Clinical study of the effects on asthma-related QOL and asthma management of a medical food in adult asthma patients
Clinical study of the effects on asthma-related QOL and asthma management of a medical food in adult asthma patients
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DOI：
10.1185/03007990903316491
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发表时间：
2009-12-01
影响因子：
2.3
通讯作者：
Stull, Dean
中科院分区：
文献类型：
--
作者：
Lindemann, Julianne;Pampe, E. David;Stull, Dean
背景：哮喘可对生活质量产生负面影响，尽管这与肺功能的客观评估没有很好的相关性。含有脂肪酸γ-亚麻酸（GLA）和二十碳五烯酸（EPA）的医疗食品EST 1009可减少哮喘患者的白三烯B-4合成。两个先前的临床研究提供的初步证据表明，医疗食品改善哮喘相关的生活质量（ARQOL）和哮喘management.Objective：评估ARQOL的影响，ARQOL的ASTHEMATIZ.Research设计和方法：该研究是一项随机，前瞻性，双盲，安慰剂对照，平行组研究21（N = 21评估）轻度至中度持续性哮喘谁消耗的医疗食品乳剂或安慰剂乳剂每天28天。所有参与者在整个研究期间继续使用哮喘药物。在基线、第14天和第28天使用简易哮喘生活质量问卷（MiniAQLQ）和哮喘控制问卷（ACQ）测量ARQOL（包括哮喘体征和症状）和哮喘控制。结果：两组患者的基线ARQOL评分、一秒用力呼气量（FEV 1）及其他指标基本平衡。MiniAQLQ总分的平均值（标准误）在安慰剂组和安慰剂组分别变化了0.73（0.38）和-0.22（0.36）（p
Background:Asthma can have a negative impact on quality of life although this is not well correlated with objective evaluations of pulmonary function. A medical food, EFF1009, containing the fatty acids gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA) decreases leukotriene B-4 synthesis in patients with asthma. Two previous clinical studies with EFF1009 provided preliminary evidence that the medical food improves asthma-related quality of life (ARQOL) and asthma management.Objective:To evaluate the impact on ARQOL of EFF1009 in adults with asthma.Research design and methods:The study was a randomized, prospective, double-blind, placebo-controlled, parallel group study in twenty-one (N = 21 evaluable) subjects with mild to moderate persistent asthma who consumed the medical food emulsion or placebo emulsion daily for 28 days. All participants continued their asthma medications throughout the study. ARQOL, including asthma signs and symptoms, and asthma control were measured using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and the Asthma Control Questionnaire (ACQ), administered at baseline, Day 14 and Day 28. Safety and tolerability parameters, including adverse events, were monitored.Results:Baseline ARQOL scores, forced expiratory volume in one second (FEV1) and other characteristics were balanced between both groups. Mean (standard error) total MiniAQLQ scores changed by 0.73 (0.38) and -0.22 (0.36) in the EFF1009 and placebo groups, respectively, (p