Clinical trial of sacubactril valsartan combined with dapagliflozin in the treatment of patients with type Ⅱ cardio-renal syndrome
Objective To observe the clinical efficacy and safety of sacubactril valsartan tablets combined with dapagliflozin tablets in the treatment of patients with type Ⅱ cardio-renal syndrome(CRS).Methods The patients with type Ⅱ CRS were divided into control group and treatment group according to cohort method.Control group was given dapagliflozin 10 mg per time,qd,orally.On the basis of control group,treatment group was given sacubactril valsartan sodium tablets 50 mg per time,bid,orally,and doubled every 2 to 4 weeks until 200 mg per time,bid.Two groups were treated for 3 months.The clinical efficacy,cardiac and renal function and safety were compared between the two groups.Results There were 89 cases in the control group and 87 cases in the treatment group.After treatment,the total effective rates of treatment and control groups were 91.95％(80 cases/87 cases)and 80.90％(72 cases/89 cases),and the difference was statistically significant(P＜0.05).After treatment,the cardiac output of treatment group and control group were(4.36±0.48)and(4.05±0.41)L·min-1,the left ventricular ejection fraction were(48.62±5.02)％and(43.21±4.51)％,the serum creatinine levels were(84.01±10.36)and(95.26±12.65)pmol·L-1,the blood urea nitrogen levels were(6.23±1.12)and(8.04±1.41)mmol·L-1,the urinary protein excretion rates were(79.03±8.27)and(86.05±10.32)μg·min-1,the urinary albumin/creatinine ratios were(90.04±15.13)and(102.16±17.26)mg·g-1,and the differences were statistically significant(all P＜0.05).The adverse drug reactions of treatment group were gastrointestinal reaction,hypotension and hypoglycemia,while those in the control group were hypoglycemia,gastrointestinal reaction and dizziness.The total incidences of adverse drug reactions in treatment and control groups were 8.05％and 6.74％without significant difference(P＞0.05).Conclusion Sacubatrol valsartan tablets combined with dapagliflozin tablets have a definitive clinical efficacy in the treatment of type Ⅱ CRS,which can improve patients'cardiac and renal function,without increasing the incidence of adverse drug reactions.
万方数据
维普
