背景:为了确定孟鲁司特在学年期间用于哮喘稳定期儿童的维持吸入类固醇(ICS)治疗对ICS使用的影响,恶化的频率,肺功能,哮喘症状,呼出气一氧化氮(FeNO)水平和运动诱导的支气管收缩(EIB)。
方法:76名6-14岁的哮喘儿童,对室内尘螨过敏的患者随机参加一项双盲试验,比较孟鲁司特治疗与匹配的安慰剂.我们研究了以下终点:ICS剂量的减少,恶化的频率,肺功能,哮喘控制测试评分,以及标准化运动跑步机挑战期间FEV1相对于基线的变化。以逐步方式调整ICS剂量以确定控制哮喘症状所需的最低剂量。
结果:我们发现FeNO基线值高于31ppb且哮喘症状在低剂量ICS下得到良好控制的儿童,孟鲁司特加性治疗获益最大;其累积ICS剂量低于仅接受ICS治疗的儿童.此外,在哮喘患儿的常规治疗中加入孟鲁司特,可显著降低加重频率和EIB保护.
结论:在学年期间,哮喘儿童的ICS治疗中添加孟鲁司特是合理的,降低哮喘症状控制良好的儿童的累积ICS剂量,以及减少恶化的次数,从而更好地控制EIB。
背景:NCT01266772。
BACKGROUND: To determine the effects of montelukast added to maintenance inhaled steroids (ICS) therapy during the school year in children with stable asthma on the ICS use, frequency of exacerbations, lung function, asthma symptoms, fractional exhaled nitric oxide (FeNO) level and exercise-induced bronchoconstriction (EIB).
METHODS: Seventy six asthmatic children aged 6-14 years, allergic to house dust mites were randomized to a double-blinded
trial comparing montelukast therapy to a matching placebo. We studied following end-points: the reduction in the ICS dose, the frequency of exacerbations, lung function, asthma control test score, and the change from baseline in FEV1 during a standardized exercise treadmill challenge. ICS dose was adjusted in a stepwise fashion to determine the lowest dose necessary to control asthma symptoms.
RESULTS: We showed that children with baseline value of FeNO above 31 ppb and well controlled asthma symptoms on low doses of ICS, benefit the most from additive therapy with montelukast; their cumulative ICS dose is lower than in children treated with ICS only. Also, the addition of montelukast to regular treatment in asthmatic children resulted in a significant reduction in the frequency of exacerbations and EIB protection.
CONCLUSIONS: It is reasonable to add montelukast to ICS therapy in asthmatic children during the school year, to lower cumulative ICS dose in children with well controlled asthma symptoms, as well as to reduce number of exacerbations, and to achieve better control of EIB.
BACKGROUND: NCT01266772.