摘要
班布特罗是一种新的长效口服支气管扩张剂,每日一次用于哮喘患者。它是特布他林的前药,被设计为缓慢代谢为特布他林。比较研究结果表明,它与其他口服支气管扩张剂具有相似的临床疗效,但副作用较小。本研究旨在验证10 mg和20 mg的班布特罗与安慰剂在一个月的治疗期间的24小时有效时间。该研究是一项双盲、随机、平行组、安慰剂对照、多中心试验。在停用口服支气管扩张剂后,开始了为期一周的安慰剂磨合期。在参照期结束时,患者被随机分配到三种治疗方案中的一种:安慰剂、bambuterol 10mg或bambuterol 20mg,每天一次在晚上。治疗期为4周。487名平均年龄为45岁的患者被纳入研究。预测的平均基线1秒用力呼气量(FEV1)和1% FEV1分别为2.05 l和62%。 Administration of 10 mg bambuterol resulted in a significant 24 h effect duration, expressed as an increase in mean daily morning and evening peak expiratory flow (PEF) (+11 l.min-1, adjusted means) throughout the study, as compared with placebo. Bambuterol, 20 mg, gave a significant 24 h effect duration in both FEV1 and morning and evening PEF as compared with placebo. Furthermore, the adverse events observed during the study were relatively few and mild.(ABSTRACT TRUNCATED AT 250 WORDS)