Price D B, Hernandez D, Magyar P, Fiterman J, Beeh K M, James I G, Konstantopoulos S, Rojas R, van Noord J A, Pons M, Gilles L, Leff J A
Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen AB25 2AY, Scotland, UK.
Thorax. 2003 Mar;58(3):211-6. doi: 10.1136/thorax.58.3.211.
Inhaled corticosteroids (ICS) affect many inflammatory pathways in asthma but have little impact on cysteinyl leukotrienes. This may partly explain persistent airway inflammation during chronic ICS treatment and failure to achieve adequate asthma control in some patients. This double blind, randomised, parallel group, non-inferiority, multicentre 16 week study compared the clinical benefits of adding montelukast to budesonide with doubling the budesonide dose in adults with asthma.
After a 1 month single blind run in period, patients inadequately controlled on inhaled budesonide (800 microg/day) were randomised to receive montelukast 10 mg + inhaled budesonide 800 microg/day (n=448) or budesonide 1600 microg/day (n=441) for 12 weeks.
Both groups showed progressive improvement in several measures of asthma control compared with baseline. Mean morning peak expiratory flow (AM PEF) improved similarly in the last 10 weeks of treatment compared with baseline in both the montelukast + budesonide group and in the double dose budesonide group (33.5 v 30.1 l/min). During days 1-3 after start of treatment, the change in AM PEF from baseline was significantly greater in the montelukast + budesonide group than in the double dose budesonide group (20.1 v 9.6 l/min, p<0.001), indicating faster onset of action in the montelukast group. Both groups showed similar improvements with respect to "as needed" beta agonist use, mean daytime symptom score, nocturnal awakenings, exacerbations, asthma free days, peripheral eosinophil counts, and asthma specific quality of life. Both montelukast + budesonide and double dose budesonide were generally well tolerated.
The addition of montelukast to inhaled budesonide is an effective and well tolerated alternative to doubling the dose of inhaled budesonide in adult asthma patients experiencing symptoms and inadequate control on budesonide alone.
吸入性糖皮质激素（ICS）可影响哮喘中的多种炎症途径，但对半胱氨酰白三烯影响甚微。这可能部分解释了在长期ICS治疗期间气道炎症持续存在以及一些患者未能实现充分哮喘控制的原因。这项双盲、随机、平行组、非劣效性、多中心16周研究比较了在成年哮喘患者中，在布地奈德基础上加用孟鲁司特与将布地奈德剂量加倍的临床获益。
在为期1个月的单盲导入期后，对吸入布地奈德（800微克/天）控制不佳的患者随机分组，分别接受孟鲁司特10毫克+吸入布地奈德800微克/天（n = 448）或布地奈德1600微克/天（n = 441），为期12周。
与基线相比，两组在多项哮喘控制指标上均显示出逐步改善。在治疗的最后10周，孟鲁司特+布地奈德组和双倍剂量布地奈德组的平均晨起呼气峰值流速（AM PEF）与基线相比改善程度相似（分别为33.5升/分钟和30.1升/分钟）。在治疗开始后的第1 - 3天，孟鲁司特+布地奈德组AM PEF相对于基线的变化显著大于双倍剂量布地奈德组（分别为20.1升/分钟和9.6升/分钟，p<0.001），表明孟鲁司特组起效更快。两组在“按需”使用β受体激动剂、平均日间症状评分、夜间觉醒次数、病情加重情况、无哮喘天数、外周嗜酸性粒细胞计数以及哮喘特异性生活质量方面均有相似改善。孟鲁司特+布地奈德和双倍剂量布地奈德总体耐受性良好。
对于仅使用布地奈德出现症状且控制不佳的成年哮喘患者，在吸入布地奈德基础上加用孟鲁司特是一种有效且耐受性良好的选择，可替代将吸入布地奈德剂量加倍。
