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首页> 外文期刊>The New England journal of medicine >Withdrawal of inhaled glucocorticoids and exacerbations of COPD
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Withdrawal of inhaled glucocorticoids and exacerbations of COPD

机译：吸入糖皮质激素的戒断和COPD的恶化

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BACKGROUND Treatment with inhaled glucocorticoids in combination with long-acting bronchodilators is recommended in patients with frequent exacerbations of severe chronic obstructive pulmonary disease (COPD). However, the benefit of inhaled glucocorticoids in addition to two long-acting bronchodilators has not been fully explored. METHODS In this 12-month, double-blind, parallel-group study, 2485 patients with a history of exacerbation of COPD received triple therapy consisting of tiotropium (at a dose of 18 once daily), salmeterol (50 μg twice daily), and the inhaled glucocorticoid fluticasone propionate (500 μg twice daily) during a 6-week run-in period. Patients were then randomly assigned to continued triple therapy or withdrawal of fluticasone in three steps over a 12-week period. The primary end point was the time to the first moderate or severe COPD exacerbation. Spirometric findings, health status, and dyspnea were also monitored. RESULTS As compared with continued glucocorticoid use, glucocorticoid withdrawal met the prespecified noninferiority criterion of 1.20 for the upper limit of the 95% confidence interval (CI) with respect to the first moderate or severe COPD exacerbation (hazard ratio, 1.06; 95% CI, 0.94 to 1.19). At week 18, when glucocorticoid withdrawal was complete, the adjusted mean reduction from baseline in the trough forced expiratory volume in 1 second was 38 ml greater in the glucocorticoid-withdrawal group than in the glucocorticoid-continuation group (P<0.001); a similar between-group difference (43 ml) was seen at week 52 (P = 0.001). No change in dyspnea and minor changes in health status occurred in the glucocorticoid-withdrawal group. CONCLUSIONS In patients with severe COPD receiving tiotropium plus salmeterol, the risk of moderate or severe exacerbations was similar among those who discontinued inhaled glucocorticoids and those who continued glucocorticoid therapy. However, there was a greater decrease in lung function during the final step of glucocorticoid withdrawal. (Funded by Boehringer Ingelheim Pharma; WISDOM ClinicalTrials.gov number, NCT00975195.)
机译：背景技术对于严重慢性阻塞性肺疾病（COPD）频繁发作的患者，建议使用吸入糖皮质激素联合长效支气管扩张剂治疗。然而，除了两种长效支气管扩张剂外，吸入糖皮质激素的益处尚未得到充分研究。方法在这项为期12个月的双盲平行研究中，有2485名患有COPD病史的患者接受了三联疗法，包括噻托溴铵（每天一次18剂），沙美特罗（每天两次50μg）和在6周的磨合期中，吸入了糖皮质激素丙酸氟替卡松（500μg，每天两次）。然后将患者随机分配为连续三联疗法或在12周内分三步停用氟替卡松。主要终点是首次中度或重度COPD急性加重的时间。还监测肺活量检查结果，健康状况和呼吸困难。结果与持续使用糖皮质激素相比，对于首次中度或重度COPD急性加重，在95％置信区间（CI）的上限下，糖皮质激素戒断达到了1.20的既定非劣效性标准（危险比，1.06; 95％CI， 0.94至1.19）。在第18周，当糖皮质激素撤药完成时，糖皮质激素撤除组的1秒钟强迫用力呼气量相对于基线的平均减少量比糖皮质激素继续治疗组高38 ml（P <0.001）。在第52周时发现相似的组间差异（43 ml）（P = 0.001）。糖皮质激素戒断组呼吸困难无变化，健康状况略有变化。结论在接受噻托溴铵加沙美特罗治疗的严重COPD患者中，中止或重度加重的风险在那些停止吸入糖皮质激素的患者和继续进行糖皮质激素治疗的患者中相似。但是，在糖皮质激素戒断的最后一步中，肺功能有较大下降。 （由勃林格殷格翰制药公司资助; WISDOM ClinicalTrials.gov编号，NCT00975195。）

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