| Objective:Make an objective evaluation on the clinical effect and safety of Yiqi Huoxue Lishui Fang based on the classical theory of "Unfavorable Blood Was Water". By observing changes inClinical symptoms and signs, Classification of cardiac function and BNP level,test the treatment effect of Yiqi Huoxue Lishui Fang on elderly heart failure disease (Qi Deficiency and Blood Stasis Syndrome, QDBSS), provide ideas and new therapeutic approaches for traditional Chinese medicine treatment in elderly heart failure disease, therefore lay a preliminary foundation for traditional Chinese medicine clinical research in new drugs.Methods:Sixty elderly heart failure and QDBSS patients were randomly divided into two groups. A control group of thirty subjects were treated with basic western medicine treatment. Selected medicine included Aspirin, Benner Pury, Furosemide, Spironolactone, Diogoxin, and Betaloc. A treatment group of thirty subjects were treated with Yiqi Huoxue Lishui Fang decoction for one dose per day in addition to basic western medicine treatment. Two groups were treated for 3 weeks. Observe the changes of BNP, TCM clinical symptoms, heart failure efficacy, Classification of cardiac function before and after the treatment as well as the adverse reactions and compliance situation in patients.Results:Sixty cases of effective follow-up were randomly divided into treatment group(30 cases) and control group(30 cases). Before treatment, two groups of gender, age, course of disease, BNP level, heart function, clinical symptoms and other baseline data of two groups showed no significant difference before the treatment by statistical analysis, and were comparable.①The curative effect in clinical signs and symptoms:in heart failure efficacy the total effective rate was 93.33% for the treatment group, and 63.33% for the control group. Between the two groups, after treatment the heart failure efficacy score decreasing rate was better in the treatment group. The difference was statistically significant(P<0.01). In TCM curative effect the total effective rate was 90.00% for the treatment group, and 46.67% for the control group. Between the two groups, after treatment TCM curative effect score decreasing rate was better in the treatment group. The difference was statistically significant (P<-.05).②The improvement of heart function:heart function grading before and after treatment in two groups were significantly improved (P< 0.01); between the two groups, the treatment group classification of cardiac function better than the control group (P<0.05), there is statistical significance. ③The efficacy in reducing BNP level:BNP level was reduced within each of the two groups (P< 0.01> P< 0.05), and the difference was statistically significant. For comparison between two groups, the BNP level of the treatment group decreased significantly compared to the control group (P< 0.01), and the difference was statistically significant.④Before and after the treatment, the control group and the treatment group were both in good safety. No obvious symptom and medication side effects were found after the medication taken.Conclusion: ①Yiqi Huoxue Decoction can significantly improve the clinical symptoms and signs of elderly patients with heart failure.② Yiqi Huoxue Decoction can significantly improve cardiac function classification of elderly patients with heart failure. ③Yiqi Huoxue Decoction can significantly decrease the level of BNP of senile heart failure. ④ Yiqi Huoxue decoction is effective and safe in the treatment of senile heart failure. |
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