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针对成年心力衰竭患者的运动心脏康复治疗。

Exercise-based cardiac rehabilitation for adults with heart failure.

作者信息

Long Linda, Mordi Ify R, Bridges Charlene, Sagar Viral A, Davies Edward J, Coats Andrew Js, Dalal Hasnain, Rees Karen, Singh Sally J, Taylor Rod S

机构信息

Institute of Health Research, University of Exeter Medical School, Exeter, UK.

出版信息

Cochrane Database Syst Rev. 2019 Jan 29;1(1):CD003331. doi: 10.1002/14651858.CD003331.pub5.

Abstract

BACKGROUND

Chronic heart failure (HF) is a growing global health challenge. People with HF experience substantial burden that includes low exercise tolerance, poor health-related quality of life (HRQoL), increased risk of mortality and hospital admission, and high healthcare costs. The previous (2014) Cochrane systematic review reported that exercise-based cardiac rehabilitation (CR) compared to no exercise control shows improvement in HRQoL and hospital admission among people with HF, as well as possible reduction in mortality over the longer term, and that these reductions appear to be consistent across patient and programme characteristics. Limitations noted by the authors of this previous Cochrane Review include the following: (1) most trials were undertaken in patients with HF with reduced (< 45%) ejection fraction (HFrEF), and women, older people, and those with preserved (≥ 45%) ejection fraction HF (HFpEF) were under-represented; and (2) most trials were undertaken in the hospital/centre-based setting.

OBJECTIVES

To determine the effects of exercise-based cardiac rehabilitation on mortality, hospital admission, and health-related quality of life of people with heart failure.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and three other databases on 29 January 2018. We also checked the bibliographies of systematic reviews and two trial registers.

SELECTION CRITERIA

We included randomised controlled trials that compared exercise-based CR interventions with six months' or longer follow-up versus a no exercise control that could include usual medical care. The study population comprised adults (> 18 years) with evidence of HF - either HFrEF or HFpEF.

DATA COLLECTION AND ANALYSIS

Two review authors independently screened all identified references and rejected those that were clearly ineligible for inclusion in the review. We obtained full papers of potentially relevant trials. Two review authors independently extracted data from the included trials, assessed their risk of bias, and performed GRADE analyses.

MAIN RESULTS

We included 44 trials (5783 participants with HF) with a median of six months' follow-up. For this latest update, we identified 11 new trials (N = 1040), in addition to the previously identified 33 trials. Although the evidence base includes predominantly patients with HFrEF with New York Heart Association classes II and III receiving centre-based exercise-based CR programmes, a growing body of studies include patients with HFpEF and are undertaken in a home-based setting. All included studies included a no formal exercise training intervention comparator. However, a wide range of comparators were seen across studies that included active intervention (i.e. education, psychological intervention) or usual medical care alone. The overall risk of bias of included trials was low or unclear, and we downgraded results using the GRADE tool for all but one outcome.Cardiac rehabilitation may make little or no difference in all-cause mortality over the short term (≤ one year of follow-up) (27 trials, 28 comparisons (2596 participants): intervention 67/1302 (5.1%) vs control 75/1294 (5.8%); risk ratio (RR) 0.89, 95% confidence interval (CI) 0.66 to 1.21; low-quality GRADE evidence) but may improve all-cause mortality in the long term (> 12 months follow up) (6 trials/comparisons (2845 participants): intervention 244/1418 (17.2%) vs control 280/1427 (19.6%) events): RR 0.88, 95% CI 0.75 to 1.02; high-quality evidence). Researchers provided no data on deaths due to HF. CR probably reduces overall hospital admissions in the short term (up to one year of follow-up) (21 trials, 21 comparisons (2182 participants): (intervention 180/1093 (16.5%) vs control 258/1089 (23.7%); RR 0.70, 95% CI 0.60 to 0.83; moderate-quality evidence, number needed to treat: 14) and may reduce HF-specific hospitalisation (14 trials, 15 comparisons (1114 participants): (intervention 40/562 (7.1%) vs control 61/552 (11.1%) RR 0.59, 95% CI 0.42 to 0.84; low-quality evidence, number needed to treat: 25). After CR, a clinically important improvement in short-term disease-specific health-related quality of life may be evident (Minnesota Living With Heart Failure questionnaire - 17 trials, 18 comparisons (1995 participants): mean difference (MD) -7.11 points, 95% CI -10.49 to -3.73; low-quality evidence). Pooling across all studies, regardless of the HRQoL measure used, shows there may be clinically important improvement with exercise (26 trials, 29 comparisons (3833 participants); standardised mean difference (SMD) -0.60, 95% CI -0.82 to -0.39; I² = 87%; Chi² = 215.03; low-quality evidence). ExCR effects appeared to be consistent different models of ExCR delivery: centre vs. home-based, exercise dose, exercise only vs. comprehensive programmes, and aerobic training alone vs aerobic plus resistance programmes.

AUTHORS' CONCLUSIONS: This updated Cochrane Review provides additional randomised evidence (11 trials) to support the conclusions of the previous version (2014) of this Cochane Review. Compared to no exercise control, CR appears to have no impact on mortality in the short term (< 12 months' follow-up). Low- to moderate-quality evidence shows that CR probably reduces the risk of all-cause hospital admissions and may reduce HF-specific hospital admissions in the short term (up to 12 months). CR may confer a clinically important improvement in health-related quality of life, although we remain uncertain about this because the evidence is of low quality. Future ExCR trials need to continue to consider the recruitment of traditionally less represented HF patient groups including older, female, and HFpEF patients, and alternative CR delivery settings including home- and using technology-based programmes.

摘要

背景

慢性心力衰竭(HF)是一项日益严峻的全球性健康挑战。心力衰竭患者承受着巨大负担,包括运动耐量低、健康相关生活质量(HRQoL)差、死亡和住院风险增加以及医疗成本高昂。之前(2014年)的Cochrane系统评价报告称,与无运动对照组相比,基于运动的心脏康复(CR)可改善心力衰竭患者的HRQoL和住院情况,并且从长期来看可能降低死亡率,而且这些降低似乎在不同患者和项目特征中是一致的。该Cochrane评价的作者指出的局限性包括:(1)大多数试验是在射血分数降低(<45%)的心力衰竭(HFrEF)患者中进行的,而女性、老年人以及射血分数保留(≥45%)的心力衰竭(HFpEF)患者代表性不足;(2)大多数试验是在医院/中心环境中进行的。

目的

确定基于运动的心脏康复对心力衰竭患者死亡率、住院情况和健康相关生活质量的影响。

检索方法

我们于2018年1月29日检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、Embase以及其他三个数据库。我们还查阅了系统评价的参考文献目录和两个试验注册库。

选择标准

我们纳入了将基于运动的CR干预与随访六个月或更长时间的无运动对照组进行比较的随机对照试验,无运动对照组可能包括常规医疗护理。研究人群为有HF证据的成年人(>18岁)——HFrEF或HFpEF。

数据收集与分析

两位综述作者独立筛选所有识别出的参考文献,并排除那些明显不符合纳入综述标准的文献。我们获取了潜在相关试验的全文。两位综述作者独立从纳入的试验中提取数据,评估其偏倚风险,并进行GRADE分析。

主要结果

我们纳入了44项试验(5783例HF患者),中位随访时间为六个月。对于此次最新更新,除了之前识别出的33项试验外,我们还识别出11项新试验(N = 1040)。尽管证据主要包括纽约心脏病协会II级和III级的HFrEF患者接受基于中心运动的CR项目,但越来越多的研究纳入了HFpEF患者,并且是在家庭环境中进行的。所有纳入的研究都包括一个无正式运动训练干预的对照组。然而,各研究中的对照组范围广泛,包括积极干预(即教育及心理干预)或仅为常规医疗护理。纳入试验的总体偏倚风险较低或不明确,除一项结果外,我们使用GRADE工具对所有结果进行了降级。心脏康复在短期(随访≤一年)内对全因死亡率可能几乎没有影响(27项试验,28组比较(2596例参与者):干预组67/1302(5.1%),对照组75/1294(5.8%);风险比(RR)0.89,95%置信区间(CI)0.66至1.21;低质量GRADE证据),但在长期(随访>12个月)可能改善全因死亡率(6项试验/组比较(2845例参与者):干预组244/14,18(17.2%),对照组280/1427(19.6%)事件):RR 0.88,95%CI 0.75至1.02;高质量证据)。研究人员未提供因HF导致死亡的数据。CR可能在短期内(随访长达一年)降低总体住院率(21项试验,21组比较(2182例参与者):(干预组180/1093(16.5%),对照组258/1089(23.7%);RR 0.70,95%CI 0.60至0.83;中等质量证据,需治疗人数:14),并且可能降低HF特异性住院率(14项试验,15组比较(1114例参与者):(干预组40/562(7.1%),对照组61/552(11.1%)RR 0.59,95%CI 0.二,0.84;低质量证据,需治疗人数:25)。CR后,短期内疾病特异性健康相关生活质量可能有临床意义的改善(明尼苏达心力衰竭生活问卷——17项试验,18组比较(1995例参与者):平均差(MD) - 7.11分,95%CI - 10.49至 - 3.73;低质量证据)。汇总所有研究,无论使用何种HRQoL测量方法,运动可能带来有临床意义的改善(26项试验,29组比较(3833例参与者);标准化平均差(SMD) - 0.60,95%CI - 0.82至 - 0.39;I² = 87%;Chi² = 215.03;低质量证据)。ExCR的效果在不同的ExCR实施模式中似乎是一致的:中心模式与家庭模式、运动剂量、单纯运动与综合项目以及单独有氧训练与有氧加抗阻项目。

作者结论

此次更新的Cochrane评价提供了额外的随机证据(1,1项试验)以支持该Cochrane评价上一版(2014年)的结论。与无运动对照组相比,CR在短期内(随访<12个月)似乎对死亡率没有影响。低至中等质量的证据表明,CR可能降低全因住院风险,并且在短期内(长达12个月)可能降低HF特异性住院率。CR可能在健康相关生活质量方面带来有临床意义的改善,尽管由于证据质量低我们对此仍不确定。未来的ExCR试验需要继续考虑招募传统上代表性不足的HF患者群体,包括老年、女性和HFpEF患者,以及替代的CR实施环境,包括家庭环境和基于技术的项目。

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