Prospective Cohort Study Of Traditional Chinese Medicine In The Treatment Of Chronic Heart Failure Based On NYHA Cardiac Function Classification

objective:1.Taking chronic heart failure as an example,put forward new ideas for rational selection of evaluation indicators and standard application of evaluation indicators,optimize research design,and improve the evaluation index system of clinical efficacy of traditional Chinese medicine.2.Observe the surrogate indicators and endpoint indicators of chronic heart failure inpatients in the Affiliated Hospital of Shandong University of Traditional Chinese Medicine,verify the reliability and validity of the preferred primary surrogate indicators and secondary surrogate indicators,and provide methods for the evaluation of alternative indicators of clinical efficacy evaluation of traditional Chinese medicine Learn to learn from.method:A prospective cohort study was conducted to collect patients with chronic heart failure hospitalized in the Affiliated Hospital of Shandong University of Traditional Chinese Medicine from September 1,2018 to December 31,2019.Produced the "Study Form of Chronic Heart Failure Patient Cohort in Hospital of Traditional Chinese Medicine" to collect relevant information during hospitalization and follow-up period.Use Epidata 3.1 software to establish a database of patients with chronic heart failure in the Hospital of Traditional Chinese Medicine and enter the data.Those who used Chinese medicine injections for ≥14days during hospitalization were the exposed group,and those who used Chinese medicine injections for less than 14 days or did not use Chinese medicine injections were the nonexposed group.A total of 231 cases were collected,of which 5 cases were dropped due to incomplete clinical data,24 cases were lost to follow-up,and 202 cases were finally included in the statistics,100 cases in the exposed group,and 102 cases in the non-exposed group.According to the results of previous studies,the preferred primary surrogate index is NYHA cardiac function classification,and the secondary surrogate index is N-terminal B-type natriuretic peptide precursor(NT-pro BNP),left ventricular ejection fraction(LVEF),and cardiac death as the primary endpoint indicator,the reliability and validity of the preferred surrogate indicators are clinically verified.Reliability verification: Comparison of the improvement of alternative indicators between the exposed group and the non-exposure group,the t test is used for those that conform to the normal distribution,and the rank sum test is used for the non-normal distribution;the end-point events of the exposed group and the non-exposure group are compared by c2 Inspection.Evaluate whether the treatment measures that can improve the endpoint indicators also have a significant effect on the surrogate indicators.Validity verification: Cox regression model is used to analyze the correlation between the improvement degree of the surrogate index and the end-point event,and to evaluate the prognostic ability of the surrogate index for the end-point event.result:1.TCM clinical efficacy evaluation indicators need to be reasonably selected according to the research content,indicator characteristics,intervention methods,and disease epidemiological characteristics.According to indicator comparison,determine the main and secondary indicators,the measurement and standardization of indicators,and the four aspects of indicator verification.Standard application.2.The main surrogate index NYHA cardiac function classification of the exposed group and the non-exposed group,the secondary surrogate index NT-pro BNP,LVEF mean difference before and after treatment were statistically significant(P<0.05),the main surrogate index NYHA after treatment Comparing the mean values of cardiac function classification(P=0.025)and the secondary surrogate indicators NT-pro BNP(P=0.048)and LVEF(P=0.039),the difference was statistically significant;the effect of traditional Chinese medicine treatment on the endpoint event(P=0.016)),the difference is statistically significant;NYHA heart function classification difference(P<0.001,HR=0.058,95.0%CI=0.025-0.135),NT-pro BNP difference(P=0.034,HR=0.968,95.0% CI= 0.940-0.998),LVEF difference(P=0.024,HR=1.300,95.0% CI=1.108-2.670)are all <0.05,which is statistically significant,and NYHA cardiac function classification has the strongest prognostic ability,followed by NT-pro BNP and LVEF.conclusion:1.In order to comply with the complexity of the TCM treatment process,the diversity of methods,and the multidimensionality of objectives,it is necessary to adopt an evaluation method of combined application of multiple indicators(primary indicators and secondary indicators).Reasonable selection and standard application of evaluation indicators can improve research efficiency and provide scientific and reliable clinical evidence for clinical efficacy evaluation of traditional Chinese medicine.2.TCM treatment can improve the NYHA cardiac function classification as the main surrogate index,and the secondary surrogate indexes are NT-pro BNP and LVEF.It also has a significant effect on the end-point index cardiogenic death;TCM treatment has the main surrogate index NYHA cardiac function classification.The secondary surrogate indicators are NT-pro BNP and LVEF,which can better predict their impact on end-point cardiogenic death.