| ObjectiveTo investigate the efficacy and safety of sacubitril/valsartan in the treatment of patients with heart failure with dilated heart disease in China,and to provide evidence for more reasonable clinical treatment.MethodsDatabases such as CNKI,Wanfang,CBM,VIP,Web of Science,Pub Med,Cochrane Library,Embase were searched.The search time was set to build the database until December 2022,and the study type was Randomized controlled trial(RCT),supplemented by manual search.Literature screening and data extraction were performed independently by 2 personnel and cross-checked,and in case of disagreement,discussed or resolved by third-party personnel.Meta-analysis was performed using Rev Man 5.3 and Stata 14.0 software after the quality evaluation of the included literature was completed.ResultsA total of 8 RCTs meeting the inclusion criteria were included in this study.5studies reported on the improvement of cardiac function class in heart failure with sacubitril/valsartan for dilated cardiomyopathy.The analysis showed that sacubitril valsartan improved cardiac function class more significantly than ACEI/ARB [RR=1.30,95% CI(1.17,1.45),Z=4.79,P<0.00001].7 studies reported LVEF outcomes,and the analysis showed that sacubitril/valsartan was more effective than ACEI/ARB in improving LVEF in patients [MD= 3.98,95% CI(2.34,5.61),Z=4.77,P<0.00001].4studies reported the results of the 6-minute walk test.The analysis showed that sacubitril/valsartan improved the 6-minute walk distance more than ACEI/ARB [MD=61.03,95% CI(49.25,72.81),Z=10.15,P<0.00001].6 studies reported the results of NT-pro BNP,and the analysis showed that sacubitril/valsartan reduced patients’ NT-pro BNP levels [MD =-224.50,95% CI(-345.26,-103.75),Z = 3.64,P = 0.0003].3 studies reported LVEDD results and the analysis showed that sacubitril/valsartan reduced LVEDD in patients more than ACEI/ARB [MD=-7.33,95%CI:(-9.50,-5.16),Z=6.63,P<0.00001].3 studies reported results on heart failure rehospitalization rates,and analysis showed that sacubitril/valsartan was more effective in reducing heart failure rehospitalization rates than ACEI/ARB [RR=0.56,95% CI(0.37,0.83),Z=2.89,P=0.004].Regarding safety,4 studies reported the incidence of total adverse reactions,and analysis showed no significant difference in the incidence of total adverse reactions with sacubitril/valsartan compared with ACEI/ARB [RR = 0.72,95% CI(0.33,1.57),Z = 0.82,P = 0.41].4 studies reported the incidence of hypotension,and analysis showed no significant difference in the incidence of hypotension with sacubitril/valsartan compared with ACEI/ ARB did not differ significantly in the incidence of hypotension [RR=1.19,95% CI(0.39,3.65),Z=0.31,P=0.75].2 studies reported the incidence of hyperkalemia and analysis showed no significant difference in the incidence of hyperkalemia with sacubitril/valsartan compared to ACEI/ARB [RR=3.03,95% CI(0.32,28.59),Z = 0.97,P = 0.33].Cardiovascular mortality、renal impairment and angioedema indicators were reported in only 1 paper,so they were not analyzed.Sensitivity analysis suggested robust results,and funnel plot and Egger test indicated no significant publication bias in this study.ConclusionIn Chinese patients with dilated cardiomyopathy and heart failure,compared with ACEI/ARB drugs,sacubitril/valsartan can effectively improve NYHA cardiac function classification,increase LVEF and 6-minute walking distance,reduce the level of NTpro BNP,narrow LVEDD,and reduce the rehospitalization rate of heart failure.The incidence of total adverse reactions and the incidence of hypotension and hyperkalemia in subgroups were not higher than ACEI/ARB,and the safety was good. |
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