中重度COPD患者吸入LAMA+LABA及ICS+LABA临床治疗效果的随机对照研究

Effectiveness and safety between LAMA+LABA and ICS+LABA in patients with moderate-to-severe chronic obstructive pulmonary disease:A randomized control study

目的对比100个/μl≤外周血嗜酸粒细胞计数<300个/μl的中重度慢性阻塞性肺疾病(COPD)患者吸入长效抗胆碱能药物(LAMA)+长效β2受体激动剂(LABA)及吸入性糖皮质激素(ICS)+LABA临床治疗效果差异。方法本研究为前瞻性队列研究,纳入2021年1月至2021年11月北京市大兴区人民医院呼吸与危重症医学科门诊随访的172例中重度COPD患者,采用单纯随机抽样法分为2组,吸入LAMA+LABA组88例及吸入ICS+LABA组84例,随访26周,对比患者肺功能第1秒用力呼气容积谷值变化、变化期呼吸困难指数评分、COPD评估测试评分及急性加重情况。结果治疗26周后,与ICS+LABA组相比,LAMA+LABA组患者肺功能第1秒用力呼气容积谷值[(1.87±0.75)L比(1.66±0.60)L]增加(t=1.98,P=0.049);患者变化期呼吸困难指数评分[(1.94±0.26)比(0.82±0.17)]改善(t=32.98,P<0.001);患者COPD评估测试评分[(10.3±4.7)分比(16.5±5.2)分]下降(t=8.21,P<0.001)。2组患者均无死亡病例,在肺炎发生率、重度急性加重方面,差异均无统计学意义(P值均>0.05)。结论血嗜酸粒细胞计数100~300个/μl的中重度COPD患者,LAMA+LABA改善患者肺功能及生活质量评分更显著,安全方面无差异,这为临床治疗提供了一定参考价值。

Objective To compare the benefits and harms of long-acting muscarinic antagonist(LAMA)+long-acting beta-agonist(LABA)and inhaled glucocorticoids(ICS)+LABA in patients with moderate-to-severe chronic obstructive pulmonary disease(COPD)with an eosinophilic count 100-300 cells/μl.Methods This was a prospective cohort study.A total of 172 patients with moderate-to-severe COPD were followed up in the Department of Respiratory and Critical Care Medicine clinic of Daxing District People's Hospital of Beijing from January 2021 to November 2021.They were randomly divided into two groups:88 cases in LAMA+LABA group and 84 cases in ICS+LABA group.The effectiveness of LAMA+LABA or ICS+LABA maintenance treatment were evaluated,and effectiveness end points were the changes from baseline in trough FEVi,transition dyspnea index(TDI)total scores,COPD assessment test(CAT)scores and exacerbations at Week 26.Results LAMA+LABA group showed superior improvement in trough FEVi at Week 26 compared with ICS+LABA group[(1.87±0.75)L vs(1.66±0.60)L,(t=1.98,P=0.049)],LAMA+LABA group demonstrated significantly superior improvement in TDI total scores at Week 26 compared with ICS+LABA group[(1.94±0.26)units vs(0.82±0.17)units],(t=32.98,P<0.001);LAMA+LABA group revealed significantly superior improvement in total CAT score at Week 26 compared with ICS+LABA group[(10.3±4.7)vs(16.5±5.2)],(t=8.21,P<0.001).There were no patient deaths during the study,and there were no differences in pneumonia or severe exacerbations between both treatment groups(both P>0.05).Conclusions LAMA+LABA was safe and showed superior clinically significant improvements in lung function and patient-related outcomes in patients with moderate-to-severe COPD with an eosinophilic count 100-300 cells/μl,which will provide certain reference for clinical treatment.