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硝苯地平缓释制剂在心绞痛中的抗心绞痛作用的持续时间和程度。

Duration and extent of antianginal effects of a sustained-release formulation of nifedipine in angina.

作者信息

Yokota M, Saito F, Izawa H, Matsunami T, Yoshida J, Inagaki H, Sotobata I

机构信息

Department of Clinical Laboratory Medicine, Nagoya University Hospital, Japan.

出版信息

Eur Heart J. 1994 Jul;15(7):965-70. doi: 10.1093/oxfordjournals.eurheartj.a060617.

Abstract

Twenty-four patients with chronic stable exertional angina pectoris were randomized in a double-blind, placebo-controlled, crossover trial to assess the efficacy and durability of a newly developed, sustained-release formulation of nifedipine (nifedipine CC) in a single 40-mg oral dose. Symptom-limited graded treadmill exercise tests were performed just before, and at 4, 7, and 24 h after a single administration of the drug or the placebo was given. Exercise tolerance at 4, 7, and 24 h after the drug were compared with the corresponding placebo values. Data could be analysed for 19 patients. Maximal exercise time, time to the onset of angina, and time to 1 mm ST segment placebo. The average maximal exercise time was significantly increased by 72, 76, and 37 s at 4, 7, and 24 h. Rate-pressure product at rest and at peak exercise showed significant changes only at 24 h compared with placebo (both P < 0.05). The maximal increase in exercise tolerance was most marked at 7 h nifedipine CC, at which time plasma drug concentration was 99.4 +/- 14.0 ng.ml-1. Thus, in patients with chronic stable exertional angina pectoris, nifedipine CC showed a prolonged improvement in exercise tolerance up to 24 h after a single oral administration.

摘要

24例慢性稳定型劳力性心绞痛患者被随机分为双盲、安慰剂对照、交叉试验,以评估新开发的硝苯地平缓释制剂(硝苯地平控释片)单次口服40 mg剂量的疗效和持久性。在单次给药或给予安慰剂之前以及给药后4、7和24小时进行症状限制分级平板运动试验。将给药后4、7和24小时的运动耐量与相应的安慰剂值进行比较。可对19例患者的数据进行分析。最大运动时间、心绞痛发作时间和ST段压低1 mm的时间与安慰剂相比,平均最大运动时间在4、7和24小时分别显著增加72、76和37秒。静息和运动峰值时的心率-血压乘积与安慰剂相比仅在24小时有显著变化(均P<0.05)。运动耐量的最大增加在硝苯地平控释片给药7小时时最为明显,此时血浆药物浓度为99.4±14.0 ng.ml-1。因此,在慢性稳定型劳力性心绞痛患者中,硝苯地平控释片单次口服后运动耐量改善可持续长达24小时。

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