2型糖尿病浊毒内蕴证中医诊断量表的研制及验证

Development and Verification of a Traditional Chinese Medicine Diagnostic Scale for Type 2 Diabetes Mellitus with Turbid-Toxin Accumulation Syndrome

研制2型糖尿病浊毒内蕴证中医诊断量表并验证量表性能。结合文献回顾和专家咨询方式建立候选条目池,并据此制定临床病例信息采集表。以2021年7月至2022年1月就诊于天津中医药大学第一附属医院的2型糖尿病患者为调查对象,收集有效临床病例信息采集表312份,随机分为研究组235例,验证组77例。对研究组采用区分度分析法、克朗巴赫系数法、相关系数法、逐步回归法4种统计学方法进行条目筛选,采用Logistic回归分析法和因子分析法进行条目赋权,并以受试者工作特征(ROC)曲线判定最终的诊断模型,计算约登指数确定诊断阈值,最终形成由苔浊垢(权重值为23,下同)、大便黏腻(16)、脘腹满闷(12)、面色晦暗(12)、烦躁(11)、皮肤褐色斑(11)、头重(10)、胸闷(5)8项条目组成的2型糖尿病浊毒内蕴证中医诊断量表,每项条目按照无、轻度、中度、重度的症状程度分别计为0、0.5、1.0、1.5分,总分为每项条目程度得分乘以权重值的总和,当总分达到33分时即诊断为浊毒内蕴证。通过研究组与验证组对建立的量表进行检验评价,结果显示研究组和验证组灵敏度分别为89.38%、89.47%,特异度分别为95.90%、89.74%,约登指数分别为0.85、0.79,阳性预测值分别为95.28%、89.47%,阴性预测值分别为90.70%、89.74%,诊断优势比分别为198.18、72.67,Kappa值分别为0.86、0.79,表明2型糖尿病浊毒内蕴证中医诊断量表具有较好的诊断能力。

To develop a traditional Chinese medicine(TCM)diagnostic scale for type 2 diabetes mellitus with turbid-toxin accumulation syndrome and to validate the performance of the scale.A candidate pool was established through literature review and expert consultation,and a clinical case information collection form was developed accordingly.Patients with type 2 diabetes mellitus admitted to the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from July 2021 to January 2022 were investigated,and 312 valid clinical case information collection forms were obtained,which were randomly divided into 235 cases in the study group and 77 cases in the validation group.Four statistical methods,namely,differentiation analysis,Cronbach's coefficient,correlation coefficient,and stepwise regression,were used to screen out the candidate items,and Logistic regression analysis and factor analysis were used to assign weights to the items,and the final diagnostic model was determined by the receiver operating characteristic(ROC)curve,and the diagnostic thresholds were calculated for the Yoden index.The final TCM diagnostic scale for type 2 diabetes mellitus was composed of 8 items:turbid dirt coating(with a weight value of 23,the same below),sticky stools(16),fullness in the epigastrium and abdomen(12),dark complexion(12),irritability(11),brown spots on the skin(11),heaviness of head(10),and chest stuffiness(5),and the degree score was 0,0.5,1.0,and 1.5 points corresponding to no,mild,moderate and severe symptoms,respectively.The total score was the sum of the degree score multiplied by the weighted value of each item,and when the total score reached 33 points,it is diagnosed as the turbid-toxin accumulation syndrome.The established scale was tested and evaluated in the study group and the validation group,and the results showed that the sensitivity of the study group and the validation group was 89.38%and 89.47%,with the specificity of 95.90%and 89.74%,the Yoden index of 0.85 and 0.79,the positive predictive value of 95.28%and 89.47%,the negative predictive value of 90.70%and 89.74%,the diagnostic advantage ratios of 198.18 and 72.67,and the Kappa values of 0.86 and 0.79,which indicated that the TCM diagnostic scale for turbid-toxin accumulation syndrome of type 2 diabetes mellitus showed good diagnostic ability.