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辅以特级初榨橄榄油或坚果的地中海饮食用于心血管疾病的一级预防
Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts


Ramón Estruch ... 心脑血管疾病 • 2018.06.21
相关阅读
• 撤稿和重发:地中海饮食对心血管疾病的一级预防。N Engl J Med 2013;368:1279-90 • 地中海饮食对心血管疾病的一级预防

地中海膳食心血管疾病一级预防终获肯定

 

秦晨曦,李立明*

北京大学医学部公共卫生学院

*通讯作者

 

心血管疾病在中国乃至全球造成了严重的疾病负担,是全球性公共卫生问题。目前公认不健康膳食是心血管疾病的重要生活方式危险因素之一1。20世纪60年代,研究者在希腊克里特岛发现了独特的地中海膳食与心血管疾病死亡率下降相关。随后,哈佛大学Willett等总结了地中海膳食主要以摄入橄榄油、水果、坚果、蔬菜和谷物为特点,同时适量摄入鱼肉和禽肉,较少摄入奶制品、红肉、加工肉制品、甜食,并随餐适量饮用红酒2

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摘要


背景

观察性队列研究和二级预防试验均表明,坚持地中海饮食习惯和心血管疾病风险呈负相关。

 

方法

本研究是一项在西班牙进行的多中心试验,我们将具有高心血管疾病风险,但纳入研究时未患心血管疾病的7,447例参与者(5580岁,57%为女性)随机分配到三个饮食组之一,即地中海饮食辅以特级初榨橄榄油组、地中海饮食辅以混合坚果组、对照饮食组(建议减少膳食脂肪摄入)。参与者接受每季度1次的教育课程。根据分组情况,分别向参与者提供免费的特级初榨橄榄油、混合坚果或非食品小礼物。主要终点为主要心血管事件(包括心肌梗死、卒中或心血管死亡)。中位随访4.8年后,根据预先设定的期中分析结果,停止试验。2013年,我们在《新英格兰医学杂志》报告了主要终点的结果。我们之后发现有偏离研究方案的情况,包括在未随机化的情况下纳入家庭成员,在11家研究中心中的1家,一些参与者在未随机化的情况下被分配至1个研究组,以及在另外1家研究中心,对随机化表的使用明显不一致。我们撤回之前已发表的报告,之前假设所有参与者均被随机分组,现在在不完全依赖于这一假设的情况下进行分析,并根据分析结果报告修订的效果估计值。

 

结果

共有288例参与者发生主要终点事件;地中海饮食辅以特级初榨橄榄油组、地中海饮食辅以混合坚果组和对照组分别发生96起(3.8%)、83起(3.4%)和109起(4.4%)事件。在包括所有参与者,并用基线特征和倾向评分校正的意向治疗分析中,与对照饮食相比,地中海饮食辅以特级初榨橄榄油和地中海饮食辅以坚果的风险比分别为0.69(95%置信区间[CI],0.53~0.91)和0.72(95% CI,0.54~0.95)。我们已知或怀疑研究中1,588例参与者的研究分组偏离了研究方案,将这些参与者的数据删除后,结果相似。

 

结论

在这项纳入心血管疾病高危人群的研究中,与被分配低脂饮食的参与者相比,在被分配地中海饮食辅以特级初榨橄榄油或坚果的参与者中,主要心血管事件的发生率较低(由西班牙卫生部de Salud Carlos III研究所等资助;在英国随机对照试验注册库注册号为ISRCTN35739639)。





作者信息

Ramón Estruch, M.D., Ph.D., Emilio Ros, M.D., Ph.D., Jordi Salas-Salvadó, M.D., Ph.D., Maria-Isabel Covas, D.Pharm., Ph.D., Dolores Corella, D.Pharm., Ph.D., Fernando Arós, M.D., Ph.D., Enrique Gómez-Gracia, M.D., Ph.D., Valentina Ruiz-Gutiérrez, Ph.D., Miquel Fiol, M.D., Ph.D., José Lapetra, M.D., Ph.D., Rosa M. Lamuela-Raventos, D.Pharm., Ph.D., Lluís Serra-Majem, M.D., Ph.D., Xavier Pintó, M.D., Ph.D., Josep Basora, M.D., Ph.D., Miguel A. Muñoz, M.D., Ph.D., José V. Sorlí, M.D., Ph.D., J. Alfredo Martínez, D.Pharm., M.D., Ph.D., Montserrat Fitó, M.D., Ph.D., Alfredo Gea, D.Pharm., Ph.D., Miguel A. Hernán, M.D., Dr.P.H., and Miguel A. Martínez-González, M.D., Ph.D. for the PREDIMED Study Investigators*
From the PREDIMED (Prevención con Dieta Mediterránea) Network (RD 06/0045) (R.E., J.S.-S., F.A., E.G.-G., V.R.-G., R.M.L.-R., L.S.-M., X.P., J.B., J.V.S., J.A.M., M.A.M.-G.) and Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (R.E., E.R., J.S.-S., M.-I.C., D.C., F.A., M. Fiol, J.L., R.M.L.-R., L.S.-M., X.P., J.B., J.V.S., J.A.M., M. Fitó, A.G., M.A.M.-G.), Instituto de Salud Carlos III, Madrid, the Department of Internal Medicine, Hospital Clinic (R.E.), the Lipid Clinic, Department of Endocrinology and Nutrition, Institut d’Investigacions Biomèdiques August Pi i Sunyer (E.R.), and the Department of Nutrition, Food Sciences, and Gastronomy, Faculty of Pharmacy and Food Sciences, Xarxa de Referència en Tecnologia dels Aliments, Instituto de Investigación en Nutrición y Seguridad Alimentaria (R.M.L.-R.), University of Barcelona, Institut Hospital del Mar d’Investigacions Mèdiques (M.-I.C., M. Fitó), the Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat (X.P.), and the Primary Care Division, Catalan Institute of Health, Institut Universitari d’Investigació en Atenció Primària (IDIAP)–Jordi Gol (M.A.M.), Barcelona, the Human Nutrition Department, Hospital Universitari Sant Joan, Institut d’Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Reus (J.S.-S.), the Department of Preventive Medicine, University of Valencia (D.C., J.V.S.), and the Primary Care Division, Valencia Institute of Health (J.V.S.), Valencia, the Department of Cardiology, University Hospital of Álava, Vitoria (F.A.), the Department of Preventive Medicine, University of Malaga, Malaga (E.G.-G.), Instituto de la Grasa, Consejo Superior de Investigaciones Científicas (V.R.-G.), and the Department of Family Medicine, Primary Care Division of Sevilla, San Pablo Health Center (J.L.), Seville, the Institute of Health Sciences, University of the Balearic Islands, and Hospital Son Espases, Palma de Mallorca (M. Fiol), the Research Institute of Biomedical and Health Sciences, Instituto Universitario de Investigaciones Biomédicas y Sanitarias, University of Las Palmas de Gran Canaria, Las Palmas (L.S.-M.), the Primary Care Division, Catalan Institute of Health, IDIAP–Jordi Gol, Tarragona-Reus (J.B.), and the Departments of Nutrition and Food Sciences and Physiology (J.A.M.) and Preventive Medicine and Public Health (A.G., M.A.M.-G.), University of Navarra, Pamplona — all in Spain; and the Departments of Epidemiology and Biostatistics (M.A.H.) and Nutrition (M.A.M.-G.), Harvard T.H. Chan School of Public Health, and the Harvard–MIT Division of Health Sciences and Technology (M.A.H.), Boston. Address reprint requests to Dr. Martínez-González at the Department of Preventive Medicine and Public Health, Facultad de Medicina–Clínica Universidad de Navarra, Irunlarrea 1, 31008 Pamplona, Spain, or at mamartinez@unav.es. *The PREDIMED study investigators are listed in the Supplementary Appendix, available at NEJM.org.

 

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