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HORMONE REPLACEMENT STUDY FOR CORONARY DISEASE

HORMONE REPLACEMENT STUDY FOR CORONARY DISEASE
冠状动脉疾病的激素替代研究
批准号:
3852894
负责人:
CURT D FURBERG
金额:
$0.0万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至

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中文摘要
翻译
冠心病是妇女死亡的主要原因。 观察性研究表明,绝经后雌激素替代治疗 在健康女性中,ERT治疗(ERT)可将新发CHD事件的风险降低50%, 在有冠心病病史的女性中,这一比例为80%。 是否添加了维生素E (PERT),以防止雌激素诱导的子宫内膜癌改变的风险, 冠心病 是否添加了抗雌激素(PERT),以防止雌激素诱导 子宫内膜癌改变冠心病的风险是未知的。 表观 ERT的心脏保护作用可能是真实的(可能通过改变 凝血因子或脂质),或者可能是由于混淆, 例如,雌激素使用者比非使用者更健康。 为了解决这个问题,我们建议参加荷尔蒙 替代研究(HRS),一项二级预防试验,3,252例绝经后患者 既往心肌梗死(M)或血管造影证实的女性 将冠心病患者随机分配至三种设盲方案之一: ERT(0.625 mg.结合雌激素),PERT(ERT +2.5 mg 醋酸甲羟孕酮/天)或安慰剂。 主要结局,6- 年CHD发病率(心肌梗死或CHD死亡),提供了一个把握度 的0.9,以检测任一激素组中37.5%的减少, 安慰剂 该试验还将比较不良事件发生率,并检查 ERT或PERT对整个队列生活质量和血脂的影响 17%的黑人和8%的西班牙裔。 HRS汇集了心血管试验领域的领先专家, 在PEPI(绝经后)经验的基础上, 雌激素/孕激素干预)。 鲍曼·格雷将担任十二个 在招募和随访方面具有良好记录的临床中心 将分别随机分配至少260名女性, 科学活动。 协调中心将组织治理 和沟通,协调设计和实施,创建和管理 数据和质量控制系统,并确保及时分析和 传播调查结果。 ERT和PERT在冠心病中的作用是一个非常重要的问题, 绝经后妇女。 如果HRS证明这些治疗可减少 没有重大不良反应的冠心病复发风险,很可能, 激素疗法(目前美国约有20%的绝经后妇女使用) 将变得更加普遍,全国冠心病发病率将下降, 实质上。
英文摘要
Coronary heart disease (CHD) is the leading cause of death in women. Observational studies suggest that postmenopausal estrogen replacement therapy (ERT) reduces the risk of a new CHD event by 50% in healthy women, and by 80% in women with prior CHD. Whether the addition of progestin (PERT) to prevent estrogen-induced endometrial cancer alters the risk of CHD. Whether the addition of progestin (PERT) to prevent estrogen-induced endometrial cancer alters the risk of CHD is unknown. The apparent cardioprotective effect of ERT might be real (perhaps mediated by changes in clotting factors or lipids) or it might be due to confounding if, for example, estrogen users are healthier than non-users. To resolve this question, we propose to participate in the Hormone Replacement Study (HRS), a secondary prevention trial, 3,252 postmenopausal women with prior myocardial infarction (M) or angiographically documented coronary disease will be randomized to one of three blinded regimens: ERT(0.625 mg. conjugated estrogen per day), PERT (ERT plus 2.5 mg medroxyprogesterone acetate per day), or placebo. The primary outcome, 6- year incidence of CHD (myocardial infarction or CHD death), offers a power of 0.9 to detect a 37.5% reduction in either hormone group compared to placebo. The trial will also compare adverse event rates, and examine the effects of ERT or PERT on quality of life and lipids in the overall cohort and in the 17% who are Black and the 8% who are Hispanic. HRS brings together leading experts in cardiovascular trials an women's health to build on the experience in PEPI (Postmenopausal Estrogen/Progestin Interventions). Bowman Gray will serve as one of twelve clinical centers with excellent track records in recruitment and follow-up will each randomize at least 260 women and participate in study-wide scientific activities. The coordinating center will organize governance and communication, coordinate design and implementation, create and manage the data and quality control systems, and assure timely analysis and dissemination of findings. The effect of ERT and PERT on CHD is a most important issue for postmenopausal women. If HRS demonstrates that these treatments reduce the risk of recurrent CHD without major adverse effects, it is likely that hormone therapy (now used by about 20% of postmenopausal women in the U.S.) would become much more common and that national CHD rates would decline substantially.
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CORONARY HEART DISEASE AND STROKE IN PEOPLE AGED 65-84
  • 批准号:
    2314225
  • 项目类别:
  • 资助金额:
    $73.3万
  • 财政年份:
    1988
  • 负责人:
    CURT D FURBERG
  • 依托单位:
CORONARY HEART DISEASE AND STROKE IN PEOPLE AGED 65-84
  • 批准号:
    2314209
  • 项目类别:
  • 资助金额:
    $66.53万
  • 财政年份:
    1988
  • 负责人:
    CURT D FURBERG
  • 依托单位:
CORONARY HEART DISEASE AND STROKE IN PEOPLE AGED 65-84
  • 批准号:
    2314219
  • 项目类别:
  • 资助金额:
    $39.37万
  • 财政年份:
    1988
  • 负责人:
    CURT D FURBERG
  • 依托单位:
CORONARY HEART DISEASE AND STROKE IN PEOPLE AGED 65-84
  • 批准号:
    2314223
  • 项目类别:
  • 资助金额:
    $62.76万
  • 财政年份:
    1988
  • 负责人:
    CURT D FURBERG
  • 依托单位:
海外基金