沙美特罗替卡松与噻托溴铵联合吸入在重度、极重度COPD稳定期中的应用

Salmeterol/Fluticasone Propionate Combined with Tiotropium in Treatment of Severe to Very Severe Stable COPD Patients

目的观察沙美特罗替卡松与噻托溴铵联合应用对重度、极重度慢性阻塞性肺疾病(COPD)稳定期患者的疗效与预后的影响。方法选取2008年5月至2009年10月于呼吸科门诊就诊的80例稳定期重度极重度COPD患者,采用完全随机法分成两组,一组单用沙美特罗替卡松(SF组),一组联合应用沙美特罗替卡松和噻托溴铵(联合组),共治疗12个月。分别于用药后1、3、6和12个月测定患者肺功能(FEV1、FVC、IC),6分钟步行试验,圣乔治问卷,急性加重次数,急性加重出现时间。结果两组患者治疗后不同时期肺功能指标(FEV1、FVC、IC)、6分钟步行试验及圣乔治问卷评分较治疗前均有明显改善(P<0.05),联合组各项指标改善更明显(P<0.05)。联合组急性加重次数较SF组明显减少(P<0.05),且急性加重出现的时间推迟(P<0.05)。两组间不良反应无显著差异(P>0.05)。结论沙美特罗替卡松与噻托溴铵联合应用于重度、极重度COPD患者能进一步改善肺功能、运动耐量及生活质量,且不良反应未见明显增加。

Objective To observe the effects of salmeterol/fluticasone combined with tiotropium in the treatment of sever to very sever COPD. Methods Eighty patients with severe to very severe stable COPD were recruited from outpatient of Central Hospital of Cangzhou between May 2008 and October 2009. The subjects were randomly divided into a salmeterol/fluticasone group and a combination group. The salmeterol/ fluticasone group received salmeterol/fluticasone propionate, and the combination group received the combination therapy of tiotropium and salmeterol/fluticasone propionate. All patients had received the treatment for 12 months. At baseline and at the end of 1-month, 3-month, 6-month, 12-month, lung function （FEV1, IC and FVC）, six-minute walk distance and the St. George＇s Respiratory Questionnaire （SGRQ） score were assessed. The number of exacerbations and the time to the first exacerbation were also recorded. Results At every visit, lung function （FEV1 , IC and FVC）, six-minute walk distance and the SGRQ score were improved in both groups compared with baseline （ P 〈 0.05 ）, especially in the combination group （P 〈 0. 05）. Compared with the salmeterol/fluticason, the combination therapy with tiotropium significantly decreased the incidence of exacerbations and prolonged the time to the first exacerbation （ P 〈 0. 05 ）. And there was no significant difference between two groups in adverse effects （P 〉 0. 05 ）. Conclusions The combination therapy with salmeterol/flutieasone propionate and tiotropium was superior to salmeterol/ fluticasone propionate in treatment of sever to very severe stable COPD patients in improving lung function, exercise tolerance, and quality of life, without additional adverse effects.