中医杂志

中医体质与疾病的相关性是中医体质学的关键科学问题之一。通过临床研究评价和验证体质与疾病的相关性,对于中医病因学和治疗学发展也具有重要意义。从临床流行病学研究的视角,分析体病相关临床研究的各种特殊性和方法学挑战,包括体病相关临床方法学研究滞后、体病关系是易受混杂因素影响的"弱相关"、体质自身的特殊性增加了体病关系研究的难度。从研究设计类型、研究对象的纳入、测量中的质量控制措施、研究数据的处理等方面,阐述体病相关临床研究的设计和实施应注意的事项并提出建议,为提高体病相关临床研究方法学质量提供参考。

The correlation between body constitution of traditional Chinese medicine(TCM) and disease is one of the key scientific issues of TCM constitutionology. Evaluating and verifying the correlation between constitution and disease through clinical research is of great significance to etiology and treatment of TCM. From the perspective of clinical epidemiology, this paper analyzed various specificities and methodological challenges in clinical research on the correlation between constitution and disease, including the lag in clinical methodological research related to constitution and diseases, the constitution and disease relationship is a "weak correlation" susceptible to confounding factors, the specificity of constitution itself increases difficulty in the research of constitution and disease relationship. From the research design type, the inclusion of research objects, the quality control measures in the measurement, the processing of research data, etc., this paper proposed the matters needing attention and related suggestions in the design and implementation of clinical research on this issue, so as to provide reference for improving the methodological quality of clinical research on the correlation between constitution and disease.