目的 系统评价中医辨证治疗慢性阻塞性肺疾病（chronic obstructive pulmonary disease，COPD）合并呼吸衰竭（respiratory failure，RF）的有效性及安全性，并对纳入研究的证候类型进行统计分析。方法 计算机检索中国知识资源总库（CNKI）、中国学术期刊数据库（Wanfang）、中文科技期刊数据库（VIP）、中国生物医学文献数据库（CBM）及PubMed、Cochrane Library、EMbase、Web of Science数据库，检索时间自建库起至2021年1月24日。按照预先设定的纳入、排除标准筛选出具有明确辨证分型的COPD合并RF的随机对照试验（randomized controlled trial，RCT）文献并提取数据，应用Cochrane协作网风险偏倚评估工具对文献方法学进行质量评价，采用Revman 5.3软件对结局指标[主要结局指标：临床有效率、病死率；次要结局指标：证候总积分、改良英国医学研究委员会呼吸困难量表（modified medical research council dyspnea scale，mMRC）评分、氧分压（pO₂）、二氧化碳分压（pCO₂）、动脉血氧饱和度（SaO₂）以及第1秒用力呼气容积（forced expiratory volume in one second，FEV1）、用力肺活量（forced vital capacity，FVC）]进行Meta分析，同时以不良反应为安全性指标评价其安全性，并对纳入研究的中医证型分布进行频次、频率统计。结果 共纳入文献34篇，涉及患者3035例，其中中医辨证治疗联合西医常规治疗组1525例，西医常规治疗组1510例。Meta分析结果显示，对比单纯西医常规治疗，中医辨证治疗联合西医常规治疗在提高临床有效率[RR=1.32，95% CI（1.21，1.44），P<0.000 01]、pO₂[MD=9.35，95% CI（7.85，10.86），P<0.000 01]、SaO₂[MD=7.08，95% CI（1.48，12.68），P=0.01]、FEV1[MD=0.48，95% CI（0.28，0.68），P<0.000 01]、FVC[MD=0.46，95% CI（0.34，0.58），P<0.000 01]方面疗效显著；在降低pCO₂[MD=-6.94，95% CI（-8.55，-5.33），P<0.000 01]、mMRC评分[MD=-0.65，95% CI（-0.76，-0.53），P<0.000 01]、证候总积分[MD=-8.53，95% CI（-9.71，-7.53），P<0.000 01]方面有一定优势，不良反应发生率较低[RR=0.37，95% CI（0.24，0.59），P<0.000 1]，但在降低病死率方面差异无统计学意义。纳入研究选择的证候类型以痰热壅肺证（37.7%）、痰湿蕴肺证（18.2%）、痰浊阻肺证（15.6%）、肺肾两虚证（15.6%）、肺脾气虚证（2.6%）多见。结论 中医辨证治疗联合西医常规治疗COPD合并RF具有较好的临床疗效，且安全性高。纳入研究证型体现了本病虚实夹杂的特点。其结果有待高质量的研究进一步验证。

Objective The efficacy and safety of TCM syndrome differentiation in the treatment of chronic obstructive pulmonary disease (COPD) complicated with respiratory failure (RF) were systematically evaluated, and the types of syndromes included in the study were statistically analyzed. Methods The randomized controlled trials (RCTs) were retrieved from CNKI, Wanfang Data, VIP Database, CBM, PubMed, Cochrane Library, Embase and Web of Science Database, from the database construction to January 24, 2021. According to preset inclusion and exclusion criteria, RCTs of COPD combined with RF with clear syndrome differentiation were screened and data were extracted. The quality of the literature methodology was evaluated using the Cochrane Collaboration Risk Bias assessment tool, and the outcome indicators were evaluated using Revman 5.3 software for Meta-analysis. The main outcome indicators included clinical response rate and fatality rate; secondary outcome indicators included total syndrome score, modified medical research council dyspnea scale (mMRC), partial oxygen pressure (pO₂), partial carbon dioxide pressure (pCO₂), arterial oxygen saturation (SaO₂), forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC). At the same time, adverse reactions were used as safety index to evaluate its safety, and the frequency and frequency statistics of the distribution of TCM syndrome types included in the study were conducted. Results A total of 34 literatures were included, involving 3035 patients, including 1525 cases in the group of TCM syndrome differentiation combined with conventional western medicine treatment, and 1510 cases in the group of conventional western medicine treatment. Meta-analysis results showed that: Compared with conventional treatment of western medicine alone, TCM syndrome differentiation combined with conventional treatment of western medicine improved the clinical effective rate [RR=1.32, 95% CI (1.21, 1.44), P<0.000 01], pO₂ [MD=9.35, 95% CI (7.85, 10.86), P<0.000 01], SaO₂ [MD=7.08, 95% CI (1.48, 12.68), P=0.01], FEV1 [MD=0.48, 95% CI (0.28, 0.68), P<0.000 01], FVC [MD=0.46, 95% CI (0.34, 0.58), P<0.000 01], significantly reduced pCO₂ [MD=-6.94, 95% CI (-8.55, -5.33), P<0.000 01], mMRC score [MD=-0.65, 95% CI (-0.76, -0.53), P<0.000 01], total syndrome score [MD=-8.53, 95% CI (-9.71, -7.53), P<0.000 01], and the incidence of adverse reactions was low [RR=0.37, 95% CI (0.24, 0.59), P<0.000 1]. But there was no statistical significance in reducing the mortality (P＞0.05). Among the syndrome types included in the study, the syndrome of phlegm-heat obstructing lung (37.7%), phlegm-dampness accumulation of lung (18.2%), phlegm-turbidity obstructing lung (15.6%), deficiency of lung and kidney (15.6%) and deficiency of lung and qi (2.6%) were the most common. Conclusion TCM syndrome differentiation combined with conventional western medicine in the treatment of COPD complicated with RF have good clinical efficacy and high safety. The syndrome types included in the study reflected the characteristics of mixed excessiveness and deficiency of the disease. The results need to be further verified by high-quality studies.

R285.64

国家自然科学基金资助项目（81973781）；河南省中医药科学研究专项课题（2019JDZX2004）；河南省特色骨干学科中医学学科建设项目（STG-ZYXKY-2020007）