氯沙坦与依那普利联用对慢性心衰患者效应及安全性的研究

Randomized study of the effect and safety of combining losartan with enalapril in patients with chronic heart failure

目的 比较氯沙坦 (Losartan)和依那普利(Enalapril)联用与依那普利单用 ,对慢性心衰 (CHF)患者在心脏功能及安全性等方面的影响。方法 采用随机两阶段交叉试验研究设计。符合入选条件的CHF患者随机分配至两个组 ,接受治疗方案的顺序不同的两阶段治疗 ,两治疗方案分别为氯沙坦和依那普利合用与依那普利加安慰剂治疗。每阶段各治疗 8周 ,其间设 2周的洗脱期。结果 联合治疗与依那普利单用相比 ,6min步行距离的增加、收缩压和舒张压的降低、LVEDV的缩小、LVEF的改善、心房利钠肽 (ANP)血浆浓度的降低等均显著 (P <0 0 5 )。而AⅡ血浆浓度的变化无统计学差异 (P >0 0 5 )。两治疗方案间对血钾、肌酐的影响无统计学差异 (P >0 0 5 )。结论 氯沙坦和依那普利联合治疗CHF患者可产生更有益的疗效 ,且是安全而耐受良好的。

Objective To compare the efficacy of enalapril alone and that of enalapril combined with losartan on the left ventricular functions in patients with chronic heart failure and evaluating the safety of the two regimens. Methods A randomized two-stage cross-over trial covering 18 weeks was used in the study. All subjects were randomized to two groups. Each group in stage 1 first received one of the two regimens: the regimen of enalapril plus palcebo and that of enalapril plus losartan for 8 weeks. After a wash-out time of 2 weeks, each group took the other regimen for another 8 weeks. During the wash-out periods placeboes were continued.Results Compared with the regimen of enalapril only, the regimen of enalapril plus losartan has better effects on the following indices: increase of distance in six-minute walk test, reduction of systolic, diastolic and mean blood pressure, improvement of LVEF and LVEDV evaluated by ultrasonic cardiogram, reduction of plasma level of ANP ( P <0 05). The two regimens have similar influence on plasma level of AII and serum levels of potassium and creatinine ( P >0 05).Conclusions For CHF patients the regimen of enalapril plus losartan is superior to that of enalapril plus placebo in most indices observed and the combination of enalapril with losartan is as safe and well-tolerated as enalapril alone.