ESTROGEN AND PROGESTIN IN HEART DISEASE

绝经后雌激素/孕激素干预（PEPI-1）试验，875例 参与者在7个中心随访三年是最大的， 最长的随机双盲安慰剂对照临床试验， 绝经后妇女的激素治疗--也是唯一的长期试验 雌激素-孕激素疗法。 这是唯一一项长期试验， 比较雌激素替代治疗（ERT）和联合治疗的效果， 雌激素替代疗法治疗心脏病 危险因素 这也是唯一的妇女谁开始ERT或 HRT在绝经后5年以上。 研究设计、激素替代方案和研究的详细信息 项目I中给出了人口，PEPI-1的主要分析也是如此。 建议在延长随访期内完成的数据。 项目II，储存库样本的研究，计划利用血浆， 已收集但未分析的尿液和其他样本 PEPI-1。 项目一和项目二，由协调小组提交 反映多中心所需的集中活动 项目，将与临床研究者一起进行， 合作项目。 项目III，由7个PEPI临床试验机构同时提交 描述了一项为期三年的前瞻性观察性随访研究 旨在：确保PEPI妇女的安全，并了解更多关于可能的 迟发性激素不良反应;研究治疗选择、依从性和 与这些决定有关的原因;并监测对心脏的长期影响 疾病危险因素和骨密度。 邀请所有与会者 至年度门诊访视（根据既定的PEPI-1进行 方案），其包括病史和有限的检查， 乳房X光检查，子宫内膜活检，以及关于质量的标准化问题， 生活、性、生殖学和药物使用。 我们将测量 主要PEPI终点（HDL-胆固醇、血压、胰岛素和 纤维蛋白原）及其协变量，以及髋部和脊柱的骨密度。

The Postmenopausal Estrogen/Progestins Intervention (PEPI-1) trial of 875 participants followed at 7 centers for three years is the largest and longest randomized double-blind placebo-controlled clinical trial of hormone treatment in postmenopausal women -- and the only long-term trial of estrogen-progestin regimens. It is the only long-term trial designed to compare the effects of Estrogen Replacement Therapy (ERT) and combined (estrogen-progestin) hormone replacement therapy (HRT) on heart disease risk factors. It is also unique for the number of women who began ERT or HRT more than 5 years after the menopause. Details of the study design, hormone replacement regimens and study population are given in Project I, as are the major analyses of PEPI-1 data proposed for completion during the extended follow-up period. Project II, Studies of Repository Samples, was planned to utilize plasma, urine and other samples already collected but not analyzed by the close of PEPI-1. Both Project I and Project II, submitted by the Coordinating Center to reflect the centralized activity necessary for a multicenter project, will be conducted with the Clinical Investigators as a cooperative project. Project III, submitted in parallel from each of the 7 PEPI Clinical Centers, describes a three year prospective observational follow-up study designed to: ensure PEPI women's safety and learn more about possible delayed adverse hormone effects; study treatment choices, compliance and reasons related to these decisions; and monitor long-term effects on heart disease risk factors and bone density. All participants will be invited to an annual clinic visit, (conducted according to the established PEPI-1 protocol) which includes a medical history and limited examination, mammogram, endometrial biopsy, and standardized questions about quality of life, sexuality, symptomatology, and medication use. We will measure primary PEPI endpoints (HDL-cholesterol, blood pressure, insulin and fibrinogen) and their covariates, and bone density at the hip and spine.