Department of Pulmonary Diseases, Medical Center Leeuwarden, Leeuwarden, Netherlands; Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
Lancet Respir Med. 2019 Apr;7(4):313-324. doi: 10.1016/S2213-2600(18)30431-4. Epub 2019 Feb 8.
Severe emphysema is a debilitating condition with few treatment options. Lung volume reduction procedures in the treatment of severe emphysema have shown excellent results in selected patients but their exact role remains unclear with studies reporting a wide variation in outcomes. We therefore aimed to evaluate the effects of volume reduction.
We did a systematic review and meta-analysis. We searched MEDLINE on Sept 29, 2016, for trials of lung volume reduction in patients with emphysema, and we did an updated search on Embase and PubMed on June 18, 2018. We only included randomised controlled studies published in English evaluating the intervention with either sham or standard of care. Inclusion was limited to trials of techniques in which there was sustainable volume reduction. Primary outcomes were residual volume, FEV, St George's Respiratory Questionnaire (SGRQ), and 6-min walk distance (6MWT). Secondary outcomes were severe adverse events (including mortality), short-term mortality, and overall mortality. We extracted summary level data from the trial publications and where necessary we obtained unpublished data. A random-effects model with the I statistic was used to determine heterogeneity and trial weight in each analysis. The study is registered with the PROSPERO database, number CRD42016045705.
We identified 4747 references in the search, and included 20 randomised controlled trials of lung volume reduction involving 2794 participants with emphysema. Following lung volume reduction from any of the interventions in pooled analyses (ie, surgery, endobronchial valve, endobronchial coil, or sclerosing agents), the mean differences compared with the control were reduction in residual volume of 0·58 L (95% CI -0·80 to -0·37), increase in FEV of 15·87% (95% CI 12·27 to 19·47), improvement in 6MWT of 43·28 m (31·36 to 55·21), and reduction in the SGRQ of 9·39 points (-10·92 to -7·86). The odds ratio for a severe adverse event, which included mortality, was 6·21 (95% CI 4·02 to 9·58) following intervention. Regression analysis showed improvements relative to the degree of volume reduction: FEV (r=0·86; p<0·0001), 6MWT (r=0·77; p<0·0001), and SGRQ (r=0·70; p<0·0001). Most studies were at high risk of bias for lack of blinding, and heterogeneity was high for some outcomes when pooled across all interventions, but was generally lower in the subgroups by intervention type.
Despite limitations of high risk of bias and heterogeneity for some analyses, our results provide support that lung volume reduction in patients with severe emphysema on maximal medical treatment has clinically meaningful benefits. These benefits should be considered alongside potential adverse events.
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严重肺气肿是一种使人虚弱的疾病，治疗选择有限。在治疗严重肺气肿时，肺减容术在选择的患者中显示出极好的效果，但由于研究报告结果差异很大，其确切作用仍不清楚。因此，我们旨在评估体积减少的效果。
我们进行了系统评价和荟萃分析。我们于 2016 年 9 月 29 日在 MEDLINE 上搜索肺气肿患者的肺减容术试验，并于 2018 年 6 月 18 日在 Embase 和 PubMed 上进行了更新搜索。我们只纳入了评估干预措施的随机对照试验，该干预措施采用了假手术或标准治疗。纳入仅限于具有可持续体积减少的技术的试验。主要结局是残气量、FEV、圣乔治呼吸问卷（SGRQ）和 6 分钟步行距离（6MWT）。次要结局是严重不良事件（包括死亡率）、短期死亡率和总死亡率。我们从试验出版物中提取汇总水平数据，必要时从未发表的数据中获取数据。使用 I 统计量的随机效应模型来确定每个分析中的异质性和试验权重。该研究在 PROSPERO 数据库中注册，编号为 CRD42016045705。
我们在搜索中发现了 4747 条参考文献，并纳入了 20 项涉及 2794 例肺气肿患者的肺减容术随机对照试验。与对照组相比，任何干预措施（手术、支气管内瓣膜、支气管内线圈或硬化剂）后，肺减容的汇总分析显示残气量减少 0.58 L（95%CI -0.80 至 -0.37），FEV 增加 15.87%（95%CI 12.27 至 19.47），6MWT 增加 43.28 m（31.36 至 55.21），SGRQ 减少 9.39 分（-10.92 至 -7.86）。干预后严重不良事件（包括死亡率）的比值比为 6.21（95%CI 4.02 至 9.58）。回归分析显示，与体积减少的程度相关的改善：FEV（r=0.86；p<0.0001）、6MWT（r=0.77；p<0.0001）和 SGRQ（r=0.70；p<0.0001）。大多数研究由于缺乏盲法而存在高偏倚风险，并且当所有干预措施汇总时，某些结局的异质性较高，但在按干预类型分组时通常较低。
尽管一些分析存在高偏倚风险和异质性的限制，但我们的结果提供了支持，即对接受最大药物治疗的严重肺气肿患者进行肺减容术具有有临床意义的益处。这些益处应与潜在的不良事件一起考虑。
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