托伐普坦对老年慢性心力衰竭合并轻中度肾功能不全伴低钠血症患者的疗效及安全性

目的:评估传统利尿剂及托伐普坦对老年慢性心力衰竭(心衰)合并轻中度肾功能不全伴低钠血症患者的疗效与安全性，为老年心衰患者的治疗提供临床依据。方法:随机对照临床试验，将老年心衰合并轻中度肾功能不全伴低钠血症患者88例随机分为对照组46例和试验组42例，两组均停用口服袢利尿剂，对照组46例在心衰常规治疗的基础上加用呋塞米4...

Efficacy of Tolvaptan in elderly chronic heart failure patients combined with mild to moderate renal insufficiency with hyponatremia

Objective To evaluate the efficacy and safety of conventional diuretic therapy versus Tolvaptan in elderly chronic heart failure patients combined with mild to moderate renal insufficiency with hyponatremia,in order to provide clinical evidence for the treatment of heart failure in the elderly.Methods This was a randomized control trial.A total of 88 elderly chronic heart failure patients combined with mild to moderate renal insufficiency with hyponatremia were randomly divided into the control group(n=46)and the experimental group(n=42).Once enrolled both groups stopped taking oral loop diuretics.In addition to routine treatment,the control group was treated with furosemide 40 mg once a day,while the experimental group was treated with Tolvaptan 15 mg once a day.The rate of effectiveness in relieving heart failure,the diuretic effects and improvement in heart and kidney function were monitored,and changes in serum potassium and sodium levels and the incidences of thirst and other adverse events were compared between the two groups.Results The effectiveness rate on heart failure was higher in the experimental group than in the control group(85.7%or 36/42 vs.65.2%or 30/46,χ²=17.855,P<0.001).After treatment,greater changes in average 24-hour urine volume from baseline(787.4±219.6 ml vs.388.6±179.6 ml,t=322.588,P<0.001),more weight loss(-2.4±2.1 kg vs.-1.7±1.6 kg,t=6.942,P=0.009),smaller changes in N-terminal pro-B-type natriuretic peptide(NT-proBNP)from baseline(-897.6±432.1 ng/L vs.-578.4±476.9 ng/L,t=539.400,P<0.001),greater changes in left ventricular ejection fraction(LVEF)from baseline(6.5±5.6%vs.1.5±5.7%,t=3.966,P=0.048),smaller changes in serum creatinine from baseline(-8.6±12.4μmol/L vs.9.6±11.3μmol/L,t=87.161,P<0.001),and greater changes in estimated glomerular filtration rate(eGFR)from baseline(1.4±1.8 ml·min-1·1.73m-2vs.-4.1±5.6 ml·min-1·1.73m-2,t=63.856,P<0.001)and in serum sodium from baseline(6.2±2.1 mmol/L vs.1.4±1.9 mmol/L,t=234.065,P<0.001)were observed in the experimental group than in the control group.There was no significant difference in the incidences of thirst,dry mouth and other adverse events between the two groups(16.7%or 7/42 vs.10.9%or 5/46,χ²=0.626,P=0.429).Conclusions Tolvaptan can effectively improve the clinical symptoms and cardiac function and correct hyponatremia in elderly chronic heart failure patients combined with mild to moderate renal insufficiency,with a good safety profile.