| Background:Refractory heart failure refractory heart failure(RHF)is a serious and terminal stage of various heart diseases,high incidence,and it’s one of today’s most important cardiovascular diseases.The chronic activation Sympathetic of nervous system and renin-angiotensin system in a long term induced myocardial remodeling and that’s the basic pathophysiological mechanism of chronic heart failure.The goal of treat heart failure is not only to improve the symptoms and the quality of life,what’s more important is according to the mechanism of myocardial remodeling to delay the development of myocardial remodeling,then decline the mortality and hospitalization rates of heart failure.In recent years,the studies found that Chinese medicine play an important role in prevent and treat of myocardial remodeling in patients with chronic heart failure.Traditional Chinese medicine on cardiac remodeling and fibrosis in patients with advanced cardiac disease has multiple targets,multi way,multi level of the overall regulatory advantages.Previous clinical studies showed that with Supplementing Qi and activating blood,yang to promote diuresis effect of Xinmailong injection could significantly improve cardiac function in patients with chronic heart failure,improve the symptoms of traditional Chinese medicine,improves exercise tolerance in patients,improvement of LV EF.But Xinmailong injection for the clinical application of patients with refractory heart failure,hematology indexes and with less prognostic relevance research,still need further observation and study.This study will focus on the observation of ventricular remodeling parameters,evaluation Xinmaitong uplift of RHF clinical curative effect.Objective:Through the observation of the effect of Xinmailong injection on refractory in patients with heart failure,left ventricular remodeling and cardiac function.Preliminary discuss the its mechanismm,and provide basis evidence for further clinical application.Method:This project is a randomized,open,controlled trial.The study included 72 cases,all cases were diagnosed with refractory heart failure(gas yang deficiency,blood stasis syndrome)and derived from the Cardiovascular ward of the first Affiliated Hospital of zhengzhou University and the first Affiliated Hospital of Henan University of TCM and from March 2015 to January 2016.All cases were randomly divided into 2 groups,the treatment group(standard treatment and Xinmailong Injection)and the control group(standard treatment)with 36 cases in each.Carried out routine preoperative examination and recorded the general clinical data of the patients after admission.Observe the treat process for 10 days and the follow-up time was 3 months.Detect the change NT-pro BNP and ST2,and through observe the effect of Xinmailong Injection on the TCM syndrome quantitative integral,New York Heart Association(NYHA),left ventricular ejection fractions(LVEF)and Minnesota living with Heart Failure Questionnaire(MLHFQ)in patients with refractory heart failure,to evaluation of efficacy and safety.Results:1.Clinical data: sex ratio of two groups of patients,average duration,average age,underlying cause,average heart rate differences between general clinical data of no statistical significance(P>0.05),NYHA cardiac functional grading,LVEDD,LVEF,NT Pro BNP,sst2 and index difference between also no unified gauge theory significance(P>0.05);treatment group take statin and anticoagulant was higher than that of the control group(P=0.001<0.05),and the difference is statistically significant;other drug taking differences between the two groups had no statistical significance(P>0.05).2.The two groups of patients before and after treatment of cardiac function evaluation results showed that the total effective rate of DLP group was 80.6%,the CL group was 70.0%,there were significant differences between the two groups(z=-2.263 P=0.024<0.05).3.Two groups of patients before TCM Syndromes of quantizing integral without significant difference(P=0.065,P>0.05),treatment for 14 days,the two groups of TCM syndrome integral treatment before were decreased,the difference is statistically significant(P=0.001,P<0.05);the treatment group decreased more significantly than the control group,the difference is statistically significant(z=3.126,P=0.002<0.05).4.After treatment,the efficacy of the two groups of heart failure(sign points,Lee)were significantly improved compared with before treatment(P<0.01),compared with the control group,there was significant difference in the improvement of physical sign score(z=2.671,P=0.008<0.05).5.In the two groups after the treatment compared IVST and LVPWP with admission and 90 days later after discharge although all of them were improved,but through paired t-test,the difference was not statistically significant(P>0.05);and when to compared within the group,the difference was statistically significant(P<0.05);the change of LVEDD after treatment has not statistically significant;but compared the 90 days later after discharge with the level before admission,through the independent sample t-test,the difference hans statistically significant(P <0.05);and compared with the control group,LVEF,FS group treated group was better than control group(P<0.05).6.Two groups of patients with NT Pro BNP and ST2 compared with those before treatment were decreased,the difference was statistically significant(P<0.05);treatment group NT Pro BNP were lower than the control group obviously,the difference is statistically significant(P=0.001<0.05),sst2 levels between the two groups has statistical difference(P=0.043,P<0.05).7.Before treatment,two groups of patients with plasma renin activity and Ang II,aldosterone expression had no significant difference,on the 14 th day after treatment two groups within groups comparison of renin activity,aldosterone decreased,but the change was not significant(P=0.673>0.05)and Ang II group decreased significantly,group compared with statistical difference(t=-5.474,P=0.001<0.05).8.Heart rate comparison: two groups of patients with heart rate after treatment than before treatment were decreased,the treatment group decreased more significantly,the difference was statistically significant(P=0.018,P< 0.05).9.90 days after discharge,the MLHFQ scores of two groups were significantly improved than before treatment,the difference was statistically significant(P=0.001,P<0.05).The treatment group was significantly higher than the control group,and the difference was statistically significant(Z=2.671,P=0.008<0.05).10.The incidence of adverse events in the two groups was compared,and the difference was not statistically significant(P>0.05).Conclusion:1.Xinmailong injection can improve refractory in patients with heart failure,left ventricular ejection fraction and reduce the concentration of NT pro BNP and improve heart function of patients,relieve clinical symptoms,improve the tolerance and quality of life activity of the patients.2.Xinmailong injection can reduce the heart rate and Ang II level,indicated it may be through inhibit the activation of RAAS and SNS,and reduce the sympathetic nerve excitability,antagonistic and reversal of myocardial remodeling.3.Added Xinmailong injection can reduce refractory heart failure patients with soluble growth stimulating protein 2 gene expression level of expression,showed that it might be by lighten heart load,and depress the expression of s ST2,then to slow down the progression of myocardial fibrosis and left ventricular remodeling.4.No obvious adverse reaction in the course of this study,Xinmailong injection can be a beneficial supplement for the treatment of refractory heart failure. |
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