Michael G DeGroote School of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Eur Respir J. 2010 Aug;36(2):269-76. doi: 10.1183/09031936.00124009. Epub 2010 Jan 28.
There are various ways to classify asthma control; however, no classification is universally accepted. This retrospective analysis compared asthma control as assessed by the Asthma Control Questionnaire (5-item version; ACQ-5), Global Initiative for Asthma (GINA) or Gaining Optimal Asthma Control (GOAL) study criteria. Pooled data at the final study week (n = 8,188) from three budesonide/formoterol maintenance and reliever therapy studies which measured ACQ-5 were stratified according to GINA or GOAL criteria and ACQ-5 score distribution. The percentages of patients with a controlled/partly controlled week (GINA), totally/well-controlled week (GOAL) and range of ACQ-5 cut-off points were compared. Patients with GINA controlled, partly controlled and uncontrolled asthma had mean ACQ-5 scores of 0.43, 0.75 and 1.62, respectively. Patients with GOAL totally controlled, well-controlled and uncontrolled asthma had ACQ-5 scores of 0.39, 0.78 and 1.63. The kappa measure of agreement was 0.80 for GINA and GOAL criteria, and 0.63 for GINA controlled/partly controlled and ACQ-5 <1.00. ACQ-5 detected clinically important improvements in 49% of patients who, according to GINA criteria, remained uncontrolled at the end of the study. Asthma control measured by GINA or GOAL criteria provides similar results. GINA Controlled/Partly Controlled and GOAL Totally Controlled/Well-Controlled correspond to ACQ-5 <1.00. The ACQ-5 is more responsive to change in a clinical trial setting than a categorical scale.
有多种方法可以对哮喘控制进行分类；然而，没有一种分类方法被普遍接受。本回顾性分析比较了哮喘控制问卷（5 项版本；ACQ-5）、全球哮喘倡议（GINA）或获得最佳哮喘控制（GOAL）研究标准评估的哮喘控制情况。从三项布地奈德/福莫特罗维持和缓解治疗研究中汇总了最终研究周（n=8188）的数据，这些研究测量了 ACQ-5，并根据 GINA 或 GOAL 标准和 ACQ-5 评分分布进行分层。比较了具有控制/部分控制周（GINA）、完全/良好控制周（GOAL）和 ACQ-5 截止值范围的患者百分比。GINA 控制、部分控制和未控制哮喘患者的平均 ACQ-5 评分分别为 0.43、0.75 和 1.62。GOAL 完全控制、良好控制和未控制哮喘患者的 ACQ-5 评分为 0.39、0.78 和 1.63。GINA 和 GOAL 标准的一致性kappa 测量值为 0.80，GINA 控制/部分控制和 ACQ-5<1.00 的一致性kappa 测量值为 0.63。根据 GINA 标准，49%的患者在研究结束时仍未得到控制，但 ACQ-5 检测到了临床重要的改善。GINA 或 GOAL 标准测量的哮喘控制提供了相似的结果。GINA 控制/部分控制和 GOAL 完全控制/良好控制与 ACQ-5<1.00 相对应。ACQ-5 在临床试验环境中比分类量表更能敏感地反映变化。
