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一项关于缬沙坦/氨氯地平或硝苯地平控释片治疗患者的动态血压和动脉僵硬度的随机多中心研究。

A randomized multicenter study on ambulatory blood pressure and arterial stiffness in patients treated with valsartan/amlodipine or nifedipine GITS.

机构信息

Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

出版信息

J Clin Hypertens (Greenwich). 2019 Feb;21(2):252-261. doi: 10.1111/jch.13457. Epub 2018 Dec 24.

Abstract

In a pre-specified subgroup analysis of a 12-week randomized multicenter study, we investigated effects of valsartan/amlodipine 80/5 mg single-pill combination (n = 75) and nifedipine GITS 30 mg (n = 75) on ambulatory blood pressure (BP) and arterial stiffness assessed by brachial-ankle pulse wave velocity (PWV) in patients with uncontrolled hypertension. At week 12, the between-treatment mean differences in systolic/diastolic BP were smaller for 24-hour and daytime (-2.1/-1.7 and -2.0/-1.5 mm Hg, respectively, P ≥ 0.22) but greater (P < 0.01) for nighttime (-4.0/-2.8 mm Hg, P ≤ 0.09), especially in sustained uncontrolled hypertension (-5.0/-4.1 mm Hg, P ≤ 0.04) and non-dippers (-6.5/-3.7 mm Hg, P ≤ 0.07), in favor of valsartan/amlodipine. At week 12, PWV was significantly reduced from baseline by valsartan/amlodipine (n = 59, P < 0.0001) but not nifedipine (n = 59, P = 0.06). The changes in PWV were significantly associated with that in ambulatory systolic BP and pulse pressure in the nifedipine (P ≤ 0.0008) but not valsartan/amlodipine group (P ≥ 0.57), with a significant interaction (P ≤ 0.045). The valsartan/amlodipine combination was more efficacious than nifedipine GITS in lowering nighttime BP in sustained uncontrolled hypertension and non-dippers, and in lowering arterial stiffness independent of BP lowering.

摘要

在一项为期 12 周的随机、多中心研究的预先指定亚组分析中,我们研究了缬沙坦/氨氯地平 80/5mg 单片复方(n=75)和硝苯地平控释 30mg(n=75)对血压控制不佳的高血压患者的动态血压(BP)和肱踝脉搏波速度(PWV)评估的动脉僵硬度的影响。在第 12 周,24 小时和白天的收缩压/舒张压的治疗间平均差异较小(分别为-2.1/-1.7 和-2.0/-1.5mmHg,P≥0.22),但夜间较大(P<0.01)(-4.0/-2.8mmHg,P≤0.09),尤其是在持续性血压控制不佳(-5.0/-4.1mmHg,P≤0.04)和非杓型血压(-6.5/-3.7mmHg,P≤0.07)患者中,有利于缬沙坦/氨氯地平。在第 12 周,与基线相比,缬沙坦/氨氯地平显著降低了 PWV(n=59,P<0.0001),而硝苯地平没有(n=59,P=0.06)。硝苯地平组(P≤0.0008)PWV 的变化与动态收缩压和脉压的变化显著相关,但缬沙坦/氨氯地平组(P≥0.57)不相关,存在显著的交互作用(P≤0.045)。缬沙坦/氨氯地平联合治疗在降低持续性血压控制不佳和非杓型高血压患者的夜间血压和降低动脉僵硬度方面比硝苯地平控释剂更有效,且独立于降压作用。

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