Clinical Study Of Qishen Granules In The Treatment Of Chronic Heart Failure

Objective:This study was designed to study the distribution and combination rule and related factors analysis of syndrome elements in patients with chronic heart failure,so as to provide reference for clinical diagnosis and treatment;to evaluate the effectiveness and safety of Qi Shen Granules in the treatment of chronic heart failure.method:1.Using the method of epidemiological investigation,191 patients with chronic heart failure in six tertiary hospitals across the country were enrolled,case observation form was designed to investigate the patient's syndrome and related factors,and descriptive statistics and logistic regression methods were used for research.2.Adopting superiority trial design,randomized,double-blind,placebo-controlled trial method,instead of 191 patients with chronic heart failure,on the basis of western medicine conventional treatment,Qi Shen granules and placebo were taken respectively.The primary outcome indicators were the percentage of NT-proBNP decrease within 12W weeks,and the secondary outcome indicators were echocardiography indicators,heart failure symptom scores,Minnesota heart failure quality of life scores,and six-minute walk test.Evaluation of the incidence of adverse reactions.result:1 Analysis of the distribution and combination of syndrome elements and related factors in patients with chronic heart failure1.1 The main symptoms of patients with chronic heart failure are chest pain,chest tightness,wheezing,edema,and palpitations.The cardiac function classification is in order of grade III(58.6%),grade ?(26.7%),and grade ?(14.7%);Hypertension,coronary heart disease,diabetes,hyperlipidemia,arrhythmia are the main ones.The frequency of hypertension and coronary heart disease are 76.4%and 65.4%respectively;the frequency of syndrome factors is blood stasis,qi deficiency,phlegm turbidity,yang deficiency,and yin deficiency,retained fluid,blood deficiency,internal heat,yang hyperactivity,poisonous evil.1.2 Distribution law,the frequency of syndrome elements in patients with decreased ejection fraction is blood stasis,qi deficiency,phlegm,yang deficiency,yin deficiency,and retained fluid in descending order;patients with intermediate ejection fraction have the highest frequency of syndrome factors and yang deficiency,followed by It is Yang deficiency,phlegm turbidity,retained fluid,and yin deficiency;the frequency of patients with preserved ejection fraction is blood stasis,qi deficiency,yin deficiency,yang deficiency,phlegm turbidity,and retained fluid;the cardinality factors of patients with cardiac function class II are in descending order Blood stasis,qi deficiency,turbid phlegm,yang deficiency,retained fluid,and yang deficiency;the frequency of syndrome elements in grade III patients is blood stasis,qi deficiency,yang deficiency,phlegm turbidity,and retained fluid in order;the frequencies of grade ? patients are blood stasis,qi deficiency in order,Yin deficiency,turbid phlegm,retained fluid,yin deficiency.1.3 Combination regulations,the combination of syndromes is in proportion to the combination of two certificates(46.1%),combination of three certificates(33.0%),combination of four certificates(17.3%),the combination of five certificates is rare;Qi deficiency of a single certificate type;in the combination of two certificates,Qi deficiency and blood stasis accounted for the highest proportion of 35.2%.Among the three syndromes,Qi deficiency,blood stasis and phlegm turbidity were the highest.Among the four syndromes,Qi deficiency,blood stasis,Yin deficiency and retained fluid were the most common.1.4 Correlation analysis,qi deficiency is positively correlated with red tongue,less coating,thin pulse,chest tightness,and ejection fraction,negatively correlated with pale tongue,yellow coating,and edema;blood stasis is positively correlated with dark tongue,astringent pulse,and red tongue,Cracks and red tongue edges are negatively correlated;yang deficiency is positively correlated with thick tongue,thin coating,pulse knot generation,heavy pulse,delayed pulse,chest pain,and edema;yin deficiency is positively correlated with red tongue,cracks,less coating,peeling,and pulse number,NYHA grade is positively correlated,negatively correlated with edema;sputum is positively correlated with purple tongue,greasy coating,thick coating,pulse string,slippery pulse,and negatively correlated with chest tightness;drinking water is positively correlated with tongue fat,white coating,slippery pulse,heavy pulse,Pulse delay,edema is positively correlated.2.Randomized Controlled Trials2.1 Baseline dataThere were no differences in the number of cases,gender,age,height,weight,body mass index,heart rate,respiratory rate,systolic blood pressure,diastolic blood pressure,medical history,predisposing factors,comorbidities,past history,primary disease,family history,and medication Statistical significance(p>0.05),with good comparability between groups.The ejection fraction and cardiac function classification were used for subgroup analysis.There was no statistically significant difference in baseline data between the groups,which was well comparable2.2 NT-proBNPAfter 12W treatment,the NT-proBNP values of both the treatment group and the placebo group decreased,and the decrease in the treatment group between the groups was accompanied by the placebo group(P=0.012).It is defined that a 30%reduction in NT-proBNP value is effective,the effective rate of the treatment group is 54.3%,and the effective compensation is allowed to be 37.1%.The difference is statistically significant(P=0.017);2.3 Echocardiographic indicatorsThe difference between the groups was not statistically significant,and the changes in LVEDD before and after the intra-group test were statistically significant(p=0.049).Subgroup analysis showed that there were statistical differences in LVPW,IVS and EF difference in patients with reduced ejection fraction after treatment(P<0.05);in patients with cardiac function level ?,there were statistical differences in LVEDD(P<0.05).In functional grade ? patients,there were statistical differences between the groups in IVS and LVPW after treatment(P<0.05).2.4 NYHAThere was no statistically significant difference in the patient's heart function classification between the groups at 4W(P>0.05),and there was a statistical difference between the 8W and 12W groups(P<0.05).2.5 Six-minute walk testThere was no statistically significant difference in the six-minute walk test at baseline,and the treatment group and the alternative were statistically different in the comparison before and after the treatment,and the performance was improved better in QSG group(P<0.05).2.6 Scores of Heart Failure Symptom Grading ScaleThe total score of the heart failure symptom classification and quantification table is comparable at baseline,and there is a difference between the treatment group and the control group at 8W and 12W after treatment(P<0.05).The total score of the heart failure symptom classification and quantification table in the treatment group declined more significantly(P<0.05).2.7 Minnesota Quality of Life Scale for Heart Failure PatientsThe baseline difference of the Minnesota Heart Failure Quality of Life Scale for patients with heart failure was not statistically significant,and there was a difference between the 8W and 12W treatment groups and the control group after treatment(P<0.05).The total score of the treatment group has a more significant downward trend(p<0.05).2.8 Safety indicatorsThe safety indicators of urea nitrogen,creatinine,CK-MB,neutrophils,blood sodium,and blood potassium were statistically different between the groups or before and after the test,but they were all within the normal range and had no actual clinical significance.No serious adverse events reported,and adverse events were not statistically different between the groups.Conclusion:1.Chronic heart failure syndrome factors are mainly blood stasis,qi deficiency,yin deficiency,yang deficiency,phlegm turbidity,and retained fluid.The syndrome factors are related to symptoms,tongue and pulse,and heart function.The distribution law has a certain relationship with the classification of cardiac function and the classification of ejection lipids.The combination rule is based on the combination of the two syndromes,with Qi deficiency and blood stasis the most common.2.On the basis of conventional Western medicine treatment,Plasma Shen Granules are safe and effective in treating chronic heart failure.