补中益气汤治疗慢性阻塞性肺疾病稳定期有效性和安全性的系统评价与Meta分析  

Systematic review and Meta-analysis on efficacy and safety of Buzhong Yiqi Decoction for stable chronic obstructive pulmonary disease

作　　者：范艺龄 苗青[1] 廖星[2] 樊长征[1] 樊茂蓉[1] 曹庆 王宁[1] 马秋晓 郝娅妮 FAN Yi-ling;MIAO Qing;LIAO Xing;FAN Chang zheng;FAN Mao-rong;CAO Qing;WANG Ning;MA Qiu-xiao;HAO Ya-ni(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Bejing 100700,China;Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中国中医科学院中医临床基础医学研究所循证医学基础研究室,北京100700 [3]北京中医药大学,北京100029

出　　处：《中国中药杂志》2020年第22期5344-5355,共12页China Journal of Chinese Materia Medica

基　　金：中国中医科学院“十三五”重点领域研究重点项目(Z0545);首都临床特色应用研究专项(Z171100001017107);中国宋庆龄基金会慢阻肺临床研究专项(2018MZFZY-010)。

摘　　要：为评价补中益气汤治疗慢性阻塞性肺疾病(COPD)稳定期有效性和安全性。该研究系统检索三大英文数据库和四大中文数据库,检索时间均从建库至2020年8月1日,根据预先确定的纳排标准筛选相关的随机对照试验(RCT),并提取资料。采用"Cochrane偏倚风险评估工具"对所纳入研究进行方法学质量评价。应用RevMan 5.3软件进行数据分析。结果共检索出389篇文献,最终纳入18个RCTs,总样本量1 566例,纳入研究总体质量不高。Meta分析结果显示,在提高6 min步行距离(6MWD),延缓第1秒用力呼气容积(FEV1)或其占预计值%、FEV1与用力肺活量(FVC)之比(FEV1/FVC)下降方面,补中益气汤单用或联合西医常规治疗均优于单独使用西医常规治疗。亚组分析显示,在降低中医症状积分方面,补中益气汤联合常规治疗优于单独使用常规治疗;在降低改良版英国医学研究委员会呼吸问卷(mMRC)分级方面,补中益气汤联合常规治疗优于单独使用常规治疗;在提高6MWD方面,补中益气汤联合常规治疗或噻托溴铵粉吸入剂优于单独使用常规治疗或噻托溴铵粉吸入剂;在延缓FEV1或其占预计值%下降方面,补中益气汤联合常规治疗或沙美特罗替卡松粉吸入剂或噻托溴铵粉吸入剂优于单独使用常规治疗或沙美特罗替卡松粉吸入剂或噻托溴铵粉吸入剂,且补中益气汤单用亦优于单独使用茶碱类药物;在延缓FEV1/FVC下降方面,补中益气汤联合常规治疗优于单独使用常规治疗,补中益气汤单用优于单独使用茶碱类药物。其他结局指标,由于仅纳入1项研究,无法进行Meta分析,而无法得出结论。由于部分研究未提及不良反应,故不能对补中益气汤单用或联合西医常规治疗的安全性作出肯定性评价。受纳入文献质量、数量的限制,该研究所得结论尚需谨慎对待,补中益气汤治疗COPD稳定期的有效性仍需更多高质量的研究去证实,且其安全性有�To systematically review the efficacy and safety of Buzhong Yiqi Decoction in the treatment of stable chronic obstructive pulmonary disease(COPD) at the stable stage. Three English databases and four Chinese databases were systematically searched from the database establishment to August 1, 2020. Randomized controlled trials(RCTs) were screened according to the pre-determined inclusion and exclusion criteria, and then the data were extracted. Methodological quality of the included studies was assessed based on Cochrane bias risk tool, and RevMan 5.3 was used for data analysis. A total of 389 articles were retrieved and finally 18 RCTs were included in this study, involving 1 566 patients, and the overall quality of the included studies was not high. Meta-analysis showed that, in terms of improving 6-minute walk distance(6 MWD), and delaying the decline of forced expiratory volume in one second(FEV1) or its % in the expected value as well as the decline in ratio of FEV1 to forced vital capacity(FVC), Buzhong Yiqi Decoction alone or in combination with conventional Western medicine was superior to conventional therapy Western medicine alone. Subgroup analysis showed that, in terms of reducing traditional Chinese medicine symptom scores, Buzhong Yiqi Decoction combined with conventional treatment was superior to conventional treatment. In terms of reducing the grade of modified medical research council(mMRC), Buzhong Yiqi Decoction combined with conventional treatment was superior to conventional treatment. In terms of improving 6 MWD, Buzhong Yiqi Decoction combined with conventional treatment or Tiotropium Bromide Powder for Inhalation was superior to conventional treatment alone or Tiotropium Bromide Powder for Inhalation alone. In terms of delaying the decline of FEV1 or its % in the expected value, Buzhong Yiqi Decoction combined with conventional treatment or Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation or Tiotropium Bromide Powder for Inhalation was superior to conventional treatment

关 键 词：补中益气汤 慢性阻塞性肺疾病稳定期 系统评价 META分析 有效性 安全性 

分 类 号：R259[医药卫生—中西医结合]