福莫特罗治疗支气管哮喘的效果观察

Efficacy of Formoterol in BronchialAsthma Patients

目的:观察福莫特罗高剂量与低剂量对支气管哮喘患者的治疗效果。方法:共有218例支气管哮喘患者参加研究。患者随机分为高剂量组(110例)和低剂量组(108例),分别给予福莫特罗24μg及12μg16周,以严重哮喘恶化作为主要研究终点,次要终点为因症状加重需要使用皮质激素、症状恶化及FEV1改变。结果:3例患者出现呼吸系统相关的严重不良反应事件(SAEs)住院:24μg组2例,12μg组1例。所有事件均与哮喘有关。明显哮喘恶化(需要全身激素治疗)两组相似,24μg组为7例(6.3%),12μg组为6例(5.5%)。两组患者治疗前后比较FEV1均有显著改善(P<0.005)。结论:福莫特罗治疗重症支气管哮喘有显著效果,12～24μg均不增加哮喘的恶化率,且二者不良反应基本相似。

Objective：To observe the effect of the high-dose and lower dose formoterol in patients with bronchial asthma.Methods：A total of 218 patients with asthma to participate in the study.Patients were randomly divided into high-dose group（n = 110） or lower dose group（108 cases） and were given formoterol 24 ug or 12 ug for 16 weeks,respectively.Serious asthma exacerbations（life threatening or requir-ing hospitalization） were the primary end point.Secondary end points included significantexacerbations requiring systemic corticosteroids,all exacerbations,and changes in FEV1.Results：2 patients had respiratory related serious adverse events（SAEs） in high-dose group and1 in lower dose group,The serious adverse events were associated with asthma.The significant asthma exacerbations（the need for systemic hormone therapy） was similar in the two groups,high-dose group was 7（6.3%） and lower dose group 6 patients（5.5%）,respectively.All formoterol treatment regimens had a significant effect on FEV1 measured after dose during the study（P 〈 0.005）.Conclusion：Treatment with formoterol for patients with severe bronchial asthma has a significant effect,12 or 24 ug was not increased asthma exacerbation rate and adverse events similar.