噻托溴铵喷雾剂替换沙美特罗替卡松治疗老年慢性阻塞性肺疾病的临床研究

目的：研究应用噻托溴铵喷雾剂替换吸入糖皮质激素/长效β2激动剂治疗老年COPD的疗效和安全性。方法：72例肺功能GOLD 3级或4级、并正使用沙美特罗替卡松粉吸入剂的老年COPD患者随机分为2组，1组换为噻托溴铵喷雾剂（LAMA组），另1组（ICS/LABA组）继续原治疗方案，比较12个月后两组的肺功能变化值、COPD评估测试评分变化值、年急性加重人数和次数、药物不良事件。结果：用药12个月时LAMA组的FEV1、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，差异具有显著性（P<0.05）；12个月内LAMA组急性加重入院的病人数和总次数低于ICS/LABA组；12个月内LAMA组肺炎的发生率低于ICS/LABA组。结论：老年COPD患者吸入噻托溴铵喷雾剂可减少急性加重和改善日常症状，并具有良好的安全性和依从性。

The effect of Tiotropium Respimat® replacing Salmeterol Xinafoate and Fluticasone Propionate in elderly patients with COPD

OBJECTIVE To investigate the efficacy and safety of Tiotropium Respimat^® replacing Salmeterol Xinafoate and Fluticasone Propionate in elderly patients with chronic obstructive pulmonary disease (COPD). METHODS 72 elderly patients with COPD who were classified as GOLD 3 or 4 and received the treatment of Salmeterol Xinafoate and Fluticasone Propionate, were randomized into LAMA group and ICS/LABA group (n=36, each). Patients in LAMA group were treated with Tiotropium Respimat^® to replace Salmeterol Xinafoate and Fluticasone Propionate, while in ICS/LABA group, patients continued to be treated with Salmeterol Xinafoate and Fluticasone Propionate. 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 drug-related adverse reactions were compared between the two groups after 12 months. RESULTS At 12 months, the declines of FEV1 and FVC were significantly reduced in the LAMA group compared with the ICS/LABA group, and significant improvements in CAT score were achieved (P<0.05). Fewer COPD exacerbations leading to hospitalization were observed in the LAMA group compared with the ICS/LABA group. And the incidence of pneumonia was also lower in the LAMA group compared with the ICS/LABA group. CONCLUSION Tiotropium Respimat^® reduced COPD exacerbations and improved lung function in elderly patients with a favorable safety profile and treatment compliance.