Leary W P, Reyes A J, Maharaj B, van der Byl K
Department of Clinical and Experimental Pharmacology, University of Natal, Durban, South Africa.
Am J Hypertens. 1991 Feb;4(2 Pt 2):147S-150S. doi: 10.1093/ajh/4.2.147s.
Forty-five patients with supine diastolic blood pressures (DBPs) above 95 mm Hg at the end of a four-week placebo run-in period were randomized to receive either 1.25 mg, 2.5 mg, or 5 mg isradipine twice daily as monotherapy for 12 weeks. Blood pressures (BP) were measured every 14 days, always by the same observer and using standard techniques. The Montevideo Mathematical Model was used to determine the time course of the response to treatment in each dosage group. Of the 33 patients who completed the study, four of the 12 patients receiving 1.25 mg isradipine twice daily had their BP controlled by weeks 10 or 12 (supine DBP less than or equal to 90 mm Hg), seven of 11 by 2.5 mg twice daily, and five of 10 by 5 mg twice daily. Mean DBPs for each dosage group were significantly reduced by week 12 (P less than .015 in all groups). The Montevideo Model allows estimation of the time after onset of treatment by which BP is reduced by a given amount. This model indicated that, with 2.5 mg isradipine twice daily, a fall in mean arterial pressure of 10 mm Hg is to be expected within three weeks of initiating drug administration.
在为期四周的安慰剂导入期结束时，仰卧位舒张压（DBP）高于95mmHg的45例患者被随机分组，接受每日两次1.25mg、2.5mg或5mg的伊拉地平单药治疗，为期12周。每14天测量一次血压（BP），始终由同一名观察者使用标准技术进行测量。使用蒙得维的亚数学模型来确定每个剂量组对治疗反应的时间过程。在完成研究的33例患者中，每日两次接受1.25mg伊拉地平治疗的12例患者中有4例在第10周或第12周时血压得到控制（仰卧位DBP小于或等于90mmHg），每日两次接受2.5mg治疗的11例患者中有7例，每日两次接受5mg治疗的10例患者中有5例。到第12周时，每个剂量组的平均DBP均显著降低（所有组P均小于0.015）。蒙得维的亚模型可以估计治疗开始后血压降低给定幅度所需的时间。该模型表明，每日两次服用2.5mg伊拉地平，在开始给药后的三周内，平均动脉压预计会下降10mmHg。
