摘要
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.
出处
《中国医药导刊》
2012年第5期817-818,共2页
Chinese Journal of Medicinal Guide