冠心病稳定性心绞痛痰瘀互结证多中心、小样本、精细化临床研究方案

Study protocol for a multi-center, small sample, fineness trial of phlegm and blood stasis syndrome for coronary heart disease

关键词:  冠心病  痰瘀互结证  多中心  小样本  精细化  研究方案

Key words:  coronary heart disease  phlegm and blood stasis syndrome  multi-center,small sample  refined  study protocol

摘要:

冠状动脉粥样硬化是冠心病血管狭窄的发病基础，在中国有研究调查发现冠心病血瘀、痰浊等标实证候要素所占比例在逐年增加，冠心病痰瘀互结证成为当今冠心病的主要证候类型之一。依托国家973计划项目，选取中国7家临床单位的冠心病痰瘀互结证患者为观察人群，冠心病气阴两虚证患者为疾病对照人群，以健康人为空白对照人群，开展多中心、小样本、精细化的临床对照试验研究，检测脂质代谢、炎症介质、内皮细胞损伤、凝血功能等评价病证关系的生化指标，检测血尿代谢组学、全基因表达谱芯片，揭示冠心病痰瘀互结证的生物学基础。该方案进行了严格的入组筛选，严谨的样本采集、运输及统一检测，从量表到临床生化指标再到蛋白组学、基因组学、代谢组学的多组学分析，全面诠释了冠心病痰瘀互结证的临床生物学基础，是冠心病证候学研究的典型范例。

Abstract:

Coronary atherosclerosis is the basis of coronary artery stenosis. In China, it has been found that the proportion of both blood stasis and phlegm turbidity in coronary heart disease(CHD) is increasing year by year, and the syndromes combined with the both has become one of the main syndromes in CHD. This study, which is based on the 973 Project, selected patients from 7 Chinese clinical units with phlegm and blood stasis syndrome of CHD as the observation group, qi and yin deficiency syndrome as disease control group and healthy as control group. This study is non-randomized controlled clinical trials research of multi-center, small sample and refined. With detection of indexes evaluating the relationship between disease and syndrome, including lipid metabolism, inflammatory mediators and endothelial cell damage, blood coagulation function, and blood-urine metabonomics, whole gene expression profiling chip, this study shows the relationship between the biochemical basic systems of phlegm and blood stasis of CHD. This study has rigorous criteria, sample collection, transportation, unified detection and multi omics analysis from scale to clinical biochemistry to proteomics and metabolomics genomics. This study protocol aims to interpret the clinical biological basic of phlegm and stasis syndrome in CHD comprehensively, can be a typical example for the further studies of syndrome in CHD.