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赖诺普利、依那普利及安慰剂每日一次给药对轻至中度高血压患者24小时血压的影响

Twenty-four hour blood pressure effect of once-daily lisinopril, enalapril, and placebo in patients with mild to moderate hypertension.

作者信息

Whelton A, Dunne B, Glazer N, Kostis J B, Miller W E, Rector D J, Tresznewsky O N

机构信息

Universal Clinical Research Center, Good Samaritan Hospital, Baltimore, MD 21239.

出版信息

J Hum Hypertens. 1992 Aug;6(4):325-31.

PMID:1331444
Abstract

This multicentre, double-blind, parallel-group, placebo-controlled study compared the antihypertensive effects of equal doses of two long-acting angiotensin converting enzyme (ACE) inhibitors. After a two-week, placebo run-in phase, 110 patients with mild to moderate hypertension were randomised to receive 10 mg lisinopril or enalapril, or placebo for 4 weeks. Office BPs were measured at regular intervals throughout the study. Twenty-four hour ambulatory blood pressure (ABP) was measured at baseline and after the first and final doses of study drug. Serum ACE activity and aldosterone were obtained concomitantly with each ABP monitoring. Office BP differences from placebo reached (P less than 0.05) or approached (P less than 0.10) statistical significance at all observations for the lisinopril group but were not significant for any observation in the enalapril group and approached significance on two occasions. After four weeks of treatment, ABP analysis revealed that the lisinopril and enalapril groups, when compared with placebo, had similar and significant systolic and diastolic AUC reductions (P less than 0.01) from baseline over the 24 h dosing interval. During the second half of the dosing interval, 13-24 h post drug administration, the lisinopril group was significantly different from placebo (systolic BP, P = 0.002; diastolic BP, P = 0.005) while the enalapril group was not. Both drugs were well tolerated. The results indicate that monotherapy with 10 mg of lisinopril is as effective as with 10 mg of enalapril, and that ABP monitoring is useful in more precisely depicting the clinical effect of the known pharmacokinetic properties of these two agents.

摘要

这项多中心、双盲、平行组、安慰剂对照研究比较了等剂量的两种长效血管紧张素转换酶(ACE)抑制剂的降压效果。在为期两周的安慰剂导入期后,110例轻至中度高血压患者被随机分为接受10 mg赖诺普利或依那普利,或安慰剂治疗4周。在整个研究过程中定期测量诊室血压。在基线以及研究药物的首剂和末剂给药后测量24小时动态血压(ABP)。每次ABP监测时同时获取血清ACE活性和醛固酮水平。赖诺普利组在所有观察点的诊室血压与安慰剂相比均达到(P<0.05)或接近(P<0.10)统计学显著性,但依那普利组在任何观察点均无显著性差异,仅在两次观察中接近显著性。治疗四周后,ABP分析显示,与安慰剂相比,赖诺普利组和依那普利组在24小时给药间隔内收缩压和舒张压的曲线下面积(AUC)均有相似且显著的降低(P<0.01)。在给药间隔的后半段,即给药后13 - 24小时,赖诺普利组与安慰剂有显著差异(收缩压,P = 0.002;舒张压,P = 0.005),而依那普利组无差异。两种药物耐受性均良好。结果表明,10 mg赖诺普利单药治疗与10 mg依那普利同样有效,并且ABP监测有助于更精确地描述这两种药物已知药代动力学特性的临床效果。

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