“冠心病中医病因及证候临床流行病学调查＂的研究方案

背景：冠心病属于临床常见疾病,具有较高的发病率和死亡率,严重威胁人类的健康和生命。中医药在冠心病的预防和治疗中发挥着重要作用,通过临床流行病学调查,掌握冠心病的中医病因和证候分布特征,将有利于进一步提高该病的中医临床疗效。 方法与设计：经过文献回顾与分析,初步建立冠心病中医病因及证候临床流行病学调查表,然后通过多次临床预调查及专家咨询、论证,制定正式的冠心病中医病因及证候临床流行病学调查表,并制订实施方案、相关规范及质量控制措施。采用冠心病中医病因及证候临床流行病学调查表在全国范围内开展多地域、大样本的冠心病中医临床流行病学调查研究。 讨论：通过多地域、大样本的冠心病中医临床流行病学调查,了解我国冠心病的中医病因及证候分布特征,可为冠心病的临床预防及中医辨治提供参考与依据,也有利于提高中医病证研究的科学化与规范化水平。 临床试验注册号：研究方案于2011年11月27日在中国临床试验注册中心进行中英文注册,注册号为ChiCTR-ECS-11001728。

Clinical epidemiology survey of the traditional Chinese medicine etiology and syndrome differentiation of coronary artery disease: study protocol of a multicenter trial

BACKGROUND： Coronary artery disease （CAD）, a common disease with high incidence and mortality rate, has seriously threatened the health and life of the public. Traditional Chinese medicine （TCM） has an important role in the prevention and treatment of this disease. Through clinical epidemiological survey, a deeper understanding of TCM etiology and syndrome characteristics in CAD would further improve clinical efficacy in the treatment of this disease.
METHODS/DESIGN： The preliminary clinical questionnaire for TCM etiology and syndrome differentiation in CAD was designed after literature reviews and analysis. Through a series of clinical pre-surveys, expert consultation and demonstration, the formal TCM clinical epidemiology questionnaire on the etiology and syndrome differentiation in CAD was finalized, after which, the study protocol, inclusive and exclusive criteria and related quality control measures were prepared. The multiregional clinical epidemiological survey with more than 5 000 participants with CAD will be carried out in 41 TCM hospitals of China for investigating the TCM etiology and syndrome differentiation of CAD.
DISCUSSION： Multiregion large sample size clinical epidemiology survey on TCM etiology and syndrome differentiation in CAD will provide further evidence in preventing CAD and improving the standardization process of syndrome research.
TRIAL REGISTRATION： This study protocol was registered at the Chinese Clinical Trial Registry on November 27, 2011 in both Chinese and English editions and the registration number is ChiCTR-ECS-11001728.