倍美力0.45)、经皮17β雌二醇(科奈拉)或安慰剂(30名患者)。 每个中心的每个臂)。参与者将被纵向跟踪，为期5年。研究的主要终点是颈动脉内膜-中层厚度(IMT)，每18个月由超声测量一次，直到研究结束。次要终点将包括EBT在基线和完成时测量的冠状动脉钙化。其他 次要终点将包括脂质风险因素(总低密度脂蛋白和高密度脂蛋白胆固醇：低密度脂蛋白亚组分、甘油三酯和脂蛋白(A)； 炎症危险因素包括同型半胱氨酸、C反应蛋白和纤维蛋白原，血液高凝状态的标志物包括凝血酶-抗凝血酶复合体(TAT‘s)、凝血酶原片段F1.2、β-血栓球蛋白和凝血酶原激活物抑制物-1(PAL-I) 阐明它们在调节MHT不良反应中的不同作用：

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. KEEPS will be a randomized double-blinded prospective, multicenter clinical trial of estrogen replacement therapy in young and healthy perimenopausal women 40-55 years of age. Each of eight centers will enroll 90 patients, for a total of 720 patients for the trial. After meeting the eligibility criteria, women will be randomized to receive either conjugated estrogens (Premarin 0.45), transdermal 17 beta estradiol (Climara) or placebo (30 patients in each arm per center). The participants will be followed longitudinally for a period of 5 years. The primary endpoint of interest will be carotid intima-medial thickness (IMT) as measured by ultrasound every 18 months until completion of the study. Secondary endpoints will include coronary calcification as measured by EBT at baseline and at completion. Other secondary endpoints will include lipid risk factors (total LDL and HDL cholesterol: LDL subfractions, triglicerides and Lp(a); inflammatory risk factors including homocysteine, C-reactive protein and fibrinogen and markers of blood hypercoagulability including thrombin-antithrombin complexes (TAT's), prothrombin fragments F1.2, beta thromboglobulin and prothrombin activator inhibitor-1 (PAl-I) The study will compare oral with transdermal estrogen treatment to further elucidate the potential role of their different actions in mediating adverse effects of MHT: