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采用营养保健品方法降低心血管代谢风险:使用阿默立平 Plus 的随机、双盲和交叉研究结果

Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus.

作者信息

Ruscica Massimiliano, Gomaraschi Monica, Mombelli Giuliana, Macchi Chiara, Bosisio Raffaella, Pazzucconi Franco, Pavanello Chiara, Calabresi Laura, Arnoldi Anna, Sirtori Cesare R, Magni Paolo

机构信息

Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy; Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Via Balzaretti 9, 20133 Milano, Italy.

Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy.

出版信息

J Clin Lipidol. 2014 Jan-Feb;8(1):61-8. doi: 10.1016/j.jacl.2013.11.003. Epub 2013 Nov 11.

DOI:10.1016/j.jacl.2013.11.003
PMID:24528686
Abstract

BACKGROUND

Primary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs, although a relevant role is now emerging for specific functional foods and nutraceuticals.

OBJECTIVES

The aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment.

SUBJECTS

Thirty patients with moderate dyslipidemia and metabolic syndrome (according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults) were included in an 8-week randomized, double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid (Armolipid Plus). Subsequently, they were subjected to another 8-week treatment with pravastatin 10 mg/d. This dosage was selected on the basis of its expected -20% efficacy in reducing low-density lipoprotein-cholesterol.

RESULTS

Treatment with Armolipid Plus led to a significant reduction of total cholesterol (-12.8%) and low-density lipoprotein-cholesterol (-21.1%), similar to pravastatin (-16% and -22.6%, respectively), and an increase of high-density lipoprotein-cholesterol (4.8%). Armolipid Plus improved the leptin-to-adiponectin ratio, whereas adiponectin levels were unchanged.

CONCLUSIONS

These results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment. Hence, it may be a safe and useful option, especially in conditions of moderate cardiovascular risk, in which a pharmacologic intervention may not be appropriate.

摘要

背景

尽管特定功能食品和营养保健品的相关作用正在显现,但通过改善生活方式/营养以及使用特定药物可实现一级心血管预防。

目的

本研究旨在评估营养保健品多靶点方法对中度心血管风险患者的有效性,并将其与普伐他汀治疗进行比较。

对象

30例中度血脂异常和代谢综合征患者(根据美国国家胆固醇教育计划成人高胆固醇检测、评估和治疗专家小组第三次报告)被纳入一项为期8周的随机、双盲交叉研究,服用安慰剂或含有红曲米提取物、黄连素、多廿烷醇、虾青素、辅酶Q10和叶酸的营养保健品组合(Armolipid Plus)。随后,他们接受了为期8周的普伐他汀10mg/d治疗。该剂量是根据其预期降低低密度脂蛋白胆固醇20%的疗效选择的。

结果

服用Armolipid Plus治疗可使总胆固醇显著降低(-12.8%)和低密度脂蛋白胆固醇显著降低(-21.1%),与普伐他汀相似(分别为-16%和-22.6%),并使高密度脂蛋白胆固醇升高(4.8%)。Armolipid Plus改善了瘦素与脂联素的比值,而脂联素水平未改变。

结论

这些结果表明,这种营养保健品方法显示出与普伐他汀治疗相当的降脂活性。因此,它可能是一种安全有效的选择,特别是在中度心血管风险的情况下,此时药物干预可能不合适。

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