SU.VI.MAX研究：一项关于抗氧化维生素和矿物质对健康影响的随机、安慰剂对照试验。

The SU.VI.MAX Study: a randomized, placebo-controlled trial of the health effects of antioxidant vitamins and minerals.

作者信息

Hercberg Serge, Galan Pilar, Preziosi Paul, Bertrais Sandrine, Mennen Louise, Malvy Denis, Roussel Anne-Marie, Favier Alain, Briançon Serge

机构信息

Institut National de la Santé et de la Recherche Médicale, Unité de Recherche Médicale INSERM/Institut National de la Recherche Agronomique/Conservatoire National des Ants et Métiers (CNAM), Paris, France.

出版信息

Arch Intern Med. 2004 Nov 22;164(21):2335-42. doi: 10.1001/archinte.164.21.2335.

DOI:10.1001/archinte.164.21.2335

PMID:15557412

Abstract

BACKGROUND

It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.

METHODS

The Supplementation en Vitamines et Mineraux Antioxydants (SU.VI.MAX) study is a randomized, double-blind, placebo-controlled primary prevention trial. A total of 13 017 French adults (7876 women aged 35-60 years and 5141 men aged 45-60 years) were included. All participants took a single daily capsule of a combination of 120 mg of ascorbic acid, 30 mg of vitamin E, 6 mg of beta carotene, 100 mug of selenium, and 20 mg of zinc, or a placebo. Median follow-up time was 7.5 years.

RESULTS

No major differences were detected between the groups in total cancer incidence (267 [4.1%] for the study group vs 295 [4.5%] for the placebo group), ischemic cardiovascular disease incidence (134 [2.1%] vs 137[2.1%]), or all-cause mortality (76 [1.2%] vs 98 [1.5%]). However, a significant interaction between sex and group effects on cancer incidence was found (P = .004). Sex-stratified analysis showed a protective effect of antioxidants in men (relative risk, 0.69 [95% confidence interval [CI], 0.53-0.91]) but not in women (relative risk, 1.04 [95% CI, 0.85-1.29]). A similar trend was observed for all-cause mortality (relative risk, 0.63 [95% CI, 0.42-0.93] in men vs 1.03 [95% CI, 0.64-1.63] in women; P = .11 for interaction).

CONCLUSIONS

After 7.5 years, low-dose antioxidant supplementation lowered total cancer incidence and all-cause mortality in men but not in women. Supplementation may be effective in men only because of their lower baseline status of certain antioxidants, especially of beta carotene.

摘要

背景

有人提出，饮食中抗氧化维生素和矿物质的摄入量较低会增加心血管疾病和癌症的发病率。然而，迄今为止，已发表的含抗氧化营养素补充剂的随机、安慰剂对照试验结果并未提供有益效果的明确证据。我们测试了营养剂量的抗氧化维生素和矿物质组合补充剂在降低普通人群癌症和缺血性心血管疾病发病率方面的疗效。

方法

抗氧化维生素和矿物质补充剂（SU.VI.MAX）研究是一项随机、双盲、安慰剂对照的一级预防试验。共纳入13017名法国成年人（7876名35至60岁的女性和5141名45至60岁的男性）。所有参与者每天服用一粒胶囊，其中含有120毫克抗坏血酸、30毫克维生素E、6毫克β-胡萝卜素、100微克硒和20毫克锌的组合，或安慰剂。中位随访时间为7.5年。

结果

两组在总癌症发病率（研究组为267例[4.1%]，安慰剂组为295例[4.5%]）、缺血性心血管疾病发病率（134例[2.1%]对137例[2.1%]）或全因死亡率（76例[1.2%]对98例[1.5%]）方面未发现重大差异。然而，发现性别与组效应在癌症发病率上存在显著交互作用（P = 0.004）。按性别分层分析显示，抗氧化剂对男性有保护作用（相对风险，0.69[95%置信区间（CI），0.53 - 0.91]），但对女性没有（相对风险，1.04[95%CI，0.85 - 1.29]）。在全因死亡率方面也观察到类似趋势（男性相对风险，0.63[95%CI，0.42 - 0.93]，女性相对风险，1.03[95%CI，0.64 - 1.63]；交互作用P = 0.11）。