Sin Don D, Tashkin Donald, Zhang Xuekui, Radner Finn, Sjöbring Ulf, Thorén Anders, Calverley Peter M A, Rennard Stephen I
Providence Heart and Lung Institute, St Paul's Hospital (iCAPTURE Centre), and Department of Medicine (Division of Respirology), University of British Columbia, Vancouver, BC, Canada.
Lancet. 2009 Aug 29;374(9691):712-9. doi: 10.1016/S0140-6736(09)61250-2.
Concern is continuing about increased risk of pneumonia in patients with chronic obstructive pulmonary disease (COPD) who use inhaled corticosteroids. We aimed to establish the effects of inhaled budesonide on the risk of pneumonia in such patients.
We pooled patient data from seven large clinical trials of inhaled budesonide (320-1280 mug/day), with or without formoterol, versus control regimen (placebo or formoterol alone) in patients with stable COPD and at least 6 months of follow-up. The primary analysis compared treatment groups for the risk of pneumonia as an adverse event or serious adverse event during the trial or within 15 days of the trial end. Cox proportional hazards regression was used to analyse the data on an intention-to-treat basis. Data were adjusted for patients' age, sex, smoking status, body-mass index, and postbronchodilator percent of predicted forced expiratory volume in 1 s (FEV(1)).
We analysed data from 7042 patients, of whom 3801 were on inhaled budesonide and 3241 were on control treatment, with 5212 patient-years of exposure to treatment. We recorded no significant difference between treatment groups for the occurrence of pneumonia as an adverse event (3% [n=122 patients] vs 3% [n=103]; adjusted hazard ratio 1.05, 95% CI 0.81-1.37) or a serious adverse event (1% [n=53] vs 2% [n=50]; 0.92, 0.62-1.35), or for time to pneumonia as an adverse event (log-rank test 0.94) or a serious adverse event (0.61). Increasing age and decreasing percent of predicted FEV(1) were the only two variables that were significantly associated with occurrence of pneumonia as an adverse event or a serious adverse event.
Budesonide treatment for 12 months does not increase the risk of pneumonia in patients with COPD during that time and therefore is safe for clinical use in such patients.
Michael Smith Foundation for Health Research.
慢性阻塞性肺疾病（COPD）患者使用吸入性糖皮质激素后肺炎风险增加，这一问题一直备受关注。我们旨在确定吸入布地奈德对此类患者肺炎风险的影响。
我们汇总了七项大型临床试验的患者数据，这些试验将吸入布地奈德（320 - 1280微克/天）（加或不加福莫特罗）与稳定期COPD患者的对照方案（安慰剂或单独使用福莫特罗）进行比较，并进行了至少6个月的随访。主要分析比较了治疗组在试验期间或试验结束后15天内发生肺炎作为不良事件或严重不良事件的风险。采用Cox比例风险回归对意向性治疗数据进行分析。数据针对患者的年龄、性别、吸烟状况、体重指数以及支气管扩张剂使用后1秒用力呼气容积占预计值的百分比（FEV₁）进行了调整。
我们分析了7042例患者的数据，其中3801例接受吸入布地奈德治疗，3241例接受对照治疗，治疗暴露时间为5212患者年。我们记录到，治疗组之间作为不良事件的肺炎发生率（3% [n = 122例患者] 对3% [n = 103例]；调整后风险比1.05，95%可信区间0.81 - 1.
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