纯中药“辨病-辨证-辨体诊疗模式”治疗2型糖尿病患者546例临床特征分析——一项真实世界回顾性研究

Analysis of Clinical Characteristics of 546 Patients with Type 2 Diabetes Mellitus Treated by Pure Chinese Medicine based on“Disease-syndrome-constitution Differentiation and Treatment Mode”:A Real-world Retrospective Study

目的基于真实世界临床数据探讨应用纯中药“辨病-辨证-辨体诊疗模式”治疗的2型糖尿病(T2DM)患者的临床特征,为临床实践提供参考。方法收集2018年8月至2020年8月在全国5家医院HIS系统中应用纯中药“辨病-辨证-辨体诊疗模式”治疗的T2DM患者共546例,采集患者的基本特征、中医病名、中医证候诊断、西医诊断、病程等信息,分析患者年龄、病程、合并疾病及中医辨病、辨证、辨体质情况,分析不同证型患者性别及年龄特征、不同性别及年龄段患者证型分布特征、不同中医诊断患者中医证型分布特征、不同病程阶段患者中医证型分布特征。结果546例患者年龄18~85岁,其中18~<60岁者共425例(77.84%);病程从首次确诊至25年,初诊期病例188例,早期病例233例,共占77.11%。合并疾病排名前5位为高脂血症(293例,53.66%)、高血压病(195例,35.71%)、动脉粥样硬化(122例,22.34%)、脂肪肝(118例,21.61%)、冠心病(74例,13.55%)。中医诊断包括消渴病298例(54.58%),其次分别是上消病124例(22.71%),脾瘅病83例(15.20%),下消病26例(4.76%),中消病15例(2.75%)。除无明显中医证候的83例脾瘅病患者外,463例患者证型包括气阴两虚证216例(39.56%),痰浊中阻证128例(23.44%)、肝郁脾虚证73例(13.37%)、脾肾气虚证22例(4.03%)、湿热内蕴证13例(2.38%)、热盛伤津证11例(2.02%);脾瘅病83例中,痰湿质56例(10.26%),气郁质19例(3.48%),阴虚质5例(0.91%),气虚质3例(0.55%)。不同性别、年龄证型分布差异有统计学意义(P<0.01)。痰浊中阻证男性多于女性,肝郁脾虚证女性多于男性。脾肾气虚证平均年龄大于湿热内蕴证(P<0.01)。结论应用纯中药“三辨诊疗模式”治疗的T2DM患者以病程小于5年的初诊期、早期为主,年龄多分布在18~<60岁,辨证以气阴两虚证、痰浊中阻证、肝郁脾虚证多见,辨体质以痰湿质为主。

ObjectiveTo analyze the clinical characteristics of real-world patients with type 2 diabetes mellitus(T2DM)treated with pure Chinese medicine based on“disease-syndrome-constitution differentiation and treatment mode”,thereby providing reference for clinical practice.Methods A total of 546 T2DM patients were collected from five hospitals in China who were treated with pure traditional Chinese medicine(TCM)based on“disease-syndrome-constitution differentiation and treatment mode”from August 2018 to August 2020.The basic characteristics,TCM disease name,TCM syndrome diagnosis,western medicine diagnosis,disease course and other information of the patients were collected,and the age,disease course,comorbid diseases,disease differentiation,syndrome differentiation and constitution differentiation were analyzed.In addition,the gender and age characteristics among patients with different TCM syndrome types,as well as the TCM syndrome characteristics among patients with different gender and age,different TCM diagnosis,and different disease course were analyzed.Results The 546 patients ranged from 18 to 85 years old,and 425 patients(77.84%)were aged 18 to<60 years old.The disease course was from the initial diagnosis to 25 years long,of which 188 cases were at the initial diagnosis and 233 cases at the early stage of the disease,accounting for 77.11%of the total.The most common comorbid diseases were hyperlipidemia(293 cases,54.58%),hypertension(195 cases,22.71%),atherosclerosis(122 cases,22.34%),fatty liver(118cases,21.61%),and coronary heart disease(74 cases,13.55%).In terms of TCM diagnosis,there were 298 cases of xiao ke(消渴)(54.58%),followed by 124 cases of xiao ke of the upper jiao(焦)(22.71%),83 cases of splenic pure heat(15.20%),26 cases of xiao ke of the lower jiao(4.76%),and 15 cases of xiao ke of the middle jiao(2.75%).Except for 83 patients with splenic pure heat who had no obvious TCM syndromes,the rest 463 patients were involved with six types,including deficiency of both qi and yin syndrome(216 cases,39.56%),turbid phlegm obstructing the middle jiao syndrome(128 cases,23.44%),liver constraint and spleen deficiency syndrome(73 cases,13.37%),spleen-kidney qi deficiency syndrome(22 cases,4.03%),damp-heat internal accumulation syndrome(13 cases,2.38%),and excessive heat injuring fluid syndrome(11 cases,2.02%).Of the 83 splenic pure heat cases,there were 56 phlegm-damp constitution(10.26%),19 qi constraint constitution(3.48%),5 yin deficiency constitution(0.91%)and 3 qi deficiency constitution(0.55%).There were statistically significant differences in TCM syndromes in terms of different genders and ages(P<0.01).Turbid phlegm obstructing the middel jiao syndrome was more common in male than female,while the liver constraint and spleen deficiency syndrome was more frequent in female.The average age of patients with spleen-kidney qi deficiency syndrome was greater than that of patients with damp-heat internal accumulation syndrome(P<0.01).Conclusion The T2DM patients treated with pure Chinese medicine based on"disease-syndrome-constitution differentiation and treatment mode”are mainly at the initial diagnosis stage and early stage with less than 5 years of the disease course,and most of them are aged 18 to<60years old.Deficiency of both qi and yin syndrome,turbid phlegm obstructing the middle jiao syndrome,and liver constraint and spleen deficiency syndrome are commonly seen,while the phlegm damp constitution is the most frequent.