Puhan Milo A, Gimeno-Santos Elena, Cates Christopher J, Troosters Thierry
Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, Zurich, Switzerland, 8001.
Center for Research in Environmental Epidemiology-CREAL, Barcelona, Spain.
Cochrane Database Syst Rev. 2016 Dec 8;12(12):CD005305. doi: 10.1002/14651858.CD005305.pub4.
BACKGROUND: Guidelines have provided positive recommendations for pulmonary rehabilitation after exacerbations of chronic obstructive pulmonary disease (COPD), but recent studies indicate that postexacerbation rehabilitation may not always be effective in patients with unstable COPD. OBJECTIVES: To assess effects of pulmonary rehabilitation after COPD exacerbations on hospital admissions (primary outcome) and other patient-important outcomes (mortality, health-related quality of life (HRQL) and exercise capacity). SEARCH METHODS: We identified studies through searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PEDro (Physiotherapy Evidence Database) and the Cochrane Airways Review Group Register of Trials. Searches were current as of 20 October 2015, and handsearches were run up to 5 April 2016. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing pulmonary rehabilitation of any duration after exacerbation of COPD versus conventional care. Pulmonary rehabilitation programmes had to include at least physical exercise (endurance or strength exercise, or both). We did not apply a criterion for the minimum number of exercise sessions a rehabilitation programme had to offer to be included in the review. Control groups received conventional community care without rehabilitation. DATA COLLECTION AND ANALYSIS: We expected substantial heterogeneity across trials in terms of how extensive rehabilitation programmes were (i.e. in terms of number of completed exercise sessions; type, intensity and supervision of exercise training; and patient education), duration of follow-up (< 3 months vs ≥ 3 months) and risk of bias (generation of random sequence, concealment of random allocation and blinding); therefore, we performed subgroup analyses that were defined before we carried them out. We used standard methods expected by Cochrane in preparing this update, and we used GRADE for assessing the quality of evidence. MAIN RESULTS: For this update, we added 11 studies and included a total of 20 studies (1477 participants). Rehabilitation programmes showed great diversity in terms of exercise training (number of completed exercise sessions; type, intensity and supervision), patient education (from none to extensive self-management programmes) and how they were organised (within one setting, e.g. pulmonary rehabilitation, to across several settings, e.g. hospital, outpatient centre and home). In eight studies, participants completed extensive pulmonary rehabilitation, and in 12 studies, participants completed pulmonary rehabilitation ranging from not extensive to moderately extensive.Eight studies involving 810 participants contributed data on hospital readmissions. Moderate-quality evidence indicates that pulmonary rehabilitation reduced hospital readmissions (pooled odds ratio (OR) 0.44, 95% confidence interval (CI) 0.21 to 0.91), but results were heterogenous (I = 77%). Extensiveness of rehabilitation programmes and risk of bias may offer an explanation for the heterogeneity, but subgroup analyses were not statistically significant (P values for subgroup effects were between 0.07 and 0.11). Six studies including 670 participants contributed data on mortality. The quality of evidence was low, and the meta-analysis did not show a statistically significant effect of rehabilitation on mortality (pooled OR 0.68, 95% CI 0.28 to 1.67). Again, results were heterogenous (I = 59%). Subgroup analyses showed statistically significant differences in subgroup effects between trials with more and less extensive rehabilitation programmes and between trials at low and high risk for bias, indicating possible explanations for the heterogeneity. Hospital readmissions and mortality studies newly included in this update showed, on average, significantly smaller effects of rehabilitation than were seen in earlier studies.High-quality evidence suggests that pulmonary rehabilitation after an exacerbation improves health-related quality of life. The eight studies that used St George's Respiratory Questionnaire (SGRQ) reported a statistically significant effect on SGRQ total score, which was above the minimal important difference (MID) of four points (mean difference (MD) -7.80, 95% CI -12.12 to -3.47; I = 64%). Investigators also noted statistically significant and important effects (greater than MID) for the impact and activities domains of the SGRQ. Effects were not statistically significant for the SGRQ symptoms domain. Again, all of these analyses showed heterogeneity, but most studies showed positive effects of pulmonary rehabilitation, some studies showed large effects and others smaller but statistically significant effects. Trials at high risk of bias because of lack of concealment of random allocation showed statistically significantly larger effects on the SGRQ than trials at low risk of bias. High-quality evidence shows that six-minute walk distance (6MWD) improved, on average, by 62 meters (95% CI 38 to 86; I = 87%). Heterogeneity was driven particularly by differences between studies showing very large effects and studies showing smaller but statistically significant effects. For both health-related quality of life and exercise capacity, studies newly included in this update showed, on average, smaller effects of rehabilitation than were seen in earlier studies, but the overall results of this review have not changed to an important extent compared with results reported in the earlier version of this review.Five studies involving 278 participants explicitly recorded adverse events, four studies reported no adverse events during rehabilitation programmes and one study reported one serious event. AUTHORS' CONCLUSIONS: Overall, evidence of high quality shows moderate to large effects of rehabilitation on health-related quality of life and exercise capacity in patients with COPD after an exacerbation. Some recent studies showed no benefit of rehabilitation on hospital readmissions and mortality and introduced heterogeneity as compared with the last update of this review. Such heterogeneity of effects on hospital readmissions and mortality may be explained to some extent by the extensiveness of rehabilitation programmes and by the methodological quality of the included studies. Future researchers must investigate how the extent of rehabilitation programmes in terms of exercise sessions, self-management education and other components affects the outcomes, and how the organisation of such programmes within specific healthcare systems determines their effects after COPD exacerbations on hospital readmissions and mortality.
背景:指南已对慢性阻塞性肺疾病(COPD)急性加重期后的肺康复给出了积极建议,但近期研究表明,急性加重期后康复对COPD病情不稳定的患者可能并不总是有效。 目的:评估COPD急性加重期后肺康复对住院率(主要结局)及其他对患者重要的结局(死亡率、健康相关生活质量(HRQL)和运动能力)的影响。 检索方法:我们通过检索Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、Embase、PEDro(物理治疗证据数据库)以及Cochrane气道综述组试验注册库来识别研究。检索截至2015年10月20日,手工检索截至2016年4月5日。 选择标准:比较COPD急性加重期后任何时长的肺康复与常规治疗的随机对照试验(RCT)。肺康复计划必须至少包括体育锻炼(耐力或力量训练,或两者皆有)。我们未对纳入综述的康复计划所需提供的最少锻炼次数设定标准。对照组接受无康复的常规社区护理。 数据收集与分析:我们预计各试验在康复计划的广泛程度(即完成的锻炼次数、锻炼训练的类型、强度和监督以及患者教育)、随访时长(<3个月与≥3个月)以及偏倚风险(随机序列生成、随机分配隐藏和盲法)方面存在实质性异质性;因此,我们在开展亚组分析之前就对其进行了定义。我们采用Cochrane在本次更新中预期使用的标准方法,并使用GRADE评估证据质量。 主要结果:对于本次更新内容,我们新增了11项研究,共纳入20项研究(1477名参与者)。康复计划在运动训练(完成的锻炼次数、类型、强度和监督)、患者教育(从无到广泛的自我管理计划)以及组织方式(在一个场所内,如肺康复,到跨多个场所,如医院、门诊中心和家庭)方面表现出很大差异。在8项研究中,参与者完成了广泛的肺康复,在12项研究中,参与者完成了从非广泛到中度广泛的肺康复。八项涉及810名参与者的研究提供了关于再次入院的数据。中等质量证据表明,肺康复降低了再次入院率(合并比值比(OR)0.44,95%置信区间(CI)0.21至0.91),但结果存在异质性(I² = 77%)。康复计划的广泛程度和偏倚风险可能为异质性提供了解释,但亚组分析无统计学意义(亚组效应的P值在0.07至0.11之间)。六项包括670名参与者的研究提供了关于死亡率的数据。证据质量较低,荟萃分析未显示康复对死亡率有统计学显著影响(合并OR 0.68,95%CI 0.28至1.67)。同样,结果存在异质性(I² = 59%)。亚组分析显示,康复计划广泛程度不同的试验以及偏倚风险高低不同的试验之间,亚组效应存在统计学显著差异,这为异质性提供了可能的解释。本次更新中新纳入的关于再次入院和死亡率的研究显示,康复的平均效果明显小于早期研究。高质量证据表明,急性加重期后肺康复可改善健康相关生活质量。八项使用圣乔治呼吸问卷(SGRQ)的研究报告了对SGRQ总分有统计学显著影响,高于最小重要差异(MID)4分(平均差(MD) -7.80,95%CI -12.12至 -3.47;I² = 64%)。研究人员还指出,SGRQ的影响和活动领域有统计学显著且重要的影响(大于MID)。SGRQ症状领域的影响无统计学意义。同样,所有这些分析均显示存在异质性,但大多数研究显示肺康复有积极作用,一些研究显示作用较大,另一些研究显示作用较小但有统计学显著作用。因随机分配隐藏不足而偏倚风险高的试验对SGRQ的影响在统计学上显著大于偏倚风险低的试验。高质量证据表明,六分钟步行距离(6MWD)平均增加了62米(95%CI 38至86;I² = 87%)。异质性尤其由显示非常大效果的研究与显示较小但有统计学显著效果的研究之间的差异所驱动。对于健康相关生活质量和运动能力,本次更新中新纳入的研究显示,康复的平均效果小于早期研究,但与本综述早期版本报告的结果相比,本综述的总体结果在重要程度上没有变化。五项涉及278名参与者的研究明确记录了不良事件,四项研究报告康复计划期间无不良事件,一项研究报告了一起严重事件。 作者结论:总体而言,高质量证据表明,康复对COPD急性加重期后患者的健康相关生活质量和运动能力有中度至较大影响。一些近期研究显示康复对再次入院率和死亡率无益处,与本综述的上次更新相比引入了异质性。对再次入院率和死亡率影响的这种异质性在一定程度上可能由康复计划的广泛程度以及纳入研究的方法学质量所解释。未来研究人员必须调查康复计划在锻炼次数、自我管理教育和其他组成部分方面的广泛程度如何影响结局,以及此类计划在特定医疗保健系统中的组织方式如何决定其对COPD急性加重期后再次入院率和死亡率的影响。
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