The Method And Key Technology Of Cohort Study For Evaluating Clinical Efficacy Of Traditional Chinese Medicine

Objective:1.To analyze the current status and problems of the research on the clinical efficacy evaluation of TCM in China,summarize the methods and key technical points of TCM clinical efficacy evaluation cohort research,and improve the TCM clinical efficacy evaluation methodology system.2.The cohort study was designed to observe the influence of traditional Chinese medicine treatment on the end point events of patients with chronic heart failure,and provide evidence-based medical evidence of traditional Chinese medicine intervention in chronic heart failure,and provide a methodological demonstration for the application of cohort study in the evaluation of clinical efficacy of traditional Chinese medicine.Method:1.Through reviewing the literature,the current status and problems of the current domestic TCM clinical efficacy evaluation cohort were investigated.Based on the research experience of the large-sample multi-center cohort study in the early stage of the research group,based on the basic principles of cohort research design,combined with the characteristics of TCM clinical diagnosis and treatment,summed up the clinical efficacy of TCM.Evaluation of cohort research methods and key technical points.2.A cohort study design was used.During the hospitalization,traditional Chinese medicine treatment is mainly based on traditional Chinese medicine injection.The exposure is defined as the application of traditional Chinese medicine injection for ?14 days.During the follow-up period,traditional Chinese medicine treatment is based on Chinese patent medicine and traditional Chinese medicine decoction.The exposure isdefined as the application of proprietary Chinese medicine or(and)Chinese medicine decoction ? 3 months.Patients with chronic heart failure admitted to the Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Rizhao City Hospital of Traditional Chinese Medicine and Weifang Traditional Chinese Medicine Hospital from January 1,2012 to December 31,2017,collected patient hospitalization through medical investigation,telephone and outpatient follow-up.General information(hospital number,age,gender,and contact information,etc.)during the follow-up period,Western medicine diagnosis(NYHA classification,primary disease,combined disease,etc.),use of Chinese and Western medicine,and occurrence of end point events.Logistic regression and Cox regression were used to analyze the correlation between hospitalization,follow-up and end-point events in patients with chronic heart failure,and the preference scores were used to correct the covariates,and then the differences between the exposed and non-exposed group events were analyzed.And then compare the differences in statistical results.Outcome:1.TCM clinical efficacy evaluation cohort research methods include selection of efficacy evaluation programs,definition and measurement of exposure factors,determination of study subjects,selection of outcome indicators,follow-up design,statistical analysis,ethical approval and registration.The key technologies of TCM clinical efficacy evaluation cohort include technical points of TCM syndrome differentiation,intelligent follow-up technology,data acquisition technology,data storage technology,data platform construction technology,data quality control technology,data processing technology and data mining technology.2.A total of 1578 patients with chronic heart failure were enrolled,19 patients died in the hospital,and 1400 patients were followed up.There was no significant difference in the incidence of cardiac death(0.68% vs 1.18%,p>0.05)and severe arrhythmia(0.27% vs 0.71%,p>0.05)between the exposed and non-exposed groups during hospitalization.Cardiac death(8.81% vs 17.26%,p<0.05)and heart failure readmission(13.28% vs 35.62%,p<0.05)were significantly lower in the exposed than non-exposedgroups during the follow-up period.Conclusion:1.A cohort study method for the evaluation of clinical efficacy of traditional Chinese medicine was established.2.Traditional Chinese medicine treatment can reduce the incidence of cardiogenic death and heart failure re-admission during follow-up of patients with chronic heart failure.