Man in't Veld A J, Holmes D G, Lasance A, de Zwart P
Department of Internal Medicine, Erasmus Hospital, Rotterdam, The Netherlands.
Am J Hypertens. 1991 Feb;4(2 Pt 2):131S-134S. doi: 10.1093/ajh/4.2.131s.
The objective of this study was to compare the effects of isradipine and placebo on blood pressure (BP) at the end of the dosing interval ('trough'). Following a three-week placebo period, 187 patients who had previously shown a response to treatment with isradipine (based on office BP measurements) were randomized to double-blind treatment with 2.5 mg isradipine twice daily or placebo for six weeks. Four of these patients withdrew from the study during the double-blind phase because of adverse events (one taking isradipine and three taking placebo). Blood pressure during the double-blind study was always measured 12 h after drug administration (trough values). The rate of normalization [defined as diastolic BP (DBP) less than or equal to 90 mm Hg] was 52/96 (54%) in the isradipine-treated group compared with 30/87 (33%) in the placebo group. A further 12/96 (12%) patients taking isradipine showed a fall in DBP of greater than or equal to 10 mm Hg, although their DBP was still not less than 90 mm Hg, compared with 5/87 (6%) patients receiving placebo. This difference was statistically significant (P = .003). Thus, isradipine in a dose of 2.5 mg twice daily lowers blood pressure over 24 h.
本研究的目的是比较伊拉地平与安慰剂在给药间隔期末（“谷值”）对血压（BP）的影响。在为期三周的安慰剂期后，187名先前对伊拉地平治疗有反应（基于诊室血压测量）的患者被随机分为两组，一组接受每日两次2.5毫克伊拉地平的双盲治疗，另一组接受安慰剂治疗，为期六周。在双盲阶段，这些患者中有4人因不良事件退出研究（1人服用伊拉地平，3人服用安慰剂）。双盲研究期间的血压总是在给药后12小时测量（谷值）。伊拉地平治疗组的血压正常化率[定义为舒张压（DBP）小于或等于90毫米汞柱]为52/96（54%），而安慰剂组为30/87（33%）。另有12/96（12%）服用伊拉地平的患者舒张压下降大于或等于10毫米汞柱，尽管其舒张压仍不低于90毫米汞柱，而接受安慰剂的患者为5/87（6%）。这种差异具有统计学意义（P = .003）。因此，每日两次2.5毫克剂量的伊拉地平可在24小时内降低血压。
