McGrath B P, Arnolda L, Matthews P G, Jackson B, Jennings G, Kiat H, Johnston C I
Br Heart J. 1985 Oct;54(4):405-14. doi: 10.1136/hrt.54.4.405.
Twenty five patients with chronic congestive cardiac failure had enalapril (n = 13) or placebo (n = 12) added to their existing regimen of digoxin and frusemide in a randomised double blind trial. Four hours after the first 5 mg dose, the enalapril group showed significant falls in blood pressure, heart rate, and concentrations of plasma angiotensin II, angiotensin converting enzyme, and noradrenaline. During the 12 week trial heart failure became worse in one enalapril treated patient (8%) and in seven placebo treated patients (58%). There were no significant changes in cardiac ejection fraction or exercise duration in either group. Plasma noradrenaline response to graded exercise and maximum exercise rate-pressure product were significantly reduced after four and 12 weeks of active treatment but unchanged with placebo treatment. There was a sustained increase in plasma potassium and a slight rise in plasma creatinine in the enalapril group. Plasma concentrations of the active drug, enalaprilate, were dose related and log enalaprilate correlated significantly with percentage of plasma angiotensin converting enzyme activity (r = -0.66). Enalapril was well tolerated and produced no adverse effects. The drug appears to be superior to placebo and offers considerable promise for the treatment of this condition.
在一项随机双盲试验中，25例慢性充血性心力衰竭患者在其现有的地高辛和速尿治疗方案基础上加用依那普利（n = 13）或安慰剂（n = 12）。在首次给予5毫克剂量4小时后，依那普利组的血压、心率以及血浆血管紧张素II、血管紧张素转换酶和去甲肾上腺素浓度均显著下降。在为期12周的试验中，1例接受依那普利治疗的患者（8%）心力衰竭加重，而7例接受安慰剂治疗的患者（58%）心力衰竭加重。两组的心脏射血分数或运动持续时间均无显著变化。积极治疗4周和12周后，分级运动时血浆去甲肾上腺素反应和最大运动率 - 压力乘积显著降低，但安慰剂治疗无变化。依那普利组血浆钾持续升高，血浆肌酐略有上升。活性药物依那普利拉的血浆浓度与剂量相关，且依那普利拉对数与血浆血管紧张素转换酶活性百分比显著相关（r = -0.66）。依那普利耐受性良好，未产生不良反应。该药物似乎优于安慰剂，为治疗这种疾病带来了很大希望。
