Development Of A Diagnostic Scale For Hemorrhagic Stroke With Phlegm-heat Syndrome

Background:TCM syndrome is a complex concept,which is a pathological summary of the diseased location and disease at a certain stage in the course of the disease.It has non-linear characteristics such as dynamic,high-dimensional,and temporal and spatial stages.The diagnosis and evaluation of syndromes in the clinic mostly rely on the personal experience of the physicians,and because of the diversification and subjectivity of clinical symptoms,it is difficult to quantify the syndromes with a certain number,making the clinical differentiation of syndromes subjective and vague.And the uncertainty has affected the promotion and application of Chinese medicine.Therefore,the standardization and standardization of syndrome diagnosis has always been the focus and difficulty of TCM clinical research.Cerebral hemorrhage is a common clinical cerebrovascular disease with a high disability and fatality rate,which brings a huge burden to the patient’s family and society.Traditional Chinese medicine refers to cerebral hemorrhage as hemorrhagic stroke.Traditional Chinese medicine has unique advantages in alleviating the condition and improving the quality of life of patients.Phlegm-heat syndrome is a common syndrome of hemorrhagic stroke.The establishment of a scientific and rigorous syndrome diagnosis scale is conducive to improving the accuracy of clinical syndrome differentiation and further strengthening the standardized diagnosis and treatment of hemorrhagic stroke.Objective:Under the guidance of TCM theory and following the principles of scale development,a diagnostic scale for phlegm-heat syndrome of hemorrhagic stroke was established.Provide a relatively rigorous quantitative diagnostic tool for the diagnosis of phlegm-heat syndrome,and further improve the syndrome diagnosis system of stroke.Methods:1.Clarify the purpose of the research and establish a working group.Combine the results of previous research and expert opinions to form a information item pool.2.The method of cross-sectional survey was adopted to collect clinical data through the developed four-diagnosis information questionnaire for hemorrhagic stroke.The data of the included 469 cases were randomly divided into training set and test set at a ratio of 7:3.3.Based on the training set data,comprehensive use of frequency analysis method,correlation coefficient method,discrimination analysis method,factor analysis method,and stepwise regression method for item selection.4.Logistic regression analysis method,factor analysis method and implicit structure analysis method were used to construct syndrome diagnosis models,and the three diagnosis models were analyzed by ROC curve respectively.The pros and cons of the three diagnosis models were compared by the size of the area under the ROC curve.5.The best diagnostic model was selected by ROC curve analysis,and the diagnostic threshold when the Youden index was the largest was used as the diagnostic threshold of the scale.The diagnostic scale for phlegm-heat syndrome of hemorrhagic stroke was initially formed.6.Based on the Test set data,the diagnostic ability of the scale is evaluated through diagnostic tests,with sensitivity,specificity,diagnostic accuracy,positive likelihood ratio,negative likelihood ratio,Kappa value,etc.as the main evaluation indicators.Results:1.After screening by frequency analysis method,correlation coefficient method,discrimination analysis method,factor analysis method,stepwise regression method and other methods,9 items were finally retained,namely,flushed face,yellow coating,greasy coating,red tongue,rough breathing,snoring,phlegm in the throat,yellow and red urine,slippery pulse2.The three diagnostic models were analyzed by ROC curve,and the size of the area under the ROC curve was as follows:Logistic regression analysis method(0.962)>factor analysis method(0.958)>implicit structure analysis method(0.955).The diagnostic model constructed by logistic regression analysis was the best,the diagnostic model constructed by factor analysis was second,and the diagnostic model constructed by implicit structure analysis was the worst.3.The "Diagnostic Scale for Hemorrhagic Stroke and Phlegm-Heat Syndrome"includes 9 items,which are 5 points for flushed face,7 points for yellow fur,4 points for greasy fur,4 points for red tongue,4 points for rough breathing,and 5 points for snoring.7 points for phlegm in the throat,3 points for yellow and red urine,3 points for slippery pulse.4.After preliminary verification,the established diagnostic scale for hemorrhagic stroke with phlegm-heat syndrome has a sensitivity of 91.67%,a specificity of 90.20%,a diagnostic accuracy of 90.58%,a positive likelihood ratio of 1.29,and a negative likelihood ratio of 0.01.Kappa The value is 0.770.Conclusion:Under the guidance of TCM theory,through the implementation of the steps of clarifying the scale function,constructing the scale framework,establishing the item pool,item screening,constructing the syndrome diagnosis model,and determining the diagnostic threshold,the "Diagnostic Scale of Phlegm-Heat Syndrome in Hemorrhagic Stroke" with the characteristics of traditional Chinese medicine and clinical practice was established.Preliminary verification of the scale was carried out through diagnostic tests,and the results showed that the scale has high sensitivity,specificity and diagnostic accuracy.It shows that the scale has good feasibility,accuracy and clinical practical value,and can provide a relatively scientific and rigorous quantitative diagnostic standard for TCM clinical research on hemorrhagic stroke with phlegm-heat syndrome.The compilation process of the scale is objective and rigorous,and the compilation method conforms to the objective clinical reality.It has a certain reference value for the standardized research on the syndromes of hemorrhagic stroke in the future,and also provides a useful reference for the compilation of the TCM syndrome diagnostic scale.