托拉塞米、呋噻米治疗慢性心力衰竭水肿的疗效和安全性比较研究

Clinical Efficacy and Safety of Torasemide in Congestive Heart Failure Patients

目的 :多中心随机双盲对照比较托拉塞米 10～ 2 0mg与呋噻米 2 0～ 40mg每日 1次口服 ,治疗慢性心力衰竭水肿的临床疗效和安全性。方法 :95例慢性心功能衰竭 (NYHA心功能分级Ⅱ～Ⅲ级 )伴轻至重度水肿患者 ,每日 1次口服托拉塞米 10～ 2 0mg(托拉塞米组n =45 )或呋噻米 2 0～ 40mg(呋噻米组n =5 0 ) ,治疗 4周。体重、水肿程度、NYHA心功能分级和 2 4h尿量、钾、钠、氯含量 ,血、尿常规 ,血生化 ,心电图等为评价指标。结果 :4周后 ,托拉塞米组和呋噻米组平均体重分别下降 ( 2 2 2± 2 81)kg、( 1 96± 2 14 )kg ,心功能改善的有效率分别占 5 5 81%、70 83 % ,水肿消失者分别占 69 2 %、41 4% ,两组间比较P均 >0 0 5。两组治疗后 2 4h尿量均大于入量10 0～ 2 0 0ml左右 ,治疗后 2 4h尿钾、钠、氯、肌酐、尿素氮的排泄较治疗前增加 ,尿钾最明显 ,4周后托拉塞米组尿钾的排泄约为治疗前的 1 7倍 ,呋噻米组为 1 5倍 ,血钾、钠、氯无下降 ,组间比较无统计学差异。托拉塞米组和呋噻米组的不良反应发生率分别为 2 0 %和 2 8%。结论 :国产托拉塞米 10～ 2 0mg每日 1次口服 ,治疗慢性心力衰竭水肿的疗效和安全性与呋噻米 2 0～ 40mg相近。

Objective:To compare the clinical efficacy and safety of torasemide 10-20 mg and furosemide 20-40 mg in congestive heart failure patients with edema in a multiple center,randomized,double blinded and parallel control trial.Methods: Ninety-one patients with New York Heart Association (NYHA) class Ⅱ or Ⅲ congestive heart failure were given orally 10 mg torasemide ( n =43) or 20 mg furosemide ( n =48) per day for 4 weeks. Body weight,edema,NYHA class and 24 h volume of urine,24 h urine potassium,sodium,cholride were evaluated. Each subject was submitted to medical,complete blood count and chemistry,urinalysis and elertrocardiogram before and at the completion of the study. Results:After 4 weeks of treatment,a decrease of body weight by (2.22±2.81) kg and (1.96±2.14) kg,an increase of one NYHA class in 55.81% and 70.83% of the patients,and disappeared edema in 69.2% and 41.4% of the patients were found respectively in torasemide and furosemide groups. There was no difference between the two groups. The patients had 100- 200 ml more urine volume than the intake volume after the administration of the two drugs. The excretion of urine potassium,sodium,chloride over a 24 h period was increased ,especially urine potassium( p <0.01) which was 1.7 times in torasemide group and 1.5 times in the furosemide group higher than that before treatment,respectively. No decrease in serum potassium,sodium,chloride on the condition of supplement of potassium chloride. The incidence of adverse reaction was 20% and 28%,respectively in the two groups ( p =0.37). Conclusion:Torasemide 10 mg or 20 mg once daily is as effective and safe in patients with chronic heart failure as furosemide 20 mg or 40 mg.