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心肌梗死后康复试验(RAMIT):急性心肌梗死后患者综合心脏康复的多中心随机对照试验。

Rehabilitation after myocardial infarction trial (RAMIT): multi-centre randomised controlled trial of comprehensive cardiac rehabilitation in patients following acute myocardial infarction.

机构信息

Department of Epidemiology, University of Wales College of Medicine, Heath Park, Cardiff, UK.

出版信息

Heart. 2012 Apr;98(8):637-44. doi: 10.1136/heartjnl-2011-300302. Epub 2011 Dec 22.

DOI:10.1136/heartjnl-2011-300302
PMID:22194152
Abstract

BACKGROUND

It is widely believed that cardiac rehabilitation following acute myocardial infarction (MI) reduces mortality by approximately 20%. This belief is based on systematic reviews and meta-analyses of mostly small trials undertaken many years ago. Clinical management has been transformed in the past 30-40 years and the findings of historical trials may have little relevance now.

OBJECTIVES

The principal objective was to determine the effect of cardiac rehabilitation, as currently provided, on mortality, morbidity and health-related quality of life in patients following MI. The secondary objectives included seeking programmes that may be more effective and characteristics of patients who may benefit more. DESIGN, SETTING, PATIENTS, OUTCOME MEASURES: A multi-centre randomised controlled trial in representative hospitals in England and Wales compared 1813 patients referred to comprehensive cardiac rehabilitation programmes or discharged to 'usual care' (without referral to rehabilitation). The primary outcome measure was all-cause mortality at 2 years. The secondary measures were morbidity, health service use, health-related quality of life, psychological general well-being and lifestyle cardiovascular risk factors at 1 year. Patient entry ran from 1997 to 2000, follow-up of secondary outcomes to 2001 and of vital status to 2006. A parallel study compared 331 patients in matched 'elective' rehabilitation and 'elective' usual care (without rehabilitation) hospitals.

RESULTS

There were no significant differences between patients referred to rehabilitation and controls in mortality at 2 years (RR 0.98, 95% CI 0.74 to 1.30) or after 7-9 years (0.99, 95% CI 0.85 to 1.15), cardiac events, seven of eight domains of the health-related quality of life scale ('Short Form 36', SF36) or the psychological general well-being scale. Rehabilitation patients reported slightly less physical activity. No differences between groups were reported in perceived overall quality of cardiac aftercare. Data from the 'elective' hospitals comparison concurred with these findings.

CONCLUSION

In this trial, comprehensive rehabilitation following MI had no important effect on mortality, cardiac or psychological morbidity, risk factors, health-related quality of life or activity. This finding is consistent with systematic reviews of all trials reported since 1983. The value of cardiac rehabilitation as practised in the UK is open to question.

摘要

背景

人们普遍认为,急性心肌梗死(MI)后的心脏康复可使死亡率降低约 20%。这种信念基于多年前进行的系统评价和荟萃分析,这些分析主要涉及小型试验。在过去的 30-40 年中,临床管理已经发生了转变,历史试验的结果现在可能相关性不大。

目的

本研究的主要目的是确定目前提供的心脏康复对 MI 后患者的死亡率、发病率和健康相关生活质量的影响。次要目标包括寻找可能更有效的方案,以及可能从中受益更多的患者特征。

设计、地点、患者、结局测量:一项多中心随机对照试验在英格兰和威尔士的代表性医院中比较了 1813 名被转诊至综合心脏康复计划或出院至“常规护理”(未转诊至康复)的患者。主要结局测量指标为 2 年时的全因死亡率。次要结局测量指标为 1 年时的发病率、卫生服务利用、健康相关生活质量、心理一般健康状况和生活方式心血管危险因素。患者入组时间为 1997 年至 2000 年,对次要结局的随访时间为 2001 年,对生存情况的随访时间为 2006 年。一项平行研究比较了 331 名在匹配的“择期”康复和“择期”常规护理(无康复)医院的患者。

结果

在 2 年时,接受康复治疗的患者与对照组患者在死亡率(RR 0.98,95%CI 0.74 至 1.30)或 7-9 年后(0.99,95%CI 0.85 至 1.15)、心脏事件、健康相关生活质量量表(“36 项简短健康调查”,SF36)的八个领域中的七个或心理一般健康状况量表上无显著差异。康复患者报告的体力活动稍少。两组在对心脏康复后整体质量的感知上无差异。来自“择期”医院比较的结果与这些发现一致。

结论

在本试验中,MI 后进行全面康复对死亡率、心脏或心理发病率、危险因素、健康相关生活质量或活动没有重要影响。这一发现与自 1983 年以来报告的所有试验的系统评价一致。英国心脏康复的实际价值值得质疑。

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