Liang Rui, Liu Dong, Li Haobo, Yan Yue, Xie Wanmu, Zhai Zhenguo
Beijing University of Chinese Medicine China-Japan Friendship School of Clinical Medicine, Beijing, China.
National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.
J Thorac Dis. 2024 Sep 30;16(9):5923-5935. doi: 10.21037/jtd-24-471. Epub 2024 Sep 26.
There is currently no effective treatment for the majority of patients with chronic obstructive pulmonary disease combined with pulmonary hypertension (COPD-PH). Numerous clinical trials have demonstrated the use of traditional Chinese medicine (TCM) herbal formulas in combination with routine western pharmacotherapy (WP) for the treatment of COPD-PH, with positive results. This meta-analysis was designed to evaluate the efficacy and safety of TCM herbal formulas in the treatment of COPD-PH.
A systematic literature search was conducted using Web of Science, PubMed, Chinese National Knowledge Infrastructure (CNKI), WanFang, and Chinese Science and Technology Journal (VIP) from database inception until October 2023. The primary outcome was pulmonary artery pressure parameters, including pulmonary artery systolic pressure (PASP) and mean pulmonary artery pressure (mPAP). Secondary outcomes included pulmonary ventilation function parameters, such as forced expiratory volume in one second (FEV1) and the ratio of FEV1 to forced vital capacity (FEV1/FVC%), as well as functional capacity assessments measured by the six-minute walk distance (6MWD). Reviewer Manager software was used for both random-effects and fixed-effects meta-analyses. We registered the protocol for this study with the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY, registry number: INPLASY2022100041).
Twenty randomized control trials with a total of 1,865 patients were included in the meta-analysis. The results of our meta-analysis revealed that TCM herbal formulas in combination with basic WP significantly reduced pulmonary artery pressure in patients with COPD-PH, including PASP [mean difference (MD) =-4.50 mmHg, 95% confidence interval (CI): -6.04, -2.95] and mPAP (MD =-4.47 mmHg, 95% CI: -5.07, -3.88). Additionally, pulmonary ventilation function and 6MWD (MD =48.13 m, 95% CI: 39.92, 56.34) were also improved in COPD-PH patients. Pulmonary ventilation function was reflected by FEV1 (MD =0.83 L, 95% CI: 0.35, 1.30) and FEV1/FVC% (MD =4.76, 95% CI: 3.75, 5.77). A total of six studies reported adverse events in detail, and all claimed that no adverse events were observed in COPD-PH patients using TCM herbal formulas.
The combination of TCM herbal formulas and basic WP might be more effective in improving the quality of life and exercise capacity of patients with COPD-PH than basic WP alone. However, the firm conclusions of our study were hampered by the low quality of the evidence.
目前，大多数慢性阻塞性肺疾病合并肺动脉高压（COPD-PH）患者尚无有效的治疗方法。大量临床试验表明，中药方剂联合常规西医药物疗法（WP）治疗COPD-PH，效果良好。本荟萃分析旨在评估中药方剂治疗COPD-PH的疗效和安全性。
从数据库建立至2023年10月，通过Web of Science、PubMed、中国知网（CNKI）、万方和维普资讯（VIP）进行系统的文献检索。主要结局指标为肺动脉压力参数，包括肺动脉收缩压（PASP）和平均肺动脉压（mPAP）。次要结局指标包括肺通气功能参数，如一秒用力呼气容积（FEV1）以及FEV1与用力肺活量的比值（FEV1/FVC%），还有通过六分钟步行距离（6MWD）进行的功能能力评估。使用Reviewer Manager软件进行随机效应和固定效应荟萃分析。我们已在国际注册系统评价和荟萃分析方案平台（INPLASY，注册号：INPLASY2022100041）上注册了本研究方案。
荟萃分析纳入了20项随机对照试验，共1865例患者。我们的荟萃分析结果显示，中药方剂联合基础WP可显著降低COPD-PH患者的肺动脉压力，包括PASP[平均差值（MD）=-4.50 mmHg，95%置信区间（CI）：-6.04，-2.95]和mPAP（MD=-4.47 mmHg，95%CI：-5.07，-3.88）。此外，COPD-PH患者的肺通气功能和6MWD（MD=48.13 m，95%CI：39.92，56.34）也有所改善。肺通气功能通过FEV1（MD=0.83 L，95%CI：0.35，1.30）和FEV1/FVC%（MD=4.76，95%CI：3.75，5.77）反映。共有6项研究详细报告了不良事件，所有研究均称使用中药方剂的COPD-PH患者未观察到不良事件。
与单纯基础WP相比，并使用中药方剂可能更有效地改善COPD-PH患者的生活质量和运动能力。然而，本研究的确切结论因证据质量低而受到影响。
