医学交流课件：Post-ATS FLAME MSL.pptxVIP

ILLUMALTE STUDYWe enrolled men and women 40 years of age or older,current or former smokers with a smoking history of at least 10 pack-years, post-bronchodilator FEV1 between 40% and 80% of predicted value, and post-bronchodilator FEV1 to forced vital capacity (FVC) ratio less than 0?70.Patients with a history of a COPD exacerbation needing treatment with antibiotics, systemic corticosteroids, or hospitalisation in the year leading up to and including randomisation were excluded.入组了40岁以上的男性和女性患者，当前或者以前吸烟并伴有至少每年10包的吸烟史。支扩剂之后FEV1在40%-80%预计值，FEV1/FVC＜0.7.同时排除前一年因COPD急性加重需要抗生素、全身激素或者住院治疗的患者。全文摘要背景：QVA149是一种联合吸入治疗方法用于治疗COPD。它联合了印达特罗和格隆溴安成为一种复合支气管扩张剂。研究的目的是比较QVA149和SFC对于中重度COPD患者在26周内的有效性、安全性和耐受性。方法：多中心双盲，双模拟，平行研究。523名患者40岁以上的COPD患者符合GOLD2-3级，在入组前一年没有急性加重史随机分为两组，分别接受一天一次的QVA或者一天两次的SFC。评估两组的有效性及安全性。首要研究终点是证明在26周时QVA149与SFC相比在支扩及后FEV1AUC0-12H的差异，259名患者随机接受了QVA149的治疗，还有264名患者接受了SFC的治疗。结果：在第26周，FEV1AUC0-12H在QVA149组显著升高；总的不良事件包括AECOPD在内是55.4%VS60.2%分别对应QVA149和SFC，严重不良事件发生率两组间相似。COPD的恶化是最频繁的严重不良事件。结论：每天一次的QVA149给药可以显著持续提高有临床意义上的肺功能与每天两次给药SFC相比，同时症状控制方面也获益也明显；这些结果暗示双重支扩剂可以作为没有急性加重的COPD患者的选择。主要研究结果在第26周，FEV1AUC0-12H在QVA149组显著升高，差异为0.138L。总的不良事件包括AECOPD在内是55.4%VS60.2%分别对应QVA149和SFC。严重不良事件发生率两组间相似.Adverse events, including COPD exacerbations, and vital signs were recorded at each visit, and electrocardiogram (ECG) and laboratory analyses (haematology, clinical chemistry, and urinalysis) were done on day 1 and week 26. Patients who had a moderate-to-severe COPD exacerbation (defined bymodifi ed Anthonisen criteria,10 commonly used in COPD clinical trials)不良事件包括AECOPD，生命特征在每次随访时被记录，心电图和实验室检查会在第一天和26周进行。中重度COPD的急性发作通过Anthonisen criteria定义。ILLUMINATE小结ObjectiveTo demonstrate that Ultibro is superior to Seretide in terms of improvements in lung function 证明ULTIBRO在提高肺功能方面优于舒利迭。To investigate the safety and tolerability of Ultibro compared with Seretide 评估与舒利迭相比，ULTIBRO安全性和依从性。Study detailInformationPIClaus VogelmeierPrimary endpointSuperiority of Ultibro over Seretide for FEV1 AUC0-12h