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一日一次缓释地尔硫䓬制剂两种剂量水平治疗稳定型心绞痛的24小时疗效:一项安慰剂对照试验。迪尔杜朗研究组

Twenty-four hour efficacy of two dose levels of a once daily sustained-release diltiazem formulation in stable angina: a placebo-controlled trial. The Dildurang Study Group.

作者信息

Frances Y, Gagey S, Stalla-Bourdillon A

机构信息

Hôpital Nord, Saint-Antoine, Marseille, France.

出版信息

Br J Clin Pharmacol. 1995 Mar;39(3):277-82. doi: 10.1111/j.1365-2125.1995.tb04449.x.

Abstract
  1. This placebo-controlled study assessed once daily sustained-release (SR) diltiazem, 200 and 300 mg, in 182 stable angina patients with positive exercise test. 2. Exercise testing was performed at baseline after a 7 day placebo run-in period, and repeated after 7 days of treatment, 25.0 +/- 0.1 h postdose. 3. Diltiazem (200 and 300 mg) produced respectively a 68% and a 64% decrease in weekly angina episodes, and placebo a 15% decrease (P < 0.05). Similarly, both dose levels produced a 70% decrease in nitroglycerin consumption, whereas no difference was obtained with placebo (P < 0.01). The increase in time to ischaemic threshold was significantly superior for 200 mg and 300 mg diltiazem when compared with placebo (75.2 and 91.5 s respectively vs 47.0 s) (P < 0.05); increase in time to anginal threshold was also significantly greater for diltiazem when compared with placebo (84.6 and 85.9 s respectively vs 43.9 s) (P < 0.05). 4. Only one patient experienced worsening of angina and had to be withdrawn from the study. 5. This study demonstrates 200 and 300 mg SR diltiazem is effective when given once-a-day in the prophylaxis of stable exertional angina. This once daily formulation should improve patients' compliance and comfort.
摘要
  1. 这项安慰剂对照研究评估了每日一次服用200毫克和300毫克缓释地尔硫䓬对182例运动试验阳性的稳定型心绞痛患者的疗效。2. 在7天的安慰剂导入期后于基线进行运动试验,并在给药后25.0±0.1小时治疗7天后重复进行。3. 地尔硫䓬(200毫克和300毫克)分别使每周心绞痛发作次数减少68%和64%,而安慰剂使发作次数减少15%(P<0.05)。同样,两种剂量水平均使硝酸甘油消耗量减少70%,而安慰剂组无差异(P<0.01)。与安慰剂相比,200毫克和300毫克地尔硫䓬使缺血阈值时间的增加显著更优(分别为75.2秒和91.5秒,而安慰剂为47.0秒)(P<0.05);与安慰剂相比,地尔硫䓬使心绞痛阈值时间的增加也显著更大(分别为84.6秒和85.9秒,而安慰剂为43.9秒)(P<0.05)。4. 只有1例患者心绞痛恶化,不得不退出研究。5. 本研究表明,每日一次服用200毫克和300毫克缓释地尔硫䓬在预防稳定型劳力性心绞痛方面有效。这种每日一次的剂型应能提高患者的依从性和舒适度。

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