Holgate S T, Arshad H, Stryszak P, Harrison J E
Southampton General Hospital, Southampton, United Kingdom.
J Allergy Clin Immunol. 2000 May;105(5):906-11. doi: 10.1067/mai.2000.105709.
Mometasone furoate (MF) is a new potent corticosteroid for use in treating asthma.
To test the lower range of the dose-response curve, effects of MF delivered by dry powder inhaler (DPI) on AMP-induced bronchoconstriction were compared with those of placebo.
In a placebo-controlled, 3-phase cross-over, single-center, double-blind study, 15 patients with mild asthma were randomized to three 2-week treatment phases (separated by 4-week washout phases) with MF DPI 50 microg twice daily, MF DPI 100 microg twice daily, or placebo. AMP challenge was performed before and at the end of each treatment phase.
Thirteen patients completed all 3 phases and were included in the primary efficacy analysis. Treatment with MF DPI 50 microg twice daily or with MF DPI 100 microg twice daily significantly reduced the bronchoconstrictor response to AMP, displacing the dose-response curve to the right by 2.81 and 3.11 doubling dilutions, respectively, compared with placebo (P <.001). The improvement in FEV(1) over the 2-week treatment phase was significantly (P < or =.033) greater during treatment with MF DPI 50 microg or 100 microg twice daily than with placebo. Peak expiratory flow rate, wheezing scores, difficulty breathing scores, nocturnal awakenings requiring salbutamol, and puffs of salbutamol per day also indicated a greater improvement in respiratory function and symptoms of asthma with MF DPI 50 or 100 microg twice daily than with placebo. Both doses of MF DPI were well tolerated.
Treatment with low doses of MF DPI decreased airway responsiveness to AMP challenge and improved secondary measures of pulmonary function and asthma symptoms.
糠酸莫米松(MF)是一种用于治疗哮喘的新型强效皮质类固醇。
为测试剂量 - 反应曲线的较低范围,将干粉吸入器(DPI)递送的MF对AMP诱导的支气管收缩的作用与安慰剂进行比较。
在一项安慰剂对照、3期交叉、单中心、双盲研究中,15例轻度哮喘患者被随机分为三个为期2周的治疗阶段(中间间隔4周洗脱期),分别接受每日两次50微克的MF DPI、每日两次100微克的MF DPI或安慰剂治疗。在每个治疗阶段开始前和结束时进行AMP激发试验。
13例患者完成了所有3个阶段并纳入主要疗效分析。与安慰剂相比,每日两次50微克的MF DPI治疗或每日两次100微克的MF DPI治疗均显著降低了对AMP的支气管收缩反应,剂量 - 反应曲线分别向右移动2.81和3.11个加倍稀释度(P <.001)。在为期2周的治疗阶段,每日两次50微克或100微克的MF DPI治疗期间FEV(1)的改善显著(P <或 =.033)大于安慰剂治疗。呼气峰值流速、喘息评分、呼吸困难评分、需要沙丁胺醇的夜间觉醒次数以及每天使用沙丁胺醇的剂量也表明,每日两次50或100微克的MF DPI治疗比安慰剂治疗在呼吸功能和哮喘症状方面有更大改善。两种剂量的MF DPI耐受性均良好。
低剂量MF DPI治疗可降低气道对AMP激发试验的反应性,并改善肺功能和哮喘症状的次要指标。