Grady D, Applegate W, Bush T, Furberg C, Riggs B, Hulley S B
Department of Epidemiology and Biostatistics, University of California, San Francisco, 94105, USA.
Control Clin Trials. 1998 Aug;19(4):314-35. doi: 10.1016/s0197-2456(98)00010-5.
The Heart and Estrogen/progestin Replacement Study (HERS) is a randomized, double-blind, placebo-controlled trial designed to test the efficacy and safety of estrogen plus progestin therapy for prevention of recurrent coronary heart disease (CHD) events in women. The participants are postmenopausal women with a uterus and with CHD as evidenced by prior myocardial infarction, coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, or other mechanical revascularization or at least 50% occlusion of a major coronary artery. Between February 1993 and September 1994, 20 HERS centers recruited and randomized 2763 women. Participants ranged in age from 44 to 79 years, with a mean age of 66.7 (SD 6.7) years. Most participants were white (89%), married (57%), and had completed high school or some college (80%). As expected, the prevalence of coronary risk factors was high: 62% were past or current smokers, 59% had hypertension, 90% had serum LDL-cholesterol of 100 mg/dL or higher, and 23% had diabetes. Each woman was randomly assigned to receive one tablet containing 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate daily or an identical placebo. Participants will be evaluated every 4 months for an average of 4.2 years for the occurrence of CHD events (CHD death and nonfatal myocardial infarction). We will also assess other major CHD endpoints, including revascularization and hospitalization for unstable angina. The primary analysis will compare the rate of CHD events in women assigned to active treatment with the rate in those assigned to placebo. The trial was designed to have power greater than 90% to detect a 35% reduction in the incidence of CHD events, assuming a 50% lag in effect for 2 years and a 5% annual event rate in the placebo group. The design, analysis, and conduct of the study are controlled by the Steering Committee of Principal Investigators and coordinated at the University of California, San Francisco. HERS is the largest trial of any intervention to reduce the risk of recurrent CHD events in women with heart disease and is the first controlled trial to seek evidence of the efficacy and safety of postmenopausal hormone therapy to prevent recurrent CHD events.
心脏与雌激素/孕激素替代治疗研究（HERS）是一项随机、双盲、安慰剂对照试验，旨在测试雌激素加孕激素疗法预防绝经后有子宫女性复发性冠心病（CHD）事件的疗效和安全性。参与者为有子宫的绝经后女性，且有冠心病，证据为既往心肌梗死、冠状动脉搭桥手术、经皮腔内冠状动脉成形术或其他机械性血运重建，或主要冠状动脉至少50%闭塞。1993年2月至1994年9月，20个HERS中心招募并随机分配了2763名女性。参与者年龄在44至79岁之间，平均年龄为66.7（标准差6.7）岁。大多数参与者为白人（89%）、已婚（57%），且完成了高中或部分大学学业（80%）。正如预期的那样，冠心病危险因素的患病率很高：62%为既往或当前吸烟者，59%患有高血压，90%的血清低密度脂蛋白胆固醇为100mg/dL或更高，23%患有糖尿病。每位女性被随机分配每天服用一片含0.625mg结合雌激素加2.5mg醋酸甲羟孕酮的片剂或一片相同的安慰剂。每4个月对参与者进行评估，平均评估4.2年，以观察冠心病事件（冠心病死亡和非致命性心肌梗死）的发生情况。我们还将评估其他主要的冠心病终点，包括血运重建和不稳定型心绞痛住院情况。主要分析将比较接受积极治疗的女性与接受安慰剂治疗的女性的冠心病事件发生率。该试验设计的检验效能大于90%，以检测冠心病事件发生率降低35%，假设效应延迟2年为50%，安慰剂组的年事件发生率为5%。该研究的设计、分析和实施由主要研究者指导委员会控制，并在加利福尼亚大学旧金山分校进行协调。HERS是减少心脏病女性复发性冠心病事件风险的任何干预措施中规模最大的试验，也是首个寻求绝经后激素疗法预防复发性冠心病事件疗效和安全性证据的对照试验。
