Remes J, Nikander P, Rehnberg S, Halinen M O, Kuikka J, Länsimies E, Pyörälä K
Ann Clin Res. 1986;18(3):124-8.
The efficacy of enalapril, a new angiotensin-converting enzyme inhibitor, was investigated in a double-blind placebo-controlled study in 24 patients with chronic heart failure. The patients belonging to NYHA functional class II-IV and treated with digoxin and diuretics were randomized to enalapril (12 patients) or placebo (12 patients) treatment for a 12-week period. Assessments were carried out at baseline and at 4 and 12 weeks during the treatment period. Complete data could be obtained on 10 patients receiving enalapril and on 11 patients receiving placebo. NYHA functional class improved by at least one class in 6 of 10 patients in the enalapril group, but only in 1 of 11 patients in the placebo group (chi 2 = 6.54; p less than 0.05). Duration of bicycle ergometer exercise increased significantly in the enalapril group from 8.8 +/- 3.4 to 11.3 +/- 4.2 (4 weeks) and to 11.2 +/- 3.6 min (12 weeks; p less than 0.05 for both), whereas it remained unchanged in the placebo group. Left ventricular ejection fraction by radionuclide ventriculography in the enalapril group increased significantly (baseline: 33.5 +/- 19.9%, 4 weeks: 40.0 +/- 20.0% (p less than 0.001), 12 weeks: 39.6 +/- 20.1% (p less than 0.01], whereas in the placebo group it did not change significantly from the baseline of 48.8 +/- 16.7%. The results indicate that enalapril induces a sustained relief of symptoms and improves exercise capacity in patients with heart failure. This subjective improvement appears to be accompanied by an increase in ejection fraction.
在一项针对24例慢性心力衰竭患者的双盲安慰剂对照研究中，对新型血管紧张素转换酶抑制剂依那普利的疗效进行了研究。将属于纽约心脏协会（NYHA）心功能II - IV级且接受地高辛和利尿剂治疗的患者随机分为依那普利组（12例患者）或安慰剂组（12例患者），治疗为期12周。在治疗期的基线、4周和12周时进行评估。在接受依那普利治疗的10例患者和接受安慰剂治疗的11例患者中可获得完整数据。依那普利组10例患者中有6例NYHA心功能分级至少改善一级，而安慰剂组11例患者中只有1例改善（χ² = 6.54；p < 0.05）。依那普利组自行车测力计运动持续时间从8.8±3.4分钟显著增加至11.3±4.2分钟（4周），并增加至11.2±3.6分钟（12周；两者p均< 0.05），而安慰剂组则保持不变。依那普利组通过放射性核素心室造影测得的左心室射血分数显著增加（基线：33.5±19.9%，4周：40.0±20.0%（p < 0.001），12周：39.6±20.1%（p < 0.01），而安慰剂组从基线的48.8±16.7%未显著变化。结果表明，依那普利可使心力衰竭患者症状持续缓解并提高运动能力。这种主观改善似乎伴随着射血分数的增加。
