Northridge D B, Rose E, Raftery E D, Lahiri A, Elder A T, Shaw T R, Henderson E, Dargie H J
Department of Cardiology, Western Infirmary, Glasgow, U.K.
Eur Heart J. 1993 Mar;14(3):403-9. doi: 10.1093/eurheartj/14.3.403.
Angiotensin converting enzyme (ACE) inhibitors are of proven value in patients with severe chronic heart failure (CHF). Studies of the effects of ACE inhibitors on exercise capacity and quality of life in mild CHF have produced conflicting results. We have studied the effects of quinapril, a new ACE inhibitor with a relatively short plasma half-life, in mild CHF. Once daily (o.d.) dosing was compared with twice daily (b.i.d.) dosing in a three-way cross-over, double-blind, placebo-controlled trial. Thirty-two patients (two female), mean age 59 (range 32-76) years were enrolled in three cardiology centres in the U.K. in 29 patients, and non-ischaemic in three. The mean (range) radionuclide ejection fraction was 20.4% (8%-47%). Following full familiarization with the protocol, the treadmill exercise time (modified Bruce protocol) was determined for each patient during a placebo run-in phase, and at the end of each of three 8-week double-blind treatment phases with quinapril o.d., quinapril b.i.d. (maximal total daily dose 20 mg) and placebo. Three patients were withdrawn due to adverse events while receiving quinapril (unstable angina, exacerbation of CHF and arrhythmia); there were no deaths and no patient was withdrawn due to hypotension. Mean exercise time (the primary end-point) was 65 s and 53 s longer in patients receiving quinapril o.d. and b.i.d. respectively compared to placebo (both P < 0.01, ANOVA). There was no significant period effect during the trial and no significant difference between the two quinapril dosing regimens. Quinapril had no significant effect on secondary end-points including ejection fraction, functional class and quality of life.(ABSTRACT TRUNCATED AT 250 WORDS)
血管紧张素转换酶(ACE)抑制剂对重度慢性心力衰竭(CHF)患者具有已证实的价值。关于ACE抑制剂对轻度CHF患者运动能力和生活质量影响的研究结果相互矛盾。我们研究了一种新型ACE抑制剂喹那普利(血浆半衰期相对较短)对轻度CHF的影响。在一项三向交叉、双盲、安慰剂对照试验中,将每日一次(o.d.)给药与每日两次(b.i.d.)给药进行了比较。1992年,英国三个心脏病中心招募了32名患者(2名女性),平均年龄59岁(范围32 - 76岁)。其中29名患者为缺血性心脏病,3名患者为非缺血性心脏病。平均(范围)放射性核素射血分数为20.4%(8% - 47%)。在患者完全熟悉方案后,在安慰剂导入期以及喹那普利o.d.、喹那普利b.i.d.(最大每日总剂量20 mg)和安慰剂三个为期8周的双盲治疗阶段结束时,为每位患者测定跑步机运动时间(改良Bruce方案)。3名患者在接受喹那普利治疗时因不良事件退出(不稳定型心绞痛、CHF加重和心律失常);无死亡病例,也没有患者因低血压退出。与安慰剂相比,接受喹那普利o.d.和b.i.d.治疗的患者平均运动时间(主要终点)分别延长了65秒和53秒(均P < 0.01,方差分析)。试验期间无显著的阶段效应,两种喹那普利给药方案之间无显著差异。喹那普利对包括射血分数、功能分级和生活质量在内的次要终点无显著影响。(摘要截短为250字)