Di Franco Antonella, Bacci Elena, Bartoli Maria Laura, Cianchetti Silvana, Dente Federico L, Taccola Mauro, Vagaggini Barbara, Zingoni Margherita, Paggiaro Pier Luigi
Respiratory Phatophysiology, Cardio-Thoracic Department, University of Pisa, via Paradisa 2, 56214 Pisa, Italy.
Pulm Pharmacol Ther. 2006;19(5):353-60. doi: 10.1016/j.pupt.2005.09.003. Epub 2005 Nov 11.
The aim of this study was to evaluate whether fluticasone propionate (FP) is effective as well as prednisone (P) in reducing sputum eosinophilia and in improving airway obstruction due to asthma exacerbations not requiring hospitalization. We measured, in a parallel-group, double-blind double-dummy, randomized study, sputum and blood inflammatory cell counts and soluble mediators in 37 asthmatic subjects during a spontaneous exacerbation of asthma (Visit 1) and after a 2 week (Visit 2) treatment with inhaled FP (1000microg bid) (Group A, n=18) or a reducing course of oral P (Group B, n=19). Asthma exacerbation was accompanied by sputum eosinophilia (eosinophils >2%) in almost all patients (95%). FP improved FEV(1) (from 53.9%+/-16.8 at Visit 1 to 76.4%+/-21.2 at Visit 2, p=0.0001) and reduced the percentage of sputum eosinophils (from 38%[0-78] to 3%[1-31, p=0.0008) as well as oral P (FEV(1): from 51.5%+/-14.4 to 83.6%+/-21.1, p=0.0001; sputum eosinophils: from 52%[1-96] to 11%[0-64], p=0.0003). At Visit 2, sputum eosinophils were significantly lower in Group A than in Group B. P but not FP induced significant decrease in blood and sputum ECP. Oxygen saturation, PEF variability, symptom score and use of rescue medication similarly improved in both groups. We conclude that FP is effective at least as well as P in reducing sputum eosinophilia and in improving airway obstruction due to asthma exacerbation. However, the cost/effectiveness ratio of this option should be further evaluated.
本研究旨在评估丙酸氟替卡松(FP)在减少痰液嗜酸性粒细胞以及改善因哮喘急性发作但无需住院治疗所致气道阻塞方面是否与泼尼松(P)同样有效。在一项平行组、双盲双模拟、随机研究中,我们对37名哮喘患者在哮喘自然发作期间(访视1)以及接受吸入FP(1000μg,每日两次)治疗2周后(访视2)(A组,n = 18)或口服P递减疗程(B组,n = 19)时的痰液和血液炎症细胞计数及可溶性介质进行了测量。几乎所有患者(95%)的哮喘急性发作都伴有痰液嗜酸性粒细胞增多(嗜酸性粒细胞>2%)。FP改善了第1秒用力呼气容积(FEV₁)(从访视1时的53.9%±16.8提高至访视2时的76.4%±21.2,p = 0.0001),并降低了痰液嗜酸性粒细胞百分比(从38%[0 - 78]降至3%[1 - 31],p = 0.0008),口服P的效果与之类似(FEV₁:从51.5%±14.4提高至83.6%±21.1,p = 0.0001;痰液嗜酸性粒细胞:从52%[1 - 96]降至11%[0 - 64],p = 0.0003)。在访视2时,A组的痰液嗜酸性粒细胞显著低于B组。P而非FP导致血液和痰液嗜酸性粒细胞阳离子蛋白(ECP)显著降低。两组的血氧饱和度、呼气峰流速(PEF)变异性、症状评分及急救药物使用情况均有类似改善。我们得出结论,在减少痰液嗜酸性粒细胞以及改善因哮喘急性发作所致气道阻塞方面,FP至少与P同样有效。然而,该方案的成本效益比应进一步评估。