Respirology：布地奈德/福莫特罗联合用药治疗COPD效果更佳

图为治疗过程中两组用药前FEV1的几何平均数的走势图，灰色为布地奈德/福莫特罗联合组,黑色为福莫特罗组

在COPD的治疗指南中推荐同时联合吸入糖皮质激素及长效的β2受体激动剂，但是这一治疗方案主要依据的是针对西方人群的临床试验，在亚洲人群中尚未有类似的临床试验研究，针对这一问题，来自日本顺天堂大学呼吸系统疾病中心的Yoshinosuke Fukuchi联合多个国家的呼吸系统疾病研究中心进行了一项针对亚洲人群的临床研究。该研究结果发表在2013年4月1号的呼吸系统疾病（Respirology）杂志上，结果表明，联合使用布地奈德/福莫特罗相对于单独使用福莫特罗，治疗效果更加显著。

该研究选取具有2年以上中、重度COPD病史的患者，依据随机、双盲、平行对照原则，将患者分为布地奈德/福莫特罗联合组及福莫特罗组，全组疗程为12周，其中布地奈德/福莫特罗联合组给予布地奈德160μg、福莫特罗4.5μg 2次/日 通过Turbuhaler®干粉吸入器吸入治疗；福莫特罗组给予福莫特罗4.5μg 2次/日 通过Turbuhaler®干粉吸入器吸入治疗。全组采用沙丁胺醇（100μg，通过pMID吸入器给药）为缓解药物。主要变量为：治疗期间用药前FEV1从基本值到平均值的变化。次要变量包括：肺功能、COPD症状，第1次COPD大发作的期限。

共1293名患者被随机分为布地奈德/福莫特罗联合组、福莫特罗组，布地奈德/福莫特罗联合组636名，福莫特罗组657名。两组的给药前FEV1较基本值均有明显提高，布地奈德/福莫特罗联合组提高4.6%，福莫特罗组提高1.5%，两组结果有显著差异，布地奈德/福莫特罗联合组：福莫特罗组为1.032。就第1次COPD大发作期限来说，两组也有显著差异（危险比为0.679）。其他次要变量的提高也均有显著差异。两组均有较好的耐受性，不良反应发生率及不良反应的类型和大多数报道类似，其中COPD发生率布地奈德/福莫特罗联合组为8.0%，福莫特罗组为9.4%；过敏性鼻炎发生率布地奈德/福莫特罗联合组为5.5%，福莫特罗组为4.9%。

由研究数据分析得知，相对于单独使用福莫特罗来说，联合使用布地奈德和福莫特罗（160μg/4.5μg,2次/日 吸入治疗）治疗中、重度COPD，不仅有更好的治疗效果和耐受性，也可以更好的改善患者的肺功能、减少COPD大发作的风险，这一结果在亚洲人群中同样适用。

Budesonide/formoterol via Turbuhaler® vs. formoterol via Turbuhaler® in patients with moderate to severe COPD: phase III multinational study results.
BACKGROUND AND OBJECTIVE
The efficacy and tolerability of budesonide/formoterol vs. formoterol in patients with moderate to severe chronic obstructive pulmonary disease (COPD) was evaluated.
METHODS
In this randomised, double-blind, parallel-group, phase III study (NCT01069289) patients with moderate to severe COPD for ≥2 years received either budesonide/formoterol 160/4.5 μg 2 inhalations twice daily (bid) via Turbuhaler® or formoterol 4.5 μg 2 inhalations bid via Turbuhaler® for 12 weeks. Salbutamol 100 μg/actuation via pMDI was available as reliever medication. Primary outcome variable: change from baseline to average during treatment in pre-dose FEV1 ; secondary outcome variables included lung function, COPD symptom measures, time to first exacerbation and tolerability.
RESULTS
1293 patients were randomised (budesonide/formoterol n=636; formoterol n=657). Both budesonide/formoterol and formoterol increased pre-dose FEV1 vs. baseline (improvements of 4.6% and 1.5% over baseline, respectively), with the increase from baseline being significantly greater with budesonide/formoterol vs. formoterol (budesonide/formoterol:formoterol ratio 1.032; 95% CI: 1.013-1.052; p=0.0011). The budesonide/formoterol group had a significantly prolonged time to first exacerbation vs. the formoterol group (hazard ratio: 0.679; 95% CI: 0.507-0.909; p=0.0094) and significantly greater improvements in many secondary outcome measures. Both treatments were well tolerated; the incidence and type of adverse events were similar to most commonly reported adverse events (budesonide/formoterol vs. formoterol): COPD (8.0% vs. 9.4%) and nasopharyngitis (5.5% vs. 4.9%).
CONCLUSIONS
Budesonide/formoterol 160/4.5 μg two inhalations bid was effective and well tolerated in patients with moderate to severe COPD, offering benefits over formoterol alone in terms of improved lung function and reduced risk of exacerbation.