POSTMENOPAUSAL ESTROGEN/PROGESTIN INTERVENTIONS

绝经后雌激素/孕激素干预(PEPI-1)试验875例 参与者在7个中心进行了三年的跟踪调查，是规模最大的 长效随机双盲安慰剂对照临床试验 绝经后妇女的激素治疗--也是唯一一项长期试验 雌激素-孕激素联合疗法。这是唯一一项设计的长期试验 雌激素替代疗法(ERT)与联合用药的疗效比较 (雌激素-孕激素)激素替代疗法(HRT)治疗心脏病 风险因素。它也是独一无二的开始ERT或 绝经后5年以上的激素替代疗法。 研究设计、激素替代疗法和研究的详细情况 项目I给出了人口，对PEPI-1的主要分析也是如此 拟在延长的后续行动期间完成的数据。 项目二，储存库样本研究，计划利用血浆， 已采集的尿液和其他样本，但在年末仍未进行分析 佩皮-1。项目一和项目二，由协调委员会提交 中心以反映多中心所需的集中化活动 项目，将与临床调查人员一起作为 合作项目。 项目三，由7个佩皮诊所分别平行提交 中心，描述了一项为期三年的前瞻性观察跟踪研究 旨在：确保佩皮妇女的安全，并了解更多可能 延迟性激素不良反应；研究治疗选择、依从性和 与这些决定相关的原因；并监测对心脏的长期影响 疾病危险因素和骨密度。所有参与者都将被邀请 到每年一次的诊所访问，(根据既定的PEPI-1进行 协议)，包括病史和有限的检查， 乳房X光检查、子宫内膜活检和有关质量的标准化问题 生活、性行为、症状学和药物使用。我们将衡量 初级Pepi终点(高密度脂蛋白-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 populations 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.