Evaluation Research Of The Criterion Of Syndrome Differentiation And Quantification For Stable Coronary Heart Disease Caused By Etiological Toxin Of Chinese Medicine

Backround Current study demonstrates that pathological products such as vascular endothelial damage, tissue necrosis and inflammatory mediator involving in the process of rupture of the vulnerable plaqueand thrombosis are closely related with etiological toxin of Chinese medicine. According to the features and dangers of acute cardiovascular events(ACE), The key pathogenesis of ACE is the blood stasis and toxin causing catastrophe, which is based on clinical experience., and establish a criterion of differentiation and diagnosis for stable coronary heart disease(CHD) caused by etiological toxin of Chinese medicine.Clinical Study I Diagnostic Standard Evaluation of the criterion of syndrome differentiation and quantification for stable CHD caused by etiological toxin of Chinese medicineObjective To evaluate the validity, reliability and clinical applicability of the criterion of syndrome differentiation and quantification for stable coronary heart disease caused by etiological toxin of Chinese medicine.Methods A total of2700CHD patients after PCI were selected from40hospitals. Sensitivity, specificity, accuracy, positive likelihood ratio and area under ROC curve were used to evaluate the validity of the diagnostic; Kappa value was used to evaluate the reliability; Positive predictive value and negative predictive value were used to evaluate the clinical applicability.Results Sensitivity, specificity, accuracy, positive likelihood ratio, area under ROC curve, Kappa value, positive predictive value and negative predictive value of the criterion of syndrome differentiation and quantification for stable coronary heart disease caused by etiological toxin of Chinese medicine were as follows:91.17%,93.91%,14.9703,93.04%,0.946,0.8415,87.51%,95.78%.The main indicators in the criterion were analyzed respectively, their Sensitivity, specificity, accuracy, positive likelihood ratio, area under ROC curve, Kappa value, positive predictive value and negative predictive value were as follows:Moderate to severe angina:93.54%,91.78%,11.38,92.63%,0.9,0.8525,91.37%,93.86%; severe bitter taste:90.01%,78.36%,4.1604,81.26%,0.779,0.5768,57.91%,95.96%;Old tongue:83.73%,76.71%,3.5956,79.44%,0.571,0.583,69.62%,88.09%; Blue or blue and purple tongue:90.62%,90.38%,9.4205,90.48%,0.911,0.8063,87.50%,92.84%; peeling coating:97.95%,99.57%,227.322,99.48%,0.939,0.853,92.86%, 99.88%; Sublingual collaterals:90.23%,92.79%,12.5091,91.96%,0.913,0.8186,85.61%,95.23%。The secondary indicators in the criterion were also analyzed respectively, their Sensitivity, specificity, accuracy, positive likelihood ratio, area under ROC curve, Kappa value, positive predictive value and negative predictive value were as follows: Hs-CRP>3mg/L:88.19%,96.21%,23.28333,94.07%,0.933,0.8478,89.44%,95.73%; Fibrinogen significantly increased in the short term:90.56%,85.92%,6.4331,87.96%,0.857,0.7579,83.46%,92.07%; CD62P significantly increased in the short term95.65%,96.53%,27.60248,96.31%,0.901,0.9046,90.41%,98.48%; History of high cholesterol:91.63%,84.66%,15.0558,87.37%,0.943,0.7417,79.19%,94.07%, History of hypertension:84.78%,78.53%,13.949,80.96%,0.938,0.6126,71.57%,89.00%; History of diabetes, FBG>7.0mmol/L:95.28%,92.09%,12.0415,53.30%,0.939,0.8744,94.99%,92.09%.Conclusion The validity, reliability and clinical applicability of the criterion of syndrome differentiation and quantification for stable coronary heart disease caused by etiological toxin of Chinese medicine are rational and considerable in clincal practice.In the criterion, Moderate to severe angina, Blue or blue and purple tongue, peeling coating, Sublingual collaterals, Hs-CRP>3mg/L, Fibrinogen significantly increased in the short term, CD62P significantly increased in the short term, History of high cholesterol, History of diabetes, FBG>7.0mmol/L have high validity, reliability and clinical applicability for the diagnosis of toxin; and also Severe bitter taste, Old tongue, History of hypertension have a certain validity, reliability and clinical applicability.Clinical Study Ⅱ Exploration of the clinical manifestations of toxin in stable CHDObjective To explore the clinical manifestations of toxin in stable coronary heart disease on the basis of criterion of syndrome differentiation and quantification for stable coronary heart disease caused by etiological toxin of Chinese medicine by using Modern statistical analysis.Methods Using the criterion, the clinical data of patients with stable CHD after PCI were in correlation analysis. Results A total of2700patients with stable CHD after PCI were selected from40hospitals,17patients were excluded for missing clinical data, and eventually2683patients aged59.85±9.63in average were enrolled, which had1795males and888females. Univariate analysis showed the following33indicators contribute to toxin of stable CHD:Age>55, Smoking, Drinking, Chest pain, Sticky in mouth, Light and dark tongue, Lilac tongue, Dark red tongue, Old tongue, Thick coating, Greasy coating, Deep pulse, Rapid pulse, Thready pulse et al. PLT,LDL-C, Fbg were higher in stable CHD patients with toxin than without toxin. Binary Logistic regression showed that Hs-CRP,Chest pain, Light and dark tongue, Sublingual collaterals, Peeling coating, Fibrinogen significantly increased in the short term, CD62P significantly increased in the short term, History of high cholesterol, History of hypertension, History of diabetes, FBG>7.0mmol/L, Severe bitter taste, Old tongue were correlated significantly with Toxin.Conclusion Hs-CRP,Chest pain, Light and dark tongue, Sublingual collaterals, Peeling coating, Fibrinogen significantly increased in the short term, CD62P significantly increased in the short term, History of high cholesterol, History of hypertension, History of diabetes, FBG>7.0mmol/L, Severe bitter taste, Old tongue were correlated significantly with Toxin.Clinical Study III Correlation Studies between severity of toxin and Chinese medicines for activating blood and removing blood stasis in stable CHDObjectives To vertify the etiology and pathogenesis of Stable Coronary Heart Disease was "Stable Coronary Heart Disease caused by Toxin, which was caused by blood stasis, Recovered when the blood stasis and toxin removed ".Methods A multi-center, large samples, prospective cohort study was adopted in the trial. All patients were given corresponding treatment according to their group. Integrated Group was given promoting blood and removing stasis drugs,6months, and standard western therapy,12months; Western Group was experiment group was given standard western therapy,12months. End points and degree of reducing toxin were the primary efficacy index, the TCM symptom score, Blood Sydrome score(BBS) and SAQ scale score were the secondary efficacy index. The follow-up times were the6th and12th monthResults A total of1956cases were involved in the study, who did not match due to age or to meet the exclusion criteria presented79cases, shedding69cases, and ultimately into the1808cases. Baseline balanced distribution between the2Groups by using propensity score. The primary efficacy evaluation in the6th and12th month: Toxin reducing rate, End points Occurrence, the TCM symptom scores, BSS, SAQ scale scores had statistically significant difference in2Groups (P<0.05),which also had statistically significant difference in each Group (P<0.05)Conclusion The degree of toxin was reduced and prognosis was improved partly in stable CHD by promoting blood and removing stasis drugs and standard western therapy, meanwhile, TCM symptom, the degree of BBS and Quality of life were also improved. It also proved the etiology and pathogenesis of Stable Coronary Heart Disease caused by Toxin of Chinese medicine was ""Stable Coronary Heart Disease caused by Toxin, which was caused by blood stasis, Recovered when the blood stasis and toxin removed",by Pathogenesis Differentiation through Drugs Effect Assessment...