| Objective:To observe the myocardial protective effect of Xiefei Lishui Mixture on ischemic heart failure patients with qi deficiency and water stagnation syndrome and its effect on the levels of MMP-2 and MMP-9 in patients’ peripheral serum.Methods:1.Protective effect of Xiefei Lishui Mixture on myocardium of ischemic heart failure patients with qi deficiency and water retention syndrome:Prospective,random,single blind,placebo-controlled clinical trial method was adopted.The study subjects were patients who were hospitalized in the Department of Cardiology of Beijing Traditional Chinese Medicine Hospital affiliated to Capital Medical University from September 2017 to January 2020 and met the diagnostic criteria of ischemic heart disease,chronic heart failure and syndrome differentiation of traditional C hinese medicine heart failure as qi deficiency and water retention syndrome.A total of 94 patients with ischemic heart failure due to qi deficiency and water stagnation were included in this study and randomly divided into treatment group(n=47)and control group(n=47).The two groups of patients received the basic treatment of heart failure according to the "Guidelines for Diagnosis and Treatment of Chronic Heart Failure"(2014 Edition).The treatment group was additionally treated with Xiefei Lishui Mixture(30g of Radix Astragali,30g of Radix Pseudostellariae,30g of Semen Lepidii,30g of Cortex Mori,30g of Poria,6g of Radix Stephaniae Tetrandrae,30g of Semen Plantaginis,15g of Fructus Polygoni Orientalis,10g of Radix Paeoniae Rubra,6g of Cortex Acanthopanacis,etc.),while the control group was additionally treated with low-dose Xiefei Lishui Mixture(the medicine taste is the same as that of the treatment group,The myocardial protective effect of Xiefei Lishui Mixture on ischemic heart failure patients with Qi deficiency and water stagnation syndrome was evaluated by observing the changes of serum NT-proBNP level,TCM syndrome score,cardiac function(LVED and LVEF levels)and MACE events in 30 days before and after treatment.2.Effect of Xiefei Lishui Mixture on Serum MMP-2 and MMP-9 Levels of Patients with Qi Deficiency and Water Shutdown Syndrome of Ischemic Heart Failure:The research object and drug intervention method are the same as above.Sixty patients with Qi Deficiency and Water Shutdown Syndrome of Chronic Ischemic Heart Failure were randomly enrolled into the treatment group and the control group with 30 cases in each group.The changes of serum MMP-2 and MMP-9 levels in patients before and after treatment were observed to explore the potential mechanism of Xiefei Lishui Mixture in myocardial protection.Results:1.94 patients were included and randomly divided into treatment group(n=47)and control group(n=47).there was no statistical difference between the two groups in demographic characteristics,measurement indicators,drug use,biochemical indicators and other baseline aspects(p>0.05).there was comparability between the two groups.(1)NT-proBNP level:the difference between the treatment group and the control group before treatment was not statistically significant(P=0.268)and was comparable.Intra-group comparison:the NT-proBNP level in the treatment group and the control group after treatment was lower than that before treatment,and the difference was statistically significant(P<0.05).Inter-group comparison:the decrease of serum NT-proBNP in the treatment group was higher than that in the control group,and the difference was statistically significant(P<0.05).(2)TCM syndrome score:① TCM syndrome total score:the difference between the treatment group and the control group is not statistically significant(P=0.633)and is comparable.Intra-group comparison:after treatment,the total score of TCM syndromes in the treatment group and the control group were all lower than that before treatment,and the difference was statistically significant(P<0.05).Inter-group comparison:after treatment,the total score of TCM syndromes in the treatment group was lower than that in the control group,and the difference was statistically significant(P<0.05).②comparison of single symptom scores of TCM syndromes:there was no significant difference in the scores of 15 symptoms before the treatment group and the control group entered the group,including shortness of breath,palpitation,fatigue and fatigue,edema of facial limbs,spontaneous perspiration,night sweat,chest tightness,dry mouth,asthma,cough,cough up phlegm,oliguria,aversion to cold and limb cold,dysphoria and abdominal distension(P>0.05).Intra-group comparison:after treatment,the TCM syndrome scores of the treatment group and the control group were all lower than the level before treatment,and the difference was statistically significant(P<0.05).Inter-group comparison:after treatment,the scores of palpitation,shortness of breath,edema of facial limbs,chest tightness,dry mouth,asthma,cough,expectoration,oliguria,aversion to cold and limb cold symptoms in the treatment group were lower than those in the control group,and the difference was statistically significant(P<0.05).(3)cardiac function evaluation index:①LVED:compared with LVED before treatment in the treatment group and the control group,the difference is not statistically significant(P=0.820),and is comparable.Intra-group comparison:LVED in the treatment group and the control group was lower than that before treatment,and the difference was statistically significant(P<0.05).Inter-group comparison:LVED in the treatment group was lower than that in the control group after treatment,and the difference was not statistically significant(P=0.455).②LVEF:Compared with the LVEF before treatment in the treatment group and the control group,the difference is not statistically significant(P=0.575)and is comparable.Intra-group comparison:LVEF of the treatment group and the control group after treatment was higher than that before treatment,the difference was statistically significant(P<0.05).Inter-group comparison:LVEF in the treatment group was higher than that in the control group after treatment,and the difference was statistically significant(P=0.032).(4)30-day MACE event:there was no death in the treatment group and the control group.one patient in the treatment group and one patient in the control group were readmitted for 30 days due to heart failure.the difference in the incidence of MACE events between the two groups(all death within 30 days,readmission for 30 days due to heart failure,sudden cardiac death within 30 days)was not statistically significant(P>0.05).(5)serum MMP-2 and MMP-9 levels:the difference between the treatment group and the control group before treatment was not statistically significant(p>0.05)and was comparable.In-group comparison,MMP-2 and MMP-9 in the treatment group and the control group were lower than the pre-treatment level after treatment,and the difference was statistically significant(P<0.05).Compared between groups,MMP-2 in the treatment group was lower than that in the control group after treatment,and the difference was not statistically significant(P=0.442).MMP-9 in the treatment group was lower than that in the control group after treatment,and the difference was statistically significant(P=0.049).Conclusion:Xiefei Lishui Mixture can further reduce NT-proBNP in patients with chronic ischemic heart failure due to qi deficiency and water stagnation,and improve clinical symptoms and cardiac function on the basis of standardized treatment.Application safety;The mechanism of myocardial protection may be related to the reduction of serum MMP-2 and MMP-9 levels. |
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