| Objective:To observe the the clinical efficacy and safety of Kangshuanyihao formulation for early intervention after acute myocardial infarction(AMI).Methods:This study is a prospective randomized control method.We would select 38 patients with AMI and syndrome of qi deficiency and blood stasis who were admitted into the Department of Cardiology of Jiangsu Hospital of Traditional Chinese Medicine from December 2018 to February 2020.These patients are divided into treatment group(Kangshuanyihao formulation+Western medicine standardized treatment)and control group(Western medicine standardized treatment),21 cases in treatment group and control group of 17 cases.Before and after lweek of treatment,the NLR,BNP,sST2,Gal-3,TCM symptom score,liver and kidney function were recorded,and the LVIDd,EF,LVMI,liver and kidney function,the main adverse cardiovascular events(MACE)were recorded before and after 1month of treatment.Results:There was no significant difference in Baseline data of the 38 patients with AMIbetween the treatment group and the control group.(P>0.05).(1)The effect of NLR:The value of NLR in the treatment group was 7.35±1.38 before treatment,and 6.00±2.160 after treatment.And in the control group it was 8.29±2.67 before treatment,and 4.17±1.46 after treatment.There was no significant difference in NLR between the two groups before treatment(P>0.05).After treatment,both NLR of the two groups were significantly lower than before(P<0.05),and the differences between the two groups were also statistically significant.(2)The effect of BNP:The BNP of the treatment group was 306.47±278.53 before treatment,and 86.38±53.04 after treatment.And in the control group it was 278.53±137.62 before treatment,and 127.29±55.90 after treatment.There was no significant difference in BNP between the two groups before treatment(P>0.05).After treatment,both BNP of the two groups were significantly lower than before(P<0.05),and the differences between the two groups have no statistical difference(P>0.05).(3)The effect of sST2 and Gal-3:There were statistically significant differences between the treatment group and the control group in sST2 and Gal-3 after 1 week of treatment.(4)The effect of LVIDd:The LVIDd of the treatment group was 49.19±5.14 before treatment,and 47.33±5.23 after treatment.And in the control group it was 49.41±4.78before treatment,and 48.23±4.85 after treatment.There was no significant difference in LVIDd between the two groups before treatment(P>0.05).After treatment,the treatment group was statistically significant(P<0.05),the control group was no significant difference and the differences between the two groups were statistically significant.(5)The effect of EF:The EF of the treatment group was 0.54±0.11 before treatment,and 0.59±0.96 after treatment.And in the control group it was 0.54±0.08 before treatment,and 0.55±0.95 after treatment.There was no significant difference in EF between the two groups before treatment(P>0.05).After treatment,the treatment group was statistically significant(P<0.05),but the control group was no significant difference and the differences between the two groups were statistically significant.(6)The effect of LVMI:The LVMI of the treatment group was 61.39±10.91before treatment,and 58.26±11.76 after treatment.And in the control group it was 66.81±11.75 before treatment,and 62.43±10.63 after treatment.There was no significant difference in LVMI between the two groups before treatment(P>0.05).After treatment,the treatment group was statistically significant(P<0.05),but the control group was no significant difference and the differences between the two groups were statistically significant.(7)The TCM symptom score of the treatment group was 20.00±1.23 before treatment,and 6.62±1.53 after treatment.And in the control group it was 19.71±1.26 before treatment,and 8.29±1.57 after treatment.There was no significant difference in TCM symptom scores between the two groups before treatment(P>0.05).After treatment,both TCM symptom scores of the two groups were significantly lower than before(P<0.05),and the differences between the two groups were also statistically significant.(8)Curative effect of TCM symptoms:There was significant difference between the two groups.(9)There were no adverse reactions such as liver and kidney function impairment in the two groups.There were no MACE such as recurrent angina nonfatal myocardial infarction,hospitalization for coronary heart disease or heart failure,arrhythmia,and cardiogenic death.Conclusions:Western medicine standardized treatment with Kangshuanyihao formulation can effectively reduce the scores of TCM symptoms in AMI patients.Besides,it can further reduce the serum NLR level,sST2 level and Gal-3 level,reduce the LVIDd and LVMI value,release the EF level.in AMI patients.It has proved that there was no liver and kidney damage and no increase in the risk of major adverse cardiovascular events,so safety of Kangshuanyihao formulation is well.But the patient's blood BNP levels had no change. |
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