糠酸莫米松/富马酸福莫特罗临床试验中哮喘持续期的青少年和成人患者的哮喘控制状态变化评估
2011/03/28
摘要
目的：本试验为采用糖皮质激素吸入治疗和长效β2受体激动剂(LABAs)治疗的哮喘持续期青少年和成人患者，提供了哮喘控制问卷调查(ACQ)的心理测量学特性，探索与哮喘控制改善相关的因素。
方法：研究数据来自于两项大型的III期随机、双盲、平行组、多中心、安慰剂-对照试验(n = 737和772)，两项试验比较糠酸莫米松/富马酸福莫特罗(MF/F)联合用药治疗与单药治疗对持续性哮喘的疗效，这些患者前期采用低剂量或中等剂量的糖皮质激素吸入治疗。收集这些数据，用于评价ACQ的心理测量学特性和ACQ改善（定义为从基线状态至治疗结束ACQ评分至少下降0.5）的预测因素。
结果：成人患者中，有15%和8%的患者分别采用低剂量和中等剂量治疗，ACQ的信度可以接受（组间相关系数≥ 0.75），基线和变化评分与哮喘相关健康的其他指标（包括哮喘生活质量问卷[AQLQ12+]各领域评分和总体评分）的基线值和变化评分相关。MF/F 治疗组在治疗26周后，获得ACQ显著变化的患者人数(48%)，多于MF组(32%)、F组(26%)和安慰剂组(18%) (P<0.001)。两项研究均显示，随机分组前采用急救药物是ACQ显著改善的一个重要预测因素。
结论：这些结果显示，ACQ具有很好的心理测量学特性，能用于检测持续哮喘患者的哮喘控制状态。ACQ证实MF/F治疗组患者在哮喘控制上显著改善。
（刘国梁 审校）
J Asthma. 2011 Feb;48(1):48-56. Epub 2010 Nov 1.
An Assessment of Change in Asthma Control among Adolescents and Adults with Persistent Asthma In Mometasone Furoate/Formoterol Fumarate Clinical Trials.
Wyrwich KW, Ireland AM, Navaratnam P, Nolte H, Gates DF.
United BioSource Corporation, Bethesda, MD, USA.
Abstract
Objective. This article provides evidence on the psychometric properties of the Asthma Control Questionnaire (ACQ) in adolescent and adult patients with persistent asthma treated with a combination of inhaled glucocorticoid and long-acting beta2-agonist (LABAs), and explores the factors associated with important improvements in asthma control.
Methods. Data from patients in two large (n = 737 and 772) Phase III, randomized, double-blind, parallel-group, multi-center, placebo-controlled studies of mometasone furoate/formoterol fumarate (MF/F) combination formulation compared with monotherapies in subjects with persistent asthma previously treated with either low- or medium-dose inhaled glucocorticoids were used to evaluate the ACQ psychometric properties and predictors of important ACQ improvement, defined as an ACQ score decline from baseline of 0.5 or more at the end of treatment.
Results. With 15% and 8% participation from adolescents in the low- and medium-dose studies, the ACQ yielded acceptable reliability (intraclass correlation coefficient ≥ 0.75), and baseline and change scores demonstrated moderate to strong correlations with other baseline measures and change scores in other measures of asthma-related health, including the Asthma Quality of Life Questionnaire (AQLQ12+) domains and total scores. More MF/F treatment group patients (48%) achieved an important ACQ change at 26 weeks compared with MF (32%), F (26%), and placebo (18%) treatment groups (p < .001). Use of rescue medications before randomization was a significant predictor of important ACQ improvement in both studies.
Conclusions. These findings support the psychometric properties of the ACQ to measure asthma control among persistent asthma patients and provide confidence in the significant improvements in asthma control demonstrated by the MF/F treatment group.
J Asthma. 2011 Feb;48(1):48-56. Epub 2010 Nov 1.
目的：本试验为采用糖皮质激素吸入治疗和长效β2受体激动剂(LABAs)治疗的哮喘持续期青少年和成人患者，提供了哮喘控制问卷调查(ACQ)的心理测量学特性，探索与哮喘控制改善相关的因素。
方法：研究数据来自于两项大型的III期随机、双盲、平行组、多中心、安慰剂-对照试验(n = 737和772)，两项试验比较糠酸莫米松/富马酸福莫特罗(MF/F)联合用药治疗与单药治疗对持续性哮喘的疗效，这些患者前期采用低剂量或中等剂量的糖皮质激素吸入治疗。收集这些数据，用于评价ACQ的心理测量学特性和ACQ改善（定义为从基线状态至治疗结束ACQ评分至少下降0.5）的预测因素。
结果：成人患者中，有15%和8%的患者分别采用低剂量和中等剂量治疗，ACQ的信度可以接受（组间相关系数≥ 0.75），基线和变化评分与哮喘相关健康的其他指标（包括哮喘生活质量问卷[AQLQ12+]各领域评分和总体评分）的基线值和变化评分相关。MF/F 治疗组在治疗26周后，获得ACQ显著变化的患者人数(48%)，多于MF组(32%)、F组(26%)和安慰剂组(18%) (P<0.001)。两项研究均显示，随机分组前采用急救药物是ACQ显著改善的一个重要预测因素。
结论：这些结果显示，ACQ具有很好的心理测量学特性，能用于检测持续哮喘患者的哮喘控制状态。ACQ证实MF/F治疗组患者在哮喘控制上显著改善。
（刘国梁 审校）
J Asthma. 2011 Feb;48(1):48-56. Epub 2010 Nov 1.
An Assessment of Change in Asthma Control among Adolescents and Adults with Persistent Asthma In Mometasone Furoate/Formoterol Fumarate Clinical Trials.
Wyrwich KW, Ireland AM, Navaratnam P, Nolte H, Gates DF.
United BioSource Corporation, Bethesda, MD, USA.
Abstract
Objective. This article provides evidence on the psychometric properties of the Asthma Control Questionnaire (ACQ) in adolescent and adult patients with persistent asthma treated with a combination of inhaled glucocorticoid and long-acting beta2-agonist (LABAs), and explores the factors associated with important improvements in asthma control.
Methods. Data from patients in two large (n = 737 and 772) Phase III, randomized, double-blind, parallel-group, multi-center, placebo-controlled studies of mometasone furoate/formoterol fumarate (MF/F) combination formulation compared with monotherapies in subjects with persistent asthma previously treated with either low- or medium-dose inhaled glucocorticoids were used to evaluate the ACQ psychometric properties and predictors of important ACQ improvement, defined as an ACQ score decline from baseline of 0.5 or more at the end of treatment.
Results. With 15% and 8% participation from adolescents in the low- and medium-dose studies, the ACQ yielded acceptable reliability (intraclass correlation coefficient ≥ 0.75), and baseline and change scores demonstrated moderate to strong correlations with other baseline measures and change scores in other measures of asthma-related health, including the Asthma Quality of Life Questionnaire (AQLQ12+) domains and total scores. More MF/F treatment group patients (48%) achieved an important ACQ change at 26 weeks compared with MF (32%), F (26%), and placebo (18%) treatment groups (p < .001). Use of rescue medications before randomization was a significant predictor of important ACQ improvement in both studies.
Conclusions. These findings support the psychometric properties of the ACQ to measure asthma control among persistent asthma patients and provide confidence in the significant improvements in asthma control demonstrated by the MF/F treatment group.
J Asthma. 2011 Feb;48(1):48-56. Epub 2010 Nov 1.
上一篇：
哮喘的特异性免疫治疗：疗效与安全性
下一篇：
伴过敏性鼻炎的轻度哮喘患者，鼻内皮质激素治疗对哮喘控制和生活质量的影响
