Walker J M, Curry P V, Bailey A E, Steare S E
Department of Cardiology, University College London Hospitals, UK.
Int J Cardiol. 1996 Feb;53(2):117-26. doi: 10.1016/0167-5273(95)02531-6.
The efficacy of nifedipine gastrointestinal therapeutic system (GITS), 60-90 mg o.d., isosorbide dinitrate, 40-60 mg b.d., and isosorbide mononitrate slow-release, 50-100 mg o.d. was assessed in a six week double-blind, parallel-group study in patients with stable angina on chronic beta-blocker treatment. Of 339 patients who entered the study, 229 were eligible for the valid case analysis of efficacy and 335 for the safety analysis. Nifedipine GITS was significantly better than isosorbide dinitrate (P < or = 0.025) in prolonging time to 1 mm ST-segment depression, time to maximum ST-segment depression, time to occurrence of angina and total exercise duration, in addition to reducing the number of angina attacks and glyceryl trinitrate consumption after six weeks therapy. Nifedipine GITS was also significantly better than isosorbide mononitrate (P < or = 0.025) in prolonging time to occurrence of angina and time to 1 mm ST-segment depression after six weeks therapy. The incidence of headache was considerably higher in both the isosorbide dinitrate and isosorbide mononitrate groups (40% and 41%, respectively) than in the nifedipine GITS group (9.5%, P < or = 0.001), and was the main reason for withdrawal from the study (isosorbide dinitrate 18/99, isosorbide mononitrate 17/99, nifedipine GITS 2/95). Peripheral oedema was more common in patients treated with nifedipine GITS (12.5%) compared to nitrates (2% in both groups, P < or = 0.01), but resulted in withdrawal of only one patient (treated with nifedipine GITS). This study suggests that the efficacy and tolerability of nifedipine GITS is superior to long acting nitrates as second-line therapy to beta-blockade in the treatment of chronic stable angina.
在一项为期六周的双盲、平行组研究中，对正在接受慢性β受体阻滞剂治疗的稳定型心绞痛患者，评估了硝苯地平胃肠道治疗系统（GITS）（每日60 - 90毫克）、二硝酸异山梨酯（每日两次，每次40 - 60毫克）和单硝酸异山梨酯缓释片（每日50 - 100毫克）的疗效。在339名进入研究的患者中，229名符合有效病例疗效分析标准，335名符合安全性分析标准。硝苯地平GITS在延长至ST段压低1毫米的时间、至最大ST段压低的时间、心绞痛发作时间和总运动持续时间方面，显著优于二硝酸异山梨酯（P≤0.025），此外，在六周治疗后还减少了心绞痛发作次数和硝酸甘油消耗量。在六周治疗后，硝苯地平GITS在延长心绞痛发作时间和至ST段压低1毫米的时间方面，也显著优于单硝酸异山梨酯（P≤0.025）。二硝酸异山梨酯组和单硝酸异山梨酯组的头痛发生率（分别为40%和41%）均显著高于硝苯地平GITS组（9.5%，P≤0.001），且是退出研究的主要原因（二硝酸异山梨酯组18/99，单硝酸异山梨酯组17/99，硝苯地平GITS组2/95）。与硝酸盐类药物（两组均为2%）相比，接受硝苯地平GITS治疗的患者外周水肿更为常见（12.5%，P≤0.01），但仅导致一名患者（接受硝苯地平GITS治疗）退出研究。本研究表明，在慢性稳定型心绞痛的治疗中，作为β受体阻滞剂的二线治疗药物，硝苯地平GITS的疗效和耐受性优于长效硝酸盐类药物。
