Yi-Ling Fan, Qing Miao, Xing Liao, Chang-Zheng Fan, Mao-Rong Fan, Qing Cao, Ning Wang, Qiu-Xiao M A, Ya-Ni Hao
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 Beijing 100700, China.
Xiyuan Hospital, China Academy of Chinese Medical Sciences Beijing 100091, China.
Zhongguo Zhong Yao Za Zhi. 2020 Nov;45(22):5344-5355. doi: 10.19540/j.cnki.cjcmm.20200904.501.
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(FEV_1) or its % in the expected value as well as the decline in ratio of FEV_1 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 FEV_1 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 or Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation or Tiotropium Bromide Powder for Inhalation alone, and Buzhong Yiqi Decoction alone was superior to Theophylline alone. In terms of delaying the decline in FEV_1/FVC, Buzhong Yiqi Decoction combined with conventional treatment was superior to conventional treatment, and Buzhong Yiqi Decoction alone was superior to Theophylline alone. Meta-analysis of other outcome measures was not available and no conclusion can be drawn due to the inclusion of only one study. As some studies did not mention the adverse reactions, no safety comments can be made for Buzhong Yiqi Decoction alone or combined with conventional Western medicine. Due to the limitations of the quality and quantity of included studies, the conclusions of this research should be treated with caution. The efficacy of Buzhong Yiqi Decoction for stable COPD still needs more high-quality studies for confirmation, and its safety needs to be further verified.
系统评价补中益气汤治疗稳定期慢性阻塞性肺疾病（COPD）的疗效和安全性。从数据库建立至2020年8月1日，系统检索3个英文数据库和4个中文数据库。根据预先设定的纳入和排除标准筛选随机对照试验（RCT），然后提取数据。基于Cochrane偏倚风险工具评估纳入研究的方法学质量，并用RevMan 5.3进行数据分析。共检索到389篇文献，最终纳入18项RCT，涉及1 566例患者，纳入研究的总体质量不高。Meta分析结果显示，在改善6分钟步行距离（6MWD）、延缓第一秒用力呼气容积（FEV_1）及其占预计值百分比的下降以及FEV_1与用力肺活量（FVC）比值的下降方面，补中益气汤单独使用或联合西医常规治疗优于单纯西医常规治疗。亚组分析显示，在降低中医症状评分方面，补中益气汤联合常规治疗优于常规治疗；在降低改良英国医学研究委员会（mMRC）分级方面，补中益气汤联合常规治疗优于常规治疗；在改善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纯常规治疗或单纯噻托溴铵粉吸入剂；在延缓FEV_1及其占预计值百分比的下降方面，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纯常规治疗或单纯沙美特罗替卡松粉吸入剂或单纯噻托溴铵粉吸入剂，且补中益气汤单独使用优于氨茶碱单独使用；在延缓FEV_1/FVC下降方面，补中益气汤联合常规治疗优于常规治疗，且补中益气汤单独使用优于氨茶碱单独使用。对其他结局指标的Meta分析因仅纳入1项研究而无法进行，无法得出结论。由于部分研究未提及不良反应，故无法对补中益气汤单独使用或联合西医常规治疗的安全性作出评价。鉴于纳入研究的质量和数量存在局限性，本研究结论应谨慎对待。补中益气汤治疗稳定期COPD的疗效仍需更多高质量研究证实，其安全性有待进一步验证。
