Kanniess F, Richter K, Böhme S, Jörres R A, Magnussen H
Pulmonary Research Institute, Hospital Grosshansdorf, Grosshansdorf, D-22927, Germany.
Pulm Pharmacol Ther. 2001;14(2):141-7. doi: 10.1006/pupt.2001.0288.
To assess the efficacy of ciclesonide, a novel corticosteroid pro-drug, we compared its effect on lung function, airway responsiveness to inhaled AMP, the composition of induced sputum, and the level of exhaled nitric oxide (NO) with the effect of budesonide in patients with asthma. Fifteen non-smoking steroid-naive patients (mean FEV(1), 94%pred) inhaled either 400 microg ciclesonide or 400 microg budesonide as a single morning dose for two weeks each separated by a > or =3 week wash-out period. The study was performed in a double-observer, randomized, cross-over design. FEV(1)increased significantly during treatment with budesonide (3.38 vs. 3.64 l P=0,003), but not after ciclesonide (3.60 vs. 3.69 l). PC(20)FEV(1)of AMP increased (P<0,001, each) after both budesonide (4.59 vs. 32.48 mg/ml, 2.8 doubling doses) and ciclesonide (3.92 vs. 20.00 mg/ml, 2.4 doubling doses). The percentage of sputum eosinophils was significantly reduced after ciclesonide (7.9 vs. 3.4% P=0.01), but not budesonide (6.0 vs. 4.3%). After both budesonide and ciclesonide, a significant (P<0.001) reduction in the level of exhaled NO occurred. In none of the parameters studied, the changes differed significantly between treatment with budesonide or ciclesonide. These data suggest that ciclesonide is equi-effective to budesonide with regard to its potency to reduce the airway responsiveness to inhaled AMP as well as airway inflammation in patients with mild asthma.
为评估新型皮质类固醇前体药物环索奈德的疗效,我们比较了其与布地奈德对哮喘患者肺功能、气道对吸入性AMP的反应性、诱导痰成分及呼出一氧化氮(NO)水平的影响。15名未吸烟、未使用过类固醇的患者(平均FEV(1)为预计值的94%),每天早晨单次吸入400微克环索奈德或400微克布地奈德,各为期两周,中间间隔≥3周的洗脱期。研究采用双盲、随机、交叉设计。布地奈德治疗期间FEV(1)显著增加(3.38升对3.64升,P = 0.003),而环索奈德治疗后未增加(3.60升对3.69升)。布地奈德(4.59毫克/毫升对32.48毫克/毫升,2.8倍剂量增加)和环索奈德(3.92毫克/毫升对20.00毫克/毫升,2.4倍剂量增加)治疗后,AMP的PC(20)FEV(1)均增加(P < 0.001)。环索奈德治疗后痰嗜酸性粒细胞百分比显著降低(7.9%对3.4%,P = 0.01),而布地奈德治疗后未降低(6.0%对4.3%)。布地奈德和环索奈德治疗后,呼出NO水平均显著降低(P < 0.001)。在所研究的各项参数中,布地奈德或环索奈德治疗的变化无显著差异。这些数据表明,在降低轻度哮喘患者气道对吸入性AMP的反应性以及气道炎症方面,环索奈德与布地奈德疗效相当。