Vivekananthan Deepak P, Penn Marc S, Sapp Shelly K, Hsu Amy, Topol Eric J
Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
Lancet. 2003 Jun 14;361(9374):2017-23. doi: 10.1016/S0140-6736(03)13637-9.
Oxidised LDL is thought to play an important part in the pathogenesis of atherosclerosis. Observational studies have associated alpha tocopherol (vitamin E), beta carotene, or both, with reductions in cardiovascular events, but not clinical trials. We did a meta-analysis to assess the effect of these compounds on long-term cardiovascular mortality and morbidity.
We analysed seven randomised trials of vitamin E treatment and, separately, eight of beta carotene treatment; all trials included 1000 or more patients. The dose range for vitamin E was 50-800 IU, and for beta carotene was 15-50 mg. Follow-up ranged from 1.4 to 12.0 years.
The vitamin E trials involved a total of 81788 patients and the beta carotene trials 138113 in the all-cause mortality analyses. Vitamin E did not provide benefit in mortality compared with control treatment (11.3 vs 11.1%, odds ratio 1.02 [95% CI 0.98-1.06] p=0.42) or significantly decrease risk of cardiovascular death (6.0 vs 6.0%, p=0.86) or cerebrovascular accident (3.6 vs 3.5%, p=0.31). Beta carotene led to a small but significant increase in all-cause mortality (7.4 vs 7.0%, 1.07 [1.02-1.11] p=0.003) and with a slight increase in cardiovascular death (3.4 vs 3.1%, 1.1 [1.03-1.17] p=0.003). No significant heterogeneity was noted for any analysis.
The lack of a salutary effect was seen consistently for various doses of vitamins in diverse populations. Our results, combined with the lack of mechanistic data for efficacy of vitamin E, do not support the routine use of vitamin E.
氧化型低密度脂蛋白被认为在动脉粥样硬化的发病机制中起重要作用。观察性研究已将α-生育酚（维生素E）、β-胡萝卜素或两者与心血管事件的减少相关联，但临床试验并非如此。我们进行了一项荟萃分析，以评估这些化合物对长期心血管死亡率和发病率的影响。
我们分析了七项维生素E治疗的随机试验，以及另外八项β-胡萝卜素治疗的试验；所有试验均纳入了1000名或更多患者。维生素E的剂量范围为50 - 800国际单位，β-胡萝卜素的剂量范围为15 - 50毫克。随访时间为1.4至12.0年。
在全因死亡率分析中，维生素E试验共涉及81788名患者，β-胡萝卜素试验涉及138113名患者。与对照治疗相比，维生素E在死亡率方面未显示出益处（11.3%对11.1%，优势比1.02 [95%置信区间0.98 - 1.06]，p = 0.42），也未显著降低心血管死亡风险（6.0%对6.0%，p = 0.86）或脑血管意外风险（3.6%对3.5%，p = 0.31）。β-胡萝卜素导致全因死亡率小幅但显著增加（7.4%对7.0%，1.07 [1.02 - 1.11]，p = 〈0.001〉），心血管死亡略有增加（3.4%对3.1%，1.1 [1.03 - 1.17]，p = 0.003）。任何分析均未发现显著的异质性。
在不同人群中，各种剂量的维生素均未显示出有益效果。我们的结果，再加上缺乏维生素E疗效的机制数据，不支持常规使用维生素E。
