扶正祛邪法治疗COPD稳定期有效性系统评价与Meta分析

Systematic Review and Meta-analysis on the Effectiveness of Tonifying Healthy Qi and Removing Pathogenic Factors Method in the Treatment of COPD at Stable Stage

目的系统评价扶正祛邪法中药复方联合西医常规措施治疗慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)稳定期患者的有效性。方法全面检索6个电子数据库中关于扶正祛邪法中药复方联合西医常规治疗COPD稳定期的随机对照试验。检索范围为2010年1月—2020年1月。文献的筛选、数据的提取及偏倚风险的评估由两名研究者独立进行,若有分歧则通过协商解决。本研究关注的主要结局指标包括总有效率、肺功能、血气分析、主要症状与生活质量改善情况。文章将采用Revman 5.3软件进行Meta分析。结果本研究最终纳入33篇符合纳入标准的随机对照试验,共包括2770例COPD稳定期患者,其中治疗组患者1384例,对照组患者1386例。临床研究整体的研究质量不高。Meta分析结果显示,与西医常规干预措施相比,扶正祛邪中药复方联合西医常规治疗具有较好的临床疗效,能够改善COPD稳定期患者肺功能[一秒用力呼气容积占预计值百分比(FEV1%pred)、用力肺活量(FVC)、一秒率(FEV1/FVC)]、血气分析[血氧分压(PaO2)、动脉血二氧化碳分压(PaCO2)]、中医症状(咳嗽积分及咳痰积分)、六分钟步行试验(6MWT)、圣乔治呼吸调查问卷(SGRQ)、慢性阻塞性肺病评估量表(CAT)、慢性阻塞性肺病预后(BODE)指数、改良呼吸困难评分(mMRC)等指标。结论扶正祛邪中药复方联合西医常规措施治疗COPD稳定期患者具有较好的临床疗效。未来需要更多的大样本、多中心、研究设计严谨的高质量随机对照试验进行更精确的评估。

Objective To systematically evaluate the efficacy of Chinese medicine based on tonifying healthy Qi and removing pathogenic factors method combined with conventional Western medicine in the treatment of stable COPD patients.Methods A total of 7 electronic databases were searched for randomized controlled trials on the treatment of COPD in stable stage with traditional Chinese medicine and Western medicine.The retrieval range was from January 2010 to January 2020.Literature screening,data extraction and bias risk assessment were conducted independently by the two researchers.If there were differences,they would be resolved through negotiation.The main outcome indicators of this study included total effective rate,lung function,blood gas analysis,main symptoms and improvement of quality of life.This paper will use Revman 5.3 software for meta-analysis.Results Finally,33 randomized controlled trials were included,including 2770 stable COPD patients,including 1384 patients in the treatment group and 1386 patients in the treatment group.The overall quality of clinical research was not high.the results of meta-analysis showed that compared with conventional Western medicine intervention measures,Chinese medicine based on tonifying healthy Qi and removing pathogenic factors method combined with routine Western medicine had better clinical efficacy,which could improve lung function(FEV1%,FVC,FEV1/FVC),blood gas analysis(PaO2,PaCO2),TCM symptoms(cough score and expectoration score),6 MWT,SGRQ,cat,BODE index,MMRC score and other indicators in stable COPD patients.Conclusion Chinese medicine based on tonifying healthy Qi and removing pathogenic factors method combined with conventional western medicine has good clinical effect in the treatment of stable COPD.In the future,more high-quality randomized controlled trials with large sample,multi center and rigorous design are needed for more accurate evaluation.