Scrutinio D, Lagioia R, Mangini S G, Mastropasqua F, Ricci A, Chiddo A, Rizzon P
Clinica del Lavoro Foundation, Institute of Care and Research Rehabilitation Medical Center, Bari, Italy.
Eur Heart J. 1989 Feb;10(2):168-76. doi: 10.1093/oxfordjournals.eurheartj.a059457.
In this double-blind, randomized placebo-controlled study the effects of two dosages of gallopamil on exercise tolerance were evaluated in 12 patients with stable effort angina. After a pre-study screening aimed at assessing the reproducibility of the exercise response, the patients entered the study which consisted of three 7-day consecutive periods during which placebo or gallopamil 50 mg t.i.d. or gallopamil 75 mg t.i.d. were administered according to a randomized sequence. 24-hour Holter monitoring and cross-sectional echocardiography were performed on the 6th and 7th day of each treatment period, respectively. On the 7th day of each treatment period, patients underwent an exercise test 2 and 8 h after the last administration of gallopamil or placebo. Blood samples for plasma gallopamil concentrations were taken just before each exercise test. The results were analysed using a three-way analysis of variance; intergroup differences were evaluated by the Newman-Keuls test. At 2 h, 11 patients with placebo and three with gallopamil experienced angina; both dosages of gallopamil significantly prolonged exercise time and -1 mm time and also reduced ST segment depression and the rate-pressure product at submaximal workload. No significant change in the rate-pressure product was observed either on the appearance of 1 mm ST depression or at peak exercise. At 8 h, 11 patients with placebo and gallopamil 50 mg t.i.d. and 10 with gallopamil 75 mg t.i.d. experienced angina; although exercise time was significantly prolonged by both dosages of gallopamil, the increase in -1 mm time and reduction of ST segment depression at submaximal workload did not reach statistical significance.(ABSTRACT TRUNCATED AT 250 WORDS)
在这项双盲、随机、安慰剂对照研究中,对12例稳定型劳力性心绞痛患者评估了两种剂量的加洛帕米对运动耐量的影响。在进行旨在评估运动反应可重复性的预研究筛查后,患者进入研究,该研究包括三个连续7天的阶段,在此期间,按照随机顺序给予安慰剂、每日三次50 mg加洛帕米或每日三次75 mg加洛帕米。在每个治疗阶段的第6天和第7天分别进行24小时动态心电图监测和横断面超声心动图检查。在每个治疗阶段的第7天,患者在最后一次服用加洛帕米或安慰剂后2小时和8小时进行运动试验。在每次运动试验前采集血样以测定血浆加洛帕米浓度。结果采用三因素方差分析进行分析;组间差异通过纽曼-基尔斯检验进行评估。2小时时,11例服用安慰剂的患者和3例服用加洛帕米的患者出现心绞痛;两种剂量的加洛帕米均显著延长了运动时间和-1 mm时间,还降低了次极量负荷时的ST段压低和心率-血压乘积。在出现1 mm ST段压低时或运动峰值时,心率-血压乘积均未观察到显著变化。8小时时,11例服用安慰剂的患者、每日三次服用50 mg加洛帕米的患者中有3例以及每日三次服用75 mg加洛帕米的患者中有10例出现心绞痛;尽管两种剂量的加洛帕米均显著延长了运动时间,但次极量负荷时-1 mm时间的增加和ST段压低的降低未达到统计学显著性。(摘要截短于250字)