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苯那普利与小剂量氨氯地平固定复方制剂治疗轻至中度原发性高血压:通过24小时无创动态血压监测进行评估

Fixed combination of benazepril and low-dose amlodipine in the treatment of mild to moderate essential hypertension: evaluation by 24-hour noninvasive ambulatory blood pressure monitoring.

作者信息

Fogari R, Zoppi A, Lusardi P, Mugellini A, Preti P, Motolese M

机构信息

Department of Internal Medicine and Therapeutics, University of Pavia, Italy.

出版信息

J Cardiovasc Pharmacol. 1997 Aug;30(2):176-81. doi: 10.1097/00005344-199708000-00005.

Abstract

The antihypertensive efficacy and tolerability of a fixed combination of benazepril (10 mg) and low-dose amlodipine (2.5 mg) were assessed in 24 patients (mean age, 43.9 years) with uncomplicated mild to moderate essential hypertension [supine diastolic blood pressure (DBP) > or = 95 and < or = 120 mm Hg)]. After 2 weeks of washout taking placebo, patients were randomized to receive the fixed combination or placebo, both administered once daily for 3 weeks, according to a double-blind, crossover design. Patients were checked at the end of the washout period and every 3 weeks thereafter. At each visit, 24-h ambulatory BP monitoring (ABPM) was performed by a noninvasive device (Spacelabs 90207); casual BP (by mercury sphygmomanometer), heart rate (HR), and body weight also were measured. The fixed combination significantly reduced systolic (SBP) and DBP values throughout the 24 h as compared with placebo, without affecting the normal BP circadian variability. The antihypertensive effect of the fixed combination could be observed to a similar extent during the day and night and was still significant 24 h after dosing. HR and body weight were not affected by the treatment. The fixed combination of benazepril 10 mg/amlodipine 2.5 mg was well tolerated, and no patient withdrew from the study because of side effects.

摘要

对24例(平均年龄43.9岁)无并发症的轻度至中度原发性高血压患者[仰卧位舒张压(DBP)≥95且≤120 mmHg]评估了贝那普利(10 mg)与小剂量氨氯地平(2.5 mg)固定复方制剂的降压疗效和耐受性。在服用安慰剂洗脱2周后,根据双盲、交叉设计,将患者随机分为接受固定复方制剂组或安慰剂组,均每日给药1次,共3周。在洗脱期结束时及之后每3周对患者进行检查。每次就诊时,使用无创设备(太空实验室90207)进行24小时动态血压监测(ABPM);还测量偶测血压(用汞柱式血压计)、心率(HR)和体重。与安慰剂相比,固定复方制剂在整个24小时内显著降低收缩压(SBP)和DBP值,且不影响正常血压的昼夜变异性。固定复方制剂的降压作用在白天和夜间均可观察到相似程度,给药后24小时仍有显著效果。HR和体重不受治疗影响。10 mg贝那普利/2.5 mg氨氯地平固定复方制剂耐受性良好,无患者因副作用退出研究。

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