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300毫克缓释地尔硫䓬与20毫克依那普利单药治疗轻至中度动脉高血压的对比研究。

Comparative study on monotherapy with sustained-release diltiazem 300 mg and enalapril 20 mg in mild to moderate arterial hypertension.

作者信息

Fermé I, Djian J, Tcherdakoff P

机构信息

Sanofi Clin Midy, Paris, France.

出版信息

J Cardiovasc Pharmacol. 1990;16 Suppl 1:S46-50.

PMID:1706014
Abstract

The antihypertensive efficacy of sustained-release diltiazem 300 mg at a single daily dose was evaluated and compared to that of enalapril 20 mg at a single daily dose, and to a combination therapy of enalapril 20 mg with sustained-release diltiazem 300 mg in patients with mild to moderate arterial hypertension (supine diastolic blood pressure between 95 and 115 mm Hg). After a washout period and a placebo period, each lasting 2 weeks, 96 patients were randomized in this double-blind study to three parallel groups that were treated for 28 days. In the groups treated with diltiazem, enalapril, or the combination of both, the drop in arterial blood pressure was 20, 11, and 19 mm Hg for supine diastolic blood pressure (supine DBP): 18, 12, and 19 mm Hg for standing diastolic blood pressure (standing DBP); 22, 20, and 23 mm Hg for supine systolic blood pressure (supine SBP); and 21, 19, and 24 mm Hg for standing systolic blood pressure (standing SBP), respectively. The reduction in DBP was significantly more pronounced in the group treated with sustained-release diltiazem 300 mg than in the group treated with enalapril 20 mg. Cardiac tolerance was good for patients treated with sustained-release diltiazem 300 mg alone or the combination therapy: no orthostatic hypotension or lengthening of the PR interval in the electrocardiogram was observed. Although side effects of sustained-release diltiazem 300 mg occurred more frequently, they were not severe and disappeared immediately when treatment was suspended.

摘要

对每日单次服用300毫克缓释地尔硫䓬的降压疗效进行了评估,并与每日单次服用20毫克依那普利的疗效以及依那普利20毫克与缓释地尔硫䓬300毫克联合治疗的疗效进行了比较,研究对象为轻度至中度动脉高血压患者(仰卧位舒张压在95至115毫米汞柱之间)。在为期2周的洗脱期和安慰剂期后,96名患者在这项双盲研究中被随机分为三个平行组,接受为期28天的治疗。在接受地尔硫䓬、依那普利或两者联合治疗的组中,仰卧位舒张压(仰卧位DBP)的血压下降分别为20、11和19毫米汞柱;站立位舒张压(站立位DBP)为18、12和19毫米汞柱;仰卧位收缩压(仰卧位SBP)为22、20和23毫米汞柱;站立位收缩压(站立位SBP)为21、19和24毫米汞柱。服用300毫克缓释地尔硫䓬治疗的组中DBP的降低明显比服用20毫克依那普利治疗的组更显著。单独使用300毫克缓释地尔硫䓬或联合治疗的患者心脏耐受性良好:未观察到体位性低血压或心电图中PR间期延长。虽然300毫克缓释地尔硫䓬的副作用发生频率更高,但并不严重,在治疗暂停后立即消失。

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