Barnes Neil, Laviolette Michel, Allen David, Flood-Page Patrick, Hargreave Frederick, Corris Paul, O'Connor Brian J, Tate Helen, Parker Debbie, Pavord Ian
Department of Respiratory Medicine, London Chest Hospital, Bonner Road, London E2 9JX, UK.
Respir Med. 2007 Aug;101(8):1652-8. doi: 10.1016/j.rmed.2007.03.007. Epub 2007 May 3.
Many patients with asthma remain symptomatic with impaired airway function on inhaled steroids. This study investigates the relationship between the clinical effect seen in response to additional treatment and the effect on airway inflammatory indices. Seventy-five adult asthmatic patients, incompletely controlled on 800 mcg budesonide/day, were randomised following a 4 week run-in period, to a double-blind, multi-centre controlled clinical trial of doubling inhaled corticosteroid (budesonide 1600 mcg/day) or adding 10mg montelukast for 12 weeks. Induced sputum was collected at baseline and end of treatment and analysed for eosinophil and neutrophil percentages, leukotrienes C4, D4 and E4, IL-8, Eosinophil Cationic Protein (ECP) and histamine. Sputum evidence of inflammation (2.0% eosinophils) was seen in only 29% of these patients and the percentage of eosinophils and other markers of airway inflammation did not change over the study period in either treatment group. There were significant improvements in am PEF (montelukast: 31.7 L/min, budesonide: 32.3 L/min) and quality of life with both treatments. We conclude that while both treatments showed similar improvements in lung function and quality of life, there was no evidence from these sputum markers measured that the effects were mediated via a reduction in airway inflammation or that the level of pre-treatment markers was associated with outcome.
许多哮喘患者在使用吸入性类固醇药物后仍有症状，气道功能受损。本研究调查了额外治疗的临床效果与气道炎症指标影响之间的关系。75名成年哮喘患者，在每天使用800微克布地奈德治疗下病情控制不完全，在经过4周的导入期后，被随机分配到一项双盲、多中心对照临床试验中，一组将吸入性糖皮质激素加倍（布地奈德1600微克/天），另一组添加10毫克孟鲁司特，治疗12周。在基线和治疗结束时收集诱导痰，分析嗜酸性粒细胞和中性粒细胞百分比、白三烯C4、D4和E4、白细胞介素-8、嗜酸性粒细胞阳离子蛋白（ECP）和组胺。这些患者中只有29%的痰液有炎症迹象（嗜酸性粒细胞2.0%），在研究期间，两个治疗组的嗜酸性粒细胞百分比和气道炎症的其他标志物均未改变。两种治疗方法在上午呼气峰流速（孟鲁司特组：31.7升/分钟，布地奈德组：32.3升/分钟）和生活质量方面均有显著改善。我们得出结论，虽然两种治疗方法在肺功能和生活质量方面都有相似的改善，但从这些测量的痰液标志物来看，没有证据表明这些效果是通过减少气道炎症介导的，也没有证据表明治疗前标志物的水平与治疗结果相关。
