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男性的生活质量与抗高血压治疗。卡托普利与依那普利的比较。生活质量高血压研究组。

Quality of life and antihypertensive therapy in men. A comparison of captopril with enalapril. The Quality-of-Life Hypertension Study Group.

作者信息

Testa M A, Anderson R B, Nackley J F, Hollenberg N K

机构信息

Department of Biostatistics, Harvard School of Public Health, Boston, MA 02115.

出版信息

N Engl J Med. 1993 Apr 1;328(13):907-13. doi: 10.1056/NEJM199304013281302.

Abstract

BACKGROUND

We conducted a multicenter trial comparing two angiotensin-converting-enzyme inhibitors to determine whether effects on quality of life during antihypertensive therapy are uniform within this pharmacologic class of agents, and to relate the effects of the drugs on quality of life to objective adverse events, such as the loss of a job or the death of a spouse.

METHODS

After a four-week washout period when they received placebo, 379 men with mild-to-moderately-severe hypertension were randomly assigned to receive captopril (25 to 50 mg twice daily, with or without hydrochlorothiazide) or enalapril (5 to 20 mg per day, with or without hydrochlorothiazide) for 24 weeks. Blood pressure, quality of life, and life events were monitored. Differences between treatments were evaluated by calibrating measures of quality of life with objective life events.

RESULTS

Throughout the treatment period, no differences were found in blood pressure, frequency of withdrawal of patients from the study, or major side effects. Patients treated with captopril had more favorable changes in overall quality of life, general perceived health, vitality, health status, sleep, and emotional control (P < 0.05 for each). The changes varied according to the quality of life at base line (P < 0.001); patients with a low quality of life at base line remained stable or improved with either drug, whereas those with a higher quality of life remained stable with captopril but worsened with enalapril. The quality-of-life scales correlated with life events and symptom distress (P < 0.001), and calibration analysis indicated that differences between treatments were clinically important.

CONCLUSIONS

Two angiotensin-converting-enzyme inhibitors, captopril and enalapril, indistinguishable according to clinical assessments of efficacy and safety, had different effects on quality of life. Calibration with life events showed that drug-induced changes are substantial and that the different effects of these two agents on quality of life can be clinically meaningful.

摘要

背景

我们进行了一项多中心试验,比较两种血管紧张素转换酶抑制剂,以确定在抗高血压治疗期间对生活质量的影响在这类药物中是否一致,并将药物对生活质量的影响与客观不良事件(如失业或配偶死亡)联系起来。

方法

在接受安慰剂的四周洗脱期后,379名轻度至中度重度高血压男性被随机分配接受卡托普利(每日两次,每次25至50毫克,加或不加氢氯噻嗪)或依那普利(每日5至20毫克,加或不加氢氯噻嗪)治疗24周。监测血压、生活质量和生活事件。通过用客观生活事件校准生活质量测量指标来评估治疗之间的差异。

结果

在整个治疗期间,血压、患者退出研究的频率或主要副作用方面均未发现差异。接受卡托普利治疗的患者在总体生活质量、一般健康感知、活力、健康状况、睡眠和情绪控制方面有更有利的变化(每项P<0.05)。这些变化根据基线时的生活质量而有所不同(P<0.001);基线时生活质量低的患者使用任何一种药物后保持稳定或有所改善,而生活质量较高的患者使用卡托普利后保持稳定,但使用依那普利后恶化。生活质量量表与生活事件和症状困扰相关(P<0.001),校准分析表明治疗之间的差异具有临床意义。

结论

根据疗效和安全性的临床评估无法区分的两种血管紧张素转换酶抑制剂卡托普利和依那普利,对生活质量有不同影响。用生活事件进行校准表明,药物引起的变化很大,这两种药物对生活质量的不同影响可能具有临床意义。

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