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利美尼定对伴有X综合征的高血压患者的血流动力学及代谢影响。一项与氨氯地平对比的双盲平行研究。

Haemodynamic and metabolic effects of rilmenidine in hypertensive patients with metabolic syndrome X. A double-blind parallel study versus amlodipine.

作者信息

De Luca N, Izzo R, Fontana D, Iovino G, Argenziano L, Vecchione C, Trimarco B

机构信息

Department of Clinical Medicine and Cardiovascular Sciences, Federico II University, Naples, Italy.

出版信息

J Hypertens. 2000 Oct;18(10):1515-22. doi: 10.1097/00004872-200018100-00021.

DOI:10.1097/00004872-200018100-00021
PMID:11057441
Abstract

OBJECTIVE

To compare the effects of rilmenidine with those of amlodipine on blood pressure, glucose metabolism, plasma lipid concentration and fibrinolysis parameters.

DESIGN

A four-month randomized double-blind, parallel group study.

PATIENTS AND METHODS

Obese hypertensive patients with hypertriglyceridaemia (> or = 2.3 mmol/l) and impaired glucose tolerance (OMS-ADA) were included (n = 52). A placebo run-in period of 2 weeks was followed by 4 months of double-blind treatment with either rilmenidine or amlodipine. Blood pressure was recorded using a mercury sphygmomanometer. Glucose metabolism was evaluated by an oral glucose tolerance test

RESULTS

Of the 52 patients recruited, 47 (21 rilmenidine and 26 amlodipine) completed the 4-month treatment period. The intention-to-treat analysis showed a comparable reduction in systolic and diastolic blood pressure (SBP, DBP) with the two anti-hypertensive treatments (rilmenidine -13.9/-13.5 mmHg; amlodipine - 17.6/-15.0 mmHg). Insulin concentrations under basal conditions and 2 h after a standard oral glucose load did not change significantly after treatment in both groups. Plasma glucose under basal conditions and 2 h after a standard oral glucose load as well as the area under the plasma glucose concentration curve tended to decrease in the rilmenidine group and to increase in the amlodipine group so that the changes in these parameters were significantly different between the two study groups (P= 0.041, P = 0.042 and P = 0.015, respectively). Plasminogen activator inhibitor type 1 (PAI-1) antigen and PAI-1 activity were only decreased in the rilmenidine group (not statistically significant).

CONCLUSION

Our results demonstrate that rilmenidine and amlodipine have a comparable anti-hypertensive effect but only rilmenidine is able to improve glucose metabolism.

摘要

目的

比较利美尼定与氨氯地平对血压、糖代谢、血脂浓度及纤溶参数的影响。

设计

一项为期四个月的随机双盲平行组研究。

患者与方法

纳入肥胖型高血压合并高甘油三酯血症(≥2.3 mmol/l)及糖耐量受损(世界卫生组织-美国糖尿病协会标准)的患者(n = 52)。经过2周的安慰剂导入期后,给予利美尼定或氨氯地平进行4个月的双盲治疗。使用汞柱式血压计记录血压。通过口服葡萄糖耐量试验评估糖代谢。

结果

在招募的52例患者中,47例(利美尼定组21例,氨氯地平组26例)完成了4个月的治疗期。意向性分析显示,两种抗高血压治疗降低收缩压和舒张压(SBP、DBP)的效果相当(利美尼定-13.9/-13.5 mmHg;氨氯地平-17.6/-15.0 mmHg)。两组治疗后基础状态下及标准口服葡萄糖负荷后2小时的胰岛素浓度均无显著变化。基础状态下及标准口服葡萄糖负荷后2小时的血浆葡萄糖以及血浆葡萄糖浓度曲线下面积在利美尼定组呈下降趋势,在氨氯地平组呈上升趋势,因此两组研究对象这些参数的变化存在显著差异(分别为P = 0.041、P = 0.042和P = 0.015)。仅利美尼定组的纤溶酶原激活物抑制剂1(PAI-1)抗原和PAI-1活性降低(无统计学意义)。

结论

我们的结果表明,利美尼定和氨氯地平具有相当的抗高血压作用,但只有利美尼定能够改善糖代谢。

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