Vliegen H W, van der Wall E E, Kragten J A, Holwerda N J, Schenkel W M, Muijs van de Moer W M, ten Kate J B, Mulder P G, Bruschke A V
Department of Cardiology, University Hospital Leiden, The Netherlands.
J Cardiovasc Pharmacol. 1993 Apr;21(4):552-9. doi: 10.1097/00005344-199304000-00007.
In a randomized, double-blind, cross-over, multicenter study with a placebo run-in phase, the efficacy and safety of two oral formulations of diltiazem, standard three or four times daily (t.i.d. or q.i.d.) and controlled release twice daily (b.i.d.), were compared in 49 patients with stable angina pectoris. ST-segment depression at maximum exercise 12 h after tablet intake was less frequently observed with diltiazem controlled release than with standard diltiazem (34 of 49, 69% vs. 43 of 49, 88%, p = 0.007). In patients with ST-segment depression after both treatments (n = 33), the average time to 1-mm ST-segment depression was 55.4 +/- 19.9 s longer with diltiazem controlled release than with standard diltiazem [476 +/- 195 vs. 422 +/- 163 s, p = 0.009; 95% confidence interval (CI) 14.8-96 s]. Reduction in mean number of anginal attacks and nitroglycerin (NTG) intake was not significantly different between treatment with standard diltiazem and diltiazem controlled release. The incidence of side effects was low and not different between the two treatments. Both formulations are equally effective in reducing the number of anginal attacks and are well tolerated. Diltiazem controlled release is more effective than standard diltiazem in preventing myocardial ischemia 12 h after tablet intake. Thus, diltiazem controlled release allows twice-daily intake frequency and may therefore be preferable to standard diltiazem in treatment of stable angina pectoris.
在一项设有安慰剂导入期的随机、双盲、交叉、多中心研究中，对49例稳定型心绞痛患者比较了两种口服地尔硫䓬制剂的疗效和安全性，一种是标准的每日三次或四次（每日三次或四次），另一种是控释剂型每日两次（每日两次）。服用片剂12小时后最大运动时的ST段压低，控释地尔硫䓬比标准地尔硫䓬观察到的频率更低（49例中的34例，69%对49例中的43例，88%，p = 0.007）。在两种治疗后均出现ST段压低的患者（n = 33）中，控释地尔硫䓬使ST段压低至1毫米的平均时间比标准地尔硫䓬长55.4±19.9秒[476±195对422±163秒，p = 0.009；95%置信区间（CI）14.8 - 96秒]。标准地尔硫䓬治疗与控释地尔硫䓬治疗之间，心绞痛发作平均次数和硝酸甘油（NTG）摄入量的减少没有显著差异。副作用发生率低，两种治疗之间无差异。两种制剂在减少心绞痛发作次数方面同样有效，且耐受性良好。控释地尔硫䓬在服用片剂12小时后预防心肌缺血方面比标准地尔硫䓬更有效。因此，控释地尔硫䓬允许每日两次的服药频率，在治疗稳定型心绞痛方面可能比标准地尔硫䓬更可取。
