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六君子汤联合西药治疗稳定期慢性阻塞性肺疾病的疗效与安全性的系统评价与Meta分析

[Systematic review and Meta-analysis on efficacy and safety of Liujunzi Decoction combined with Western medicine for stable chronic obstructive pulmonary disease].

作者信息

Yi-Ling Fan, Qing Miao, Xing Liao, Chang-Zheng Fan, Mao-Rong Fan, Qing Cao, Ning Wang, Qiu-Xiao M A, Ya-Ni Hao

机构信息

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.

出版信息

Zhongguo Zhong Yao Za Zhi. 2020 Nov;45(22):5331-5343. doi: 10.19540/j.cnki.cjcmm.20200720.501.

Abstract

To systematically review the efficacy and safety of Liujunzi Decoction combined with Western medicine in the treatment of stable chronic obstructive pulmonary disease(COPD). Three English databases and four Chinese databases were systematically searched from the database establishment to April 1, 2020. We screened randomized controlled trial(RCT) according to the pre-determined inclusion and exclusion criteria, then extracted data. Methodological quality of included studies was assessed with Cochrane bias risk evaluation tool. Data were analyzed by using RevMan 5.3. A total of 401 articles were retrieved and finally 17 RCTs were included in this study, involving 1 447 patients, and the overall quality of the included studies was not high. Meta-analysis showed that, in reducing traditional Chinese medicine symptom score, Liujunzi Decoction combined with conventional Western medicine or Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation was superior to conventional Western medicine or Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation alone. In reducing the grade of modified medical research council(mMRC), Liujunzi Decoction combined with Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation was superior to Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation alone. In reducing COPD assessment test(CAT) score, Liujunzi Decoction combined with conventional Western medicine was superior to conventional Western medicine alone. In delaying the decline of forced expiratory volume in one second(FEV_1) or % in the expected value, Liujunzi Decoction combined with conventional Western medicine or Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation was superior to conventional Western medicine or Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation alone. In delaying the decline of ratio of FEV_1 to forced vital capacity(FEV_1/FVC), Liujunzi Decoction combined with conventional Western medicine was superior to conventional Western medicine alone, but there was no statistical difference between Liujunzi Decoction combined with Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation and Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation alone. In reducing acute exacerbation rate, there was no statistical difference between Liujunzi Decoction combined with Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation and Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation alone. On the other outcome measures of Liujunzi Decoction combined with other Western medicine, Meta-analysis could not be conducted and conclusions due to the inclusion of only one study. In terms of the occurrence of adverse reactions, some studies did not mention, so the safety of Liujunzi Decoction combined with Wes-tern medicine could not be determined in this paper. Due to the limitations of the quality and quantity of inclu-ded studies, the efficacy of Liujunzi Decoction combined with Western medicine for COPD still needs more high-quality studies for confirmation, and its safety needs to be further verified.

摘要

系统评价六君子汤联合西药治疗稳定期慢性阻塞性肺疾病(COPD)的疗效及安全性。系统检索3个英文数据库和4个中文数据库,检索时间从建库至2020年4月1日。按照预先设定的纳入与排除标准筛选随机对照试验(RCT),然后提取数据。采用Cochrane偏倚风险评估工具对纳入研究的方法学质量进行评价。使用RevMan 5.3软件进行数据分析。共检索到401篇文献,最终纳入17项RCT,涉及1447例患者,纳入研究的整体质量不高。Meta分析结果显示,在降低中医症状评分方面,六君子汤联合常规西药或沙美特罗替卡松粉吸入剂优于单纯常规西药或沙美特罗替卡松粉吸入剂;在降低改良英国医学研究委员会(mMRC)分级方面,六君子汤联合沙美特罗替卡松粉吸入剂优于单纯沙美特罗替卡松粉吸入剂;在降低慢性阻塞性肺疾病评估测试(CAT)评分方面,六君子汤联合常规西药优于单纯常规西药;在延缓第1秒用力呼气容积(FEV₁)或其占预计值百分比下降方面,六君子汤联合常规西药或沙美特罗替卡松粉吸入剂优于单纯常规西药或沙美特罗替卡松粉吸入剂;在延缓FEV₁与用力肺活量比值(FEV₁/FVC)下降方面,六君子汤联合常规西药优于单纯常规西药,但六君子汤联合沙美特罗替卡松粉吸入剂与单纯沙美特罗替卡松粉吸入剂比较差异无统计学意义;在降低急性加重率方面,六君子汤联合沙美特罗替卡松粉吸入剂与单纯沙美特罗替卡松粉吸入剂比较差异无统计学意义。对于六君子汤联合其他西药的其他结局指标,因仅纳入1项研究无法进行Meta分析及得出结论。在不良反应发生情况方面,部分研究未提及,故本文无法确定六君子汤联合西药的安全性。由于纳入研究的质量和数量有限,六君子汤联合西药治疗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。

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