单吸入器三联疗法治疗慢性阻塞性肺疾病的Meta分析

Efficacy and Safety of Single-Inhaler Triple Therapy in the Treatment of Chronic Obstructive Pulmonary Disease:A Meta-Analysis

目的系统评价单吸入器三联疗法治疗慢性阻塞性肺疾病(COPD)的有效性与安全性。方法利用计算机检索PubMed,Embase,The Cochrane Library,以及中国知网、维普数据库、万方数据库,收集单吸入器三联疗法(试验组)、,以及各对照亚组[吸入性糖皮质激素/长效β2受体激动剂(LABA)组、LABA/长效抗胆碱能药物组、开放三联组](对照组)治疗COPD的随机对照试验(RCT),采用Cochrane手册进行方法学评价,采用RevMan 5.3软件进行Meta分析。结果纳入9个RCTs,共20236例患者。与对照组比较,试验组的中重度年急性加重率显著降低[OR=0.62,95%CI(0.49,0.79),P<0.0001],圣乔治医院呼吸调查问卷(SGRQ)评分显著降低[MD=-0.99,95%CI(-1.58,-0.40),P=0.001],第1秒用力呼气容积显著升高[MD=0.06,95%CI(0.03,0.08),P<0.00001],不良反应发生率相当[OR=0.48,95%CI(0.24,0.98),P=0.04],肺炎发生率相当[OR=1.20,95%CI(0.98,1.47),P=0.07]。结论单吸入器三联疗法治疗COPD疗效良好,可显著改善患者的肺功能,提高其生存质量和治疗依从性,间接减少了患者的经济负担,降低了用药错误率,且安全性较好。

Objective To systematically evaluate the efficacy and safety of single-inhaler triple therapy in the treatment of chronic obstructive pulmonary disease(COPD).Methods PubMed,Embase,The Cochrane Library,CNKI,VIP and WanFang databases were searched to collect the randomized controlled trials(RCTs)related to the treatment of COPD,which were divided into the experimental group(single-inhaler triple therapy)and the control subgroups[inhaled glucocorticoid/long-actingβ2-agonists(LABA)group,LABA/long-acting anticholinergic drugs group,open triple group].The methodology was evaluated by the Cochrane Handbook and Meta-analysis was performed by RevMan 5.3 software.Results A total of 9 RCTs and 20326 patients were included.Compared with those in the control groups,the annual acute exacerbation rate of moderate and severe in the experimental group was significantly lower[OR=0.62,95%CI(0.49,0.79),P<0.0001],the SGRQ score in the experimental group was significantly lower[MD=-0.99,95%CI(-1.58,-0.40),P=0.001],the forced expiratory volume in one second(FEV1)in the experimental group was significantly increased[MD=0.06,95%CI(0.03,0.08),P<0.00001],the incidence of adverse reactions in the experimental group was similar[OR=0.48,95%CI(0.24,0.98),P=0.04],and the incidence of pneumonia in the experimental group was similar[OR=1.20,95%CI(0.98,1.47),P=0.07].Conclusion Single-inhaler triple therapy is effective and safe in the treatment of patients with COPD,which can significantly improve patients’lung function,quality of life and treatment compliance,and indirectly reduce patients’economic burden and medication error rate.