比索洛尔与雷米普利治疗高血压伴左心室肥厚患者的比较：一项随机、开放、盲终点（PROBE）试验。

Comparison between nebivolol and ramipril in patients with hypertension and left ventricular hypertrophy: a randomized open blinded end-point (PROBE) trial.

机构信息

Ibn Sina Hospital, School of Medicine, University of Ankara, Ankara, Turkey.

出版信息

Eur Rev Med Pharmacol Sci. 2011 Dec;15(12):1359-68.

PMID:22288296

Abstract

AIMS

To compare the effects of nebivolol and ramipril on left ventricular hypertrophy in hypertensive patients.

MATERIALS AND METHODS

The study was conducted with a pre-randomised blinded endpoint (PROBE) design in which 106 patients with mild-to-moderate hypertension and left ventricular hypertrophy were randomised to ramipril (n = 52) or to nebivolol (n = 54) and treated for 39 weeks. The doses of ramipril and nebivolol were 2.5 and 5 mg/day, respectively. After 4-8 weeks, in patients with not normalised diastolic blood pressure, a thiazide diuretic was added (indapamide 2.5 mg or hydrochlorothiazide 12.5 mg/day). In the ramipril group, thiazide diuretic was added in 97% of subjects and in nebivolol group in 92%. The effect of treatment on left ventricular mass was assessed by two-dimensional guided M-mode transthoracic echocardiography, at baseline and at the end of the treatment. Left ventricular mass index (LVMI) was calculated and indexed to body surface area (g/m2) and height2.7 (g/height2.7). Blood pressure (BP) was measured at baseline, after 4, 8, 12, 24 and 39 weeks with a standard mercury sphygmomanometer.

RESULTS

Both left ventricular mass (LVM) and mass index (LVMI) decreased significantly after treatment with ramipril (LVMI -14.8 g/m2, -7.3 g/height2.7; p < 0.001), and after treatment with nebivolol (LVMI -31.9 g/m2, -15.6 g/height2.7; p < 0.001). The difference between ramipril and nebivolol (-17.1 g/m2, -8.3 g/height2.7) with regards to reduction of LVMI was statistically significant (p < 0.001). No differences were observed between the two groups in terms of normalization of LVMI. Both drugs decreased BP similarly after 39 weeks of treatment

CONCLUSIONS

The present study shows that both nebivolol and ramipril decrease LVMI. Nebivolol 5 mg/daily treatment reduced LVMI significantly more than ramipril 2.5 mg/daily. Both drugs similarly decreased BP during the treatment.

摘要

目的

比较比索洛尔和雷米普利对高血压患者左心室肥厚的影响。

材料和方法

本研究采用预随机盲终点（PROBE）设计，将 106 例轻中度高血压合并左心室肥厚患者随机分为雷米普利组（n=52）或比索洛尔组（n=54），治疗 39 周。雷米普利和比索洛尔的剂量分别为 2.5 和 5 mg/天。4-8 周后，对于舒张压未正常的患者，加用噻嗪类利尿剂（吲达帕胺 2.5 mg 或氢氯噻嗪 12.5 mg/天）。雷米普利组 97%的患者加用噻嗪类利尿剂，比索洛尔组 92%的患者加用噻嗪类利尿剂。治疗前后采用二维超声心动图引导 M 型经胸超声心动图评估左心室质量的变化。左心室质量指数（LVMI）按体表面积（g/m2）和身高 2.7（g/身高 2.7）计算。治疗前、治疗后 4、8、12、24 和 39 周时用标准汞柱血压计测量血压（BP）。

结果

雷米普利（LVMI 减少 14.8 g/m2，-7.3 g/身高 2.7；p<0.001）和比索洛尔（LVMI 减少 31.9 g/m2，-15.6 g/身高 2.7；p<0.001）治疗后左心室质量（LVM）和质量指数（LVMI）均显著降低。雷米普利和比索洛尔（LVMI 减少 17.1 g/m2，-8.3 g/身高 2.7）降低 LVMI 的差异具有统计学意义（p<0.001）。两组间 LVMI 正常化率无差异。两组患者治疗 39 周后血压均明显下降。