主 办:北 京 中 医 药 大 学
ISSN 1006-2157 CN 11-3574/R

北京中医药大学学报 ›› 2018, Vol. 41 ›› Issue (10): 848-853.doi: 10.3969/j.issn.1006-2157.2018.10.010

• 临床研究 • 上一篇    下一篇

2型糖尿病中医证候要素诊断量表的研制及考评*

赵灵燕1, 毕力夫1, 陈建新2, 赵慧辉2, 杨易2, 张亚军3, 张星光1, 王伟2#   

  1. 1 内蒙古医科大学公共卫生学院 呼和浩特 010010;
    2 北京中医药大学;
    3 内蒙古医科大学中医学院
  • 收稿日期:2018-02-12 出版日期:2018-10-30 发布日期:2018-10-30
  • 通讯作者: 王伟,男,博士,教授,博士生导师,研究方向:中医药干预心血管疾病的临床和基础研究,E-mail:wangwei@bucm.edu.cn
  • 作者简介:赵灵燕,女,博士,副教授,硕士生导师
  • 基金资助:
    国家科技重大专项重大新药创制资助项目(No.2009ZX09502),内蒙古医科大学博士启动基金资助项目(No.bsjj201411),内蒙古医科大学慢性病分子流行病学创新团队资助项目(No.YKD2017KJCXTD015)

Development and evaluation of the TCM pattern element diagnostic scale for type 2 diabetes mellitus*

Zhao Lingyan1, Bi Lifu1, Chen Jianxin2, Zhao Huihui2, Yang Yi2, Zhang Yajun3, Zhang Xingguang1, Wang Wei2#   

  1. 1 School of Public Health, Inner Mongolia Medical University, Inner Mongolia 010010, China;
    2 Beijing University of Chinese Medicine, Beijing 100029, China;
    3 School of Traditional Chinese Medicine of Inner Mongolia Medical University, Inner Mongolia 010100, China
  • Received:2018-02-12 Online:2018-10-30 Published:2018-10-30

摘要: 目的 将量表研制方法引入中医证候诊断领域,建立2型糖尿病(T2DM)中医证候要素诊断量表,探索运用量表的方法进行证候规范化研究。方法 采用多中心临床流行病学调查方法,在全国5家三级甲等医院共收集249例中医四诊信息合格的T2DM病例,统一辨证。工作小组在文献研究基础上初步确定各证候要素四诊条目池,对179例样本信息,采用相关系数、逐步回归、因子分析法联合进行条目筛选, Logistic回归法进行条目赋分,受试者工作特征(ROC)曲线法确定诊断阈值,建立T2DM中医证候要素诊断量表。运用70例样本进行量表信度、效度考评。结果 T2DM中医证候要素诊断量表包括9个证候要素,分别为:气虚证、阴虚证、内湿证、燥热证、阳虚证、血瘀证、津亏证、痰浊证、气滞证,诊断阈值分别为:11、9、8、13、8、10、12、7、4分。量表的分半信度为0.878,Cronbach’s α为0.844,因子分析提取3个公因子,累计方差贡献率69.123%,各证候要素得分与量表总分相关系数0.471~0.794。结论 T2DM中医证候要素诊断量表包括9个证候要素,具有较好的信度、效度,可用于临床或科研证候诊断,并为中医证候规范化研究提供了新的思路和方法。

关键词: 2型糖尿病, 量表, 信度, 效度, 证候

Abstract: Objective To establish a diagnostic scale of TCM pattern elements of type 2 diabetes mellitus(T2DM) by introducing the scale development method into the diagnosis of TCM patterns and to explore the standardization of TCM pattern by developing relevant scale. Methods Data obtained with TCM four diagnostic methods was collected from 249 qualified patients with T2DM in five grade 3 and first-class hospitals around the country by using a multi-center clinical epidemiology survey. Pattern differentiation was centrally made after all the information was collected. The entry pool of four TCM diagnostic methods of each pattern was initially identified on the basis of literature research. Correlation coefficient, stepwise regression and factor analysis methods were jointly used to do entry screening on the data of 179 samples. Logistic regression was conducted to do entry assignment, and ROC curve was used to determine the diagnostic threshold to establish the diagnosis scale of T2DM TCM pattern elements. 70 samples were used to do reliability and validity evaluation of the scale. Results There were nine pattern elements in T2DM Diagnostic Scale of TCM patterns, namely, pattern of qi deficiency, yin deficiency, internal dampness, dryness-heat, yang deficiency, blood stasis, liquid depletion, phlegm turbidity and qi stagnation, whose diagnostic threshold were: 11 points, 9 points, 8 points, 13 points, 8 points, 10 points, 12 points, 7 points and 4 points respectively. The split-half reliability of the scale was 0.878, and its Cronbach’sα was 0.844. Three common factors were extracted with factor analysis. The cumulative variance contribution rate was 69.123% and the correlation coefficient of the score of each pattern element to the total score was 0.471-0.794. Conclusions There are nine pattern elements in the diagnostic scale of T2DM TCM factors, which is of good reliability and validity, and can be used for clinical or research pattern diagnosis. It provides new ideas and methods for the study of TCM pattern standardization.

Key words: Type 2 diabetes, scale, reliability, validity, TCM syndrome

中图分类号: 

  • R255.4