| ObjectiveSacubitril/valsartan(SV),enkephalinase and angiotensin receptor inhibitor(ARNI),is a major breakthrough in the treatment of heart failure(HF)in recent years.Multiple clinical studies have shown that SV improves symptoms and prognosis,and reduces heart failure mortality and hospitalization rates.Clinical findings showed that there were differences in the efficacy of SV for HF caused by different causes.The purpose of this study was to compare the efficacy and safety of SV in HF caused by ischemic cardiomyopathy(ICM)and dilated cardiomyopathy(DCM),so as to provide a basis for more individualized treatment.MethodsICM patients with HF and DCM patients with HF in Shandong Provincial Hospital from November 2017 to February 2019 were selected as the observation objects.All patients were confirmed with chronic HF clinical symptoms,to the New York Heart Association(NYHA)classification standard HF cardiac function Ⅱ~Ⅳ level,by echocardiography and left ventricular ejection fraction(LVEF)of 45%or less.Patients with severe liver or renal insufficiency and severe hypotension(<80/50mmhg)should be excluded.In this study,a total of 122 patients were enrolled,which were divided into ICM group(n=72)and DCM group(n=50)according to the etiology.The ICM group was divided into ICM control group(n=40)and ICM treatment group(n=32)according to the patients’ willingness,and the DCM control group(n=30)and DCM treatment group(n=20)according to the patients’ willingness.Since some patients did not complete the 12-month follow-up before the completion of the paper,the total number of subjects observed at the 12th month was 102.ICM group(n=62),including ICM control group(n=37)and ICM treatment group(n=25);DCM(n=40),in which,DCM control group(n=24)and DCM treatment group(n=16).The enrolled patients were given individualized routine HF treatment with diuretics,nitrates,and beta blockers.In the control group,ACEI/ARB drugs were given individually on the basis of conventional treatment.According to symptoms,blood pressure and heart rate tolerance,the dose was gradually increased from small to maximum tolerance.The treatment group was given Sacubitril/valsartan sodium tablets on the basis of conventional treatment(product name:Novartis Pharma Schweiz AG)(if the patient has been using ACEI drugs before,it is necessary to stop using it for 36 hours,and if the patient has been using ARB drugs before,it will be changed to the treatment of Sacubitril/valsartan sodium tablets directly).The starting dose was 25 mg/time,2 times/day.According to the symptoms and the tolerance of blood pressure and heart rate,the small dose was gradually increased to the maximum tolerance dose,generally no more than 200 mg,2 times/day.All patients with HF were followed up for a period of 12 months,and the relevant indicators before and after the start of medication were recorded at 1st,3rd,6th and 12th month,including(1)laboratory indicators:creatinine(Cr),alanine aminotransferase(ALT),aspartate aminotransferase(AST),n-terminal B natriuretic peptide(NT-proBNP);(2)echocardiography:left ventricular end-diastolic diameter(LVEDD),left ventricular ejection fraction(LVEF);(3)blood pressure,heart rate;(4)adverse reactions occurred.SPSS 25.0 software was used to process the measured data,and the normal test and homogeneity test of variance were conducted.The measured data conforming to the normal distribution were expressed as mean standard±deviation.Independent sample t test was used for inter-group comparison,paired samplet test was used for intra-group comparison.The counting data were compared by chi-square test.P<0.05 was considered statistically significant for all tests.Results1.General clinical dataGender,history of smoking,family history,history of hypertension,history of hyperlipidemia,and the use of ACEI/ARB、β-receptor blockers,diuretics、nitrates and cardiac enhancers were compared between the ICM group and the DCM group,and between the control group and the treatment group.The differences were not statistically significant(P>0.05).Age and hi story of diabetes were significantly different between the two groups(P<0.05):age and prevalence of diabetes were significantly higher in the ICM group than in the DCM group.There was no significant difference in clinical characteristics between the control group and the treatment group(P>0.05).2.Treatment effectLVEDD,LVEF and NT-proBNP of each group had no significant difference before medication(P>0.05),and showed an overall improvement trend with time.LVEDD in ICM group did not change much at 1st and 3rd month after the start of medication(P>0.05).At 6th month,LVEDD in treatment group was significantly lower than that before medication(P=0.028).At 12th month,LVEDD in treatment group was significantly lower than that in control group(P=0.039).However,LVEF in the treatment group at 3td month was significantly lower than that before treatment(P=0.040),was continuously improved at 6th and 12th month(P6=0.034,P12=0.000),and treatment group at 6th and 12th month was significantly lower than that in the control group(P6=0.018,P12=0.017).LVEDD in the DCM group did not change significantly at 1st,3rd and 6th month after the start of medication(P>0.05).At 12th month,LVEDD in the treatment group was significantly lower than that before medication(P=0.023).There was no significant difference at all time points between the control group and the treatment group(P>0.05).LVEF in the treatment group at 6th month was significantly lower than that before treatment(P=0.031),and it continued to decrease in December,and the treatment group at 12th month was significantly lower than the control group(P=0.012).In the treatment group,compared with the DCM group,the ICM group started to be lower than the DCM group at 6th month of LVEDD,but there was no statistical significance(P>0.05).At 12th month,the ICM group was significantly lower than the DCM group due to a large reduction rate(P=0.039).Since 3rd month,LVEF in the ICM group was higher than that in the DCM group,but there was no statistical significance(P>0.05).It decreased continuously in both groups at 6th and 12th month,and the reduction was larger in the ICM group than in the DCM group,so the ICM group at 6th and 12th month was significantly larger than that in the DCM group(P6=0.041,P12=0.035).After the treatment,NT-proBNP in each group at 1st month was significantly lower than before the treatment(P<0.05),but after 3、6、12 months,there was no significant change,between the two groups on each time point(P>0.05).3.Heart rate and Blood pressureThere was no significant difference in heart rate between ICM group,DCM group,control group and treatment group before and after medication(P>0.05).The blood pressure of ICM group and DCM group both decreased at 1st month,but P>0.05.There was no significant difference between the control group and the treatment group(P>0.05).The blood pressure of ICM group decreased slightly more than that of DCM group,but P>0.05.At 3rd、6th and 12th month after the start of the drug,the blood pressure of the two groups showed little change(P>0.05).4.Medication safetyThere was no significant difference in BUN,Cr,ALT and AST,between ICM group and DCM group,control group and treatment group before and after medication(P>0.05).5.Adverse reactionsThere were 3 cases of hypotension in the ICM group,including 2 cases of dizziness and 1 case of palpitation.Hypotension(<90/60 mmHg)occurred in 2 patients in the DCM group,and dizziness occurred in 1 patient.All symptoms were mild,and were restored to normal after drug reduction or suspension for 1-2 days,and then continued drug treatment.No hepatic or renal impairment or blood images were found in the two groups,and there was no angioedema.ConclusionSV can improve ventricular remodeling and cardiac function in ICM and DCM-induced HF.The improvement of SV in ICM HF patients is better than that of DCM,and the medication safety is consistent. |