ESTROGEN REPLACEMENT AND CVD OUTCOMES IN DIABETIC WOMEN

描述：(改编自《调查者摘要》)糖尿病强加于 绝经后妇女的发病率和死亡率负担巨大。它是 与心肌梗死风险增加三到九倍有关 梗塞(MI)，外周血管风险增加8倍 心血管疾病的风险增加了三倍。 观察性研究表明，激素替代疗法(HRT) 通过以下方式降低绝经后女性患冠心病的风险 50%，而HRT对下肢外周动脉的影响 疾病是未知的。激素替代疗法对女性糖尿病患者冠心病的影响 没有经过评估。这项病例队列研究的目的是检查 绝经后激素替代疗法(单独雌激素或与孕激素)之间的关系 绝经后II型女性的冠心病(非致命性心肌梗死和致命性冠心病) 糖尿病。次要结果包括下肢截肢和 全因死亡。调查人员表示，一个独特的机会是 由于Group Health的自动化数据库，可用于进行此研究 合作社，华盛顿西部的一家健康维护组织，拥有 超过500,000名成员，包括大约7,000名II型妇女 糖尿病。年龄在45岁至80岁之间的女性，患有或流行II型糖尿病 在1986至1990年间，将使用为 关于糖尿病患者的管理和结果的持续研究。从这个队列和 按年龄分层随机抽取1,500名女性参加 次队列。这些妇女加上那些有兴趣的结果(非致命的 心肌梗死和致命性冠心病；下肢截肢；或队列进入之间的死亡 和1998年9月[8至12年随访])将构成分析 一群人。将审查医疗记录以确认资格和 结果以及收集关于病史、人口统计的数据 特征和混杂变量。HRT的使用将根据以下因素确定 计算机化的药房记录。将使用描述性方法分析数据 统计学、分类生存方法和考克斯回归，应用 方法采用病例队列研究设计。调查人员表示 这项研究将扩大关于阿司匹林安全性和有效性的知识 HRT在心血管并发症高危女性中的应用。

DESCRIPTION: (Adapted from Investigator's Abstract) Diabetes imposes a tremendous burden of morbidity and mortality on postmenopausal women. It is associated with a three- to nine-fold increase in risk of myocardial infarction (MI), an eight-fold increase in risk of peripheral vascular disease, and a threefold increase in risk for cardiovascular mortality. Observational studies indicate that hormone replacement therapy (HRT) reduces the risk of coronary heart disease (CHD) in postmenopausal women by 50 percent, while the effect of HRT on lower extremity peripheral arterial disease is unknown. The effects of HRT on CHD in women with diabetes have not been evaluated. The purpose of this case-cohort study is to examine the association between postmenopausal HRT (estrogen alone or with progestin) and CHD (nonfatal MI and fatal CHD) in postmenopausal women with Type II diabetes. Secondary outcomes include lower extremity amputations and all-cause mortality. The investigators state that a unique opportunity is available to conduct this study due to automated databases at Group Health Cooperative, a health maintenance organization in western Washington with over 500,000 members, including approximately 7,000 women with Type II diabetes. Women aged 45 to 80, with incident or prevalent Type II diabetes between 1986 and 1990, will be identified using criteria established for an ongoing study on management and outcomes in diabetics. From this cohort an age-stratified random sample of 1,500 women will be selected for the sub-cohort. These women plus those with the outcomes of interest (nonfatal MI and fatal CHD; lower extremity amputations; or death between cohort entry and September, 1998 [8 to 12 years follow-up]) will comprise the analytic cohort. Medical records will be reviewed to confirm eligibility and outcomes as well as to collect data on medical history, demographic characteristics and confounding variables. HRT use will be determined from computerized pharmacy records. Data will be analyzed using descriptive statistics, categorical survival methods, and Cox regression, applying methods specific to the case-cohort study design. The investigators state that this study will extend knowledge regarding the safety and efficacy of HRT in a subgroup of women at high risk for cardiovascular complications.