| Chronic heart failure(CHF)is a complex clinical syndrome characterized by dyspnea,reduced exercise tolerance,and peripheral edema due to impairment of cardiac structure or systolic and diastolic function.It is the end-stage manifestation of the progression of various cardiovascular diseases.According to the "Report on Cardiovascular Health and Diseases in China 2021",the weighted prevalence rate of heart failure(HF)is 1.3%among Chinese adults aged ≥ 35 years,with a population of approximately 13.7 million.Even though modern medicine has been continuously applying new drugs for heart failure in recent years,however,both morbidity and mortality of HF in China remain continuously on the rise.Professor Shi Dazhuo has been specialized in the clinical work on prevention,diagnosis,and treatment of cardiac diseases for a long time,with combining traditional Chinese medicine(TCM)and Western medicine.Based on the knowledge of TCM concerning CHF,integrated with modern research and clinical practical experience,the tutor advances the therapeutic approach to the CHF focusing on "deficiency","blood stasis","water" and syndrome characteristics of different disease stages.According to the distribution of TCM syndromes in cardiac function classification for CHF and Professor Shi’s academic thoughts regarding the management of CHF,the study is designed to evaluate the effectiveness and safety of his empirical prescription on treating CHF by conducting a clinical trial of his Yixin decoction.This thesis consists of the retrospective study and the self-control clinical study.Objective:A retrospective study was conducted to identify the distribution characteristics of TCM symptoms in patients with CHF related to the cardiac function classification,so as to provide basis for subsequent clinical study.Based on the clinical standard therapy,a self-control study was conducted to observe and evaluate the efficacy and safety of Yixin decoction in treating CHF with qi deficiency,blood stasis and fluid retention syndrome.1、A study on the distribution characteristics of TCM syndromes in patients with CHF according to different cardiac function classifications.Methods:The data from patients who were hospitalized in the Department of Cardiology due to CHF for the first time between January 1,2018 and September 30,2022,were selected through the Haitai electronic inpatient medical record system of Xiyuan Hospital of Chinese Academy of traditional Chinese medicine,excluding patients with incomplete information on the four diagnostic data,subsequently the database was set up by EXECL after standardization of the collected data,and SPSS version 26.0 was used for statistical analysis.The measurement data are presented as x ± s,One-way ANOVA or rank sum test was used to compare the differences,while Pearson test to analyse the correlation.Count data are presented as frequencies and percentages,with the chi-square test to compare the differences and Spearman’s method to analyse the correlation.(All tests were considered statistically significant at P<0.05.)Results:1.Ultimately,a total of 833 patients with CHF were accepted for analysis in this study,consisting of 410(49.22%)males and 423(50.78%)females.The age of the patients ranged from 20 to 100 years,with a mean age of 73.75±12.16 years.Among them,632(75.87%)cases were concomitant with hypertension,581(69.75%)cases with coronary atherosclerotic heart disease and 508(60.98%)cases with dyslipidaemia.2.In descending order,the number of patients with different cardiac function grades was grade Ⅲ,grade Ⅱ,and grade Ⅳ.No statistically significant differences were found in the gender distribution of patients with different grades of cardiac function(P>0.05),while the age,serum NT-proBNP,TnT,CK-MB,CREA,UA,CHOL,TG,HDL-C,HCY,hsCRP,Cl,and Ca levels and echocardiographic indices LVEF,LAD were found to be statistically different.(P<0.05).As the cardiac function class increased,serum NT-proBNP,TnT,CREA and UA levels increased and serum Cl and Ca levels and LVEF decreased in all three groups of CHF patients(P<0.001).3.Characteristics of the distribution of TCM syndromes in CHF patients were qi deficiency,blood stasis and fluid retention>qi and yin deficiency,blood stasis>qi deficiency,blood stasis and phlegm blockage>yang deficiency,blood stasis and fluid retention>qi deficiency and blood stasis>qi and yin deficiency>qi deficiency in the heart and lungs,respectively,among which there was no statistical difference in gender distribution,(P>0.05).Patients with yang deficiency,blood stasis and fluid retention were older than those with qi and yin deficiency,qi deficiency and blood stasis,qi deficiency,blood stasis and fluid retention syndrome(P=0.002,0.001,<0.001),who were younger than patients with qi and yin deficiency and blood stasis(P<0.001),and serum hsCRP levels were lower than those with qi deficiency,blood stasis and phlegm blockage syndrome(P=0.035).Patients with qi and yin deficiency syndrome had lower serum NT-proBNP levels than those with qi deficiency in the heart and lungs(P=0.002),CREA and LVEF were higher than those with qi deficiency in the heart and lungs syndrome(P=0.029,0.011),CK-MB and hsCRP were lower than those with qi deficiency and blood stasis(P=0.028,0.035).And patients with qi and yin deficiency and blood stasis had higher serum TnT level than those with qi deficiency and blood stasis(P=0.038),while CREA higher than those with qi deficiency in the heart and lungs syndrome(P=0.017).Compared to patients with qi deficiency and Blood stasis,CHOL was lower in qi deficiency,blood stasis and phlegm blockage syndrome(P=0.017).4.Statistical differences(P<0.05)existed in the distribution of TCM syndromes in CHF patients with various cardiac function grades.NYHA class Ⅱ patients mostly presented with qi deficiency and blood stasis syndrome or qi deficiency and blood stasis and fluid retention syndrome,class Ⅲ patients featured qi deficiency,blood stasis and fluid retention syndrome,or qi deficiency,blood stasis and phlegm blockage syndrome,or qi and yin deficiency and blood stasis syndrome,and class Ⅳ patients appeared to have qi deficiency and blood stasis and fluid retention syndrome,or yang deficiency,blood stasis and fluid retention syndrome.There is a positive correlation between cardiac function grading and qi deficiency and blood stasis and fluid retention syndrome,yang deficiency,blood stasis and fluid retention syndrome,and qi deficiency,blood stasis and phlegm blockage syndrome,with correlation coefficients of 0.091,0.128 and 0.157 respectively(P<0.05).And cardiac function grading was negatively correlated with qi deficiency in the heart and lungs syndrome,qi and yin deficiency syndrome,or qi deficiency and blood stasis syndrome,with correlation coefficients of-0.304,-0.159 and-0.150 respectively(P<0.001),but it is not related to qi and yin deficiency,blood stasis syndrome(P>0.05).2、A self-control clinical study on the efficacy and safety of Yixin decoction in combination with conventional Western medical treatment on CHF with qi deficiency,blood stasis and fluid retention syndrome.Methods:Using a clinical observational study with a three-month period by before-andafter comparison in the same patient,60 CHF patients aged 30～85 years old with qi deficiency,blood stasis and fluid retention syndrome were enrolled at clinic in Xiyuan Hospital between January 1,2022 and March 1,2023,who were prescribed Yixin decoction in addition to conventional Western medicine treatment by Professor Shi,while the patients were excluded who combined with acute cardiovascular disease,severe cardiopulmonary insufficiency,major systemic disease,difficulty in cooperating with the trial and refusal to sign the informed consent form.The variations in the patients’ indicators were documented before and after treatment in their own research medical records,including TCM syndrome and symptom scores,NYHA functional classification,left ventricular ejection fraction(LVEF),serum N-terminal prohormone of B-type natriuretic peptide(NT-proBNP)levels,Minnesota Living with Heart Failure Questionnaire(MLHFQ)score,echocardiographic indicators as well as safety indicators,and the statistical analysis of the obtained data was performed by SPSS version 26.0.Paired samples t-test and non-parametric Wilcoxon rank sum test were used to analyse the measurement data,and chi-square test and rank sum test were used to analyse the count data.(All tests were considered statistically significant at P<0.05.)Results:1.The current study included 60 patients,and 2 were excluded because of no TCM intake,resulting in the final inclusion for analysis by 58 CHF patients with qi deficiency,blood stasis and fluid retention syndrome who attended Professor Shi’s clinic,consisting of 40(68.96%)males and 18(31.04%)females were included.The range fluctuating from 32 to 85 years,with an average of 61.38±13.71 years.There were 24(41.38%)cases and 34(58.62%)cases of NYHA cardiac function grade Ⅱ and Ⅲ,respectively.According to the LVEF,the number of patients with HFrEF,HFmrEF and HFpEF were 19(32.76%),15(25.86%)and 24(41.38%),respectively.The causes of CHF included 40(68.96%)coronary heart disease,9(15.52%)dilated cardiomyopathy,and 9(15.52%)rheumatic heart disease.2.According to the frequency of occurrence,the comorbid diseases were 33(56.90%)dyslipidemia,31(53.45%)hypertension,25(43.10%)diabetes mellitus,18(31.04%)arrhythmia,11(18.97%)ventricular aneurysm and 8(13.79%)hyperuricemia.Commonly used western drugs of patients who was enrolled in the study included ARNi(46 cases,79.31%),βblockers(45 cases,77.59%),antiplatelet aggregation drugs(40 cases,68.96%),lipid-lowering drugs(36 cases,62.07%),MRA(27 cases,46.55%),SGLT2i(23 cases,46.55%),diuretics(20 cases,34.48%),CCB(19 cases,32.76%),non-SGLT2i hypoglycemic drugs(17 cases).29.31%),ACEi/ARB(11 cases,18.97%),anticoagulants(10 cases,17.24%).3.The mean serum NT-proBNP values in patients before and after treatment were(812.35± 919.66)and(286.75 ± 295.62)pg/ml,respectively(P<0.001),LVEF before and after treatment respectively were(44.36±11.16)and(51.03 ± 10.22)%(P<0.001),LAD before and after treatment were(42.43±6.44)and(39.62 ± 6.54)mm(P<0.001),LVEDD before and after treatment(56.21±9.36)and(52.22±7.65)mm(P<0.001),and RVAD before and after treatment(22.62 ± 3.05)and(21.24 ± 2.56)mm(P=0.001).It is therefore clear that the patients’ serum NT-proBNP levels after treatment was significantly lower than that before treatment,and the LVEF after treatment was higher than that before treatment.LAD,LVEDD and RVAD were all smaller than those before treatment.4.The analysis of the curative effect of TCM syndrome showed that the overall effective rate of Yixin decoction was 98.28%,markedly effective in 25 cases(43.11%),effective in 32 cases(55.17%),ineffective in 1 case(1.72%),and no patients with aggravated symptoms were found.The average scores of syndromes before and after treatment were 28.21 ± 4.30 and 11.34± 4.12,respectively,and the difference was statistically significant(P<0.001).Cardiac function was significantly improved in 35 cases(60.34%),effective improvement in 21 cases(36.21%),and no change in 2 cases(3.45%).The quality of life of the patients was evaluated by MLHFQ,and the average total score before and after treatment,was 56.50±11.03,24.66±8.44 respectively,with the post-treatment score being significantly lower than pre-treatment.5.The plasma D-Di,PT,APTT,Fbg,CREA,ALT and AST levels of the patients before treatment were(0.50±0.18)mg/L,(12.50±1.74)s,(29.05 ± 3.16)s,(3.13 ± 0.50)g/L,(84.64± 18.45)pmol/L,(20.84 ± 10.40)U/L and(19.99±6.27)U/L.While post-treatment levels of D-Di,PT,APTT,Fbg,CREA,ALT,and AST were(0.42±0.12)mg/L,(11.66 ± 0.96)s,(27.10± 3.40)s,(2.94 ± 0.56)g/L,(75.00 ± 19.96)μmol/L,(17.49 ± 8.98)U/L and(17.33 ± 4.61)U/L.Therefore,participants’ plasma levels of D-Di,PT,APTT,Fbg,CREA,ALT and AST after treatment were lower than pre-treatment,with statistically significant differences(P<0.05).Conclusion:According to the syndrome characteristics of CHF,which is qi deficiency,blood stasis and fluid retention,it was found that on the basis of conventional Western medicine treatment,Yixin decoction can effectively and safely reduce serum NT-proBNP level,increase LVEF and diminish LAD,LVEDD and RVAD,improve patients’ symptoms,cardiac function and quality of life. |
