Lechat P, Garnham S P, Desche P, Bounhoure J P
Département de Pharmacologie Clinique, Hôpital Pitié-Salpétrière, Paris, France.
Am Heart J. 1993 Sep;126(3 Pt 2):798-806. doi: 10.1016/0002-8703(93)90933-z.
The aim of this 3-month double-blind, placebo-controlled, multicenter trial was to evaluate the clinical efficacy and safety of perindopril, a new long-acting angiotensin-converting enzyme inhibitor in the second-line treatment of mild to moderate chronic congestive heart failure. After a run-in period of at least 14 days, 125 patients with grade II or III New York Heart Association chronic congestive heart failure on baseline diuretic therapy were randomized to perindopril, 2 mg (n = 61), or placebo (n = 64), once daily. Assessment was at 2-week intervals for the first month and then monthly for the 2 following months. After 2 weeks, active treatment was increased to perindopril, 4 mg once daily, if systolic blood pressure was 100 mm Hg or greater. Apart from sex, the two groups were homogeneous before treatment. As shown by the end-point analysis, the increase in exercise time was greater with perindopril than with placebo for both the ergometric bicycle (+111 +/- 21 versus +16 +/- 20 seconds; p = 0.002) and the treadmill (+171 +/- 39 versus +36 +/- 42 seconds; p = 0.024). Compared with placebo, this increase in exercise tolerance with perindopril was accompanied by an improvement in New York Heart Association functional class (p = 0.009), overall heart failure severity score (p < 0.001), and cardiothoracic ratio (p = 0.05). Of the 12 withdrawals from the study, seven were attributed to adverse events, two in the perindopril group and five, including one death, in the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)
这项为期3个月的双盲、安慰剂对照、多中心试验的目的是评估培哚普利(一种新型长效血管紧张素转换酶抑制剂)在轻至中度慢性充血性心力衰竭二线治疗中的临床疗效和安全性。在至少14天的导入期后,125例接受基线利尿剂治疗的纽约心脏协会II级或III级慢性充血性心力衰竭患者被随机分为培哚普利组(2 mg,n = 61)或安慰剂组(n = 64),每日一次。在第一个月每2周进行一次评估,随后的2个月每月进行一次评估。2周后,如果收缩压为100 mmHg或更高,活性治疗增加至培哚普利4 mg每日一次。除性别外,两组在治疗前具有同质性。终点分析表明,对于测力计自行车运动(+111±21秒对+16±20秒;p = 0.002)和跑步机运动(+171±39秒对+36±42秒;p = 0.024),培哚普利组的运动时间增加幅度均大于安慰剂组。与安慰剂相比,培哚普利组运动耐量的增加伴随着纽约心脏协会功能分级的改善(p = 0.009)、整体心力衰竭严重程度评分的改善(p < 0.001)和心胸比率的改善(p = 0.05)。在退出研究的12例患者中,7例归因于不良事件,培哚普利组2例,安慰剂组5例,包括1例死亡。(摘要截短于250字)