Li Jiansheng, Xie Yang, Wang Minghang, Li Suyun, Yu Xuefeng, Zhang Nianzhi, Zhu Zhengang, Zhang Wei, Feng Jihong, Sun Zikai, Lin Lin, Sun Zhijia, Zhang Hailong, Yu Xueqing
Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, No. 156 Jin-shui East Road, Zhengzhou, 450046, Henan, People's Republic of China.
Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, 450046, Henan, People's Republic of China.
Chin Med. 2025 May 20;20(1):66. doi: 10.1186/s13020-025-01117-x.
Traditional Chinese medicine (TCM) is widely used in the management of chronic obstructive pulmonary disease (COPD). This study aimed to evaluate the clinical efficacy of comprehensive therapy based on TCM patterns for patients with stable, severe to very severe COPD.
A multicenter, randomised, double-blind, placebo-controlled trial was conducted. Eligible patients were randomly allocated in equal proportions to two groups: the trial group, which received TCM-based therapy with Bu-Fei Jian-Pi, and Bu-Fei Yi-Shen, and Yi-Qi Zi-Shen granules tailored to TCM syndromes, and the control group, which received a placebo resembling Chinese medicine. Both groups also received conventional Western medicine as part of their treatment. Acute exacerbations (AEs), lung function, dyspnea scores, the 6-min walking test (6MWT), and the COPD assessment test (CAT) were assessed over 12 months of treatment, with an additional 12 months of follow-up.
A total of 467 patients were included in the analysis with 228 in the experimental group and 239 in the control group. The Chinese herbal granules group significantly reduced AEs (0.63 vs. 1.03 events, P = 0.002), improved mMRC scores (-0.17 points, 95% CI -0.30 to -0.03; P = 0.015), 6MWT (29.24 m, 95% CI 10.71-47.77; P = 0.002), and CAT (-3.11 points, 95% CI -4.13 to -2.09, P < 0.001), compared with the control group. No significant differences were observed between the two groups in terms of FVC (l) and FEV (both in litres and as percentage).
Comprehensive therapy based on TCM patterns demonstrated efficacy in patients with severe to very severe COPD, reducing the frequency of AEs, improving dyspnea and exercise capacity, and alleviating symptoms.
ClinicalTrials.gov, NCT02270424. Registered 17 October 2014, https://clinicaltrials.gov/study/NCT02270424?id=NCT02270424&rank=1 .
中医广泛应用于慢性阻塞性肺疾病（COPD）的管理。本研究旨在评估基于中医证型的综合疗法对稳定期重度至极重度COPD患者的临床疗效。
进行了一项多中心、随机、双盲、安慰剂对照试验。符合条件的患者按等比例随机分为两组：试验组接受基于中医的补肺健脾、补肺益肾以及根据中医证候定制的益气滋肾颗粒治疗，对照组接受形似中药的安慰剂治疗。两组均接受常规西药作为治疗的一部分。在12个月的治疗期间及额外12个月的随访中，评估急性加重（AE）、肺功能、呼吸困难评分、6分钟步行试验（6MWT）和慢性阻塞性肺疾病评估测试（CAT）。
共有467例患者纳入分析，试验组228例，对照组239例。与对照组相比，中药颗粒组显著减少了急性加重次数（0.63次对1.03次，P = 0.002），改善了改良英国医学研究委员会（mMRC）评分（-0.17分，95%可信区间-0.30至-0.03；P = 0.015）、6MWT（29.24米，95%可信区间10.71 - 47.77；P = 0.002）和CAT（-3.11分，95%可信区间-4.13至-2.09，P < 0.001）。两组在用力肺活量（FVC，升）和第一秒用力呼气容积（FEV，升及百分比）方面未观察到显著差异。
基于中医证型的综合疗法对重度至极重度COPD患者显示出疗效，减少了急性加重的频率，改善了呼吸困难和运动能力，并缓解了症状。
ClinicalTrials.gov，NCT02270424。2014年10月17日注册，https://clinicaltrials.gov/study/NCT02270424?id=NCT02270424&rank=1 。
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