Woodcock B G, Thürmann P A, Pfleiderer S, Reifart N
Department of Clinical Pharmacology, Johann Wolfgang Goethe University, Frankfurt/Main, FRG.
Eur J Clin Pharmacol. 1992;43(6):587-90. doi: 10.1007/BF02284955.
The ability of a fatty-alcohol matrix, slow-release tablet of nifedipine 60 mg to maintain a 24-hour anti-ischaemic action in the fixed dose of 60 mg once daily has been investigated in a randomised, placebo-controlled, double-blind trial. 12 normotensive patients with angiographically proven coronary artery disease (stenosis of at least one major vessel > or = 70%) were studied. The anti-ischaemic response was assessed over a period of 4 days as changes in the exercise-induced ST-segment depression 6 h and 24 h post-dose, and ST-segment changes in 24-h ambulatory ECGs. A measurable anti-ischaemic response was observed in 8 of the 12 patients. Exercise-induced ST-segment depression 6 h after the administration of nifedipine was reduced by 30% compared to placebo, and there was still a measurable anti-ischaemic response 24-h post-dosing. Both responses were independent of changes in exercise blood pressure. In 7 patients with ischaemic episodes in the 24-h ECGs, nifedipine treatment had only a minor effect on the intensity and duration of ischaemia. It is concluded that a significant anti-ischaemic effect lasting 24 h could be demonstrated using effort-induced ST-segment changes in patients with angiographically proven coronary heart disease, who were treated once daily with nifedipine 60 mg as a fatty-alcohol slow release tablet.
在一项随机、安慰剂对照、双盲试验中,研究了硝苯地平60毫克脂肪醇基质缓释片以每日一次60毫克的固定剂量维持24小时抗缺血作用的能力。研究了12名经血管造影证实患有冠状动脉疾病(至少一根主要血管狭窄≥70%)的血压正常患者。在4天的时间内,通过给药后6小时和24小时运动诱发的ST段压低变化以及24小时动态心电图中的ST段变化来评估抗缺血反应。12名患者中有8名观察到了可测量的抗缺血反应。与安慰剂相比,硝苯地平给药后6小时运动诱发的ST段压低降低了30%,给药后24小时仍有可测量的抗缺血反应。这两种反应均与运动血压变化无关。在24小时心电图中有缺血发作的7名患者中,硝苯地平治疗对缺血的强度和持续时间仅有轻微影响。得出的结论是,对于经血管造影证实患有冠心病且每日一次服用60毫克硝苯地平脂肪醇缓释片治疗的患者,利用运动诱发的ST段变化可证明有持续24小时的显著抗缺血作用。