Grosclaude M, Cerruti J L, Delannay B, Hérent M, Spilthooren F, Desfougères J L
Centre Claude Bernard, 07500 Guilherand Gronges.
Eur Ann Allergy Clin Immunol. 2003 Nov;35(9):356-62.
It is now recommended to add an inhaled long-acting beta 2-agonist, or as an alternative, to add a leukotriene-antagonist, in patients whose asthma is insufficiently controlled with an inhaled corticosteroid alone. A randomised, multicentre, open-label, parallel-group study was carried out in 246 patients of at least 15 years, whose asthma was not adequately controlled with a medium dose of an inhaled corticosteroid. They received either fluticasone/salmeterol combination 250/50 micrograms one inhalation twice daily or CFC beclomethasone dipropionate 250 micrograms two puffs twice daily plus montelukast 10 mg in the evening for 12 weeks. The mean morning PEFR (main criterion) was significantly (p = 0.017) more improved with fluticasone/salmeterol (+44.2 L/min) than with beclomethasone dipropionate plus montelukast (+31.0 L/min). Other outcomes showed significantly better improvements (p 0.022 Pound) with fluticasone/salmeterol than with beclomethasone plus montelukast. The two treatments were well tolerated. Fluticasone/salmeterol provided a better asthma control than beclomethasone dipropionate plus montelukast in patients insufficiently controlled with an inhaled corticosteroid alone.
对于仅使用吸入性糖皮质激素但哮喘控制不佳的患者，目前建议加用吸入性长效β2受体激动剂，或者作为替代方案，加用白三烯拮抗剂。一项随机、多中心、开放标签、平行组研究在246例年龄至少15岁、使用中等剂量吸入性糖皮质激素但哮喘控制不佳的患者中开展。他们分别接受氟替卡松/沙美特罗复方制剂250/50微克，每日两次，每次吸入1吸，或二丙酸倍氯米松250微克，每日两次，每次2喷，加孟鲁司特10毫克，每晚服用，疗程为12周。与二丙酸倍氯米松加孟鲁司特（+31.0升/分钟）相比，氟替卡松/沙美特罗组的平均晨间呼气峰流速（主要指标）显著改善更多（p = 0.017）（+44.2升/分钟）。其他结果显示，氟替卡松/沙美特罗组的改善也显著优于二丙酸倍氯米松加孟鲁司特组（p < 0.022）。两种治疗的耐受性均良好。对于仅使用吸入性糖皮质激素但控制不佳的患者，氟替卡松/沙美特罗比二丙酸倍氯米松加孟鲁司特能更好地控制哮喘。
