目的 系统评价百令胶囊治疗慢性阻塞性肺疾病(COPD)稳定期患者的临床疗效和安全性。方法 检索 PubMed、Embase、Web of Science、Cochrane Library、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普中文期刊全文数据库(VIP)、万方数据库等数据库,筛选并纳入 2022 年 9 月 20 日以前发表的百令胶囊联合常规疗法治疗COPD 稳定期患者的随机对照试验(RCT),采用 Cochrane 风险评价对纳入研究进行质量评价,然后用 RevMan 5.4 软件对临床疗效指标进行 Meta 分析。结果 共纳入 14 项 RCTs,1 082 例患者。Meta 分析结果显示,与对照组比较,常规治疗加用百令胶囊可提高患者 1 秒钟用力呼气容积(FEV₁)[MD=0.37,95%CI(0.19,0.56),P<0.000 01]、肺活量(FVC)[MD=0.32,95%CI(0.14,0.49),P=0.000 4]、FEV₁/FVC[MD=5.33,95%CI(3.36,7.29),P<0.000 01],延长 6 分钟步行距 离[MD=57.05, 95%CI (45.91, 68.18), P<0.000 01], 降低1年内COPD急性发作次数[MD=-1.12,95%CI(-1.54,-0.70),P<0.000 01]。所纳入的研究均未报道严重不良反应。结论 百令胶囊联合常规治疗可以改善COPD 稳定期患者的肺功能、提高患者活动能力,减少急性发作次数,且安全性较高。

Objective To systematically evaluate the clinical efficacy and safety of Bailing Capsule in the treatment of patients with stable chronic obstructive pulmonary disease (COPD). Methods The databases of PubMed, Embase, Web of Science, Cochrane Library, CNKI, CBM, VIP and Wanfang Database were searched, and the randomized controlled trials published before September 20, 2022 of Bailing Capsule combined with conventional therapy in the treatment of stable patients with COPD were screened and included. The quality of the included studies was evaluated by Cochrane risk assessment, and then the clinical efficacy indexes were analyzed by RevMan 5.4 software. Results A total of 14 RCTs involving 1 082 patients were included. Meta-analysis results showed that compared with the control group, the routine treatment plus Bailing Capsule could improve the FEV₁[MD=0.37, 95%CI (0.19,0.56), P<0.000 01], FVC[MD=0.32, 95%CI (0.14, 0.49), P=0.0004], FEV₁/FVC[MD=5.33, 95%CI (3.36, 7.29), P<0.000 01], prolong the 6-minute walking distance[MD=57.05, 95%CI (45.91, 68.18), P<0.000 01], reduce the number of COPD acute attacks within one year[MD=-1.12, 95%CI (-1.54, -0.70), P<0.000 01]. No serious adverse reactions were reported in the included studies. Conclusion Bailing Capsule combined with routine treatment can improve pulmonary function, improve patient's activity ability, reduce the number of acute attacks, and has high safety.

R286.4

国家自然科学基金面上项目(82074367);中日友好医院横向课题(2018-HX-96)