RANDOMIZED TRIALS OF VITAMIN SUPPLEMENTS AND EYE DISEASE

本申请拟进行随机、双盲安慰剂- 对照试验，以检验补充维生素C 抗氧化维生素可降低老年性黄斑变性的风险 (AMD)白内障这项建议包括继续目前正在进行的 作为医生健康研究（PHS）的一部分进行的调查， 扩大这些研究，将妇女纳入新设立的 妇女健康研究（WHS）。PHS是一项随机、双盲、 阿司匹林用于降低心血管疾病的安慰剂对照试验 在22,071名美国男性中， 1982年，40岁至84岁的医生。WHS是一个随机的，双- 一项关于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初级预防，以及低剂量 阿司匹林在预防心血管疾病中的作用， 1992年，年龄在50岁或以上的美国女护士，从年开始注册。 1992年夏天。所有白内障和AMD的自我报告将得到证实 通过医疗记录审查。 主要目的是通过随机比较l） β-胡萝卜素补充剂是否能降低男性AMD的风险， 女性，2）β-胡萝卜素补充剂是否会降低 男性和女性的白内障，3）维生素E补充剂是否减少 女性AMD的风险，4）维生素E补充剂是否能降低 女性患白内障的风险，以及5）是否隔日、低剂量阿司匹林 降低女性患白内障的风险。预计到年底， 后续期间将有大约1 660起事件， PHS中有600例白内障和AMD病例，1，150例病例 白内障480例，AMD 480例。 对涉及β-胡萝卜素的随机研究的初步分析， 维生素E和阿司匹林治疗将是AMD或白内障的发病率 治疗组和安慰剂组。生存分析将用于 确定发生AMD或白内障的时间是否存在差异 诊断. 还将对AMD和白内障的发病率进行前瞻性研究 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， 前瞻性研究包括全身性高血压心血管 疾病，血液胆固醇，血压吸烟，酒精 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.