| Objectove:Through follow-up observation of patients with heart failure with mildly reduced ejection fraction(HFmrEF)after taking Shengmai Huoxue Decoction,the improvement of TCM syndromes,clinical recovery,serological indexes and imaging indexes were observed to explore the advantages of Shengmai Huoxue Decoction in promoting the recovery of cardiac function and improving the symptoms of heart failure,so as to provide clinical basis for the treatment of HFmrEF patients with TCM.Methods:From September 2021 to September 2022,70 cases of cardiovascular medicine outpatient and ward cases in Linyi Hospital of Traditional Chinese Medicine affiliated to Shandong University of Traditional Chinese Medicine were collected.The selected cases were in line with the diagnosis of heart failure with mild reduction of ejection fraction and TCM syndrome differentiation.They were randomly divided into two groups,35 cases in each group.The control group was given standardized western medicine treatment of chronic heart failure,and the treatment group was treated with Shengmai Huoxue Decoction on the basis of the control group.The observation period was 12 weeks.The changes of cardiac function classification(NYHA),serum N-terinal B-type natriuretic peptide prosoma(NTproBNP),six minutes walk test(6MWT),left ventricular ejection fraction(LVEF),left ventricular end diastolic diameter(LVEDd),Minnesota Living With Heart Failure Questionnaire(MLHFQ)and TCM symptom scores were compared between the two groups before and after treatment.The clinical efficacy and safety were evaluated.Results:1.This clinical study included a total of 70 patients who met the criteria,including 5 cases in the control group;the treatment group lost 3 cases;no death occurred during the followup period.The remaining 62 cases completed the study,including 32 cases in the treatment group and 30 cases in the control group.The total shedding rate was 11.4 %.There was no significant difference in the general data(age,gender,course of disease,cardiac function and basic diseases)between the two groups(P > 0.05).2.Comparison of main efficacy indicators(NT-proBNP,LVEF,LVEDd):(1)The level of plasma NT-proBNP in the treatment group and the control group was improved after treatment(P < 0.05),and the improvement in the treatment group was better than that in the control group(P < 0.05).(2)The LVEF and LVEDd of the two groups were improved after treatment(P < 0.05),and the improvement of the treatment group was better than that of the control group(P < 0.05).(3)The distance of 6MWT after treatment in both groups was improved compared with the previous(P<0.05),and the improvement in the treatment group was better than that in the control group(P<0.05).3.Comparison of cardiac function grading(NYHA): The cardiac function grading of the two groups of patients after treatment was improved.The total effective rate of the treatment group was 93.75 %,and the total effective rate of the control group was 76.67 %.The improvement of the treatment group was better than that of the control group(P < 0.05).4.Comparison of TCM syndromes :(1)The total scores of TCM syndromes in the two groups were improved after treatment(P < 0.05),and the improvement in the treatment group was better than that in the control group(P < 0.05).(2)After treatment,there was no significant improvement in the single symptom scores of palpitation,edema of face and limbs,spontaneous sweating,asthma and oliguria in the two groups(P > 0.05),while the single symptom scores of shortness of breath,fatigue,chest tightness / pain,chills,cold limbs and irritability were significantly improved(P < 0.05).(3)The total effective rate was 93.75 % in the treatment group and 56.67 % in the control group.The treatment group was superior to the control group(P < 0.05).5.Comparison of the scores of MLHFQ: 1 the scores of MLHFQ in both groups were improved after treatment(P < 0.05),and the improvement in the treatment group was superior to that in the control group(P < 0.05),2 the total effective rate was 90.63% in the treatment group and 70% in the control group,the improvement of MLHFQ score in the treatment group was superior to that in the control group(P < 0.05).6.Safety comparative analysis: the Vital Signs of the two groups were stable before and after treatment,and the clinical indexes such as ECG,blood routine,electrolytes,liver and kidney function had no obvious changes before and after treatment.Conclusion:Shengmai Huoxue decoction can obviously decrease NT-proBNP level,increase left ventricular ejection fraction,recover left ventricular function and improve heart function classification(NYHA)in HFmrEF patients with Qi deficiency and blood stasis,the clinical symptoms of HFmrEF patients with qi-deficiency and blood-stasis syndrome can be relieved,the quality of life can be improved,and the safety of Shengmai Huoxue decoction is higher,so it is worthy of further study and clinical popularization. |
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