Boulet Louis-Philippe, Bateman Eric D, Voves Robert, Müller Thomas, Wolf Susanne, Engelstätter Renate
Institut de cardiologie et de pneumologie de l'Université Laval, Hôpital Laval, 2725 Chemin Sainte-Foy, Québec City, Que., Canada G1V 4G5.
Respir Med. 2007 Aug;101(8):1677-86. doi: 10.1016/j.rmed.2007.03.001. Epub 2007 Apr 19.
To compare the effects of once-daily ciclesonide and twice-daily fluticasone propionate in patients with moderate persistent asthma.
Patients aged 12-75 years with moderate bronchial asthma entered a 1-4 week run-in period. For inclusion into the 12-week, randomized, open-label treatment period, patients had to have a forced expiratory volume in 1s (FEV1) of either 60-80% of predicted or 80% of predicted and a defined use of rescue medication and asthma symptoms, depending on previous treatment. Patients received ciclesonide 320 microg once daily (ex-actuator) or fluticasone propionate 200 microg twice daily. Primary efficacy endpoint was change from baseline in FEV1.
In total, 474 patients were randomized. FEV1 increased significantly from baseline with ciclesonide and fluticasone propionate in the intention-to-treat (ITT) and per-protocol (PP) analyses (all p < 0.0001). Treatment difference was -31 mL (95% confidence interval [CI]: -121, 59) in the PP analysis, demonstrating non-inferiority of ciclesonide. Similar findings were seen for other measures of lung function. In the ITT population, asthma symptom scores and rescue medication use decreased with both treatments (all p < 0.0001). Improvement in health-related quality of life (HRQoL) from baseline was significantly greater with ciclesonide than fluticasone (p = 0.005; one-sided). There were no cases of oral candidiasis in patients receiving ciclesonide and nine cases (3.8%) in those receiving fluticasone propionate (p = 0.002; one-sided).
Treatment with once-daily ciclesonide and twice-daily fluticasone propionate resulted in similar improvements in lung function in patients with moderate persistent asthma. Ciclesonide showed significant improvements in oral candidiasis and HRQoL over fluticasone.
比较每日一次的环索奈德与每日两次的丙酸氟替卡松对中度持续性哮喘患者的疗效。
年龄在12 - 75岁的中度支气管哮喘患者进入为期1 - 4周的导入期。为纳入为期12周的随机、开放标签治疗期，患者的一秒用力呼气容积（FEV1）必须为预测值的60 - 80%或预测值的80%，且根据先前治疗情况有明确的急救药物使用和哮喘症状。患者接受每日一次320微克（从吸入器喷出）的环索奈德或每日两次200微克的丙酸氟替卡松。主要疗效终点为FEV1相对于基线的变化。
总共474例患者被随机分组。在意向性分析（ITT）和符合方案分析（PP）中，环索奈德和丙酸氟替卡松治疗后FEV1均较基线显著增加（所有p < 0.0001）。PP分析中的治疗差异为 - 31毫升（95%置信区间[CI]： - 121，59），表明环索奈德不劣于丙酸氟替卡松。其他肺功能指标也有类似结果。在ITT人群中，两种治疗均使哮喘症状评分和急救药物使用减少（所有p < 0.0001）。与丙酸氟替卡松相比，环索奈德使健康相关生活质量（HRQoL）从基线的改善显著更大（p = 0.005；单侧）。接受环索奈德的患者未出现口腔念珠菌病病例，接受丙酸氟替卡松的患者中有9例（3.8%）出现（p = 0.002；单侧）。
每日一次的环索奈德与每日两次的丙酸氟替卡松治疗使中度持续性哮喘患者的肺功能有相似改善。与丙酸氟替卡松相比，环索奈德在口腔念珠菌病和HRQoL方面有显著改善。
