Lancet. 1999 Aug 7;354(9177):447-55.
There is conflicting evidence on the benefits of foods rich in vitamin E (alpha-tocopherol), n-3 polyunsaturated fatty acids (PUFA), and their pharmacological substitutes. We investigated the effects of these substances as supplements in patients who had myocardial infarction.
From October, 1993, to September, 1995, 11,324 patients surviving recent (< or = 3 months) myocardial infarction were randomly assigned supplements of n-3 PUFA (1 g daily, n=2836), vitamin E (300 mg daily, n=2830), both (n=2830), or none (control, n=2828) for 3.5 years. The primary combined efficacy endpoint was death, non-fatal myocardial infarction, and stroke. Intention-to-treat analyses were done according to a factorial design (two-way) and by treatment group (four-way).
Treatment with n-3 PUFA, but not vitamin E, significantly lowered the risk of the primary endpoint (relative-risk decrease 10% [95% CI 1-18] by two-way analysis, 15% [2-26] by four-way analysis). Benefit was attributable to a decrease in the risk of death (14% [3-24] two-way, 20% [6-33] four-way) and cardiovascular death (17% [3-29] two-way, 30% [13-44] four-way). The effect of the combined treatment was similar to that for n-3 PUFA for the primary endpoint (14% [1-26]) and for fatal events (20% [5-33]).
Dietary supplementation with n-3 PUFA led to a clinically important and statistically significant benefit. Vitamin E had no benefit. Its effects on fatal cardiovascular events require further exploration.
关于富含维生素E（α-生育酚）、n-3多不饱和脂肪酸（PUFA）及其药物替代品的益处，证据存在冲突。我们研究了这些物质作为补充剂对心肌梗死患者的影响。
从1993年10月至1995年9月，11324例近期（≤3个月）心肌梗死存活患者被随机分配接受n-3多不饱和脂肪酸补充剂（每日1克，n = 2836）、维生素E（每日300毫克，n = 2830）、两者联合补充剂（n = 2830）或不补充（对照组，n = 2828），为期3.5年。主要联合疗效终点为死亡、非致命性心肌梗死和中风。意向性分析根据析因设计（双向）和治疗组（四向）进行。
n-3多不饱和脂肪酸治疗可显著降低主要终点风险，但维生素E无此作用（双向分析相对风险降低10%[95%CI 1 - 18]，四向分析为15%[2 - 26]）。获益归因于死亡风险降低（双向14%[3 - 24]，四向20%[6 - 33]）和心血管死亡风险降低（双向17%[3 - 29]，四向30%[13 - 44]）。联合治疗对主要终点（14%[1 - 26]）和致命事件（20%[5 - 33]）的效果与n-3多不饱和脂肪酸相似。
膳食补充n-3多不饱和脂肪酸带来了临床上重要且具有统计学意义的益处。维生素E无益处。其对致命心血管事件的影响需要进一步探索。
