Magnussen Helgo, Hofman Jerzy, Staneta Pawel, Lawo John-Philip, Hellwig Michael, Engelstätter Renate
Center for Pneumology and Thoracic Surgery, Pulmonary Research Institute, Hospital Grosshansdorf, Grosshansdorf, Germany.
J Asthma. 2007 Sep;44(7):555-63. doi: 10.1080/02770900701537081.
This 12-week, double-blind, parallel-group study compared the efficacy and safety of once daily ciclesonide and twice daily fluticasone propionate in patients aged 12-75 years with persistent asthma. Patients were randomized to once-daily ciclesonide 80 micro g (n = 278) or 160 micro g (n = 271), or twice daily fluticasone propionate 88 micro g (n = 259) (all ex-actuator). Significant improvements from baseline were seen in all three treatment groups for forced expiratory volume in 1 second, asthma symptom scores and rescue medication use (all p < 0.0001). Asthma exacerbation rates were low (each ciclesonide group, n = 2; fluticasone group, n = 1). Adverse event reporting indicated good tolerability. Once daily ciclesonide 80 micro g or 160 micro g showed comparable efficacy and tolerability to twice daily fluticasone propionate 88 micro g in persistent asthma.
这项为期12周的双盲平行组研究比较了12至75岁持续性哮喘患者每日一次使用环索奈德与每日两次使用丙酸氟替卡松的疗效和安全性。患者被随机分为每日一次使用80微克环索奈德(n = 278)或160微克环索奈德(n = 271),或每日两次使用88微克丙酸氟替卡松(n = 259)(均为实际吸入量)。所有三个治疗组在1秒用力呼气量、哮喘症状评分和急救药物使用方面均较基线有显著改善(均p < 0.0001)。哮喘恶化率较低(环索奈德各治疗组,n = 2;丙酸氟替卡松组,n = 1)。不良事件报告显示耐受性良好。在持续性哮喘中,每日一次使用80微克或160微克环索奈德与每日两次使用88微克丙酸氟替卡松的疗效和耐受性相当。