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依那普利治疗原发性高血压的多中心试验。

A multicenter trial of enalapril in the treatment of essential hypertension.

作者信息

Gavras H

出版信息

Clin Ther. 1986;9(1):24-38.

PMID:3028633
Abstract

The therapeutic profile of enalapril in mild to moderate uncomplicated essential hypertension was assessed in 265 patients who participated in a multicenter, open-label, prospective study lasting eight weeks. There were 54 younger (aged 39 years or less), 136 middle-aged (40 to 59 years), and 75 older patients (60 years or over). Monotherapy with enalapril in a single daily dosage regimen ranging between 5 and 40 mg resulted in normotension (in the sitting position) in 73% of the younger, 50% of the middle-aged, and 56% of the older patients. Normotension was achieved with 5 mg/day of enalapril in 41%, 18%, and 37% of the subgroups, respectively. Both systolic and diastolic pressures at the end of eight weeks of treatment were significantly lower (P less than 0.01) in the younger patients than in the other two age groups. White patients had significantly greater (P less than 0.001) response of both systolic and diastolic blood pressures than did black patients and required significantly smaller (P less than 0.01) average daily dosages of enalapril (14 mg versus 22 mg, respectively). The overall incidence of side effects was 14% among all 276 patients enrolled in the study. Most were mild and transient, but six patients discontinued enalapril during the first week of therapy because of side effects. There were no cases of rash, dysgeusia, hematological disorders, or deterioration in renal function, but there were two cases of pruritus, one of glossitis associated with an upper respiratory infection, and three of dry cough or wheezing. Angioedema was not observed. Monotherapy with enalapril, usually in a single daily dose of 10 to 20 mg, was effective in inducing normotension in approximately half of the middle-aged and older hypertensive individuals and in nearly three fourths of those below age 40. In this study it was generally well tolerated, with a relatively small incidence of side effects.

摘要

在一项为期八周的多中心、开放标签、前瞻性研究中,对265例患者评估了依那普利治疗轻度至中度单纯性原发性高血压的疗效。其中有54例年轻患者(39岁及以下),136例中年患者(40至59岁),以及75例老年患者(60岁及以上)。采用每日一次、剂量范围在5至40毫克的依那普利单药治疗,结果显示,73%的年轻患者、50%的中年患者和56%的老年患者实现了血压正常(坐位)。分别有41%、18%和37%的亚组患者使用5毫克/天的依那普利实现了血压正常。治疗八周结束时,年轻患者的收缩压和舒张压均显著低于其他两个年龄组(P<0.01)。白人患者的收缩压和舒张压反应显著大于黑人患者(P<0.001),且所需依那普利的平均日剂量显著更小(P<0.01)(分别为14毫克和22毫克)。在该研究纳入的所有276例患者中,副作用的总发生率为14%。大多数副作用轻微且短暂,但有6例患者在治疗第一周因副作用而停用依那普利。未出现皮疹、味觉障碍、血液系统疾病或肾功能恶化的情况,但有2例瘙痒、1例与上呼吸道感染相关的舌炎,以及3例干咳或喘息。未观察到血管性水肿。通常每日单次剂量为10至20毫克的依那普利单药治疗,能使约一半的中年和老年高血压患者以及近四分之三的40岁以下患者实现血压正常。在本研究中,依那普利总体耐受性良好,副作用发生率相对较低。

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