Menezes Marcelo B, Teixeira Antônio L, Terra Filho João, Vianna Elcio O
Department of Medicine, University of S. Paulo Medical School at Ribeirão Preto, Brazil.
Respir Med. 2008 Oct;102(10):1385-91. doi: 10.1016/j.rmed.2008.04.022. Epub 2008 Jul 15.
Adding a long-acting beta(2)-agonist to inhaled corticosteroids (ICS) for asthma treatment is better than increasing ICS dose in improving clinical status, although there is no consensus about the impact of this regimen on inflammation. In this double-blind, randomized, parallel group study, asthmatics with moderate to severe disease used budesonide (400 mcg/day) for 5 weeks (run-in period); then they were randomized to use budesonide (800 mcg/day--BUD group) or budesonide plus formoterol (400 mcg and 24 mcg/day, respectively--FORMO group) for 9 weeks (treatment period). Home PEF measurements, symptom daily reporting, spirometry, sputum induction (for differential cell counts and sputum cell cultures), and hypertonic saline bronchial challenge test were performed before and after treatments. TNF-alpha, IL-4 and eotaxin-2 levels in the sputum and cell culture supernatants were determined. Morning and night PEF values increased in the FORMO group during the treatment period (p<0.01), from 435+/-162 to 489+/-169 and 428+/-160 to 496+/-173 L/min, respectively. The rate of exacerbations in the FORMO group was lower than in the BUD group (p<0.05). Neutrophil counts in sputum increased in both groups (p<0.05) and leukocyte viability after 48 h-culture increased in the FORMO group (p<0.05). No other parameter changed significantly in either group. This study showed that adding formoterol to budesonide improved home PEF and provided protection from exacerbations, although increase of leukocyte viability in cell culture may be a matter of concern and needs further investigation.
在哮喘治疗中，在吸入性糖皮质激素（ICS）基础上加用长效β₂受体激动剂在改善临床状况方面优于增加ICS剂量，尽管对于该治疗方案对炎症的影响尚无共识。在这项双盲、随机、平行组研究中，中重度哮喘患者使用布地奈德（400微克/天）治疗5周（导入期）；然后将他们随机分为使用布地奈德（800微克/天——布地奈德组）或布地奈德加福莫特罗（分别为400微克和24微克/天——福莫特罗组）治疗9周（治疗期）。在治疗前后进行家庭呼气峰流速（PEF）测量、症状每日报告、肺功能测定、痰液诱导（用于细胞分类计数和痰液细胞培养）以及高渗盐水支气管激发试验。测定痰液和细胞培养上清液中的肿瘤坏死因子-α（TNF-α）、白细胞介素-4（IL-4）和嗜酸性粒细胞趋化因子-2水平。在治疗期，福莫特罗组的早晚PEF值均升高（p<0.01），分别从435±162升至489±169升/分钟和从428±160升至496±173升/分钟。福莫特罗组的病情加重率低于布地奈德组（p<0.05）。两组痰液中的中性粒细胞计数均增加（p<0.05），福莫特罗组48小时培养后的白细胞活力增加（p<0.05）。两组的其他参数均无显著变化。该研究表明，在布地奈德基础上加用福莫特罗可改善家庭PEF并预防病情加重，尽管细胞培养中白细胞活力增加可能值得关注，需要进一步研究。
