布地格福吸入气雾剂治疗慢性阻塞性肺疾病患者的系统性评价  

Systematic review on budegfort inhalation aerosol in treatment of chronic obstructive pulmonary disease

作　　者：姜爱雯[1] 张瑞雪 赵学萍 陈丽萍[3] 蒲洁琨 杜佩珊 Jiang Ai-wen;Zhang Rui-xue;Zhao Xue-ping;Chen Li-ping;Pu Jie-kun;Du Pei-shan(Department of Pharmacy,the First Affiliated Hospital of Hebei North University,Zhangjiakou 075000,China;College of Pharmacy,Hebei North University,Zhangjiakou 075000,China;Department of Respiratory and Critical Care Medicine,the First Affiliated Hospital of Hebei North Usniversity,Zhangjiakou 075000,China;Department of Cardiac Rehabilitation,Zhangjiakou First Hospital,Zhangjiakou 075000,China)

机构地区：[1]河北北方学院附属第一医院药学部,张家口075000 [2]河北北方学院药学院,张家口075000 [3]河北北方学院附属第一医院呼吸与危重症医学科,张家口075000 [4]张家口市第一医院心脏康复科,张家口075000

出　　处：《中国药物应用与监测》2025年第1期185-188,共4页Chinese Journal of Drug Application and Monitoring

基　　金：张家口市2021年市级科技计划项目(2121162D)。

摘　　要：目的系统评价布地格福吸入气雾剂治疗慢性阻塞性肺疾病(COPD)的临床疗效和安全性。方法通过计算机检索PubMed、Clinical Trails.gov、中国生物医学文献数据库、中国知网、万方数据库、维普数据库等(检索时间为建库至2024年1月),收集布地格福吸入气雾剂治疗COPD的临床疗效和安全性的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取和质量评价,采用RevMan 5.3统计软件进行Meta分析。结果最终纳入11项RCT,共3113例患者,Meta分析结果显示,布地格福吸入气雾剂在临床有效率(RR=1.12,95%CI=1.06~1.17,P<0.01)、用力肺活量(MD=0.37,95%CI=0.14~0.61,P=0.01)、1秒率(MD=6.82,95%CI=4.23~9.40,P<0.01)、COPD疾病评分(CAT)(MD=-4.29,95%CI=-7.22~-1.37,P=0.004)、圣乔治呼吸问卷(SGRQ)分值(MD=-7.12,95%CI=-12.46~-1.77,P=0.009)均高于对照组,差异具有统计学意义;两组患者在第1秒用力呼气容积(FEV_(1))(RR=1.00,95%CI=0.96~1.04,P=0.96)、不良反应发生率(RR=1.13,95%CI=0.95~1.33,P=0.16)及严重不良反应发生率(RR=0.64,95%CI=0.35~1.17,P=0.15)差异无统计学意义。结论基于目前的证据,在治疗COPD方面,布地格福吸入气雾剂临床疗效更好且安全性高。Objective To systematically evaluate the efficacy and safety of budegfort inhalation aerosol in the treatment of chronic obstructive pulmonary disease.Methods A search was performed in databases including PubMed,Clinical Trails.gov,CBM,CNKI,Wanfang and VIP to collect randomized controlled trials(RCT)of clinical efficacy and safety about budegfort inhalation aerosol for COPD,the retrieval time was from database establishment to Jan.2024.After data extraction and quality evaluation,Meta-analysis was carried out by RevMan 5.3 statistical software.Results A total of 11 RCT including 3113 patients were enrolled.Meta-analysis showed that the total effective rate(RR=1.12,95%CI=1.06-1.17,P<0.01),forced vital capacity(MD=0.37,95%CI=0.14-0.61,P=0.01),FEV1/FVC(MD=6.82,95%CI=4.23-9.40,P<0.01),CAT(MD=-4.29,95%CI=-7.22--1.37,P=0.004)and SGRQ score(MD=-7.12,95%CI=-12.46--1.77,P=0.009)in the budegfort inhalation aerosol group were higher than those in the control group,showing statistically significant differences.There were no significant differences in the FEV_(1)(RR=1.00,95%CI=0.96-1.04,P=0.96),the incidence of adverse drug reactions(RR=1.13,95%CI=0.95-1.33,P=0.16)and serious adverse drug reactions(RR=0.64,95%CI=0.35-1.17,P=0.15)between the two groups.Conclusion Based on current evidence,budegfort inhalation aerosol shows better clinical efficacy and comparable safety in the treatment of COPD.

关 键 词：布地格福吸入气雾剂 慢性阻塞性肺疾病 META分析 

分 类 号：R563.9[医药卫生—呼吸系统]