Evolution of the GOLD documents for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Controversies and questions.
Evolution of the GOLD documents for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Controversies and questions.
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DOI：
10.1164/rccm.201305-0846ed
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发表时间：
2013-07
影响因子：
24.7
通讯作者：
R. Yusen
中科院分区：
文献类型：
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作者：
R. Yusen
慢性阻塞性肺疾病全球倡议（GOLD）2011年修订的慢性阻塞性肺疾病（COPD）诊断、管理和预防全球战略共识报告将COPD定义为“一种常见的可预防和可治疗的疾病，特征在于持续的气流受限，其通常是进行性的，并且与气道和肺中对有毒有害物质的增强的慢性炎症反应相关。气体或粒子”（1）。GOLD 2011报告要求进行肺量测定来诊断COPD，并将使用支气管扩张剂后FEV 1/FVC固定比率0.70作为气流限制的肺量测定标准。GOLD 2007出版物（GOLD 2006修订版）对呼气气流阻塞进行了类似的定义和分级（1、2、3和4期）（表1）（2）。肺量测定阶段/3级和4级表示高风险，阶段/1级和2级表示非高风险。由于FEV 1不能可靠地预测COPD患者的呼吸困难程度、运动受限和健康状况损害，GOLD 2011报告在气流阻塞分级中增加了症状和加重风险，以帮助定义风险组和严重程度分级系统（图1，A、B、C和D类）。尽管存在许多经验证的呼吸问卷，但GOLD 2011报告建议使用改良的英国医学研究理事会（mMRC）问卷（0 - 4级）或COPD评估测试（CAT）（0 - 40级）进行症状评估。GOLD作者选择问卷评分截止值来区分症状负担较高的患者（mMRC呼吸困难量表评分>2或CAT评分>10）和负担较低的患者。GOLD 2011报告将COPD急性加重定义为“一种急性事件，其特征为患者呼吸道症状恶化，超出正常的日常变化，并导致药物治疗的变化。”在过去一年中，两次或两次以上“轻度”（需要改变吸入治疗的呼吸道症状）或“中度”（需要医疗干预的呼吸道症状，包括短期抗生素和/或口服类固醇）急性加重或COPD急性加重相关住院（“重度急性加重”）表明复发性急性加重的风险较高。GOLD 2011年报告建议将肺量测定和急性加重史分类，将患者归入风险类别。如果这些标准在风险分配中产生差异，则报告建议分配到更高的风险类别。修订后的GOLDCOPD分类引起了争议。一些利益相关者认为他们没有足够的投入（3）。修订版产生了许多关于症状测量工具选择和高/低症状评估和加重史截止值的问题。关于修订版发布之前和之后的验证和可靠性测试的程度和结果的问题已经出现。例如，2011年分类是否比2007年分类具有更好的预测特性，其使用的变革管理是否导致更好的结果？最近的研究在不同的患者和环境中评估和比较了GOLD 2007和GOLD 2011分类模式，产生了有趣的，有时是相互矛盾的结果。这些研究还确定了一些可能导致今后修订标准的问题。Han及其同事（4）评估了症状工具选择的影响（例如，CAT vs. mMRC）对GOLD 2011患者类别分配和COPD加重风险的影响。在他们对4,484例COPD患者的前瞻性纵向队列COPDGene研究数据的回顾性分析中，他们评估了至少6个月（平均20个月）随访期间的急性加重严重程度和事件发生率。他们使用了GOLD 2011分类所需的数据，但CAT除外。相反，他们使用了圣乔治呼吸问卷（SGRQ）（0 - 100;高风险评分> 25，低风险评分25）作为CAT（高风险评分> 10，低风险评分10）的替代品。为了进一步完善GOLD分类，他们分析了来自GOLD 2011气流受限和急性加重史组合定义的亚组的数据。他们发现症状测量（MRC与SGRQ）影响GOLD类别分配。关于未校正的结局分析，C类（低症状1高加重史）组与B类（高症状1低加重史）组的加重率无显著差异。C类患者相对较少。作者确实检测到高风险D类亚组中急性加重率的差异。因此，该研究表明，将患者分配到风险组的机制显著影响了结局;一些风险组没有不同的结局，而D组亚类则有不同的结局。Soriano及其同事（5）对来自西班牙COCOMICS（评估西班牙COPD多组分指数的协作队列）研究11个队列的3，633例患者的预测因子和生存结局数据进行了回顾性分析。该研究使用mMRC进行症状评估。对于急性加重史，仅采集了与住院相关的事件（重度类别）。队列有很大的风险组分类异质性。使用未校正分析，GOLD 2011 A组的生存率最好，D组最差，B和C组介于A组和D组之间。GOLD 2007和GOLD 2011风险组比较未显示随访1年、3年和10年时的死亡率差异。与Han及其同事的研究类似，COCOMICS研究
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 revision of the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (COPD) consensus report defined COPD as “a common preventable and treatable disease, characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases” (1). The GOLD 2011 report required spirometry to diagnose COPD and the postbronchodilator FEV1/FVC fixed ratio of ,0.70 as the spirometric criterion for airflow limitation. The GOLD 2007 publication (GOLD 2006 revision) similarly defined and graded (stages 1, 2, 3, and 4) expiratory airflow obstruction (Table 1) (2). Spirometric stages/grades 3 and 4 indicate high risk and stages/ grades 1 and 2 indicate nonhigh risk. Because the FEV1 does not reliably predict the degree of breathlessness, exercise limitation, and health status impairment in patients with COPD, the GOLD 2011 report added symptoms and exacerbation risk to the airflow obstruction grading to help define risk groups and a severity staging system (Figure 1, categories A, B, C, and D). Although many validated respiratory questionnaires exist, the GOLD 2011 report recommended the modified British Medical Research Council (mMRC) questionnaire (scaled 0 to 4) or the COPDAssessment Test (CAT) (scaled 0 to 40) for symptom assessment. TheGOLD authors chose questionnaire scoring cutoffs to separate patients with a higher symptom burden (mMRC dyspnea scale score of >2 or a CAT score of >10) from those with a lower burden. The GOLD 2011 report defined a COPD exacerbation as “an acute event characterized by a worsening of the patient’s respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication.” Two or more “mild” (respiratory symptoms requiring change of inhaled treatment) or “moderate” (respiratory symptoms requiring medical intervention including a short course of antibiotic and/or oral steroids) exacerbations or a COPD exacerbation-related hospitalization (“severe exacerbation”) in the preceding year indicate high risk for recurrent exacerbations. The GOLD 2011 report recommended spirometric and exacerbation history classification to place patients into a risk category. If these criteria produce a discrepancy in risk assignment, the report recommends assignment to the higher risk category. The revised GOLDCOPD classification created controversy. Some stakeholders felt that they did not have adequate input (3). The revision generated many questions about choice of symptom measurement tool and cut-offs for the high/low symptom assessment and exacerbation history. Questions about the degree of and the results of validation and reliability testing before and after the revision’s publication have arisen. For example, does the 2011 classification have better predictive characteristics than the 2007 classification, and does its use change management that leads to better outcomes? Recent studies that evaluated and compared the GOLD 2007 and GOLD 2011 classification schemas in different patients and settings have produced interesting and sometimes conflicting results. The studies have also identified some issues that may lead to future criteria revisions. Han and colleagues (4) assessed the influence of symptom instrument choice (e.g., CAT vs. mMRC) on GOLD 2011 patient category assignment and COPD exacerbation risk. In their retrospective analysis of data from the prospective longitudinal cohort COPDGene study of 4,484 patients with COPD, they assessed exacerbation severity and event rates during a minimum of 6 months (mean, 20 mo) of follow-up. They used the required data for GOLD 2011 categorization with the exception of the CAT. Instead, they used the St. George’s Respiratory Questionnaire (SGRQ) (scaled 0 to 100; high risk score > 25, low risk score, 25) as a surrogate for the CAT (high risk score> 10, low risk score , 10). To further refine the GOLD classification, they analyzed data from subgroups defined by combinations of GOLD 2011 airflow limitation and exacerbation history. They found that the symptom measure (MRC vs. SGRQ) influenced the GOLD category assignment. Regarding unadjusted outcomes analyses, the category C (low symptom 1 high exacerbation history) group did not have a significantly different exacerbation rate than the category B (high symptom 1 low exacerbation history) group. Category C had a relatively small number of patients. The authors did detect a difference in exacerbation rates within the highrisk category D subgroups. Thus, the study showed that the mechanism for assigning patients to a risk group significantly affected the outcomes; some risk groups did not have different outcomes, and group D subcategories had differential outcomes. Soriano and colleagues (5) conducted a retrospective analysis of predictor and survival outcomes data from 3,633 patients who came from 11 cohorts in the Spanish COCOMICS (Collaborative Cohorts to Assess Multicomponent Indices of COPD in Spain) study. The study used the mMRC for symptom assessment. For exacerbation history, it only captured events associated with hospitalization (severe category). The cohorts had great risk group categorization heterogeneity. Using unadjusted analyses, the GOLD 2011 group A had the best survival, group D had the worst, and groups B and C fell between groups A and D. The GOLD 2007 and GOLD 2011 risk group comparison did not show a difference in mortality at 1, 3, and 10 years of follow-up. Similar to the Han and colleagues study, the COCOMICS study