COPD稳定期的管理摘要.ppt

临床访视时测定的FEV1 0670研究中信必可对FEV1 的改善作用优于福莫特罗，这可能是由于两个研究准备期的治疗方法不同所致。 在0670研究的准备期，由于口服激素和福莫特罗的治疗，FEV1增加。随机后，信必可是唯一能预防 FEV1 立即下降的药物。 尽管FEV1逐渐下降，但与其他治疗相比，在12个月的研究期中，信必可仍维持着对FEV1的改善作用。 虽然气短的严重程度可通过气道阻塞的程度（以FEV1 占预计值的百分比表示）粗略估计，但目前接受的观点是肺容量的改变，而不是FEV1 本身，可引起气短。因此运动时气短的改善可不伴有或仅有极少量的FEV1改善。 * 信必可改善HRQL（SGRQ 总分） 两个研究均使用了SGRQ和SF 36，但是根据CPM，P指南的建议，这里使用的数据来自于 SGRQ。 图中数据限于SGRQ总分，因为这是评估临床相关性的基础，总分减少4分被认为是与临床相关的阳性改变1。 信必可组的改变显著超过了临床相关阳性改变值。 参考文献 1. PW Jones. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J 2002;19(3): 398-404. * 长期布地奈德/福莫特罗治疗，与氟替卡松/沙美特罗相比，与更少的各种慢阻肺急性加重相关。与氟替卡松/沙美特罗相比，布地奈德/福莫特罗显著降低由于急性加重所致的口服糖皮质激素、使用抗生素、住院治疗、急诊的发生率26.0%、29.0%、29.1%、21.0%。 * 长期布地奈德/福莫特罗治疗，与氟替卡松/沙美特罗相比，与更少肺炎以及因肺炎导致的住院风险相关。与布地奈德/福莫特罗相比，氟替卡松/沙美特罗显著增加： 肺炎风险73%， 因肺炎导致的住院风险74%， 初级保健中心诊断肺炎风险56%， 门诊诊断肺炎风险75%， 肺炎住院天数82%。 * * * * What were the effects on FEV and health status? At week 18, when ICS withdrawal was completed the reduction in trough FEV1 from baseline FEV1 was thirty eight ml greater with ICS withdrawal than on ICS use This difference was signifcant(P .0001). A similar difference was also seen at week fifty-two . Interestingly the decrease of FEV occurred after reducing fluticasone from 100 μg BID to placebo.The reduction of FEV does not seem to have a predictive effect on exacerbations. ICS withdrawal had no effect on the mMRC score but an effect on SGRQ. The importance of the change in SGRQ is unclear, as it was below the frequently used minimum clinically important difference and has no relationship to differences in the number of exacerbations. We observed statistically significant reduction from baseline in trough FEV 1 at week 18, when glucocorticoid withdrawal was complete, The reduction was 38 ml greater in the ICS withdrawal group than in the glucocorticoid-continuation group (P0.001). A similar difference of43 ml was seen at week 52 * * 健康状况--SGRQ评分 3年治疗期评分降低均值： 沙美特罗替卡松组：-3.0（vs 安慰剂组和沙美特罗组 p0.001） 氟替