糖尿病性冠心病湿热证诊断标准的量化诊断研究

Quantitative Diagnosis Research of Dampness-Heat Syndrome with Diabetic Coronary Heart Disease

目的建立糖尿病性冠心病湿热证的量化诊断标准,为临床实践和证候量化诊断研究提供依据。方法通过检索中国知网(CNKI)、万方数据、维普(VIP)数据库、中国生物医学文献服务系统(SinoMed)等与糖尿病性冠心病湿热证相关文献数据库,同时补充以图书形式出版的标准和医案专著,对文献进行提取分析并建立症状条目池。构建德尔菲问卷,进行德尔菲法专家调查,从条目池中筛选出诊断糖尿病性冠心病的关键条目并确定其权重赋值。开展多中心的横断面调查,采用诊断性试验方式确定诊断阈值。结果共纳入各类文献24篇,经过对术语的提取、拆分和归并后,建立了包含52个症状和13条舌脉象的症状条目池。经两轮德尔菲法专家调查后确定核心条目17个,并按条目不同的均数区间分别赋予3分、2分、1分的权重。由广东、陕西等地的医院收集了376例糖尿病性冠心病患者的临床资料,通过计算约登指数确定16分是本标准最佳诊断阈值,此时的敏感度为0.809,特异度为0.958,受试者工作特征曲线(Receiver Operator Characteristic Curve,ROC)下面积为0.943。结论本研究确定了首个糖尿病性冠心病湿热证的量化诊断标准,可为临床诊断糖尿病性冠心病湿热证提供依据,研制过程对中医证候规范研究具有借鉴意义。

Objective To establish quantitative diagnostic criteria for the dampness-heat syndrome with diabetic coronary heart disease,providing a basis for clinical practice and syndrome diagnosis.Methods By searching various literature databases,including China CNKI,Wanfang data,VIP database,and China biomedical literature service system(SinoMed),as well as supplementing with standard publications and monographs in book form,relevant to the dampness-heat syndrome with diabetic coronary heart disease.Literature was extracted and analyzed to establish a pool of symptom entries.A Delphi questionnaire was constructed to conduct expert surveys using the Delphi method,selecting key items for the diagnosis of diabetic coronary heart disease and determining their weight values.The multicenter cross-sectional survey was conducted,to determine the diagnostic threshold using diagnostic tests.Results A total of 24 articles were included,and after extracting,splitting,and merging terms,a symptom item pool containing 52 symptoms and 13 tongue-pulse manifestations was established.After two rounds of Delphi expert surveys,17 core items were determined,and different average ranges were assigned weights of 3,2,and 1 points.Clinical data of 376 patients with diabetic coronary heart disease were collected from hospitals in Guangdong and Shaanxi provinces.By calculating the Youden index,a diagnostic threshold of 16 points was determined as the optimal cutoff value for this standard,with a sensitivity of 0.809,specificity of 0.958,and an area under the receiver operating characteristic curve(ROC)of 0.943.Conclusion This study established the first quantitative diagnostic standard for the dampness-heat syndrome with diabetic coronary heart disease.It provided a basis for the clinical diagnosis of this syndrome and the development process had reference significance for the traditional Chinese medicine syndrome specification.