| Objective:To objectively evaluate the clinical efficacy and safety of Xinyang tablets and Xinyin tablets in the treatment of CHF,and objectively evaluate the advantages of traditional Chinese medicine in the treatment of CHF,we carried out a prospective,randomized,double-blind,multi-center controlled clinical study,taking the currently accepted treatment of CHF as a control.Methods:A total of 240 patients with heart failure who met the inclusion criteria were randomly divided into two groups according to a 2: 1 ratio.The patients in each group were divided into the experimental group(taking Xinyang tablet)controlled group(taking Xin Yang tablets analog drugs)of qi-yang deficiency with blood stasis and retention of water-dampness,the test group(taking xinyin tablets)and the controlled group of qi-yin deficiency with blood stasis and retention of water-dampness.All the patients recived the Optimal medicine basic treatment,which lasted for 8 weeks.The change of cardiac function,exercise tolerance,TCM syndrome score and Minnesota quality of life score during the whole treatment were observed,the safety of medication was evaluated,the follow-up adverse reactions events and causes of shedding were recorded,and the SPSS19.0 software was used for statistics analysis.Results:A total of 240 patients with heart failure were enrolled in this study,of which 207 cases were finally completed,including 71 cases of Xinyang tablet treatment group,35 cases of Xinyang tablet analog drug group,67 cases of Xinyin tablet treatment group and 34 cases of Xinmin tablet analog drug.Xinyang tablets group and Xinyang tablets analog drug group,Xinyin tablet group and Xinyin tablet simvastatin group compared with good balance between groups.The difference among the general data,cardiac function level,LVEF level,BNP level,Syndrome score,6WMD,Minnesota quality of life scores and related safety indicators,was not statistically significant(P>0.05).In the aspects of cardiac function,LVEF,BNP,TCM syndrome score,6MWD and Minnesota quality of life score,Xinyang tablet group compared with Xinyang tablet analog drug group,Xinyin tablet group compared with Xinyin tablets analog drug group,the difference before and after comparison,was statistically significant(P<0.05).Xinyang tablet group compared with Xinyang tablet analog group,Xinyin tablet group and Xinyin tablet analog group compared with the improvement trend of LVEF,BNP,6MWD more obvious;the efficiency of Xinyang tablet group in improving asthma,edema,Fatigue,chills,spontaneous symptoms,is higher than the Xinyang tablets analog drug group;the efficiency of Xinyin tablets in the palpitations,asthma,two zygomatic redness,dry mouth and throat symptoms,is higher than the heart-shading film simulation Medicine group.The treatment group and the control group had no obvious abnormalities in the safety indexes(liver and kidney function,electrolytes,etc.)before and after the treatment,with no significant difference between the two groups(P>0.05).There was no significant difference between the treatment group and the control group in the incidence of adverse reactions,loss of follow-up and loss rate(P>0.05).Conclusion:On the basic of Optimal medicine treatment,traditional Chinese medicine Xinyang tablets and Xinyin tablets can further improve the patients’ heart function,LVEF,BNP,TCM syndrome score,6WMD and Minnesota quality of life score,relieve heart failure symptoms and improve exercise Tolerance,and with the extension of treatment time,the efficacy showed a continuous upward trend.At the same time both drugs are safe,had no obvious toxic effects.Xinyang tablets and Xinyin tablets should be used on the pattern identification as the basis for determining treatment,which is an effective drug for the treatment of chronic heart failure,and is worthy of clinical promotion. |