J Am Coll Cardiol. 1983 Oct;2(4):755-63. doi: 10.1016/s0735-1097(83)80316-7.
Ninety-two patients with heart failure refractory to digitalis and diuretic therapy had captopril (n = 50) or placebo (n = 42) added to their therapeutic regimen in a randomized, double-blind trial. During a 2 week dosage titration period, one captopril-treated patient died of an intracerebral hemorrhage. Over the remaining 10 week evaluation period, 1 captopril-treated patient (2%) was excluded from the study because of treatment failure as compared with 12 discontinuations (4 deaths and 8 failures [29%]) among the placebo group (p less than 0.001). Eighty percent of patients in the captopril group exhibited some degree of clinical improvement, whereas only 27% in the placebo group did so (p less than 0.001). The therapeutic advantage of captopril over placebo was evidenced by a mean improvement of 0.52 (2.8 +/- 0.1 to 2.3 +/- 0.1) in the New York Heart Association functional class value as compared with 0.03 (2.9 +/- 0.1 to 2.8 +/- 0.1) with placebo (p less than 0.0001). There was a 24% mean increase in exercise tolerance with captopril (495 +/- 22 to 614 +/- 27 seconds) as compared with 0.4% with placebo (480 +/- 28 to 483 +/- 43 seconds) (p less than 0.01); the captopril group had an increase in the ejection fraction from a mean baseline value of 0.19 +/- 0.02 to 0.22 +2- 0.02 as compared with 0.19 +/- 0.02 to 0.18 +/- 0.002 (p less than 0.05) in the placebo group. A cohort analysis revealed that improvement in exercise tolerance with captopril was gradual and progressive throughout the 12 weeks. Improvement in specific symptoms of heart failure, that is, dyspnea, fatigue and orthopnea, and the reduction of edema also were greater in the captopril-treated patients (p less than 0.05 to p less than 0.001). Captopril therapy was well tolerated, although symptomatic hypotension after the first dose caused withdrawal of three patients (3%) from the study. It was concluded that captopril is an effective adjunctive treatment to digitalis and diuretic drugs for patients with refractory heart failure.
在一项随机双盲试验中，92例对洋地黄和利尿剂治疗无效的心力衰竭患者被纳入治疗方案，其中50例患者服用卡托普利，42例患者服用安慰剂。在为期2周的剂量滴定期内，1例接受卡托普利治疗的患者死于脑出血。在剩余的10周评估期内，1例接受卡托普利治疗的患者（2%）因治疗失败被排除在研究之外，而安慰剂组有12例患者停药（4例死亡，8例治疗失败[29%]）（p<0.001）。卡托普利组80%的患者有一定程度的临床改善，而安慰剂组只有27%的患者有改善（p<0.001）。与安慰剂组相比，卡托普利组纽约心脏协会心功能分级值平均改善0.52（从2.8±0.1改善至2.3±0.1），而安慰剂组仅改善0.03（从从2.9±0.1改善至2.8±0.1）（p<0.0001）。卡托普利组患者运动耐量平均增加24%（从495±22秒增加至614±27秒），而安慰剂组仅增加0.4%（从480±28秒增加至483±43秒）（p<0.01）；卡托普利组射血分数从平均基线值0.19±0.02增加至0.22±0.02，而安慰剂组从0.19±0.02降至0.18±0.002（p<0.05）。队列分析显示，卡托普利组患者运动耐量在整个12周内逐渐改善。卡托普利治疗的患者在心力衰竭特定症状（即呼吸困难、疲劳和端坐呼吸）的改善以及水肿的减轻方面也更明显（p<0.05至p<0.001）。卡托普利治疗耐受性良好，尽管首剂后出现症状性低血压导致3例患者（3%）退出研究。研究得出结论，对于难治性心力衰竭患者，卡托普利是洋地黄和利尿剂药物的有效辅助治疗药物。
