Reported Pneumonia in Patients With COPD Findings From the INSPIRE Study
Reported Pneumonia in Patients With COPD Findings From the INSPIRE Study
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DOI：
10.1378/chest.09-2992
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发表时间：
2011-03-01
期刊：
影响因子：
9.6
通讯作者：
Wedzicha, Jadwiga A.
中科院分区：
文献类型：
--
作者：
Calverley, Peter M. A.;Stockley, Robert A.;Wedzicha, Jadwiga A.
背景：肺炎是COPD的重要并发症，在接受吸入性皮质类固醇（ICS）的患者中更常见。对COPD患者的临床病程和易患肺炎的因素知之甚少。我们调查了患者的特点和症状发生前肺炎报告的调查新标准预防减少急性发作（INSPIRE）study.Methods：这是一项为期2年，双盲，双模拟平行研究的1,323例患者随机沙美特罗/丙酸氟替卡松50/500微克bid（SFC）或噻托溴铵18微克每日一次（Tio）。基线人口统计学，包括血清C-反应蛋白（CRP）水平，进行了测量，并完成每日记录卡（DRCs）。结果：我们确定了87例肺炎报告不良事件记录（SFC = 62; Tio = 25）在74例患者（SFC = 50; Tio = 24），相比之下，2,255急性加重（SFC = 1,185; Tio = 1,070）。肺炎在严重呼吸困难患者和基线CRP水平> 10 mg/L的患者中更常见。治疗组间新发肺炎（之前未出现急性加重症状的事件）的数量相似，但在接受ICS的患者中，经治疗或未经治疗的未消退急性加重后更可能发生肺炎（SFC = 32; Tio = 7）。当分析仅限于放射学证实的事件时，也看到了类似的结果。结论：COPD患者肺炎的发生率远低于急性加重。ICS治疗的过量事件似乎与持续的症状性加重相关。早期识别和治疗这些事件以预防肺炎值得进一步研究。试验登记处：ClinicalTrials.gov;编号：NCT 00361959;研究编号：SC040036; URL：clinicaltrials.gov CHEST 2011; 139（3）：505-512
Background: Pneumonia is an important complication of COPD and is reported more often in patients receiving inhaled corticosteroids (ICSs). Little is known about the clinical course and factors predisposing to pneumonia in patients with COPD. We investigated patient characteristics and symptoms occurring before pneumonia reports in the Investigating New Standards for Prophylaxis in Reduction of Exacerbations (INSPIRE) study.Methods: This was a 2-year, double-blind, double-dummy parallel study of 1,323 patients randomized to salmeterol/fluticasone propionate 50/500 mu g bid (SFC) or tiotropium 18 mu g once daily (Tio). Baseline demographics, including serum C-reactive protein (CRP) levels, were measured, and daily record cards (DRCs) were completed.Results: We identified 87 pneumonia reports from adverse event records (SFC = 62; Tio = 25) in 74 patients (SFC = 50; Tio = 24), compared with 2,255 exacerbations (SFC = 1,185; Tio = 1,070). Pneumonia was more common in patients with severe dyspnea and in those with a baseline CRP level > 10 mg/L. Numbers of de novo pneumonias (events that were not preceded by symptoms of an exacerbation) were similar between treatment groups, but pneumonia was more likely after either a treated or untreated unresolved exacerbation in patients receiving ICSs (SFC = 32; Tio = 7). Similar results were seen when analysis was confined to radiologically confirmed events.Conclusions: Pneumonia is much less frequent than exacerbation in COPD. The excess of events with ICS treatment appears to be associated with protracted symptomatic exacerbations. Earlier identification and treatment of these events to prevent pneumonia merits further investigation. Trial registry: ClinicalTrials.gov; No.: NCT00361959; Study No.: SC040036; URL: clinicaltrials.gov CHEST 2011; 139(3):505-512