Quantitative Study Of Diagnostic Criteria For Coronary Heart Disease With Phlegm Syndrome

Objective:The purpose of this study is to determine the indicators and their weight for Coronary Heart Disease(CHD)with Phlegm syndrome on the basis of our previous literature research and expert consultation in the method of prospective,diagnostic,cross-sectional investigation.Hoping to establish a objective and quantifiable diagnostic criteria for CHD with Phlegm syndrome,to improve the diagnostic accuracy of CHD patients with Phlegm syndrome,to lay a foundation for the system of diagnosis,treatment,drug discovery and development,and curative effect evaluation,to promote the application of traditional Chinese medicine(TCM)in the clinical,and finally to promote the modernization and internationalization of TCM.Methods:The factors related to CHD with Phlegm syndrome are obtained from our previous research achievements among which 57 potential indicators are selected through the ancient literature and modern literature connected with the syndrome differentiation of CHD,and then using Delphi expert consultation method to determine the indicators of this study from the 57 differentiation elements.Through cross-sectional survey research,the related syndrome differentiation information is collected which are from eligible patients with coronary atherosclerotic heart disease from Guangdong hospital of Traditional Chinese Medicine in July 2016 to February 2017.With the reference to The Chinese Medicine New Drug Clinical Research Guiding Principles and The Diagnostic Criteria for Phlegm Syndrome of Traditional Chinese Medicine,TCM syndrome differentiation is carried on among suitable CHD patients,and then patients are devided into phlegm group and non-phlegm group briefly.Then checking the correctness and integrity of the information gathering table after the case collection is over and recording the data of qualified information collection table in the EXCEL to establish an electronic database.The mean and standard deviation is used for the statistical description of quantitative data.The t test or rank sum test is selected on the basis of normality test results.The x2 test or Fisher' s exact probability method is adopted for the test of qualitative data.With the result of syndrome differentiation as dependent variable,each syndrome elements as independent variables,to analyze the relationship between independent variable and dependent variable in the method of binary unconditioned logistic regression,then determine the indicators and their weight for CHD with Phlegm syndrome according to the results of Logistic regression.Results:128 volunteers participated in the study,and 122 information collection table of them are recorded authentic and complete and entered into the Excel database after serious re-check.1.122 patients were divided into 82 cases of phlegm syndrome group,40 cases of non-phlegm syndrome group according to their differentiation results.Phlegm syndrome,accounted for 67.21%of patients with CHD,is the main syndrome of CHD.2.The chi-square test showed that the difference on distribution of gender,merge disease(hypertension,hyperuricemia and diabetes mellitus),smoking and drinking between phlegm syndrome group and non-phlegm syndrome group was not statistically significant(All Pvalues were greater than 0.05).The age and course of the CHD was non-normally distributed within each group,a rank sum test for the comparison between two groups resulted in P>0.05,the diversity was not significant.The baseline data is balanced between two groups of patients,and is also comparable.3.The number of stable angina,unstable angina,ST-segment elevation myocardial infarction(STEMI)and non-ST-segment elevation myocardial infarction(NSTEMI)in phlegm syndrome group and non-phlegm syndrome group is 9 and 3,43 and 20,16 and 11,14 and 6 respectively,rank sum test resulted in P=0.579>0.05,there are no significant diversity between phlegm syndrome group and non-phlegm syndrome group in the type of CHD.4.The frequency of each differentiation elements is as follows:obesity(30),LDL-C?3.37mmol/L(32),drowsiness(6),greasy fur(31),slippery pulse(46),snoring(17),greasy in mouth(13),corpulent tongue(33),teeth print on the tongue(9),water tongue(11),pulse string(77),heavy head and body(12),cough up phlegm(22),choking sensation in chest(110),blockage of the stomach duct(36),dizziness(34),circumgyration(12),chest pain(72),lassitude(40),anorexia(51),nausea and vomiting(5).5.Based on the result of syndrome differentiation as the dependent variable,with the remaining signs and symptoms,objective indicators as independent variables,to do the logistic regression analysis by calculating the frequency of signs and symptoms and objective indicators that is greater than or equal to 5%.Selecting the Enter method to screen the differentiation index step by step.A total of 11 elements were selected into the regression model,regression prediction model of Coronary heart disease with phlegm syndrome are as follows:logitP=-2.638 +1.963X1+ 1.005X2 + 2.025X4 + 2.319X5 +0.665X6+0.638X7+1.573X8 + 1.765X13 + 0.507X15 + 1.405X16 + 0.43X20The results indicated that the regression coefficient of each differentiation elements in regression forecasting model are positive and X5(slippery pulse),X4(greasy fur),XI(obesity),X13(cough up phlegm),X8(corpulent tongue),X16(dizziness)are statistically significant(P<0.05),odds ratio are 10.17,7.574,7.119,5.844,4.822 and 4.075 respectively.6.Hosmer-Lemeshow test display x2=8.071,P =0.427>0.05,shows that the regression model of goodness of fit is comparatively ideal.Through the probability forecast figure found basic data in U shape distribution,for the predictive effect of phlegm syndrome and phlegm syndrome are all well,phlegm syndrome is better than that of the non-phlegm syndrome.Conclusion:The results of the study shows that greasy fur,slippery pulse,obesity,cough up phlegm have greater contribution to the diagnostic of CHD with Phlegm syndrome,and can be used as main differentiation factor of CHD with phlegm syndrome,with other elements such as corpulent tongue,dizziness and LDL-C?3.37mmol/L can be secondary indicators.Using the regression forecasting model helps to evaluate the possibility of phlegm syndrome in patients with coronary heart disease,which can be used as auxiliary method of coronary heart disease differentiation.But the study sample size is small,leading to certain instability of the parameter estimates.