Rytilä P, Ghaly L, Varghese S, Chung W, Selroos O, Haahtela T
Skin and Allergy Hospital, Helsinki University Central Hospital, Helsinki, Finland.
Eur Respir J. 2008 Oct;32(4):989-96. doi: 10.1183/09031936.00062307. Epub 2008 May 28.
A total of 144 patients with lower airway symptoms suggestive of asthma, but who did not fulfil the functional criteria of asthma, were included in a randomised, double-blind, placebo-controlled 8-week "proof-of-concept" study with mometasone furoate (MF), 400 microg once daily. The primary efficacy variable was the mean change from baseline in six morning and evening weekly symptom scores: cough, sputum production, wheeze, shortness of breath, chest tightness and exercise-induced cough/wheeze. Total symptom scores were calculated after treatment for 4 and 8 weeks. Compared with placebo, MF improved total morning symptom score at 8 weeks. Changes in total evening symptom scores did not differ between treatments. MF improved all individual symptom scores more than placebo, although the differences in changes between treatments were not always statistically significant. Morning and evening peak expiratory flow rates increased with MF compared with placebo. MF reduced eosinophils and the levels of eosinophilic cationic protein in induced sputum. The results show that symptoms suggestive of asthma exist in patients without significant beta(2)-agonist reversibility or diurnal variability in peak flow. Once-daily MF may benefit some of these patients and a short course with inhaled corticosteroids may be tried. Responders should be better identified in further studies.
共有144例有提示哮喘的下呼吸道症状但未符合哮喘功能标准的患者被纳入一项为期8周的随机、双盲、安慰剂对照的“概念验证”研究,使用糠酸莫米松(MF),每日一次400微克。主要疗效变量是每周早晚六个症状评分(咳嗽、咳痰、喘息、气短、胸闷和运动诱发的咳嗽/喘息)从基线的平均变化。治疗4周和8周后计算总症状评分。与安慰剂相比,MF在8周时改善了早晨总症状评分。治疗组之间晚上总症状评分的变化没有差异。与安慰剂相比,MF改善了所有个体症状评分,尽管治疗组之间变化的差异并不总是具有统计学意义。与安慰剂相比,MF使早晚呼气峰值流速增加。MF降低诱导痰中的嗜酸性粒细胞和嗜酸性阳离子蛋白水平。结果表明,在没有显著的β₂激动剂可逆性或呼气峰值流速昼夜变化的患者中存在提示哮喘的症状。每日一次的MF可能使其中一些患者受益,可尝试短期吸入糖皮质激素治疗。在进一步研究中应更好地识别反应者。