目的 系统评价纳美芬治疗慢性阻塞性肺疾病（COPD）并发Ⅱ型呼吸衰竭的临床疗效和安全性。方法 检索中文学术期刊全文数据库（CNKI）、维普中文期刊全文数据库（VIP）、中国生物医学文献数据库（CBM）、万方数据库（Wanfang Data）、PubMed、Web of Science、The Cochrane Library、Embase和Wiley Online Library，检索时间均为建库至2021年4月30日，收集纳美芬（试验组）对比纳洛酮或空白对照（对照组）治疗COPD并发Ⅱ型呼吸衰竭的随机对照试验（RCTs）。由2名评价者对符合纳入的研究进行独立的质量评价、数据提取后采用RevMan 5.3软件对结局指标数据进行 Meta分析。结果 共纳入13篇RCTs，1 122例患者。Meta分析结果显示，试验组的临床有效率［RR=1.22，95% CI（1.15，1.29），P<0.01］、pH增加值［SMD=1.01，95% CI （0.67，1.34），P<0.01］、氧分压（pO₂）增加值［SMD=1.87，95% CI（1.73，2.02），P<0.01］、二氧化碳分压（pCO₂）下降值［SMD=-0.91，95% CI（-1.03，-0.78），P<0.01］、第1秒用力呼气量（FEV1）增加值［SMD=1.06，95% CI（0.87，1.25），P<0.01］均优于对照组，且未增加药物不良反应发生率 ［RR=1.50，95% CI（0.55，4.08），P>0.05］。结论 纳美芬能显著改善COPD并发Ⅱ型呼吸衰竭患者呼吸衰竭症状，改善肺功能。

Objective To systematically evaluate the efficacy and safety of nalmefene in the treatment of chronic obstructive pulmonary disease (COPD) complicated with type Ⅱ respiratory failure. Methods Data was retrieved from CNKI, VIP, Wanfang Data, CBM, PubMed, Web of Science, The Cochrane Library, Embase, Wiley Online Library until the 30 th January 2021. Screening a randomized controlled trial (RCT) of nalmefene (experimental group) vs naloxone or blank control (control group) in the treatment of COPD complicated with type Ⅱ respiratory failure. Two reviewers conducted independent quality evaluations for the included studies. After data extraction, RevMan 5.3 software was used for Meta-analysis. Results A total of 13 RCTs and 1 122 patients were included. Meta-analysis results showed that the nalmefene group in the clinical effective rate [RR= 1.22, 95%CI (1.15, 1.29), P<0.01], pH arise [SMD= 1.01, 95%CI (0.67, 1.34), P<0.01], pO₂ arise [SMD= 1.87, 95%CI (1.73, 2.02), P<0.01], pCO₂ decline [SMD= -0.91, 95%CI (-1.03, -0.78), P<0.01], FEV1 arise [SMD= 1.06, 95%CI (0.87, 1.25), P<0.01] were better than those of the control group, and the incidence of adverse drug reactions was not increased [RR= 1.50, 95%CI (0.55, 4.08), P>0.05]. Conclusion Nalmefene can significantly improve the respiratory symptoms of COPD patients with type Ⅱ respiratory failure, improve lung function.

R974;R969.3

河北省衡水市科技计划（2016014092Z）