摘要
福莫特罗和糖皮质激素建立治疗(FACET)研究首次为研究吸入类固醇和长效β 2激动剂对哮喘特异性生活质量的长期影响提供了机会。本研究的目的是:评估长期(1年)福莫特罗和增加布地奈德剂量对哮喘患者生活质量的影响;2)确定当临床指标持续改善时,初始生活质量的改善是否持续;3)评估临床指标变化与生活质量变化的长期关系。在852名哮喘成人中,来自5个国家的470人参与了这项生活质量评估。在服用了1600微克布地奈德4周后,病人被随机分为200 microg (Bud200)或800 microg布地奈德(Bud800)结合24 microg formoterol (F)或安慰剂每日1年。哮喘生活质量问卷(AQLQ)竣工和常规临床指标以招生和随机化和七次在接下来的12months. During the run-in, there was an improvement in AQLQ score (changes (delta) in overall score approximately 0.50; p<0.0001). After randomization, there was a further improvement in the Bud800+F group (delta=0.21; p=0.028). One month post-randomization, improvements in all groups stabilized and were sustained throughout the 12 months in a pattern very similar to that observed for the conventional clinical indices. The correlation of individual patient changes in clinical indices and changes in AQLQ score during the 12-month randomized period were weak to moderate (maximum r=0.51). Improvements in quality of life, which were greatest in the 800 microg budesonide plus 24 microg formoterol group, were sustained throughout the 12 months in a similar manner to the clinical indices. Long-term changes in conventional clinical indices cannot be used to predict the effect of treatment on individual patient experience.