Kardos Peter, Wencker Marion, Glaab Thomas, Vogelmeier Claus
Group Practice and Center for Respiratory and Sleep Medicine, Allergy, Maingau Hospital, Scheffelstrasse 2, 60318 Frankfurt am Main, Germany.
Am J Respir Crit Care Med. 2007 Jan 15;175(2):144-9. doi: 10.1164/rccm.200602-244OC. Epub 2006 Oct 19.
Exacerbations of chronic obstructive pulmonary disease (COPD) greatly contribute to declining health status and the progression of the disease, thereby incurring significant direct and indirect health care costs. The prevention of exacerbations, therefore, is an important treatment goal.
To assess the impact of combination therapy with salmeterol/fluticasone propionate compared with salmeterol alone on moderate and severe exacerbations in patients with severe COPD and a history of repeated exacerbations.
Randomized, double-blind, parallel-group study. After a 4-wk run-in period, 994 clinically stable patients were randomized to one of two treatment groups: 507 patients received the salmeterol/fluticasone combination 50/500 micro g twice daily and 487 received salmeterol 50 micro g twice daily for 44 wk.
The total number of exacerbations was 334 in the combination therapy and 464 in the salmeterol group (p < 0.0001). The annualized rate of moderate and severe exacerbations per patient was 0.92 in the combination therapy and 1.4 in the salmeterol group, corresponding to a 35% decrease. In addition, the mean time to first exacerbation in the combination therapy group was significantly longer compared with that of the salmeterol group (128 vs. 93 d, p < 0.0001). Other endpoints, including health-related quality of life, peak expiratory flow, and use of rescue medication, were significantly improved in the combination therapy group. Both treatments were well tolerated.
This study demonstrates that combination therapy with salmeterol/fluticasone compared with salmeterol monotherapy significantly reduces the frequency of moderate/severe exacerbations in patients with severe COPD.
慢性阻塞性肺疾病（COPD）急性加重会极大地导致健康状况下降和疾病进展，从而产生巨大的直接和间接医疗费用。因此，预防急性加重是一个重要的治疗目标。
评估沙美特罗/丙酸氟替卡松联合治疗与单独使用沙美特罗相比，对重度COPD且有反复急性加重病史患者中重度急性加重的影响。
随机、双盲、平行组研究。经过4周的导入期后，994例临床稳定的患者被随机分为两个治疗组之一：507例患者每日两次接受50/500μg沙美特罗/丙酸氟替卡松联合治疗，487例患者每日两次接受50μg沙美特罗治疗，为期44周。
联合治疗组急性加重总数为334次，沙美特罗组为464次（p<0.0001）。联合治疗组每位患者中度和重度急性加重的年化率为0.92，沙美特罗组为1.4，相当于降低了35%。此外，联合治疗组首次急性加重的平均时间明显长于沙美特罗组（128天对93天，p<0.0001）。联合治疗组的其他终点指标，包括健康相关生活质量、呼气峰值流速和急救药物使用情况，均有显著改善。两种治疗耐受性均良好。
本研究表明，与沙美特罗单药治疗相比，沙美特罗/丙酸氟替卡松联合治疗可显著降低重度COPD患者中度/重度急性加重的频率。
