北京白三烯 课件.ppt

Zeiger, Am J Med 2005, 118:649-657 Mild Asthma Montelukast vs Inhaled Corticosteroid StudyMIAMI Montelukast vs.Inhaled Beclomethasone孟鲁司特同吸入皮质激素对中度哮喘的对照研究 *Once daily at bedtime **200 μg twice daily Adapted from Malmstrom K et al Ann Intern Med 1999;130(6):487-495. Montelukast vs. Inhaled Beclomethasone (12-week study) 研究设计 Period I Single-blindrun-in Period II Double-blindtreatment Period III Double-blindwashout Placebo (n=895) Montelukast 10 mg* (n=387) Placebo (n=257) Placebo Beclomethasone 400 μg** (n=251) –2 0 4 8 12 15 Weeks 50 40 30 20 10 0 –10 *200 μg twice daily via spacer **N values refer to all patients included in the intention-to-treat analysis for morning PEFR. ***Once daily at bedtime Adapted from Malmstrom K et al Ann Intern Med 1999;130(6):487-495. Montelukast vs. Inhaled Beclomethasone (12-week study) 孟鲁司特起效速度快 Change in Morning PEFR in 895 Patients Age 15–85 Years Mean + SEchange from baseline (L/min) Days on active treatment 1 3 5 7 9 11 13 15 17 19 21 Beclomethasone 400 μg* (n=244)** Montelukast 10 mg*** (n=372)** Placebo (n=244)** *Once daily at bedtime **200 μg twice daily via spacer p0.05 vs. placebo for both active treatments at week 12 Adapted from Malmstrom K et al Ann Intern Med 1999;130(6):487-495; Data on file, MSD. Montelukast vs. Inhaled Beclomethasone (12-week study) 外周血嗜酸性细胞数的变化 Mean ? SE eosinophilcount (103/μl) Montelukast 10 mg* (n=387) Beclomethasone 400 μg** (n=251) Placebo (n=257) Weeks 0.05 0.00 –0.05 –0.10 –0.15 0 3 6 9 12 15 Placebo Washout 895 Patients Age 15–85 Years Montelukast vs. Inhaled Beclomethasone (12-week study) 哮喘发作的情况 Time to First Asthma Attack in 895 Patients Age 15–85 Years *200 μg twice daily via spacer **Once daily at bedtime ***p=0.006 montelukast vs. placebo; p=0.001 beclomethasone vs. placebo NS = no significant difference between montelukast and beclomethasone Adapted from Malmstrom K et al Ann Intern Med 1999;130(6):487-495; Data on file, MSD. Proporti