| Objective:To demonstrate the efficacy and safety of Hongshenqimao Mixture in the clinical treatment of CHF patients by observe the clinical effect of Hongshenqimao Mixture in the patients of heart-ki-dney yang deficiency type chronic heart failure related indicators such as Serum NT-pro BNP,sST2 level and others.To provide a more powerful theoretical basis for the combination of conventional western medicine in patients with CHF and Hongshenqimao Mixture.Methods:Divided the 60 cases patients into control group and treatment group(each group 30 cases)by the method of random number table.These patients were hospitalized between March 2015 to January 2017 in Traditional Chinese Medical Hospital of Pingdingshan,and meet the inclusion criteria of heart and kidney deficiency type of CHF.The control group use conventional treatment of the western medicine which recommended by 2014 China heart failure diagnosis and treatment guidelines.The treatment group was treated with Hongshenqimao Mixture and conventional treatment of western medicine.The times of treatment of two groups is 12 weeks.The changes of symptom scores,heart function,the serum NT-pro BNP.sST2,echocardiography(LVEF、LVED),NYHA heart function classification,6 minutes walk test and Minnesota Heart Failure Quality of Life Scale before and after treatment in two groups were systematically observed and compared.Compare the changes in general indicators such as liver and kidney function before and after treatment of two groups to assess the effectiveness and safety of the drug.Results:1 Comparison of general clinical dataThere was no statistically significant difference between the two groups(P>0.05)in gender,age,weight,smoking and drinking history,primary disease and CHF course.2 NT-pro BNPAfter treatment,the NT-pro BNP of the two groups was significantly lower than before,the difference before and after treatment is statistically significant(P<0.01).After treatment,the NT-pro BNP in the treatment group decreased from 1798.8 ± 308.4pg/ml to 1044.9 ± 229.3pg/ml,and the control group decreased from 1851.5 ± 362.3pg/ml to 1154.9 ±186.8pg/ml.Compared with the control group,the level of NT-pro BNP after treatment in the treatment group was significantly lower(P<0.05).3 sST2After treatment,two groups of sST2 were significantly decreased than before(P<0.01),The treatment group dropped from 719.67 ± 13 1.21pg/m to 522.16 ± 90.83 pg/m.The control group dropped from 732.34± 120.89pg/m to 550.38 ± 76.10pg/m.After treatment,sST2 in the treatment group decreased more than the control group(P<0.01).4 Echocardiography(LVEF、LVED)After treatment,LVEF of two groups were significantly improved(P<0.01).The LVEF of treatment group was raised from 43.83 ±3.71%to 50.86±4.28%,the LVEF of the control group was raised from 44.55 ± 2.76%to 49.48 ± 4.73%.After treatment,LVEF was significantly higher in the treatment group than in the control group(P<0.05).The LVED of the two groups after treatment both drop statistically than before(P<0.05).After treatment,the LVED of treatment group drop from 57.55 ± 6.89mm to 51.28 ± 5.06mm,LVEF of the control group drop from 56.89 ± 5.65mm to 53.76 ± 4.74mm.Compared with the LVED after treatment between the two groups,the treatment group’s level is lower(P<0.05).5 NYHA heart function classificationComparison of NYHA cardiac function classification before and after treatment,the two groups are significantly depressed(P<0.01),The total effective rate of the treatment group was 93.3%,the total effective rate of the control group was 75.9%.The difference between the two groups are statistically significant(P<0.05).6 6-MWT distanceAfter treatment,two groups of 6-MWT were significantly improved(P<0.01).The 6-MWT of treatment group was raised from 271.21 ± 69.92m to 398.34 ± 79.49m,the 6-MWT of the control group was raised from 274.9±63.89m to 326.01 ± 70.39m.Comparison between groups,6-MWT in the treatment group was higher than that in the control group(P<0.05).Comparison of the efficacy of the two groups after treatment,the total effective rate of the treatment group was 96.6%,the total effective rate in the control group was 79.3%,There was significant differences in contrast(P<0.05).7 Quality of life score of MinnesotaAfter treatmen,compared of the total score of quality of life,two groups of sST2 were significantly improved than before(P<0.01),The treatment group dropped from 36.10 ±1.86 to 22.38 ±1.95,the control group dropped from 35.07 ±2.99 to 23.97 ± 2.68.Compared with the control group,the total score of the treatment group decreased significantly after treatment(P<0.05).8 Score of TCM symptomsAfter treatment,the scores of TCM syndromes in the two groups were descend significantly than before(P<0.01).The treatment group dropped from 11.83±2.41 to 6.05 ± 1.61,the control group dropped from 12.55 ± 1.94 to 7.69 ± 1.81.Comparison between groups,the level of TCM syndromes decreased significantly in the treatment group(P<0.05).The total efficiency of the treatment group was 93.3%,the total effective rate of the control group was 82.8%.Compared two groups of CHF patients efficacy of TCM symptoms,there was statistically significant difference(P<0.05).9 Drug safety evaluationDuring monitoring,there is no significant change between the two groups of patients blood,urine,stool,liver and kidney function,and electrolytes.There was no obvious adverse reaction before and after treatment in the treatment group.The control group appears occasionally such as slow heart rate or low blood pressure,it to return to normal by adjusting the dosage.Conclusion:Compared with simple western medicine treatment,treatment combined with Hongshenqimao Mixture and western medicine is more effective.The former can be further reduced the serum NT-pro BNP、sST2,echocardiography(LVEF、LVED),6-MWT distance,quality of life score of Minnesota,and the score of TCM symptoms.In the course of treatment,there were no exception in the general information and safety indicators of the two group.And there were no obvious adverse reactions.So combined with traditional Chinese medicine for treatment of CHF is safe and effective in clinical applications. |
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