Hossack K F, Kannagi T, Day B, Bruce R A
Am Heart J. 1984 Jun;107(6):1215-20. doi: 10.1016/0002-8703(84)90280-1.
The efficacy of a calcium slow channel-blocking drug, diltiazem (360 mg/day), was compared to placebo in 15 men with exertional angina during a 21-week study. Symptom-limited exercise testing was used to evaluate the effects of the drug. Analysis of variance indicated the increase in the values of three time-related variables, time to onset of angina, time to onset of 1 mm ST depression, and total duration of exercise, were highly significant (all p less than 0.001). The increase from the second week of placebo to the last week of diltiazem was 4 X 1 minutes for time to angina, 2 X 4 minutes for time to 1 mm ST depression, and 2 X 3 minutes for total duration. In addition, the differences between mean values of these variables for placebo and corresponding diltiazem period at weeks 3 and 4 were significant (p less than 0.01, p less than 0.01, p less than 0.05) and for diltiazem week 20 and placebo week 21 were significant (p less than 0.005, p less than 0.01, p less than 0.005). Weekly angina frequency was reduced from a mean of 17 episodes/week during placebo to one episode/week during diltiazem (p less than 0.001). Submaximal pressure-rate product was reduced significantly during diltiazem (p less than 0.001), and the ECG evidence of myocardial ischemia was reduced by diltiazem at submaximal (p less than 0.02) and maximal exercise (p less than 0.001). The drug was well tolerated and appears to be effective monotherapy for exertional angina.
在一项为期21周的研究中，对15名劳力性心绞痛男性患者比较了钙慢通道阻滞剂地尔硫䓬（360毫克/天）与安慰剂的疗效。采用症状限制性运动试验来评估药物的效果。方差分析表明，三个与时间相关的变量值增加，即心绞痛发作时间、ST段压低1毫米的发作时间和运动总时长，差异极为显著（均p < 0.001）。从安慰剂治疗的第二周增加到地尔硫䓬治疗的最后一周，心绞痛发作时间增加了4×1分钟，ST段压低1毫米的发作时间增加了2×4分钟，运动总时长增加了2×3分钟。此外，这些变量在安慰剂组和地尔硫䓬组第3周和第4周的均值差异显著（p < 0.01、p < 0.01、p < 0.05），在第20周地尔硫䓬组和第21周安慰剂组之间也显著（p < 0.005、p < 0.01、p < 0.005）。每周心绞痛发作频率从安慰剂治疗期间的平均每周17次降至地尔硫䓬治疗期间的每周1次（p < 0.001）。在使用地尔硫䓬期间，次极量压力 - 心率乘积显著降低（p < 0.001），并且地尔硫䓬在次极量运动（p < 0.02）和极量运动（p < 0.001）时均可减少心肌缺血的心电图证据。该药物耐受性良好，似乎是劳力性心绞痛的有效单一疗法。
