RANDOMIZED TRIALS OF VITAMIN SUPPLEMENTS AND EYE DISEASE

这项申请建议进行随机、双盲安慰剂- 用对照试验来检验补充剂 抗氧化维生素降低老年性黄斑变性的风险 (AMD)和白内障。该提案包括继续当前正在进行的 作为医生健康研究(PHS)的一部分进行的调查 扩大这些研究，将妇女纳入新成立的 妇女健康研究(WHS)。小灵通是一种随机、双盲、 使用阿司匹林减少心血管疾病的安慰剂对照试验 在22,071名美国男性中进行了一项关于癌症和β-胡萝卜素的调查。 1982年，医生的年龄在40岁到84岁之间。WHS是一个随机的，双重的- β-胡萝卜素和维生素E的盲法安慰剂对照试验 癌症和心血管疾病的一级预防，以及低剂量 阿司匹林预防心血管疾病，在40,000多人中 美国女护士，1992年年龄在50岁或以上，注册开始于 1992年夏天。所有关于白内障和AMD的自我报告都将得到证实 通过病历审查。 (主要目的是通过随机比较确定L) 补充β-胡萝卜素是否能降低男性患AMD的风险 女性，2)补充β-胡萝卜素是否降低患糖尿病的风险 男性和女性的白内障，3)补充维生素E是否会减少 女性患AMD的风险，4)补充维生素E是否会降低 女性患白内障的风险，以及5)是否隔天服用小剂量阿司匹林 降低女性患白内障的风险。预计到年末， 在随访期内将有大约1,660起事件 小灵通的白内障和AMD事件600例，以及1150例事件 世界卫生组织白内障病例和老年性黄斑变性480例。 对涉及β-胡萝卜素的随机研究的初步分析， 维生素E和阿司匹林治疗会使AMD或白内障的发病率降低 治疗组和安慰剂组。生存分析将被用于 确定AMD或白内障的发病时间是否存在差异 诊断。 老年性黄斑变性和白内障的发病率也将进行前瞻性的调查。 其他抗氧化剂，包括维生素A、C和E(男性)。其他 AMD和白内障的潜在危险因素也将是 前瞻性调查包括系统性高血压和心血管疾病 疾病、血胆固醇、血压、吸烟、饮酒 摄入量、身高、体重指数和糖尿病。

This application proposes to conduct randomized, double-blind placebo- controlled trials to test the hypothesis that supplementation with antioxidant vitamins reduces the risk of age-related macular degeneration (AMD) and cataract. This proposal includes continuation of current ongoing investigations conducted as part of the Physicians' Health Study (PHS) and expansion of these studies to include women in the newly established Women's Health Study (WHS). The PHS is a randomized, double-blind, placebo-controlled trial of aspirin use in reducing cardiovascular disease, and beta-carotene in reducing cancer, among 22,071 male U.S. physicians aged 40 to 84 years in 1982. The WHS is a randomized, double- blind, placebo-controlled trial of beta-carotene and vitamin E in the primary prevention of cancer and cardiovascular disease, and low-dose aspirin in the prevention of cardiovascular disease, among over 40,000 female U.S. nurses, aged 50 or older in 1992, with enrollment to begin in the summer of 1992. All self-reports of cataract and AMD will be confirmed by medical record review. The primary aims are to determine through randomized comparisons l) whether beta-carotene supplementation reduces the risk of AMD in men and women, 2) whether beta-carotene supplementation reduces the risk of cataract in men and women, 3) whether vitamin E supplementation reduces the risk of AMD in women, 4) whether vitamin E supplementation reduces the risk of cataract in women, and 5) whether alternate day, low-dose aspirin reduces the risk of cataract in women. It is expected that by the end of the follow-up period there will be approximately 1,660 incident cases of cataract and 600 incident cases of AMD in the PHS, and 1,150 incident cases of cataract and 480 incident cases of AMD in the WHS. The primary analysis for the randomized studies involving beta-carotene, vitamin E, and aspirin treatment will be incidence of AMD or cataract in the treatment and placebo groups. Survival analysis will be used to determine whether there is a difference in time to AMD or cataract diagnosis. The incidence of AMD and cataract will also be investigated prospectively for other antioxidants including vitamins A, C, and E (in men). Other potential risk factors for AMD and cataract which will also be investigated prospectively include systemic hypertension cardiovascular disease, blood cholesterol, blood pressure cigarette smoking, alcohol intake, height body mass index, and diabetes.