长效β_2激动剂/吸入糖皮质激素加用噻托溴铵Respimat~治疗高龄慢性阻塞性肺疾病

Effectiveness of Tiotropium Respimat combined with inhaled corticosteroid/long-acting β_2-agonist in elderly patients with COPD

目的:研究在长效β_2激动剂/吸入糖皮质激素(ICS/LABA)基础上加用噻托溴铵Respimat~(LAMA)治疗高龄慢性阻塞性肺疾病(COPD)患者的疗效和安全性。方法:54例肺功能GOLD 3级或4级、并使用ICS/LABA的高龄COPD患者随机分为2组,1组加用噻托溴铵Respimat~,另1组继续原治疗方案,比较用药12个月时2组的肺功能变化、COPD评估测试评分变化、年急性加重人数和次数、药物相关不良事件。结果:用药12个月时LAMA+ICS/LABA组的第1秒用力呼气容积(FEV_1)、用力肺活量(FVC)年下降值低于ICS/LABA组,COPD评估测试评分改善值高于ICS/LABA组(均P<0.05);LAMA+ICS/LABA组急性加重的入院总次数低于ICS/LABA组(P<0.05);2组均未发生严重心血管事件,药物相关不良事件无统计学差异。结论:在ICS/LABA基础上加用噻托溴铵Respimat~可改善老年COPD患者的肺功能和临床症状,安全性和依从性好。

Objective： To investigate the efficacy and safety of Tiotropium Respimat combined with inhaled corticosteroid（ ICS）/long-acting β2-agonist（ LABA） in elderly patients with chronic obstructive pulmonary disease（ COPD）. Methods：Fifty-four elderly COPD patients,who were classified as GOLD 3 or 4 and received ICS/LABA treatment,were randomized into LAMA ＋ ICS/LABA group and ICS/LABA group. Patients in LAMA ＋ ICS/LABA group were treated with Tiotropium Respimat plus ICS/LABA,and those in ICS/LABA group were given ICS/LABA. The annual declines of FEV1 and FVC,the improvements in COPD Assessment Test（ CAT） score,the number of COPD exacerbations leading to hospitalization,and the incidence of major adverse cardiovascular events and drug-related adverse reactions were compared between the two groups after 12 months. Results： After 12 months,LAMA ＋ ICS/LABA significantly reduced the declines of FEV1 and FVC versus ICS/LABA. There were significant improvements in CAT score in LAMA ＋ ICS/LABA group versus ICS/LABA group. Fewer COPD exacerbations leading to hospitalization were observed in the LAMA ＋ ICS/LABA group than in ICS/LABA group. There was no significant difference in the incidence of drug-related adverse reactions between the two groups and no major adverse cardiovascular events were observed. Conclusion： In elderly COPD patients,addition of Tiotropium Respimat to ICS/LABA demonstrated significant improvements in lung function and health status compared to ICS/LABA.