目的 系统评价在常规西药治疗基础上加用健脾益气类中药在改善COPD稳定期肺脾气虚证患者运动耐力方面的有效性和安全性。方法 检索万方、维普、CNKI、SinoMed、Embase、PubMed及Cochrane Library数据库，包括在ClinicalTrials.gov及ChiCTR注册的临床研究。纳入对比常规西药治疗基础上加用健脾益气类中药与常规西药治疗在改善COPD稳定期肺脾气虚证患者临床疗效方面差异的随机对照试验，选择6 min步行距离为主要结局，肺功能、呼吸困难症状评分、BODE指数、BMI及临床有效率为次要结局，同时记录不良事件发生情况。使用RoB-2工具进行偏倚风险评估，RevMan软件（5.4.1版本）进行Meta分析，GRADE pro GDT进行证据质量评价。结果 共纳入42项随机对照试验（3214名患者），纳入研究质量总体偏低，与对照组相比，COPD稳定期肺脾气虚证患者在吸入型支气管舒张剂治疗基础上辨证应用健脾益气类中药治疗，可增加6 min步行距离，MD=30.22m，95% CI为［24.41，36.02］（中等质量证据）。在降低呼吸困难症状评分、改善肺功能、降低BODE指数、提升BMI水平方面差异也存在统计学意义。纳入研究未报道严重不良反应。结论 COPD稳定期肺脾气虚证患者在运动耐力方面可从健脾益气类中药联合西药治疗中获益。

Objectives To explore the effectiveness and safety of TCM herbal medicine of invigorating the Spleen and supplementing Qi for improving exercise tolerance in stable COPD patients with Lung and Spleen Qi Deficiency Syndrome (LSQDS).Methods We searched Wanfang Data, CNKI, VIP, SinoMed, PubMed, Embase and Cochrane Library for articles, theses and conference papers, as well as ClinicalTrials.gov, ChiCTR for registered trials. We included RCTs comparing combination therapy (TCM herbal medicine of invigorating the Spleen and supplementing Qi plus inhaled bronchodilators) versus standard control (inhaled bronchodilators only) in stable COPD patients with LSQDS. 6MWD was the primary outcome, while pulmonary function, symptom scores, BODE index, BMI, and effective rate were secondary outcomes. Adverse events were also recorded. Risk of bias were evaluated with RoB-2 tool. Data synthesis and analysis were on RevMan software (version 5.4.1). Quality of evidence was assessed using GRADE pro GDT.Results 42 RCTs of 3214 participants were included to evaluate the additional effects of TCM. Qualities of the studies included were in low grades generally. Compared with bronchodilators only, the addition of TCM herbal therapy can improve patients'' 6MWD of about 30.22m, 95%CI [24.41, 36.02] (moderate-quality evidence). Other outcomes including symptom scores, pulmonary function, BMI and BODE index can also benefit from combination therapy. No serious adverse event was reported.Conclusions Stable COPD patients with LSQDS could benefit from the addition of TCM herbal therapy in exercise tolerance.

AR2-031

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