Fiorentini C, Guillet C, Guazzi M
Istituto di Cardiologia, Università di Milano, Italia.
Arch Mal Coeur Vaiss. 1989 Dec;82 Spec No 5:39-46.
The efficacy and acceptability of Rilmenidine (RIL) were assessed in a multicentre, controlled, double-blind trial versus hydrochlorothiazide (HCZ) in patients with mild to moderate hypertension. After an initial 4 week washout period on placebo, patients with diastolic BP of between 90 and 110 mmHg were administered in monotherapy either RIL 1 mg or HCZ 25 mg for four weeks (Day 0-Day 28). In the following four weeks (Day 28-Day 56), those with diastolic BP of over 90 mmHg were given, in association, the antihypertensive agent that they had not received initially. The other patients continued the trial with single daily doses of monotherapy. Two hundred and fourty four patients (48.4 +/- 0.6 years) with supine systolic and diastolic BP of 155.86 +/- 0.96 mmHg and 101.02 +/- 0.28 mmHg respectively were randomly allocated to two comparable treatment groups (RIL, n = 120 and HCZ, n = 124). The systolic and diastolic BP decreased significantly between Day 0 and Day 28, as much at Day 14 as at Day 28 in both treatment groups. The antihypertensive effect was comparable: at Day 28 the mean fall in systolic/diastolic BP was 16/10 mmHg in the RIL group and 15/9 mmHg in the HCZ group (NS). The clinical acceptability was equivalent in the two groups: secondary effects were responsible for one patient's withdrawal in each group and their incidence was 5% on average, 10% for the most common.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项多中心、对照、双盲试验中,对轻度至中度高血压患者评估了利美尼定(RIL)与氢氯噻嗪(HCZ)相比的疗效和可接受性。在最初4周的安慰剂洗脱期后,舒张压在90至110 mmHg之间的患者接受单药治疗,分别给予1 mg利美尼定或25 mg氢氯噻嗪,为期4周(第0天至第28天)。在接下来的4周(第28天至第56天),舒张压超过90 mmHg的患者联合给予他们最初未接受的抗高血压药物。其他患者继续接受单药每日一剂的试验。244例患者(48.4±0.6岁),仰卧位收缩压和舒张压分别为155.86±0.96 mmHg和101.02±0.28 mmHg,被随机分配到两个可比的治疗组(利美尼定组,n = 120;氢氯噻嗪组,n = 124)。在两个治疗组中,第0天至第28天收缩压和舒张压均显著下降,第14天和第28天下降幅度相同。降压效果相当:第28天时,利美尼定组收缩压/舒张压平均下降16/10 mmHg,氢氯噻嗪组为15/9 mmHg(无显著性差异)。两组的临床可接受性相当:每组均有1例患者因不良反应退出试验,不良反应发生率平均为5%,最常见的不良反应发生率为10%。(摘要截断于250字)