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西拉普利和卡托普利与安慰剂对慢性心力衰竭患者运动试验影响的比较:一项双盲、随机、多中心试验。西拉普利 - 卡托普利多中心研究组。

Comparison of the effects of cilazapril and captopril versus placebo on exercise testing in chronic heart failure patients: a double-blind, randomized, multicenter trial. The Cilazapril-Captopril Multicenter Group.

出版信息

Cardiology. 1995;86 Suppl 1:34-40. doi: 10.1159/000176944.

DOI:10.1159/000176944
PMID:7614505
Abstract

In order to compare directly the efficacy of two different angiotensin-converting enzyme (ACE) inhibitors in terms of clinical status and exercise capacity, 443 patients with chronic heart failure (New York Heart Association classes II-IV) were randomized into a 24-week double-blind study to receive cilazapril (CLZ) 1-2.5 mg once daily (n = 221), captopril (CPT) 25-50 mg three times daily (n = 108), or placebo (PLA) for 12 weeks followed by CLZ 2.5 mg (n = 114) in addition to their standard heart failure therapy. The majority were New York Heart Association functional class II (56-62%), and the most frequent etiology of chronic heart failure was coronary heart disease (35-42%), followed by dilative cardiomyopathy (approximately 28%). Both ACE inhibitors prolonged the exercise tolerance test duration at all visits, and the effect at week 12 (CLZ 62.2 +/- 7.5 s; CPT 73.1 +/- 10.7 s) was significantly greater than after PLA (28.1 +/- 12.2 s; p = 0.011 and p = 0.005, respectively). Furthermore, the distance walked during 6 min increased at all visits with ACE inhibitors (NS vs. PLA). CLZ was more effective in patients with the most impaired physical ability at baseline as defined by exercise tolerance test duration < or = 6 min (p = 0.0036 at week 12 and p = 0.0150 at week 24) and by walking test < or = 400 m (p = 0.0004 at week 12 and p = 0.0009 at week 24). Similar results were obtained with CPT for the walking test (p = 0.0369 at week 12 and p = 0.0142 at week 24).(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

为了直接比较两种不同的血管紧张素转换酶(ACE)抑制剂在临床状况和运动能力方面的疗效,443例慢性心力衰竭患者(纽约心脏协会II-IV级)被随机分为一项为期24周的双盲研究,接受西拉普利(CLZ)1-2.5毫克每日一次(n = 221)、卡托普利(CPT)25-50毫克每日三次(n = 108)或安慰剂(PLA)治疗12周,之后除标准心力衰竭治疗外,114例患者加用CLZ 2.5毫克。大多数患者为纽约心脏协会功能II级(56-62%),慢性心力衰竭最常见的病因是冠心病(35-42%),其次是扩张型心肌病(约28%)。两种ACE抑制剂在所有访视时均延长了运动耐量试验持续时间,第12周时的效果(CLZ 62.2±7.5秒;CPT 73.1±10.7秒)显著大于服用安慰剂后(28.1±12.2秒;p分别为0.011和0.005)。此外,使用ACE抑制剂时,6分钟内行走的距离在所有访视时均增加(与安慰剂相比无显著性差异)。根据运动耐量试验持续时间≤6分钟(第12周时p = 0.0036,第24周时p = 0.0150)和步行试验≤400米(第12周时p = 0.0004,第24周时p = 0.0009)定义,CLZ对基线时身体能力受损最严重的患者更有效。CPT在步行试验中也得到了类似结果(第12周时p = 0.0369,第24周时p = 0.0142)。(摘要截断于250字)

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引用本文的文献

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Med J Armed Forces India. 1998 Oct;54(4):331-334. doi: 10.1016/S0377-1237(17)30598-1. Epub 2017 Jun 26.
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Adverse effects of ACE inhibitors in patients with chronic heart failure and/or ventricular dysfunction : meta-analysis of randomised clinical trials.血管紧张素转换酶抑制剂对慢性心力衰竭和/或心室功能障碍患者的不良反应:随机临床试验的荟萃分析
Drug Saf. 2003;26(12):895-908. doi: 10.2165/00002018-200326120-00004.
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A review of quality-of-life evaluations in patients with congestive heart failure.
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Pharmacoeconomics. 1999 Sep;16(3):247-71. doi: 10.2165/00019053-199916030-00003.
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North of England evidence based development project: guideline for angiotensin converting enzyme inhibitors in primary care management of adults with symptomatic heart failure.英格兰北部循证发展项目:成人症状性心力衰竭初级护理管理中血管紧张素转换酶抑制剂指南
BMJ. 1998 May 2;316(7141):1369-75. doi: 10.1136/bmj.316.7141.1369.