Instituto de Investigación Hospital Universitario de la Princesa (IISP), Universidad Autónoma de Madrid, Cátedra UAM-Linde, Madrid, Spain.
Department of Pulmonary Medicine, Kepler-University-Hospital, Linz, Austria; Faculty of Medicine, Johannes-Kepler-University, Linz, Austria.
Lancet Respir Med. 2015 Jun;3(6):443-50. doi: 10.1016/S2213-2600(15)00157-5. Epub 2015 May 17.
There is no universal consensus on the best staging system for chronic obstructive pulmonary disease (COPD). Although documents (eg, the Global Initiative for Chronic Obstructive Lung Disease [GOLD] 2007) have traditionally used forced expiratory volume in 1 s (FEV1) for staging, clinical parameters have been added to some guidelines (eg, GOLD 2011) to improve patient management. As part of the COPD Cohorts Collaborative International Assessment (3CIA) initiative, we aimed to investigate how individual patients were categorised by GOLD 2007 and 2011, and compare the prognostic accuracy of the staging documents for mortality.
We searched reports published from Jan 1, 2008, to Dec 31, 2014. Using data from cohorts that agreed to participate and had a minimum amount of information needed for GOLD 2007 and 2011, we did a patient-based pooled analysis of existing data. With use of raw data, we recalculated all participant assignments to GOLD 2007 I-IV classes, and GOLD 2011 A-D stages. We used survival analysis, C statistics, and non-parametric regression to model time-to-death data and compare GOLD 2007 and GOLD 2011 staging systems to predict mortality.
We collected individual data for 15 632 patients from 22 COPD cohorts from seven countries, totalling 70 184 person-years. Mean age of the patients was 63·9 years (SD 10·1); 10 751 (69%) were men. Based on FEV1 alone (GOLD 2007), 2424 (16%) patients had mild (I), 7142 (46%) moderate (II), 4346 (28%) severe (III), and 1670 (11%) very severe (IV) disease. We compared staging with the GOLD 2007 document with that of the new GOLD 2011 system in 14 660 patients: 5548 (38%) were grade A, 2733 (19%) were grade B, 1835 (13%) were grade C, and 4544 (31%) were grade D. GOLD 2011 shifted the overall COPD severity distribution to more severe categories. There were nearly three times more COPD patients in stage D than in former stage IV (p<0·05). The predictive capacity for survival up to 10 years was significant for both systems (p<0·01) but area under the curves were only 0·623 (GOLD 2007) and 0·634 (GOLD 2011), and GOLD 2007 and 2011 did not differ significantly. We identified the percent predicted FEV1 thresholds of 85%, 55% and 35% as better to stage COPD severity for mortality, which are similar to the ones used previously.
Neither GOLD COPD classification schemes have sufficient discriminatory power to be used clinically for risk classification at the individual level to predict total mortality for 3 years of follow-up and onwards. Increasing intensity of treatment of patients with COPD due to their GOLD 2011 reclassification is not known to improve health outcomes. Evidence-based thresholds should be searched when exploring the prognostic ability of current and new COPD multicomponent indices.
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目前对于慢性阻塞性肺疾病（COPD），并没有通用的分期系统。尽管传统上，一些文件（例如全球慢性阻塞性肺疾病倡议[GOLD] 2007 年版）都使用 1 秒用力呼气量（FEV1）进行分期，但一些指南（例如 GOLD 2011 年版）中已经加入了临床参数，以改善患者的管理。作为 COPD 队列协作国际评估（3CIA）计划的一部分，我们旨在研究如何根据 GOLD 2007 年和 2011 年版对个体患者进行分类，并比较这些分期文件在预测死亡率方面的准确性。
我们检索了 2008 年 1 月 1 日至 2014 年 12 月 31 日发表的报告。通过对同意参与并具有 GOLD 2007 年和 2011 年所需最低信息量的队列的数据进行汇总分析，我们对现有数据进行了基于患者的 pooled 分析。使用原始数据，我们重新计算了所有患者的 GOLD 2007 Ⅰ-Ⅳ类和 GOLD 2011 A-D 期的分配。我们使用生存分析、C 统计量和非参数回归来对死亡时间数据进行建模，并比较 GOLD 2007 和 GOLD 2011 分期系统，以预测死亡率。
我们从 7 个国家的 22 个 COPD 队列收集了 15632 名患者的个人数据，总计 70184 人年。患者的平均年龄为 63.9 岁（标准差 10.1）；10751 名（69%）为男性。根据单纯 FEV1（GOLD 2007），2424 名（16%）患者为轻度（Ⅰ），7142 名（46%）为中度（Ⅱ），4346 名（28%）为重度（Ⅲ），1670 名（11%）为极重度（Ⅳ）疾病。我们将 GOLD 2007 与新的 GOLD 2011 系统进行了比较，涉及 14660 名患者：5548 名（38%）为 A 级，2733 名（19%）为 B 级，1835 名（13%）为 C 级，4544 名（31%）为 D 级。GOLD 2011 使 COPD 严重程度的总体分布向更严重的类别转移。与前一阶段相比，D 期 COPD 患者增加了近三倍（p<0.05）。两个系统对生存 10 年的预测能力都有显著意义（p<0.01），但曲线下面积仅为 0.623（GOLD 2007）和 0.634（GOLD 2011），而且 GOLD 2007 和 2011 之间没有显著差异。我们确定了 85%、55%和 35%的预测 FEV1 百分比阈值，作为更好地对 COPD 严重程度进行分期以预测 3 年及以上的死亡率的指标，这些阈值与之前使用的指标相似。
无论是 GOLD COPD 分类方案，都没有足够的区分能力，无法在个体水平上用于临床风险分类，以预测 3 年及以上的总死亡率。由于 GOLD 2011 重新分类，增加 COPD 患者的治疗强度，是否能改善健康结果，目前尚不清楚。在探索当前和新的 COPD 多成分指标的预后能力时，应寻找基于证据的阈值。
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