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缓释硝苯地平作为单一药物或辅助药物治疗原发性高血压——一项安慰剂对照交叉研究。

Slow-release nifedipine as a single or additional agent in the treatment of essential hypertension--a placebo-controlled crossover study.

作者信息

Wing L M, Chalmers J P, West M J, Bune A J

出版信息

Clin Exp Hypertens A. 1985;7(8):1173-85. doi: 10.3109/10641968509073583.

Abstract

The efficacy and safety of a new slow-release formulation of nifedipine ("Adalat Retard") were assessed in a double-blind cross-over trial in 19 subjects with essential hypertension (14 male, 5 female--ages: 34-72 years), 14 of whom continued previous antihypertensive medication. There were two 6 week treatment phases in which nifedipine 20 mg twice daily and placebo tablets twice daily were administered in random order. Supine mean blood pressure was 115 +/- 2 mm Hg during the placebo phase and 105 +/- 2 mm Hg during the nifedipine phase (p less than 0.001); and standing mean blood pressure was 121 +/- 2 mm Hg after placebo and 110 +/- 2 mm Hg after nifedipine (p less than 0.001). The magnitude of the blood pressure difference between the two phases was not related either to age or to the placebo phase blood pressure. The hypotensive effect of nifedipine was observed when administered as a single agent or in combination with diuretic and/or beta blocker. Heart rate was increased after nifedipine--75 +/- 2 beats/minute compared with 71 +/- 2 beats/minute after placebo (p less than 0.01). In this dose nifedipine (as "Adalat Retard") is an effective hypotensive agent which is a useful addition to presently available therapy.

摘要

在一项双盲交叉试验中,对19名原发性高血压患者(14名男性,5名女性,年龄34 - 72岁)评估了一种新型硝苯地平缓释制剂(“Adalat Retard”)的疗效和安全性,其中14名患者继续服用先前的抗高血压药物。试验有两个为期6周的治疗阶段,随机依次给予硝苯地平20毫克每日两次和安慰剂每日两次。安慰剂阶段仰卧平均血压为115±2毫米汞柱,硝苯地平阶段为105±2毫米汞柱(p<0.001);安慰剂后站立平均血压为121±2毫米汞柱,硝苯地平后为110±2毫米汞柱(p<0.001)。两个阶段之间血压差异的幅度与年龄或安慰剂阶段血压均无关。硝苯地平作为单一药物或与利尿剂和/或β受体阻滞剂联合使用时均观察到降压效果。硝苯地平给药后心率增加——与安慰剂后71±2次/分钟相比为75±2次/分钟(p<0.01)。在此剂量下,硝苯地平(“Adalat Retard”)是一种有效的降压药物,是现有治疗方法的有益补充。

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