GlaxoSmithKline, Research Triangle Park, NC 27709-3398, USA.
Eur Respir J. 2009 Sep;34(3):641-7. doi: 10.1183/09031936.00193908. Epub 2009 May 14.
Inhaled corticosteroids (ICS) are important in reducing exacerbation frequency associated with chronic obstructive pulmonary disease (COPD). However, little is known about the risk of associated infections. In a post hoc analysis of the TOwards a Revolution in COPD Health (TORCH) study, we analysed and identified potential risk factors for adverse event reports of pneumonia in this randomised, double-blind trial comparing twice-daily inhaled salmeterol (SAL) 50 microg, fluticasone propionate (FP) 500 microg, and the combination (SFC) with placebo in 6,184 patients with moderate-to-severe COPD over 3 yrs. Despite a higher withdrawal rate in the placebo arm, after adjusting for time on treatment, a greater rate of pneumonia was reported in the FP and SFC treatment arms (84 and 88 per 1,000 treatment-yrs, respectively) compared with SAL and placebo (52 and 52 per 1,000 treatment-yrs, respectively). Risk factors for pneumonia were age > or =55 yrs, forced expiratory volume in 1 s <50% predicted, COPD exacerbations in the year prior to the study, worse Medical Research Council dyspnoea scores and body mass index <25 kg.m(-2). No increase in pneumonia deaths with SFC was observed; this could not be concluded for FP. Despite the benefits of ICS-containing regimens in COPD management, healthcare providers should remain vigilant regarding the possible development of pneumonia as a complication in COPD patients receiving such therapies.
吸入皮质类固醇（ICS）在降低慢性阻塞性肺疾病（COPD）相关的恶化频率方面非常重要。然而，对于相关感染的风险知之甚少。在一项针对 COPD 健康的革命性研究（TORCH）的事后分析中，我们分析并确定了在这项比较沙美特罗（SAL）50 微克、丙酸氟替卡松（FP）500 微克和 SFC 每日两次吸入治疗中度至重度 COPD 患者的随机、双盲试验中，与肺炎不良事件报告相关的潜在危险因素，该试验共纳入了 6184 名患者，为期 3 年。尽管安慰剂组的退出率较高，但在调整了治疗时间后，FP 和 SFC 治疗组的肺炎报告率（分别为 84 和 88 例/1000 治疗年）高于 SAL 和安慰剂组（分别为 52 和 52 例/1000 治疗年）。肺炎的危险因素为年龄≥55 岁、1 秒用力呼气量（FEV1）<50%预计值、研究前一年内 COPD 恶化、更严重的医学研究理事会呼吸困难评分和体重指数（BMI）<25 kg·m-2。未观察到 SFC 治疗组肺炎死亡人数增加；对于 FP 则不能得出结论。尽管 ICS 治疗方案在 COPD 管理中具有益处，但医疗保健提供者仍应警惕 COPD 患者接受此类治疗时肺炎可能成为并发症。
