百令胶囊治疗慢性阻塞性肺疾病稳定期患者临床疗效及安全性的系统评价

Systematic evaluation of clinical efficacy and safety of Bailing Capsule in treatment of chronic obstructive pulmonary disease at stable period

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,1082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<0.00001]、肺活量(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<0.00001],延长6分钟步行距离[MD=57.05,95%CI(45.91,68.18),P<0.00001],降低1年内COPD急性发作次数[MD=-1.12,95%CI(-1.54,-0.70),P<0.00001]。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 1082 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<0.00001],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<0.00001],prolong the 6-minute walking distance[MD=57.05,95%CI(45.91,68.18),P<0.00001],reduce the number of COPD acute attacks within one year[MD=-1.12,95%CI(-1.54,-0.70),P<0.00001].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.