沙库巴曲缬沙坦钠片治疗急性心力衰竭患者的临床研究

Clinical trial of sacubitril valsartan tables in the treatment of patients with acute heart failure

目的观察沙库巴曲缬沙坦钠片治疗急性失代偿性心力衰竭的临床疗效和安全性。方法将急性失代偿性心力衰竭患者用随机数表法分为对照组和试验组。对照组在常规心力衰竭治疗基础上采用马来酸依那普利叶酸片口服治疗,每次2.5 mg,bid,试验组在常规心力衰竭治疗基础上采用沙库巴曲缬沙坦钠片口服治疗,起始剂量每次50 mg,bid,之后根据血压调整剂量,最大剂量每次200 mg,bid,并维持最大剂量。2组患者均连续治疗1个月。比较2组患者的临床疗效、血压和心率水平变化、心脏功能和结构情况,以及药物不良反应的发生情况。结果试验组和对照组均纳入40例。治疗后,试验组和对照组的总有效率分别为90.00%(36例/40例)和70.00%(28例/40例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的收缩后分别为(122.35±7.86)和(126.76±7.31)mmHg;心率分别为(69.27±4.33)和(73.32±4.54)time·min^(-1);左心室射血分数(LVEF)分别为(47.13±1.60)%和(42.51±1.38)%;左心室收缩期内径(LVESD)分别为(42.32±1.47)和(47.36±1.54)mm;左心室舒张末期内径(LVEDD)分别为(52.53±1.50)和(55.51±2.80)mm;试验组上述指标与对照组比较,差异均有统计学意义(均P<0.05)。试验组和对照组的总药物不良反应发生率分别为2.50%和0,差异无统计学意义(P>0.05)。结论沙库巴曲缬沙坦钠片比马来酸依那普利治疗急性失代偿性心力衰竭的疗效更佳。

Objective To observe the clinical efficacy and safety of the treatment of acute decompensated heart failure(ADHF)with sacubitril valsartan sodium tablets.Methods Patients with acute decompensated heart failure were divided into control group and treatment group by random number table method.The control group was treated with enalapril maleate folic acid tablets orally on the basis of conventional heart failure treatment,2.5 mg each time,bid.The treatment group was treated with sacubitril valsartan sodium tablets orally on the basis of conventional heart failure treatment.The initial dose was 50 mg each time,bid,and then the dose was adjusted according to blood pressure.The maximum dose was 200 mg each time,bid,and the maximum dose was maintained.Both groups were treated continuously for 1 month.The clinical efficacy,blood pressure and heart rate changes,cardiac function and structure,and adverse drug reactions were compared between the two groups.Results Forty cases were included in the treatment group and the control group,respectively.After treatment,the clinical efficacies in the treatment and control groups were 90.00%(36 cases/40 cases)and 70.00%(28 cases/40 cases),respectively,and there was difference between two groups(P<0.05).After treatment,the systolic blood pressure of the treatment group and the control group were(122.35±7.86)and(126.76±7.31)mmHg,respectively.The heart rates were(69.27±4.33)and(73.32±4.54)time·min^(-1),respectively.The left ventricular ejection fraction(LVEF)was(47.13±1.60)%and(42.51±1.38)%,respectively.The left ventricular systolic diameter(LVESD)was(42.32±1.47)and(47.36±1.54)mm,respectively.The left ventricular end-diastolic diameter(LVEDD)was(52.53±1.50)and(55.51±2.80)mm,respectively.The above indexes in the treatment group were significantly different from those in the control group(all P<0.05).The total incidence of adverse drug reactions in the treatment group and the control group was 2.50%and 0,respectively,and the difference was not statistically significant(P>0.05).Conclusion Sacubitril valsartan is more effective than enalapril maleate in the treatment of acute decompensated heart failure.