固肾定喘丸治疗慢性阻塞性肺疾病的有效性和安全性的系统评价

A Systematic Review of Efficacy and Safety of Gushen Dingchuan Pills in the Treatment of Chronic Obstructive Pulmonary Disease

目的评价固肾定喘丸治疗慢性阻塞性肺疾病的有效性和安全性。方法检索Medline、Embase、Cochrane Library和中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方医学数据库(Wanfang)、中文科技期刊数据库(维普VIP),检索时间为从各数据库建立至2020年2月,筛选及纳入固肾定喘丸单独或联合化学药物治疗慢性阻塞性肺疾病的临床随机对照试验(RCTs)。并且应用ROB量表对纳入文献逐个进行质量评价和资料提取,应用Review Manager 5.3软件,采用Meta分析的方法进行证据整合分析。结果共纳入5篇随机对照文献。固肾定喘丸联合化学药物治疗慢性阻塞性肺疾病有效率明显高于单纯常规西医治疗[RR=1.23,95%CI(1.13,1.34),P<0.00001]。肺功能方面,FEV1/FVC改善[MD=6.62,95%CI(3.77,9.47),P<0.00001],FVC[MD=0.42,95%CI(0.30,0.54),P<0.00001]、FEV1[MD=0.45,95%CI(0.33,0.57),P<0.00001]结果显示均高于单纯常规西医治疗。生活质量方面,2篇研究进行SGRO量表评分,结果显示固肾定喘丸联合治疗SGRO量表评分降低高于单纯西医治疗[MD=-7.73,95%CI(-9.36,-6.11),P<0.00001]。安全性方面,共2项研究报道了相关不良反应,1篇研究报道两组均无不良反应发生,1篇研究报道固肾定喘丸联合治疗与单纯西医治疗的不良反应差异无统计学意义(P>0.05)。结论固肾定喘丸联合治疗慢性阻塞性肺疾病可提高临床有效率,同时可改善肺功能,提高患者生活质量,不良反应较少,安全性可靠。

Objective:To evaluate the efficacy and safety of Gushen Dingchuan Pills in the treatment of chronic obstructive pulmonary disease(COPD).Methods:Medline,Embase,Cochrane Library,China Journal full-text Database(CNKI),China Biomedical Literature Database(CBM),Wanfang Medical Database(Wanfang Med),Chinese Journal of Science and Technology Database(VIP)were searched from inception to Feb 2020 to screen and include the clinical randomized controlled trials(RCTs)of Gushen Dingchuan Pills alone or in combination with chemical therapy for COPD.The quality evaluation and data extraction were carried out by using ROB scale,and meta-analysis was carried out by using Review Manager 5.3 software for evidence integration analysis.Results:A total of 5 RCTs were included.The effective rate of Gushen Dingchuan Pills combined with chemical medicine in treating COPD was significantly higher than that of conventional western medicine[RR=1.23,95%CI(1.13,1.34),P<0.00001].In terms of lung function,FEV1/FVC%[MD=6.62,95%CI(3.77,9.47),P<0.00001],FVC[MD=0.42,95%CI(0.30,0.54),P<0.00001],FEV1[MD=0.45,95%CI(0.33,0.57),P<0.00001]were all higher than those treated by western medicine alone.In the aspect of quality of life,the scores of SGRO in 2 studies showed that the scores of SGRO in the combined treatment with Gushen Dingchuan Pills were lower than those in the treatment of western medicine treatment alone[MD=-7.73,95%CI(-9.36,-6.11),P<0.00001].In the aspect of safety,2 studies reported related adverse reactions,of which 1 reported no adverse reactions occurred in both groups,the other reported no significant difference between the combined treatment of Gushen Dingchuan Pills and western medicine treatment alone(P>0.05).Conclusion:The combined treatment of Gushen Dingchuan Pills can improve the clinical effective rate of COPD;meanwhile,it can improve the lung function,improve the quality of life of patients with less adverse reactions.