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PICNIC研究的原理与设计:针对营养不良的住院心力衰竭患者的营养干预项目。

Rationale and design of PICNIC study: nutritional intervention program in hospitalized patients with heart failure who are malnourished.

作者信息

Gámez-López Antonio L, Bonilla-Palomas Juan L, Anguita-Sánchez Manuel, Moreno-Conde Mirian, López-Ibáñez Cristina, Alhambra-Expósito Rosa, Castillo-Domínguez Juan C, Villar-Ráez Antonia, Suárez de Lezo José

机构信息

Sección de Cardiología, Servicio de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain.

Sección de Cardiología, Servicio de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain.

出版信息

Rev Esp Cardiol (Engl Ed). 2014 Apr;67(4):277-82. doi: 10.1016/j.rec.2013.07.013. Epub 2013 Nov 17.

DOI:10.1016/j.rec.2013.07.013
PMID:24774590
Abstract

INTRODUCTION AND OBJECTIVES

Hospitalized patients with heart failure who are malnourished present a worse prognosis than those with an adequate nutritional status. It is unknown whether a nutritional intervention can modify the prognosis of these patients. The aim of this study is to assess the efficacy of a nutritional intervention on morbidity and mortality in hospitalized patients with heart failure who are malnourished.

METHODS

PICNIC is a multicentre, randomized, controlled trial in which hospitalized patients with heart failure and malnutrition, as defined by the Mini Nutritional Assessment, are randomly assigned to conventional management of heart failure or conventional management of heart failure and an individualized nutritional intervention consisting of 3 points: optimization of diet, specific recommendations, and prescription, if deemed necessary, of nutritional supplements. A sample size of 182 patients for a maximum follow-up of 12 months has been estimated. The primary endpoint is time to death from any cause or rehospitalization because of heart failure. Analysis is by intention to treat.

CONCLUSIONS

PICNIC study will determine the prognostic impact of a nutritional intervention in hospitalized patients with heart failure who are malnourished.

摘要

引言与目的

营养不良的心力衰竭住院患者的预后比营养状况良好的患者更差。目前尚不清楚营养干预是否能改善这些患者的预后。本研究旨在评估营养干预对营养不良的心力衰竭住院患者发病率和死亡率的疗效。

方法

PICNIC是一项多中心、随机、对照试验,其中根据简易营养评估定义为营养不良的心力衰竭住院患者被随机分配接受心力衰竭常规管理或心力衰竭常规管理以及个体化营养干预,个体化营养干预包括3个方面:饮食优化、具体建议以及必要时开具营养补充剂处方。估计样本量为182例患者,最长随访12个月。主要终点是任何原因导致的死亡时间或因心力衰竭再次住院的时间。分析采用意向性分析。

结论

PICNIC研究将确定营养干预对营养不良的心力衰竭住院患者的预后影响。

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