硝苯地平胃肠治疗系统早晚给药治疗原发性高血压的比较。

P Greminger, P M Suter, D Holm, R Kobelt, W Vetter
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引用次数: 42

摘要

硝苯地平胃肠道治疗系统(GITS)是最近开发的控释制剂,每天一次给药。我们在一项包括15名原发性高血压患者的随机双盲交叉研究中评估了早晚给药的影响。5例患者因不符合要求(3例)或无法忍受的副作用(2例)而被排除在血压分析之外。为了评估降压疗效的确切持续时间,进行了无创自动动态血压监测。在安慰剂期后,患者在1000或2200小时给予30毫克硝苯地平GITS。24小时收缩压和舒张压记录了两种硝苯地平方案在整个期间持续的降压效果,而不影响昼夜节律。统计分析显示早晚用药无显著差异。两名患者因为无法忍受的副作用(分别是疲劳和肌肉痉挛)而停药。另外两例出现轻度可逆性头痛,没有引起停药。总之,我们的结果证明30mg硝苯地平GITS对中度原发性高血压患者有持续的降压效果。给药时间对白天和夜间血压控制没有影响。
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Morning versus evening administration of nifedipine gastrointestinal therapeutic system in the management of essential hypertension.

The nifedipine gastrointestinal therapeutic system (GITS) is a recently developed controlled-release formulation for once-a-day dosing. We evaluated the influence of morning versus evening administration of the drug in a randomized double-blind cross-over study including 15 essential hypertensives. Five patients had to be excluded from blood pressure analysis because of noncompliance (three cases) or intolerable side effects (two cases). To assess the exact duration of the antihypertensive efficacy noninvasive automatic ambulatory blood pressure monitoring was performed. After a placebo period patients were given 30 mg nifedipine GITS either at 1000 or 2200 hours. Twenty-four-hours systolic and diastolic blood pressure profiles documented a sustained antihypertensive effect of both nifedipine regimens throughout the whole period without affecting the circadian rhythm. Statistical analysis revealed no significant difference between morning and evening administration. Two patients stopped their medication because of intolerable side effects (fatigue and muscle cramps, respectively). Two more cases suffered from mild reversible headache which provoked no discontinuation of the drug. In conclusion our results document a sustained antihypertensive efficacy of 30 mg nifedipine GITS in patients with moderate essential hypertension. Time of administration has no impact on day- and nighttime blood pressure control.

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