摘要
本研究的目的是比较氢溴酸非诺特罗(50微克)和溴化异丙托品(20微克)固定组合的长期安全性,使用由非氯代推进剂氢氟烷34a (HFA-MDI)配制的计量吸入器(MDI)。使用传统的氟氯化碳推进剂(CFC-MDI, Berodual/Bronchodual)。该研究是根据上市药物安全性评估(SAMM)指南设计的,以尽可能地反映在正常处方条件下使用多氯二苯醚的情况。来自法国99个中心、德国95个中心和意大利24个中心的227名慢性气道阻塞(CAO)患者被纳入研究。在2周的测试期之后,患者以2:1的比例被随机分配(1348名患者接受HFA-MDI, 679名患者接受CFC-MDI),在12周的开放标签期接受灵活剂量组合方案(2支,每天2-4次,由研究者指定)。两组不良事件的总发生率具有可比性。此外,呼吸系统副作用的发生率也相似,其中CAO加重或支气管炎是最常见的记录事件。HFA配方的安全性与德国和法国/意大利市场上使用的氟氯化碳计量吸入器相当。HFA134a或CFC驱动吸入器在从CFC-转向HFA-MDI(随机化前2周与随机化后2周)方面没有检测到临床显著差异。HFA-MDI组患者报告味觉投诉的频率更高(随机化前0.7%,随机化后3.4%)。 This, however, was an expected finding as the HFA134a formulation does have a different taste to the CFC formulation. No difference between formulations was observed in the incidences of coughing or paradoxical bronchospasm. The incidence of falls in FEV1 >15% within 15 min following inhalation at each of the clinic visits was 1.2% for both CFC- and HFA-MDIs. In conclusion, administration of a fenoterol/ipratropium bromide combination via hydrofluoroalkane-metered dose inhaler is as safe as delivery by the currently available chlorofluorocarbon-metered dose inhaler, in an extended population of patients with CAO under normal prescribing conditions.