基于运动的心脏康复治疗冠心病。
完整摘要 · 中文译文
背景：冠心病（CHD）是全球首要死因。在中低收入国家，冠心病死亡率保持稳定，而在高收入国家则呈下降趋势，这意味着更多冠心病患者带病生存，需要支持以管理其症状和预后。以运动为基础的心脏康复（CR）旨在改善冠心病患者的健康结局。 目的：评估以运动为基础的心脏康复（单纯运动训练或联合心理社会/教育干预）与“无运动”对照相比，对冠心病患者死亡率、发病率和健康相关生活质量（HRQoL）的临床效果和成本效果。 检索方法：我们更新了此前Cochrane系统综述的检索，检索了CENTRAL、MEDLINE、Embase、Web of Science、CINAHL以及两个临床试验注册库，检索时间截至2026年3月。 纳入标准：我们纳入了针对冠心病成年患者的以运动为基础的心脏康复随机对照试验（RCT），对照为“无运动”对照组，随访时间为六个月或更长。 结局指标：主要结局包括死亡率（全因和心血管）、致死性和非致死性心肌梗死（MI）、血运重建（冠状动脉旁路移植术（CABG）和经皮冠状动脉介入治疗（PCI））以及住院（全因和心血管）。次要结局包括健康相关生活质量（HRQoL）和成本效果。我们将随访时间分为短期（6至12个月）、中期（>12至36个月）和长期（>36个月）。 偏倚风险：我们使用 Cochrane 偏倚风险评估工具1（RoB 1）评估偏倚风险。 合成方法：我们尽可能使用荟萃分析对每个结局的结果进行合成，采用随机效应模型计算二分类结局的风险比（RR）和95%置信区间（CI），以及连续结局的均数差（MD）。我们按随访时间对荟萃分析进行分层，并使用单变量荟萃回归探索研究间异质性的潜在来源。当无法进行荟萃分析时，我们采用叙述性方法综合结果。我们使用GRADE评估短期随访（最常见的时间点）主要结局的证据确定性。 纳入研究：本系统综述纳入了107项试验（26,886名冠心病（CHD）成人患者）。本次更新确定了22项新试验（3456名受试者）。大多数受试者为心肌梗死后或血运重建后患者；其平均年龄范围为47至81岁。尽管78%的试验纳入了女性，但女性仅占所有受试者的17%。大多数试验在高收入地区开展，包括欧洲（51/107，48%）、亚洲（28/107，26%）和北美（14/107，13%）。26项试验（其中11项为本次更新新增）在低收入和中等收入国家（LMICs）进行。总体而言，试验报告质量较差，但有证据表明在过去十年中质量有所改善。 结果汇总：短期随访（6至12个月）与无结构化运动相比，基于运动的心脏康复（CR）很可能降低全因死亡率（RR 0.86，95% CI 0.74至1.00；30项试验，10,391名受试者；额外获益所需治疗人数（NNTB）125，95% CI 75至∞；中等确定性证据），并可能降低心血管死亡率（RR 0.87，95% CI 0.68至1.11；20项试验，7277名受试者；NNTB 200，95% CI 82至额外有害结局所需治疗人数（NNTH）238；中等确定性证据）。它使心肌梗死（MI）大幅减少（RR 0.72，95% CI 0.54至0.95；25项试验，8584名受试者；NNTB 71，95% CI 47至435；高确定性证据）。它使冠状动脉旁路移植术（CABG）风险几乎没有差异（RR 1.00，95% CI 0.78至1.28；21项试验，4532名受试者；高确定性证据），并且经皮冠状动脉介入治疗（PCI）可能也几乎没有差异（RR 0.86，95% CI 0.65至1.13；13项试验，3465名受试者；中等确定性证据）。它很可能降低全因住院（RR 0.65，95% CI 0.51至0.82；21项试验，3868名受试者；NNTB 17，95% CI 12至32；中等确定性证据），但我们对其对心血管原因住院的影响不确定（RR 0.80，95% CI 0.35至1.82；6项试验，1550名受试者；低确定性证据），且存在显著异质性（I2 = 59%）。我们检测到全因住院存在小研究偏倚，但其他结局未检测到。证据表明，基于运动的心脏康复在多个结局维度上使健康相关生活质量（HRQoL）出现具有临床意义的改善，包括SF-36分量表（生理组分、心理组分、生理 躯体功能、体能表现、总体健康、活力和社交功能评分）以及EQ-5D评分，随访至12个月。八项经济学评价研究一致表明，以运动为基础的心脏康复在质量调整生命年方面具有成本效益。Meta回归显示，大多数研究层面的特征不能解释异质性，尽管在干预设置和研究样本量方面观察到一些差异。证据确定性从低到高不等。由于不精确（95%置信区间宽）、可能的发表偏倚以及研究间的异质性，我们降低了证据等级。我们判断若干研究在某些领域存在高偏倚风险，主要由于报告不完整或研究层面的失访。对于临床结局，我们认为该偏倚风险对效应估计的影响有限。约四分之一的纳入试验开展于心脏护理的较早时期，即当代最佳药物治疗广泛应用之前。 作者的结论：与不运动相比，以运动为基础的心脏康复（CR）可改善冠心病（CHD）患者的结局，包括显著降低心肌梗死和住院风险，全因死亡率和心血管死亡率可能有小幅降低，并在长达12个月的随访中改善健康相关生活质量（HRQoL）。在更长随访期（>12个月）中，以运动为基础的心脏康复与心血管死亡率和心肌梗死降低相关。冠心病患者的心脏康复也被证明具有成本效益。近期试验增加了女性参与者的纳入，采用了替代性的心脏康复实施模式（居家和数字化支持），并在低收入和中等收入国家（LMICs）开展，从而提高了研究结果的全球普适性。 资助：内部来源：英国格拉斯哥大学——为GD和RST的时间提供资助支持；荷兰拉德堡德大学医学中心——为FdV、DT和NS的时间提供资助支持。外部来源：既往NIHR Cochrane基础设施资金对Cochrane心脏组的资助。其中所表达的观点和意见仅代表作者本人，并不一定反映系统评价计划、NIHR、NHS或卫生和社会保健部的观点。 注册：既往版本可通过 doi.org/10.1002/14651858.CD001800.pub4；doi.org/10.1002/14651858.CD001800.pub3；doi.org/10.1002/14651858.CD001800.pub2；doi.org/10.1002/14651858.CD001800；DOI 10.1016/j.amjmed.2004.01.009 获取。
完整摘要 · 英文原文
RATIONALE: Coronary heart disease (CHD) is the leading cause of death globally. CHD mortality rates remain steady in low- and middle-income countries but are declining in high-income countries, meaning more people are living with CHD and need support to manage their symptoms and prognosis. Exercise-based cardiac rehabilitation (CR) aims to improve the health outcomes of people with CHD. OBJECTIVES: To assess the clinical and cost-effectiveness of exercise-based CR (exercise training alone or combined with psychosocial/educational interventions) compared with 'no exercise' control, on mortality, morbidity and health-related quality of life (HRQoL) in people with CHD. SEARCH METHODS: We updated searches from the previous Cochrane review, searching CENTRAL, MEDLINE, Embase, Web of Science, CINAHL, and two clinical trials registers in March 2026. ELIGIBILITY CRITERIA: We included randomised controlled trials (RCTs) of exercise-based CR, compared with 'no exercise' control, with follow-up of six months or longer, in adults with CHD. OUTCOMES: Primary outcomes included mortality (all-cause and cardiovascular), fatal and non-fatal myocardial infarction (MI), revascularisation (coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI)), and hospitalisation (all-cause and cardiovascular). Secondary outcomes included HRQoL and cost-effectiveness. We categorised follow-up as short-term (6 to 12 months), medium-term (> 12 to 36 months), and long-term (> 36 months). RISK OF BIAS: We assessed risk of bias with the Cochrane Risk of bias 1 tool (RoB 1). SYNTHESIS METHODS: We synthesised results for each outcome using meta-analysis where possible, using random-effects models to calculate risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes, and mean differences (MD) for continuous outcomes. We stratified meta-analyses by follow-up duration and used univariable meta-regression to explore potential sources of between-study heterogeneity. Where meta-analysis was not possible, we narratively synthesised results. We used GRADE to assess certainty of evidence for primary outcomes at short-term follow-up (the most common time point). INCLUDED STUDIES: This review included 107 trials (26,886 adults with CHD). This update identified 22 new trials (3456 participants). Most participants were post-MI or post-revascularisation; their mean age ranged from 47 to 81 years. Although 78% of trials included women, they represented only 17% of the participants overall. Most trials were conducted in high-income settings in Europe (51/107, 48%), Asia (28/107, 26%) and North America (14/107, 13%). Twenty-six trials (11 in this update) were undertaken in low- and middle-income countries (LMICs). Overall, trial reporting was poor, although there was evidence of an improvement in quality over the last decade. SYNTHESIS OF RESULTS: Short-term follow-up (6 to 12 months) Compared to no structured exercise, exercise-based CR likely reduces all-cause mortality (RR 0.86, 95% CI 0.74 to 1.00; 30 trials, 10,391 participants; number needed to treat for an additional beneficial outcome (NNTB) 125, 95% CI 75 to ∞; moderate-certainty evidence) and may reduce cardiovascular mortality (RR 0.87, 95% CI 0.68 to 1.11; 20 trials, 7277 participants; NNTB 200, 95% CI 82 to number needed for an additional harmful outcome (NNTH) 238; moderate-certainty evidence). It results in a large reduction in MI (RR 0.72, 95% CI 0.54 to 0.95; 25 trials, 8584 participants; NNTB 71, 95% CI 47 to 435; high-certainty evidence). It makes little to no difference in risk of CABG (RR 1.00, 95% CI 0.78 to 1.28; 21 trials, 4532 participants; high-certainty evidence), and likely little to no difference in PCI (RR 0.86, 95% CI 0.65 to 1.13; 13 trials, 3465 participants; moderate-certainty evidence). It likely reduces all-cause hospital admissions (RR 0.65, 95% CI 0.51 to 0.82; 21 trials, 3868 participants; NNTB 17, 95% CI 12 to 32; moderate-certainty evidence) but we are uncertain about its effects on cardiovascular hospitalisation (RR 0.80, 95% CI 0.35 to 1.82; 6 trials, 1550 participants; low-certainty evidence), with substantial heterogeneity (I2 = 59%). We detected small-study bias for all-cause hospitalisation, but not for other outcomes. Evidence indicated clinically meaningful increases in HRQoL with exercise-based CR across several outcome domains, including SF-36 subscales (physical component, mental component, physical functioning, physical performance, general health, vitality, and social functioning scores) and EQ-5D scores up to 12 months' follow-up. Eight economic evaluation studies consistently showed exercise-based CR to be cost-effective in terms of quality-adjusted life years gained. Meta-regression showed that most study-level characteristics did not explain heterogeneity, though some variation was seen by intervention setting and study sample size. Certainty of evidence ranged from low to high. We downgraded due to imprecision (wide 95% CIs), possible publication bias, and heterogeneity across studies. We judged several studies at high risk of bias in some domains, primarily due to incomplete reporting or study-level attrition. For clinical outcomes, we considered that the impact of this risk of bias on effect estimates was limited. Around a quarter of included trials were conducted in earlier eras of cardiac care, prior to the widespread adoption of contemporary optimal medical therapy. AUTHORS' CONCLUSIONS: Compared with no exercise, exercise-based CR improves outcomes for people with CHD, including significantly reduced risk of MI and hospitalisation, a likely small reduction in all-cause and cardiovascular mortality, and improved HRQoL up to 12 months' follow-up. Over longer-term follow-up (> 12-months), exercise-based CR is associated with reduced cardiovascular mortality and MI. CR for people with CHD was also shown to be cost-effective. Recent trials have increased inclusion of women, used alternative models of CR delivery (home and digitally supported) and have been undertaken in LMICs, increasing the global generalisability of findings. FUNDING: Internal sources: University of Glasgow, UK - funding support for the time of GD and RST. Radboud University Medical Centre, NL - funding support for the time of FdV, DT and NS. External sources: past NIHR Cochrane Infrastructure funding to Cochrane Heart. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health and Social Care. REGISTRATION: Previous versions available via doi.org/10.1002/14651858.CD001800.pub4; doi.org/10.1002/14651858.CD001800.pub3; doi.org/10.1002/14651858.CD001800.pub2; doi.org/10.1002/14651858.CD001800; DOI 10.1016/j.amjmed.2004.01.009.