Rapola J M, Virtamo J, Ripatti S, Huttunen J K, Albanes D, Taylor P R, Heinonen O P
National Public Health Institute, Helsinki, Finland.
Lancet. 1997 Jun 14;349(9067):1715-20. doi: 10.1016/S0140-6736(97)01234-8.
Epidemiological data suggest that the intake of antioxidants such as alpha-tocopherol (vitamin E) and beta-carotene has an inverse correlation with the incidence of coronary heart disease. The results from clinical trials of antioxidant supplementation in people with known coronary heart disease are inconclusive.
We studied the frequency of major coronary events in 1862 men enrolled in the alpha-tocopherol beta-carotene Cancer Prevention Study (smokers aged between 50 and 69 years) who had a previous myocardial infarction. In this randomised, double-blind. placebo-controlled study, men had received dietary supplements of alpha-tocopherol (50 mg/day), beta-carotene (20 mg/day), both, or placebo. The median follow-up was 5.3 years. The endpoint of this substudy was the first major coronary event after randomisation. Analyses were by intention to treat.
424 major coronary events (non-fatal myocardial infarction and fatal coronary heart disease) occurred during follow-up. There were no significant differences in the number of major coronary events between any supplementation group and the placebo group (alpha-tocopherol 94/466; beta-carotene 113/461; alpha-tocopherol and beta-carotene 123/497; placebo 94/438 [log-rank test, p = 0.25]). There were significantly more deaths from fatal coronary heart disease in the beta-carotene (74/461, multivariate-adjusted relative risk 1.75 [95% CI 1.16-2.64], p = 0.007) and combined alpha-tocopherol and beta-carotene groups (67/497, relative risk 1.58 [1.05-2.40], p = 0.03) than in the placebo group (39/438), but there was no significant increase in the alpha-tocopherol supplementation group (54/466, relative risk 1.33 [0.86-2.05], p = 0.20).
The proportion of major coronary events in men with a previous myocardial infarction who smoke was not decreased with either alpha-tocopherol or beta-carotene supplements. In fact, the risk of fatal coronary heart disease increased in the groups that received either beta-carotene or the combination of alpha-tocopherol and beta-carotene; there was a non-significant trend of increased deaths in the alpha-tocopherol group. We do not recommend the use of alpha-tocopherol or beta-carotene supplements in this group of patients.
流行病学数据表明，摄入抗氧化剂如α-生育酚（维生素E）和β-胡萝卜素与冠心病发病率呈负相关。在已知患有冠心病的人群中补充抗氧化剂的临床试验结果尚无定论。
我们研究了1862名曾患心肌梗死、参加α-生育酚β-胡萝卜素癌症预防研究的男性（年龄在50至69岁之间的吸烟者）发生主要冠状动脉事件的频率。在这项随机、双盲、安慰剂对照研究中，男性接受了α-生育酚（50毫克/天）、β-胡萝卜素（20毫克/天）、两者联合或安慰剂的膳食补充剂。中位随访时间为5.3年。该亚研究的终点是随机分组后首次发生的主要冠状动脉事件。分析采用意向性分析。
随访期间发生了424例主要冠状动脉事件（非致命性心肌梗死和致命性冠心病）。任何补充剂组与安慰剂组之间主要冠状动脉事件的数量均无显著差异（α-生育酚组94/466；β-胡萝卜素组113/461；α-生育酚和β-胡萝卜素组123/497；安慰剂组94/438[对数秩检验，p = 0.25]）。β-胡萝卜素组（74/461，多变量调整相对风险1.75[95%可信区间1.16 - 2.64]，p = 0.007）和α-生育酚与β-胡萝卜素联合组（67/497，相对风险1.58[1.05 - 2.40]，p = 0.03）中死于致命性冠心病的人数显著多于安慰剂组（39/438），但α-生育酚补充剂组（54/466，相对风险1.33[0.86 - 2.05]，p = 0.20）无显著增加。
对于曾患心肌梗死的吸烟男性，补充α-生育酚或β-胡萝卜素均未降低主要冠状动脉事件的比例。事实上，接受β-胡萝卜素或α-生育酚与β-胡萝卜素联合补充剂的组中，致命性冠心病的风险增加；α-生育酚组有死亡增加的非显著趋势。我们不建议在这类患者中使用α-生育酚或β-胡萝卜素补充剂。
