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一项为期八周的多中心随机双盲研究，旨在评估固定剂量氨氯地平/贝那普利联合用药与氨氯地平作为一线治疗药物在中国轻度至中度高血压患者中的疗效和耐受性。

An eight-week, multicenter, randomized, double-blind study to evaluate the efficacy and tolerability of fixed-dose amlodipine/benazepril combination in comparison with amlodipine as first-line therapy in chinese patients with mild to moderate hypertension.

作者信息

Ueng Kwo-Chang, Lin Lung-Chun, Voon Wen-Chol, Lin Ming-Cheng, Liu Yen-Bin, Su Ho-Ming, Chang Po-Yuan, Lin Tsung-Hsien, Chen Wei-Liang, Wu Chau-Chung, Lai Wen-Ter, Lin Chung-Sheng

机构信息

Division of Cardiology and Cardiovascular Research Group, Institute of Medicine, Chung-Shan Medical University Hospital, Taiwan.

出版信息

Blood Press Suppl. 2008 Jun;1:24-31.

PMID:18705532

Abstract

AIMS

This study sought to compare the antihypertensive efficacy and tolerability of a fixed-dose combination with amlodipine/benazepril with that of amlodipine monotherapy in Chinese hypertensive subjects.

RESULTS

This multicenter, double-blind, 8-week study randomized 111 patients to fixed-dose amlodipine besylate/benazepril HCl (2.5/5 mg/day titrated to 5/10 mg/day as needed at week 4 to reach goal blood pressure (BP) <140/90 mmHg) or amlodipine besylate monotherapy (5 mg/day titrated to 10 mg/day as needed). At week 8, patients randomized to combination therapy compared with monotherapy had a comparable BP control rate (56.0% vs. 46.2%; p = 0.32). Fixed-dose combination resulted in similar reductions in sitting systolic (SBP) and diastolic BP (DBP) compared with monotherapy (SBP: -19.3 +/- 12.5 vs. -20.9 +/- 13.3 mmHg; DBP: -9.2 +/- 10.4 vs. -11.3 +/-9.3 mmHg; both p=NS). Safety profiles did not differ between groups, but cough was more common in the combination group (11.0% vs. 0%; p = 0.013).

CONCLUSIONS

In this group of patients, comparable antihypertensive effects were seen with the fixed-dose combination therapy, compared with amlodipine monotherapy. Both treatments appeared well tolerated in the studied population, but cough was more common in the fixed-dose combination group.

摘要

目的

本研究旨在比较氨氯地平/贝那普利固定剂量复方制剂与氨氯地平单药治疗在中国高血压患者中的降压疗效及耐受性。

结果

这项多中心、双盲、为期8周的研究将111例患者随机分为两组，一组接受氨氯地平/贝那普利固定剂量复方制剂（起始剂量为苯磺酸氨氯地平/盐酸贝那普利2.5/5mg/天，第4周根据需要滴定至5/10mg/天以达到目标血压<140/90mmHg），另一组接受苯磺酸氨氯地平单药治疗（起始剂量为5mg/天，根据需要滴定至10mg/天）。在第8周时，随机接受联合治疗的患者与接受单药治疗的患者相比，血压控制率相当（56.0%对46.2%；p=0.32）。与单药治疗相比，固定剂量复方制剂导致的坐位收缩压（SBP）和舒张压（DBP）降低幅度相似（SBP：-19.3±12.5对-20.9±13.3mmHg；DBP：-9.2±10.4对-11.3±9.3mmHg；两者p值均无统计学意义）。两组的安全性概况无差异，但咳嗽在联合治疗组中更常见（11.0%对0%；p=0.013）。