真实世界研究中经支气管镜单向活瓣肺减容术治疗重度异质性肺气肿的疗效与安全性分析  

Efficacy and safety of Zephyr Endobronchial Valve for the treatment of Heterogeneous Emphysema based on Real world Study

作　　者：谢秀芳[1] 李先华[1] 李兴明[1] 黄勇 冯起校 王宪刚[1] 罗进[1] 魏冲 刘劲燕 XIE Xiu-fang;LI Xian-hua;LI Xing-ming;HUANG Yong;FENG Qi-xiao;WANG Xian-gang;LUO Jin;WEI Chong;LIU Jin-yan(Department of Respiratory and Critical Care Medicine,The First People's Hospital of Neijiang,Neijiang,Sichuan 641000,China;Department of Respiratory and Critical Care Medicine,Chongqing People's Hospital,Chongqing 401000,China;Department of Respiratory and Critical Care Medicine,Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University,Guangzhou,Guangdong 510000,China)

机构地区：[1]重庆医科大学内江附属医院/内江市第一人民医院呼吸与危重症医学科,四川内江641000 [2]重庆市人民医院呼吸与危重症医学科,重庆401000 [3]南方医科大学中西医结合医院呼吸与危重症医学科,广东广州510000

出　　处：《临床肺科杂志》2023年第3期345-352,共8页Journal of Clinical Pulmonary Medicine

基　　金：四川省卫生健康委员会重点研究项目(No.17ZD003)。

摘　　要：目的 评价真实世界经支气管镜置入单向活瓣(Zephyr EBV)肺减容术治疗中国无旁路通气重度异质性肺气肿患者的疗效与安全性。方法 该研究是一项真实世界多中心、前瞻性队列研究,纳入2017年4月1日至2020年4月1日在中国3个中心收治的重度异质性肺气肿患者,分为EBV治疗组及标准药物治疗组(SOC)组。研究的主要终点是治疗12个月吸入支气管扩张剂后两组受试者与基线相比FEV1改善≥15%的比率。次要终点为两组受试者一年后FEV1、六分钟步行距离(6-MWD)、圣乔治呼吸问卷(SGRQ)评分的变化。结果 60名受试者被纳入研究,EBV组20例,SOC组40例。治疗12个月时,55%的EBV受试者和25%的SOC受试者FEV1改善≥15%(P<0.001),两组间绝对差值为30.0%,RR:2.2 [95%CI:22.84%~57.16%;P<0.001意向性分析],差异有显著统计学意义。从基线到治疗后12个月,EBV组FEV1、6-MWD、SGRQ评分等各项观察指标均优于SOC组(均P<0.05)。结论 真实世界研究中,经支气镜置入Zephyr EBV显著改善中国无旁路通气重度异质性肺气肿患者的肺功能、提高患者活动耐受性、改善生活质量。Objective To assess the efficacy and safety of Zephyr valve Endobronchial Valve(EBV) for treating Chinese patients with severe heterogeneous emphysema without collateral ventilation based on Real world Study.Methods The study was a real-world multicenter, prospective cohort study of patients with severe heterogeneous emphysema admitted to three centers in China from April 1, 2017, to April 1, 2020, who were assigned to the EBV treatment group and the standard drug treatment group(SOC).The subjects from the SOC group received Standard-of-Care;those with EBV underwent placement of Zephyr EBV valves during the same session. The primary outcome was the percentage of subjects who showed improvement in the post-bronchodilator(post-BD) FEV1of ≥15% after 1-year follow-up. Secondary endpoints were: the difference between an absolute change in FEV1, Six-Minute Walk Distance(6MWD), and St.George’s Respiratory Questionnaire(SGRQ) after 12months.Results A total of 60 subjects(20 EBV, and 40 SOC) were included. At 12 months of treatment, 55% of EBV subjects and 25% of SOC subjects showed an FEV1≥15%(P<0.001),and the absolute difference between the two groups was 30.0%, RR:2.2 [95% CI: 22.84% to 57.16%;P<0.001;Intention-to-Treat], the difference was statistically significant.From baseline to 12 months after treatment,FEV1,6-MWD,and SGRQ scores in the EBV group were better than those in the SOC group(All P<0.05).Conclusion In a real-world study,Zephyr valve EBV can improve lung function,dyspnea,and quality of lifein Chinese patients with severe heterogeneous emphysema without bypass ventilation.

关 键 词：支气管镜肺减容术 旁路通气 Zephyr单向活瓣 肺气肿 真实世界研究 

分 类 号：R563.3[医药卫生—呼吸系统]