Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Ann Allergy Asthma Immunol. 2013 Mar;110(3):198-203.e3. doi: 10.1016/j.anai.2012.12.016. Epub 2013 Jan 29.
Eosinophilic inflammation of the small airways is a key process in asthma that often smolders in treated patients. The long-term effects of add-on therapy on the persistent inflammation in the small airways remain unknown.
To examine the effects of add-on therapy with either ciclesonide, an inhaled corticosteroid with extrafine particles, or montelukast on small airway inflammation.
Sixty patients with stable asthma receiving inhaled corticosteroid treatment were enrolled in a randomized, open-label, parallel comparison study of 24-week add-on treatment with ciclesonide or montelukast. Patients were randomly assigned to 3 groups: ciclesonide (n = 19), montelukast (n = 22), or no add-on as controls (n = 19). At baseline and at weeks 4, 12, and 24, extended nitric oxide analysis; pulmonary function tests, including impulse oscillometry; blood eosinophil counts; and asthma control tests (ACTs) were performed.
A total of 18 patients in the ciclesonide group, 19 in the montelukast group, and 15 in the control group completed the study and were analyzed. With repeated-measures analysis of variance, ciclesonide produced a significant decrease in alveolar nitric oxide and a significant improvement in ACT scores over time. Montelukast produced significant decreases in alveolar nitric oxide concentrations and blood eosinophil counts over time and slightly improved ACT scores, whereas no such changes were observed in the control group. Alveolar nitric oxide concentrations with ciclesonide and reactance area at low frequencies with montelukast produced greater improvements over time compared with control.
Ciclesonide add-on therapy and montelukast add-on therapy may act differently, but both separately can improve small airway abnormalities and provide better asthma control.
umin.ac.jp/ctr Identifier: UMIN000001083.
小气道嗜酸性粒细胞炎症是哮喘的一个关键过程，在接受治疗的患者中常常持续存在。附加治疗对小气道持续炎症的长期影响尚不清楚。
研究附加治疗用环索奈德（一种具有超细颗粒的吸入性皮质类固醇）或孟鲁司特对小气道炎症的影响。
纳入 60 例稳定期哮喘患者，接受吸入皮质类固醇治疗，进行为期 24 周的附加治疗，随机、开放标签、平行比较环索奈德或孟鲁司特的治疗。患者随机分为 3 组：环索奈德组（n = 19）、孟鲁司特组（n = 22）或不添加附加药物作为对照组（n = 19）。在基线和第 4、12、24 周时进行扩展的一氧化氮分析、肺功能测试（包括脉冲振荡法）、血液嗜酸性粒细胞计数和哮喘控制测试（ACT）。
共有 18 例环索奈德组、19 例孟鲁司特组和 15 例对照组患者完成研究并进行了分析。通过重复测量方差分析，环索奈德治疗可显著降低肺泡一氧化氮浓度，并随着时间的推移显著改善 ACT 评分。孟鲁司特治疗可随着时间的推移显著降低肺泡一氧化氮浓度和血液嗜酸性粒细胞计数，并略微改善 ACT 评分，而对照组无明显变化。与对照组相比，环索奈德治疗可使肺泡一氧化氮浓度和孟鲁司特治疗的电抗区低频的改善更为显著。
环索奈德附加治疗和孟鲁司特附加治疗可能作用机制不同，但均可改善小气道异常，提供更好的哮喘控制。
umin.ac.jp/ctr 标识符：UMIN000001083。
