沙库巴曲缬沙坦联合达格列净治疗老年慢性心力衰竭合并2型糖尿病患者的临床研究

Clinical trial of sacubactril valsartan combined with dagliprazin in the treatment of elderly patients with chronic heart failure and type 2 diabetes mellitus

目的观察沙库巴曲缬沙坦联合达格列净对老年慢性心力衰竭(CHF)合并2型糖尿病(T2DM)患者心功能及血糖波动的影响。方法将老年CHF合并T2DM患者分为试验组和对照组。对照组患者给予厄贝沙坦片,qd,每次150 mg,美托洛尔缓释片,qd,起始剂量23.75 mg,2周后剂量增至47.5 mg,以及晨服达格列净片,qd,每次5 mg,患者耐受性良好则增加剂量至每次10 mg。试验组给予达格列净片,qd,每次5 mg,患者耐受性良好则增加剂量至每次10 mg,同时给予沙库巴曲缬沙坦钠片治疗,bid,每次50 mg,患者耐受性良好则每2~4周倍增剂量,不得超过每次200 mg。2组患者均持续治疗6个月。比较2组患者的临床疗效、心功能、血糖波动、安全性及预后。结果试验组和对照组分别入组47和49例。治疗后,试验组和对照组的总有效率分别为93.62%(44例/47例)和79.59%(39例/49例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的左心室射血分数(LVEF)分别为(55.34±8.22)%和(46.59±6.80)%,心脏指数(CI)分别为(2.54±0.41)和(2.37±0.39)L·min^(-1)·m^(-2),餐后血糖波动(PGE)分别为(1.45±0.31)和(1.86±0.46)mmol·L^(-1),最大血糖波动幅度(LAGE)分别为(3.42±1.05)和(4.47±1.39)mmol·L^(-1),主要心血管不良事件(MACE)率、再入院率分别为4.26%(2例/47例)、2.13%(1例/47例)和18.37%(9例/49例)、14.29%(7例/49例),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应为尿路感染和低血压,对照组发生的药物不良反应为尿路感染和血管性水肿,试验组和对照组的总药物不良反应发生率分别为6.38%(3例/47例)和4.08%(2例/49例),在统计学上差异无统计学意义(P>0.05)。结论沙库巴曲缬沙坦钠片联合达格列净片能够改善老年CHF合并T2DM患者的心功能,降低血糖波动,提高总有效率,并改善预后,同时药物安全性良好。

Objective To observe the effect of sacubitril valsartan combined with dapagliflozin on cardiac function and blood glucose fluctuation in elderly patients with chronic heart failure(CHF)and type 2 diabetes mellitus(T2DM).Methods The elderly patients with CHF and T2DM were divided into treatment group and control group.Patients in the control group were given irbesartan tablets,150 mg each time,metoprolol sustained-release tablets,qd,with an initial dose of 23.75 mg,and the dose was increased to 47.5 mg after 2 weeks,and dap ag liflozin tablets was taken in the morning,qd,5 mg each time.If the patient was well tolerated,the dose was increased to 10 mg each time.The treatment group was given dapagliflozin tablets,qd,5 mg each time,and the dose was increased to 10 mg each time if the patient was well tolerated.At the same time,sacubitril valsartan sodium tablets was given,bid,50 mg each time.If the patient was well tolerated,the dose should be doubled every 2-4 weeks,not exceeding 200 mg each time.The two groups were treated for 6 months.The cardiac function,blood glucose fluctuation,drug safety and prognosis were compared between the two groups.Results Forty-seven cases and forty-nine cases were included in the treatment and control group,respectively.After treatment,the total effective rates in the treatment and control group were 93.62%(44 cases/47 cases)and 79.59%(39 cases/49 cases),and there were significant differences(P<0.05).After treatment,left ventricular ejection fraction(LVEF)in the treatment group group and the control group were(55.34±8.22)and(46.59±6.80)%;cardiac indexes(CI)were(2.54±0.41)and(2.37±0.39)L·min^(-1)·m^(-2);postprandial glucose excursions(PGE)were(1.45±0.31)and(1.86±0.46)mmol·L^(-1);the largest amplitudes of glycemic excursions(LAGE)were(3.42±1.05)and(4.47±1.39)mmol·L^(-1);the incidence rates of major cardiovascular adverse events(MACE)were 4.26%(2 cases/47 cases)and 2.13%(1 cases/47 cases);readmission rates were 18.37%(9 cases/49 cases)and 14.29%(7 cases/49 cases).There were statistically significant differences in the above indexes between the treatment group and the control group.(all P<0.05).The adverse drug reactions in the treatment group were urinary tract infection and hypotension,and the adverse drug reactions in the control group were urinary tract infection and angioedema,and the total adverse drug reaction rate of the two groups was 6.38%(3 cases/47 cases)and 4.08%(2 cases/49 cases),and there was no statistical significance(P>0.05).Conclusion The combined treatment of sacubitril valsartan sodium tablets and dapagliflozin tablets can improve cardiac function,reduce blood glucose fluctuation,increase the total effective rate,and improve the prognosis of elderly patients with CHF and T2DM,with good drug safety.