Allergy and Asthma Medical Group and Research Center, San Diego, Calif. 92123, USA.
J Allergy Clin Immunol. 2011 Jan;127(1):167-72. doi: 10.1016/j.jaci.2010.08.042. Epub 2010 Nov 18.
Direct correlation of assessments of a validated composite measure such as the Asthma Control Questionnaire (ACQ) and risk of exacerbation has not been previously demonstrated in a randomized controlled trial.
To evaluate the ability of the ACQ score over time to predict risk of a future asthma exacerbation.
This analysis included data from a 12-week placebo-controlled trial (N = 292) of AMG 317, an IL-4 receptor α antagonist, in patients with moderate to severe atopic asthma. At baseline, patients had an ACQ score ≥1.5. Exacerbations were defined as requirement for systemic corticosteroids. A Cox proportional hazards model was used, with ACQ score as the time-dependent covariate. The analysis was repeated for individual components of the ACQ.
Each 1-point increase in ACQ was associated with a 50% increased risk of exacerbation (hazard ratio, 1.50; 95% CI, 1.03-2.20) for the following 2-week period. Evaluation of individual ACQ components also demonstrated a similar trend, though each to a lesser degree than the full composite ACQ.
Although based on a retrospective analysis, with small number of exacerbations, these findings support the utility of the composite ACQ score measurement to predict risk of future exacerbation in clinical trials and clinical practice. The composite ACQ score measurement was found to be a better predictor of future risk than individual ACQ components.
在随机对照试验中,尚未以前瞻性方式证实经过验证的综合指标(如哮喘控制问卷(ACQ))的评估与加重风险之间的直接相关性。
评估 ACQ 评分随时间推移预测未来哮喘加重风险的能力。
本分析纳入了一项为期 12 周、安慰剂对照的 AMG 317(一种 IL-4 受体 α 拮抗剂)治疗中重度特应性哮喘患者的研究数据(N=292)。在基线时,患者的 ACQ 评分≥1.5。将加重定义为需要全身皮质类固醇治疗。采用 Cox 比例风险模型,ACQ 评分为时间依赖性协变量。对 ACQ 的各个组成部分进行了重复分析。
ACQ 每增加 1 分,在接下来的 2 周内,加重风险增加 50%(风险比,1.50;95% CI,1.03-2.20)。对 ACQ 的各个组成部分的评估也显示出类似的趋势,但每个组成部分的程度均小于完整的综合 ACQ。
尽管这些发现基于回顾性分析,且加重事件的数量较少,但仍支持综合 ACQ 评分测量在临床试验和临床实践中预测未来加重风险的效用。综合 ACQ 评分测量被发现是预测未来风险的更好指标,优于各个 ACQ 组成部分。