新英格兰医学杂志2014-01-20 11:46 PM

Primary Prevention of Cardiovascular Disease with a Mediterranean Diet 地中海饮食预防原发性心血管疾病

Abstract 论文摘要 Background Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events. 背景 观察性队列研究和二级预防试验显示坚持地中海饮食与心血管疾病风险之间呈负相关。我们进行了一项针对该饮食方式对心血管事件一级预防的随机试验。 Methods In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years. 方法 在西班牙的一个多中心试验中,我们将三种饮食之一随机分配给受测者:即地中海饮食为主且辅以额外初榨橄榄油,或地中海饮食辅以混合坚果,或是控制性饮食(建议少吃食物中的脂肪)。要求所筛选的受测者是可能得心血管疾病的高危人群但参加测试时还未得任何心血管病。参与者每季度接受个人和团体教育课程,并根据所分配组不同,分别免费提供额外初榨橄榄油,混合坚果,或者非食用的小礼物。我们将主要心血管事件的发生率(心肌梗死,卒中或心血管原因造成的死亡)作为首次终止点。我们以中期分析结果为基础,在持续随访中值时间4.8年后,停止了该实验。 Results A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported. 结果 共有7447名受测者被录取(年龄范围在55至80岁); 其中57%为女性。根据本人报告的摄入量和生物标志物的分析来看,这两组地中海饮食受测群体都很好的坚持实施了饮食干预 。首次终点事件发生在288人受测者中。与对照组相比(109项事件),被分配地中海饮食为主辅以额外初榨橄榄油的组(96项事件)多变量调整后的危险比为0.70(95%信心区间[CI],0.54至0.92),被分配地中海饮食辅以坚果的组(83项事件)多变量调整后的危险比为0.72(95%CI,0.54〜0.96)。没有节食有关的负面反应的报告。 Conclusions Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. 结论 在高心血管疾病风险的人群中,地中海饮食辅以额外橄榄油或坚果的饮食结构能降低主要心血管事件的发病率。 (Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com number, ISRCTN35739639.) (由西班牙政府卡洛斯三世研究所和其他资助;Controlled-Trials.com号为ISRCTN35739639)

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