Celis H, Staessen J, Fagard R, Thijs L, Amery A
Department of Pathophysiology, University of Leuven, Belgium.
J Cardiovasc Pharmacol. 1993 Aug;22(2):300-4. doi: 10.1097/00005344-199308000-00020.
Twelve patients with essential hypertension were randomized in a double-blind cross-over study to investigate the blood pressure BP-lowering activity of isradipine regular formulation (RF) 2.5 mg twice daily (between 7 and 8 a.m. and at approximately 6 p.m.), and isradipine modified release (MR), 5 mg once daily (between 7 and 8 a.m.). The two randomized treatment periods were separated by a placebo period. Patient compliance was similar between placebo and isradipine RF and MR treatment. As compared with placebo, isradipine RF decreased daytime BP by 10 mm Hg systolic (SBP, p < 0.001) and by 6 mm Hg diastolic (DBP, p < 0.01), and night SBP and DBP by 7 (p < 0.05) and 3 mm Hg (P = NS), respectively. Isradipine MR reduced the daytime SBP 8 mm Hg (p < 0.05) and DBP by 3 mm Hg (p = NS), and the night SBP by 1 mm Hg (p = NS) and DBP by < 1 mm Hg (P = NS). Analysis of variance showed that the interaction terms between the effects of treatment and time of day were not significant for SBP (F = 1.56, p = 0.24) or DBP (F = 1.40, p = 0.26) with isradipine RF treatment, but they were significant for SBP (F = 6.33, p = 0.03) and DBP (F = 5.12, p = 0.04) with isradipine MR treatment. Therefore, the BP-lowering effect of isradipine MR 5 mg once daily appears to weaken as the day progresses.(ABSTRACT TRUNCATED AT 250 WORDS)
12名原发性高血压患者被随机纳入一项双盲交叉研究,以调查依拉地平常规制剂(RF)每日两次、每次2.5毫克(上午7点至8点之间以及下午约6点)和依拉地平缓释制剂(MR)每日一次、每次5毫克(上午7点至8点之间)的降压活性。两个随机治疗期之间有一个安慰剂期。安慰剂组与依拉地平RF组和MR组的患者依从性相似。与安慰剂相比,依拉地平RF使白天收缩压(SBP)降低10毫米汞柱(p<0.001),舒张压(DBP)降低6毫米汞柱(p<0.01),夜间SBP和DBP分别降低7毫米汞柱(p<0.05)和3毫米汞柱(P=无统计学意义)。依拉地平MR使白天SBP降低8毫米汞柱(p<0.05),DBP降低3毫米汞柱(p=无统计学意义),夜间SBP降低1毫米汞柱(p=无统计学意义),DBP降低<1毫米汞柱(P=无统计学意义)。方差分析表明,依拉地平RF治疗时,治疗效果与一天中时间的交互项对SBP(F=1.56,p=0.24)或DBP(F=1.40,p=0.26)无显著意义,但依拉地平MR治疗时,对SBP(F=6.33,p=0.03)和DBP(F=5.12,p=0.04)有显著意义。因此,依拉地平MR每日一次5毫克的降压效果似乎会随着一天的进展而减弱。(摘要截短至250字)