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ESTROGEN REPLACEMENT AND CVD OUTCOMES IN DIABETIC WOMEN

ESTROGEN REPLACEMENT AND CVD OUTCOMES IN DIABETIC WOMEN
糖尿病女性的雌激素替代和 CVD 结果
批准号:
2735323
负责人:
Katherine M. Newton
金额:
$20.87万
依托单位国家:
美国
项目类别:
财政年份:
1997
资助国家:
美国
项目状态:
已结题
起止时间:
1997-07-01 至 2000-06-30

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中文摘要
翻译
描述:(改编自研究者摘要)糖尿病使 绝经后妇女的发病率和死亡率的巨大负担。 是 与心肌梗死风险增加3 - 9倍有关 心肌梗死(MI),外周血管疾病风险增加8倍, 疾病,心血管死亡风险增加三倍。 观察性研究表明,激素替代疗法(HRT) 降低绝经后妇女患冠心病的风险, 50%,而HRT对下肢外周动脉 疾病未知。 HRT对女性糖尿病患者冠心病的影响 没有被评估。 这项病例队列研究的目的是检查 绝经后HRT(单独雌激素或雌激素与孕酮) 和CHD(非致死性MI和致死性CHD) 糖尿病 次要结局包括下肢截肢, 全因死亡率 研究人员指出,一个独特的机会是 由于Group Health的自动化数据库, 合作社,一个健康维护组织在西部华盛顿与 超过500,000名成员,其中包括约7,000名患有II型糖尿病的女性 糖尿病 年龄在45 - 80岁之间的女性,患有偶发或流行的II型糖尿病 在1986年至1990年期间,将使用为 正在进行的糖尿病管理和结局研究。 从这个队列中, 年龄分层随机抽样的1,500名妇女将被选为 子队列。 这些妇女加上那些有关注结果的妇女(非致命性) MI和致死性CHD;下肢截肢;或队列入组之间的死亡 1998年9月[8至12年随访])将包括分析 队列。 将审查医疗记录以确认合格性, 结果以及收集病史、人口统计学 特征和混杂变量。 HRT的使用将根据 电脑化药房记录 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 具体到病例队列研究设计的方法。 调查人员表示, 本研究将扩展关于安全性和有效性的知识, HRT在心血管并发症高危女性亚组中的应用
英文摘要
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.
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