关键词: 沙库巴曲缬沙坦, 达格列净, 射血分数保留的心力衰竭, Meta分析, 有效性, 安全性

Abstract:

Objective To discuss the clinical efficacy of sacubitril/valsartan （SV） combined with dapagliflozin （DAPA） in the treatment of heart failure with preserved ejection fraction （HFpEF）， and to clarify the effectiveness and safety of the combination therapy， so as to provide evidence-based basis for clinical treatment decisions. Methods The randomized controlled trials on SV combined with DAPA for HFpEF were retrieved from Chinese and English databases including CNKI， Wanfang， VIP， SinoMed， PubMed， the Cochrane Library， Embase， Web of Science， China Medical Journal Network， ClinicalTrials.gov， and the International Traditional Medicine Clinical Trial Registry Platform， with the search period from the establishment of the databases to July 2025. Two researchers independently completed literature screening and data extraction， and evaluated the risk of bias of the included literature. The Cochrane risk assessment tool was used for quality evaluation； the heterogeneity test was conducted using I 2 to assess the degree of heterogeneity among the study results； when I 2<50%， a fixed effect model was used； when I 2≥50%， a random effect model was used. Sensitivity analysis was performed for studies with high heterogeneity to verify the stability of the results. RevMan 5.4 and Stata 18.0 software were used for Meta-analysis. Results A total of 10 randomized controlled trials involving 1 015 patients were included. The Meta-analysis results showed that compared with SV alone， the combination of SV and DAPA had more advantages in improving the total clinical effective rate ［odds ratio（OR）=5.52， 95% confidence interval（CI）：2.87—10.62， P<0.000 01］， improving the quality of life of patients （OR=5.54， 95%CI：3.59—7.50， P<0.000 01）， improving the left ventricular ejection fraction（LVEF） （OR=3.66， 95%CI：1.69—5.63， P=0.000 3） and the 6-minute walking distance （6MWD）［mean difference（MD）=48.70， 95%CI：1.40—96.00， P=0.04］， reducing the N-terminal pro-B-type natriuretic peptide （NT-proBNP） level ［standardized mean difference（SMD）=-1.84， 95%CI：-2.99—-0.69）， P=0.002］， reducing the incidence of major adverse cardiovascular events（MACE） （OR=0.38， 95%CI：0.22—0.67， P=0.000 8）， and reducing 2 h postprandial glucose（2hPG） （MD=-1.19， 95%CI：-2.08—-0.30）， P=0.009）， and the differences were statistically significant. There were no statistically significant differences between experimental group and control group in the incidence of adverse reactions， fasting blood glucose（FBG） level， and glycated hemoglobin（HbA1c） level （P>0.05）. Conclusion The combination of SV and DAPA in the treatment of HFpEF can effectively improve clinical efficacy. It has certain advantages in improving the patient’s cardiac function， enhancing the quality of life， and reducing 2hPG， and does not increase the risk of adverse reactions or MACE， showing good safety.

Key words: Sacubitril valsartan, Dapagliflozin, Heart failure with preserved ejection fraction, Meta-analysis, Efficacy, Safety