Evaluation Of Clinical Efficacy Of Integrated Traditional Chinese And Western Medicine Treatment Of Stable Coronary Artery Disease Based On Real World Clinical Data

Stable coronary artery disease(SCAD),although standard drug treatments such as aspirin,statins,and angiotensin converting enzyme inhibitors can greatly improve the prognosis,there is still a high risk of residual cardiovascular events.How to further reduce the risk of recurrent adverse cardiovascular events in stable coronary heart disease has become a key issue in current research.Previous randomized controlled trials have shown that integrated traditional Chinese and western medicine can further reduce the risk of recurrent cardiovascular events of SCAD,but it is difficult to reflect the characteristics of TCM syndrome differentiation and individualized treatment.Therefore,a new measure is urgently needed to objectively evaluate the clinical effect of integrated traditional Chinese and western medicine intervention on SCAD.In recent years,the real world research(RWS)can evaluate the effect of complex interventions in clinical practice,which is in line with the characteristics of clinical practice of TCM.Undoubtedly,it brings an opportunity for the breakthrough of clinical research of TCM and integrated traditional Chinese and western medicine.Based on this,our research group adopted a prospective,multi-center,cohort study design to evaluate the clinical efficacy of integrated traditional Chinese and western medicine in patients with SCAD in the real world,and objectively evaluate the advantages of integrated traditional Chinese and western medicine in SCAD.Combined with the diagnosis and quantitative standard of toxic syndrome in stable stage of coronary artery disease(CAD),the clinical characteristics of toxic syndrome in patients with stable stage of coronary heart disease were studied,and the theory of"etiologcial toxin"was verified,so as to provide reference for clinical diagnosis and treatment of SCAD,prevention of cardiovascular thrombosis events and secondary prevention of CAD.Part 1 Clinical evaluation research on stable coronary artery disease treatment with integrated traditional Chinese and western medicine based on real world clinical dataObjective:Based on real-world clinical data to evaluate the clinical advantages of integrated traditional Chinese and western medicine in SCAD.Methods:Adopting a prospective,multi-center,cohort study design,combined with a one-year follow up,successfully enrolled 5,080 patients with SCAD,based on the length of time the patients took traditional Chinese medicine(?12 weeks/year,or those who had taken TCM for more than 12 weeks before entering the group and continued to take TCM after entering the group)is divided into the integrated traditional Chinese and western medicine group(n=2431 cases)and the western medicine group(n=2649 cases).The clinical outcome indicators are the primary composite endpoint events(cardiogenic death,non-fatal myocardial infarction,revascularization),and secondary endpoint events(all cause death,stroke,hospital admission due to unstable angina/heart failure/malignant arrhythmia),and evaluate the safety of TCM combined with western medicine according to the adverse reactions during the follow up process.Results:The two groups of patients except for body mass index,history of hypertension,history of peripheral atherosclerosis,history of stroke,history of myocardial infarction,coronary artery bypass grafting,high sensitivity Creactive protein,cold coagulation syndrome,qi stagnation syndrome,there is no significant difference in phlegm turbidity syndrome and blood stasis syndrome,and they are comparable(P>0.05),except for gender,age,smoking history,drinking history,diabetes history,hyperlipidemia history,fasting blood glucose,total cholesterol,triglycerides,there are differences in high density lipoprotein cholesterol,low density lipoprotein cholesterol,personality characteristics,and exercise frequency(P<0.05).There were 153 cases(6.29%)in the integrated traditional Chinese and western medicinegroup and 228 cases(8.61%)in the western medicine group.Compared with the western medicine group,the integrated traditional Chinese and Western medicine group could significantly reduce the occurrence of the main composite endpoint events,and the results were statistically significant(adjusted HR by Cox regression for the baseline data with difference,HR,0.72;CI,0.58-0.89;P=0.003).Forthe secondary composite endpoint,the integrated traditional Chinese and western medicine group also had a significant decrease compared with the wester medicine group,and the results were comparable(HR after adjustment of baseline data,0.81;95%CI,0.66-0.99;P=0.039).Since the occurrence of revascularizeation may be affected by subjective factors,we further compared the occurrence of "hard endpoint"events commonly used in cardiovascular trials(cardiogenic death,non-fatal myocardial infarction,stroke)and found that the combination of Chinese and Western medicine group can significantly reduce its incidence(HR after adjustment of baseline data,0.36;95%CI,0.09-0.85;P=0.010).The incidence of composite endpoint events(cardiogenic death,non-fatal myocardial infarction,revascularization,stroke,hospital admission due to unstable angina pectoris/heart failure/malignant arrhythmia)was lower in the integrated traditional Chinese and Western medicine group than in the western medicine group,but the result difference was not significant(adjusted HR,0.87;95%CI,0.73-1.04;P=0.116).Through the propensity score matching method,the integrated traditional Chinese and western medicine group(n=1097)and the western group(n=1097)were successfully matched.After matching,there was no significant difference in baseline data such as gender,age,and cardiovascular risk factors between the two groups(P>0.05),after matching,the results obtained by analyzing the clinical outcome indicators again are consistent with the above results.The integrated traditional Chinese and western medicine group has the primary endpoint(HR,0.64;95%CI,0.49-0.85;P=0.002)and the secondary endpoint(HR,0.75;95%CI,0.56-0.99;P=0.040),the incidence of "hard endpoint" events(HR,0.69;95%CI,0.43-0.92;P=0.032)was significantly lower than the western medicine group.Although the incidence of end-point events was lower in the integrated traditional Chinese and western medicine group than in the western medicine group,the difference was not significant(HR,0.93;95%CI,0.73-1.17;P=0.522).The incidence of adverse events in the integrated traditional Chinese and western medicine group was significantly lower than that in the western medicine group,and the difference was statistically significant(P<0.0001).Comparing the two groups,the incidence of skin ecchymosis and abnormal liver function in the integrated traditional Chinese and western medicine group was lower than that in the western medicine group,and the difference was statistically significant(P<0.05).Conclusion:Integrated Chinese and Western medicine treatment can significantly reduce the primary endpoint events(cardiogenic death,non-fatal myocardial infarction,and revascularization)and "hard endpoint"events(cardiogenic death,non-fatal death type myocardial infarction,stroke)of patients with SCAD during the 1-year follow up and secondary composite endpoint events(all-cause death,stroke and admission due to UA/HF/malignant arrhythmia),combination of Chinese and Western medicine did not increase the adverse reactions such as bleeding and security is worthy of further study.Part 2 The influence of SCAD with blood stasis and toxin syndrome on occurrence of cardiovascular eventsObjective:Based on real world clinical data,we study the clinical manifestations of toxin syndrome in patients with SCAD,and verify the theory of "etiological toxin",so as to give full play to the advantages of TCM in the field of CAD prevention and treatment.Methods:Adopt prospective,multi-center,cohort study design method,combined with clinical cardiovascular event follow up,to further explore the risk factors of cardiovascular events.Combining with the diagnosis and quantification criteria of"toxin" syndrome in SCAD,the clinical features of "toxin" syndrome in patients with SCAD are studied,and the theory of "etiological toxin"is verified.Results:42.73%of the 541 patients with cardiovascular events after one year of follow up were currently smoking,36.65%had a history of drinking,80.11%had hypertension,48.25%had hyperlipidemia,47.70%had diabetes;Previous CABG had 5.16%,54.14%had previous PCI history,28.55%had a history of myocardial infarction,24.49%had a history of stroke,and 32.60%had a history of peripheral atherosclerosis.The median BMI level of the patient was 25.83 kg/m2,the median fasting blood glucose level was 6.20 mmol/L,the median Hs-CRP level was 1.35 mg/L,the median level of HDL-C was 1.14 mmol/L,and the median level of LDL-C The median level of TC is 2.37mmol/L,the median level of TC is 4.05mmol/L,and the median level of TG is 1.62mmol/L.The Logistic multivariate stepwise analysis was performed,and the results showed that the Sig values of age,diabetes,hypertension,LDL-C,and TG were all<0.05,which was statistically significant and was positively correlated with cardiovascular events.According to the "Practical Diagnostic Criteria of Blood Stasis Syndrome" and"Quantitative Criteria for Diagnosis of Toxin-induced Diseases in Stable Coronary Heart Disease",987 patients with stable coronary heart disease with blood stasis syndrome and 1159 patients with blood stasis syndrome with non-toxic syndrome were screened out.Cardiovascular events occurred in 138 cases(13.98%)in the toxic syndrome group and 88 cases(7.59%)in the non-toxic syndrome group.The incidence of events in the toxic syndrome group was significantly higher than that in the non-toxic syndrome group(P<0.001).The relative risk(RR)was 1.841,the attributable risk(AR)was 6.39%,the rate of cardiovascular events,that is,the attributable risk percentage(ARR)was 45.65%,and the OR was 1.978(95%CI 1.492-2.623).From the above,it can be seen that the diagnosis of "etiological toxin" and the quantitative criteria in stable coronary heart disease can be used as the identification of high risk patients with stable coronary heart disease and the diagnosis of "etiological toxin ".The survival analysis of the two groups showed that the incidence of cardiovascular events in the toxic syndrome group was significantly higher than that of the non-toxic syndrome group,and the result was statistically significant(after adjusting the baseline data,the HR was 1.452;95%CI,1.066-1.978;P=0.018).Conclusion:1 This study found that nearly half of SCAD patients still need to improve their lifestyles through research on the risk factors of SCAD patients,and doctors still need to strengthen lifestyle and secondary prevention education for SCAD patients and popularize the knowledge of healthy life content.2 The "Diagnosis and quantification criteria for the diagnosis and quantification of disease caused by toxins in stable coronary heart disease" can be used to identify high risk patients with SCAD,giving full play to the advantages of TCM in the prevention and treatment of CAD in the field of "preventing disease prevention" and laying a foundation for further improving the level of secondary prevention of SCAD.