Petru M A, Crawford M H, Kennedy G T, Amon K W, O'Rourke R A
Am Heart J. 1985 Jan;109(1):99-103. doi: 10.1016/0002-8703(85)90422-3.
In order to assess the long-term efficacy of diltiazem for the treatment of angina pectoris, eight patients with chronic stable exertional angina who were previously entered into a 4-month randomized, double-blind placebo controlled study, were studied for an additional 12-months. The patients continued to take diltiazem, 360 mg/day, and underwent treadmill exercise testing after 10 and 16 months of therapy. A single-blind placebo week was introduced after 16 months and a treadmill test was performed at the end of this week. Diltiazem therapy continued to augment exercise duration until 0.1 mV of ECG ST depression at 10 and 16 months as compared to the final placebo period: 573 +/- 133 (SD) seconds at 10 months; 565 +/- 148 seconds at 16 months; vs 431 +/- 151 seconds at final placebo (both p less than 0.001). Also, the time to angina pectoris was prolonged on diltiazem by 181 seconds at 16 months (p less than 0.01) and the total duration of exercise was increased by 101 seconds (p less than 0.001) as compared to placebo. In addition, angina frequency decreased from 17 +/- 11 attacks/week on placebo to 0.6 +/- 0.6 attacks/week during diltiazem therapy at 16 months. Two of the eight patients noted mild pedal edema, but no other adverse effects were experienced. Thus diltiazem, 360 mg/day, can be an effective single agent for the long-term treatment of chronic stable angina pectoris.
为评估地尔硫䓬治疗心绞痛的长期疗效，对8例慢性稳定劳力性心绞痛患者进行了研究，这些患者之前参加了一项为期4个月的随机、双盲、安慰剂对照研究，并在此基础上又进行了12个月的研究。患者继续服用地尔硫䓬，每日360毫克，并在治疗10个月和16个月后进行平板运动试验。在16个月后引入为期一周的单盲安慰剂期，并在该周结束时进行平板试验。与最终安慰剂期相比，地尔硫䓬治疗在10个月和16个月时持续增加运动持续时间，直至心电图ST段压低0.1毫伏：10个月时为573±133（标准差）秒；16个月时为565±148秒；而最终安慰剂期为431±151秒（两者p均小于0.001）。此外，与安慰剂相比，地尔硫䓬治疗在16个月时使心绞痛发作时间延长了181秒（p小于0.01），运动总持续时间增加了101秒（p小于0.001）。另外，心绞痛发作频率从安慰剂治疗时的每周17±11次发作降至地尔硫䓬治疗16个月时的每周0.6±0.6次发作。8例患者中有2例出现轻度足踝水肿，但未出现其他不良反应。因此，每日360毫克的地尔硫䓬可作为慢性稳定型心绞痛长期治疗的有效单一药物。
