聚焦COPD急性加重.ppt

* * * * * * * Page * References: Casaburi R et al. Eur Respir J 2002;19:217-224 Brusasco V et al. Thorax 2003;58:399-404 Dusser D et al. Eur Respir J 2006;28:547-555 Tonnel A-B et al. Int J COPD 2008;3:301-310 Chan CK et al. Can Respir J 2007;14:465-472 Niewoehner DE et al. Ann Intern Med 2005;143:317-326 Powrie DJ et al. Eur Respir J 2007;30:472-478 References: Casaburi R et al. Eur Respir J 2002;19:217-224 Brusasco V et al. Thorax 2003;58:399-404 Dusser D et al. Eur Respir J 2006;28:547-555 Tonnel A-B et al. Int J COPD 2008;3:301-310 Chan CK et al. Can Respir J 2007;14:465-472 Niewoehner DE et al. Ann Intern Med 2005;143:317-326 Powrie DJ et al. Eur Respir J 2007;30:472-478 * * 本图介绍了POET-COPD研究的设计，这是一项双盲双模拟的随机对照试验。 在2周导入期之后，入组患者被随机化分组，分别接受噻托溴铵(每天18微克）或沙美特罗(每天50微克）治疗1年，并在治疗结束后延长随访30天。 在研究前已使用噻托溴铵的患者被要求先换用异丙托溴铵（每天160微克）治疗，直至随机分组时停药。 在研究开始前已使用LABA（长效β2激动剂）的患者可在导入期继续用药。 在研究开始前接受固定剂量LABA+ICS（吸入型糖皮质激素）联合治疗的患者在研究开始前需要改为ICS单药治疗 在双盲研究期间，允许患者继续使用除抗胆碱能药物和LABA以外的任何常规COPD药物。 随机化分组后，患者在第2、4、8、12个月时按规定就诊，在就诊当月之外的每个月接受电话随访。对于中途停药的患者，会持续记录其生命体征或死亡原因直至研究结束。 POET-COPD的主要研究结果已于2011年3月正式发表于新英格兰医学杂志。 * * * * * Tiotropium significantly increased the time to first exacerbation (primary endpoint) compared with salmeterol by 42 days (187 vs 145 days in the first quartile of patients), corresponding to a 17% reduction in risk (HR 0.83; 95% CI 0.77-0.90; P0.001). Given that less than 50% of patients experienced an exacerbation, it was not possible to calculate the median time to first exacerbation, therefore the time to first exacerbation in the first quartile of patients was calculated instead. Randomized patients taking ≥1 dose of study medication included in analysis. COPD exacerbations with onset during actual treatment. Hazard ratio based on Cox proportional hazards regression model including terms for (pooled) centre and treatment. * Randomized patients taking ≥1 dose of study medication included in analysis. COPD exacerbations with onset during actual treatment. Hazard ratio