Systematic Study Of Diagnostic Standard Of Traditional Chinese Medicine Syndrome In Coronary Heart Disease Patients After Percutaneous Coronary Intervention

Part1Traditional Chinese Medicine Syndrome Typing Standards for Patients with Coronary Heart Disease after Percutaneous Coronary InterventionObjective:To summarize the distribution laws of traditional Chinese medicine (TCM) syndrome of patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI) and to establish the CMsyndrome typing standards, thus analyzing its feasibility and practicability by experts’questionnaire.Methods:According to our previous results, we have formulated the experts’ questionnaire, carried out a survey of105experts from45hospitals in17provinces and municipalities across China, and established the Epidata Database. Data were analyzed using SPSS13.0, thus summarizing the TCM syndrome types in patients with CHD after PCI. The syndrome typing standards were established, and its feasibility and practicability were analyzed.Results:Totally105questionnaires were distributed and recruited. Of which,103were effective. The effective rate was98.1%. According to the frequency of the syndrome types, the cumulative percent≥80%and coefficient of variation (CV)≤0.40could be taken as the standards for main syndrome types, and they were blood stasis syndrome, qi deficiency syndrome, and sputum turbidity syndrome. Symptoms with the cumulative percent≥80%and coefficient of variation (CV)≤0.40could be taken as elements supporting the diagnosis of this syndrome type. The approval of the questionnaire was reflected by the percentage.Conclusion:The reliance for the TCM syndrome typing of patients with CHD after PCI was provided by summarizing103TCM experts in the field of cardiovascular diseases. Part2Diagnostic Standard Evaluation of Traditional Chinese Medicine Syndrome with Coronary Heart Disease after Percutaneous Coronary InterventionObjective:To evaluate the validity, reliability and clinical applicability of traditional Chinese medicine (TCM) syndrome diagnostic standard with coronary heart disease (CHD) after percutaneous coronary intervention (PCI), what was established by expert consultation.Methods:A total of1050CHD patients after PCI were selected from23hospitals. Sensitivity, specificity, accuracy, positive likelihood ratio and area under ROC curve were used to evaluate the validity of the diagnostic. Observe agreement rate and Kappa value were used to evaluate the reliability. Positive predictive value and negative predictive value were used to evaluate the clinical applicability.Results:The sensitivity, specificity, accuracy, positive likelihood ratio, area under ROC curve, observe agreement rate, Kappa value, positive predictive value and negative predictive value of each TCM syndrome in CHD patients after PCI were as follows:95.26%、93.70%、94.86%、15.13、0.924、98.76%、0.969、97.76%、87.24%(blood stasis syndrome),96.42%、95.34%、96%、20.70、0.957、99.52%、0.990、97.02%、94.42%(Qi deficiency syndrome),88.19%、96.46%、94.19%、24.89、0.923、96.67%、0.915、90.39%、95.58%(phlegm syndrome),91.06%、98.77%、97.05%、74.22、0.95、98.67%、0.960、95.54%、97.46%(cardiac blood stasis syndrome),98.41%、96.73%、97.33%、30.10、0.976、98.86%、0.976、94.40%、99.09%(Qi deficiency blood stasis syndrome),94.81%、94.75%、94.76%、18.07、0.948、97.71%、0.918、72.73%、99.20%(sputum-stasis stagnation syndrome).Conclusion:The validity, reliability and clinical applicability of TCM syndrome diagnostic standard for CHD patients after PCI are rational and considerable in clinical practice. Part3Chinese medicines for activating blood and removing blood stasis on the clinical outcome after percutaneous coronary intervention:a meta-analysis of randomized controlled trials Objective:To systematically evaluate the efficacy of Chinese medicines (CM) for activating blood and removing blood stasis (ABRBS) in reducing cardiovascular events in coronary heart disease (CHD) patients after percutaneous coronary intervention (PCI).Methods:Clinical randomized controlled trials on the efficacy of CM for ABRBS that was approved by State Food and Drug Administration for CHD patients after PCI were reviewed. The literature published during September1979to September2012, without limitation of blinding method and language, was collected from Cochrane Library, clinical trial registration database, US National Library of Medicine of PubMed, ChinaInfo, China National Knowledge Infrastructure (CNKI), Chinese Biological Medical literature database CBM, China Science and Technology Journal Database VIP, China Proceedings of Conference Full-text Database, and Chinese Doctoral Dissertations&Master’s Theses Full-Text Databases. The primary end point was a composite of recurrent angina pectoris, myocardial infarction, cardiac death, heart failure, and the secondary end point was restenosis. Quality evaluation was performed for the literature according to Jadad scoring method, and Meta-analysis was carried out using Review Manager (RevMan)5.2software.Results:A total of26randomized controlled trials on combined use of CM with western medicine (WM) with Jadad scores>2were included. In comparison to the WM alone, the combined treatments significantly reduced the events of the primary composite end point (RR=0.28,95%CI[0.23,0.35], P<0.01) and restenosis (RR=0.41,95%CI[0.32,0.52], P<0.01), the recurrence rate of angina pectoris (RR=0.33,95%CI[0.26,0.41], P<0.01), acute myocardial infarction (RR=0.28,95%CI[0.15,0.51], P<0.01), cardiac death (RR=0.29,95%CI[0.09,0.88], P=0.03) and heart failure (RR=0.22,95%CI[0.09,0.56], P=0.001).Conclusion:Combined use of CM with WM reduced cardiovascular events in CHD patients after PCI.