托伐普坦片联合沙库巴曲缬沙坦钠片治疗心力衰竭伴低钠血症患者的临床研究

Clinical trial of tolvaptan tablets combined with sacubatrovalsartan sodium tablets in the treatment of patients with heart failure and hyponatremia

目的观察托伐普坦片联合沙库巴曲缬沙坦钠片治疗心力衰竭伴低钠血症患者的临床疗效及安全性。方法将124例心力衰竭伴低钠血症患者随机分为对照组和试验组,每组62例。对照组给予沙库巴曲缬沙坦钠片每次100 mg,bid,口服;试验组在对照组治疗的基础上,给予托伐普坦片每次15 mg,qd,口服,根据血清钠浓度,酌情增减,最大剂量不超过60 mg·d^-1,若血钠≥150 mmol·L^-1可暂时停药。2组患者均治疗7 d。比较2组患者的临床疗效,心功能和钠离子水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为95.16%(59例/62例)和83.87%(52例/62例),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分别为(47.08±5.42)%和(42.69±5.33)%,心输出量分别为(4.62±0.53)和(4.15±0.51)L·min^-1,钠离子分别为(142.13±12.17)和(132.69±10.24)mmol·L^-1,差异均有统计学意义(均P<0.05)。对照组未发生药物不良反应,试验组发生的药物不良反应以口渴为主。试验组和对照组的总药物不良反应发生率分别为3.23%和0,差异无统计学意义(P>0.05)。结论托伐普坦片联合沙库巴曲缬沙坦钠片治疗心力衰竭伴低钠血症患者的临床疗效确切,其能有效地改善心功能和低钠血症,且不增加药物不良反应的发生率。

Objective To observe the clinical effect and safety of tolvaptan tablets combined with sacubatrovalsartan sodium tablets in the treatment of patients with heart failure and hyponatremia.Methods A total of 124 patients with heart failure and hyponatremia were randomly divided into control and treatment groups with 62 cases per group.The control group was treated with sacubatrovalsartan sodium 100 mg per time,bid,orally.The treatment group was treated with tovaptan tablets 15 mg per time,qd,orally,and the dosage was adjusted according to the serum sodium concentration,the maximum dosage was no more than 60 mg·d^-1,and the drug could be temporarily stopped if the blood sodium≥150 mmol·L^-1,on the basis of control group.Two groups were treated for 7 days.The clinical efficacy,cardiac function and levels of Na+,and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 95.16%(59 cases/62 cases)and 83.87%(52 cases/62 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:left ventricular ejection fraction were(47.08±5.42)%and(42.69±5.33)%,cardiac output were(4.62±0.53)and(4.15±0.51)L·min^-1,Na+were(142.13±12.17)and(132.69±10.24)mmol·L^-1,the differences were statistically significant(all P<0.05).There was no adverse drug reaction occurred in the control group.The adverse drug reactions of treatment group were thirst.The incidences of total adverse drug reactions in treatment and control groups were 3.23%and 0 without significant difference(P>0.05).Conclusion Tolvaptan tablets combined with sacubatrovalsartan sodium tablets have a definitive clinical efficacy in the treatment of patients with heart failure and hyponatremia,which can effectively improve heart function and hyponatremia,without increasing the incidence of adverse drug reactions.