Manson J E, Gaziano J M, Spelsberg A, Ridker P M, Cook N R, Buring J E, Willett W C, Hennekens C H
Department of Medicine, Harvard Medical School, Boston, MA, USA.
Ann Epidemiol. 1995 Jul;5(4):261-9. doi: 10.1016/1047-2797(94)00091-7.
The evidence for a potential benefit of antioxidant vitamins in the prevention and therapy of atherosclerotic disease is derived from laboratory, clinical, and observational epidemiologic studies but remains inconclusive. Data from randomized clinical trials are sparse, particularly for women. Therefore, it is both timely and important to conduct large-scale primary and secondary prevention trials of antioxidants and cardiovascular disease (CVD). The Women's Antioxidant and Cardiovascular Study (WACS) is a randomized, double-blind, placebo-controlled secondary prevention trial of the balance of benefits and risks of antioxidant vitamins (vitamins E and C, and beta-carotene) among 8000 women with preexisting CVD. This secondary prevention trial will be conducted as a companion to the recently started Women's Health Study, a primary prevention trial of vitamin E and beta-carotene, as well as aspirin. In the WACS, US female health professionals aged 40 years and older with a history of myocardial infarction, angina pectoris, coronary revascularization, stroke, transient cerebral ischemia, carotid endarterectomy, or peripheral artery surgery will be randomly assigned, utilizing a 2 x 2 x 2 factorial design, to receive vitamin E, vitamin C, beta-carotene, and/or placebo. Cardiovascular end points include nonfatal myocardial infarction, nonfatal stroke, coronary revascularization procedures, and total CVD mortality. The present article describes the rationale, design, and methods of the trial.
抗氧化维生素在动脉粥样硬化疾病预防和治疗中具有潜在益处的证据来源于实验室、临床及观察性流行病学研究，但仍无定论。随机临床试验的数据较少，尤其是针对女性的数据。因此，开展抗氧化剂与心血管疾病（CVD）的大规模一级和二级预防试验既及时又重要。女性抗氧化剂与心血管疾病研究（WACS）是一项针对8000名已有心血管疾病的女性进行的随机、双盲、安慰剂对照的二级预防试验，旨在研究抗氧化维生素（维生素E、维生素C和β-胡萝卜素）的利弊平衡。这项二级预防试验将作为最近启动的女性健康研究的配套试验开展，女性健康研究是一项关于维生素E、β-胡萝卜素以及阿司匹林的一级预防试验。在WACS中，年龄在40岁及以上、有心肌梗死、心绞痛、冠状动脉血运重建、中风、短暂性脑缺血、颈动脉内膜切除术或外周动脉手术史的美国女性健康专业人员将采用2×2×2析因设计被随机分配，以接受维生素E、维生素C、β-胡萝卜素和/或安慰剂。心血管终点包括非致命性心肌梗死、非致命性中风、冠状动脉血运重建手术以及心血管疾病总死亡率。本文介绍了该试验的基本原理、设计和方法。
