Li Jiansheng, Wang Minghang, Xie Yang, Li Suyun, Yu Xueqing, Li Fengsen, Xue Hanrong, Li Zegeng, Zhang Nianzhi, Liu Guiying, Zhang Wei, Miao Qing, Sun ZiKai, Ge Zhenghang, Ma Zhanping, Cai Hongyan, Sun Zhijia, Zhang Hailong, Wang Yanfang
Co-Construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases, Henan and Education Ministry of China, Zhengzhou, China.
Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, China.
J Evid Based Med. 2025 Jun;18(2):e70023. doi: 10.1111/jebm.70023.
Chronic obstructive pulmonary disease (COPD) is a critical disease, with lung function closely linked to disease severity. This study aimed to evaluate the clinical efficacy of treatments for stable COPD in patients with pulmonary function Grades I and II.
We conducted a multicenter, randomized, double-blind, placebo-controlled trial (registration number: NCT01486186). A total of 502 patients were randomly assigned to an experimental group (n = 251, treated with Bufei, Bufei Jianpi, and Bufei Yishen granules based on traditional Chinese medicine [TCM] syndromes) and a control group (n = 251, treated with a Chinese medicine-based placebo). Acute exacerbations (AEs), lung function, clinical symptoms, 6-min walking distance (6MWD), and dyspnea were assessed over 12 months of treatment and 12 months of follow-up.
A total of 432 patients, including 214 and 218 patients in the experimental and control groups, respectively, completed the trial. The early treatment group had fewer AEs (p < 0.05), better clinical symptom scores (p < 0.05), longer 6MWD (p < 0.05), and better Modified Medical Research Council (mMRC) scores than the control group (p < 0.05). No significant differences were found in forced vital capacity (FVC) and forced expiratory volume in first second (FEV1%) between the two groups, but there was a significant difference in FEV1 and the annual rate of FEV1 decline between the groups over 2 years (p < 0.05).
Treatment with TCM for stable COPD significantly reduced AEs, increased the 6MWD, and alleviated dyspnea in patients with pulmonary function Grades I and II. FEV1 was improved, and the slower FEV1 decline indicates a potential benefit in mitigating disease progression.
慢性阻塞性肺疾病（COPD）是一种严重疾病，其肺功能与疾病严重程度密切相关。本研究旨在评估肺功能Ⅰ级和Ⅱ级的稳定期COPD患者治疗的临床疗效。
我们进行了一项多中心、随机、双盲、安慰剂对照试验（注册号：NCT01486186）。总共502例患者被随机分配至试验组（n = 251，根据中医证候给予补肺、补脾肺、补肺益肾颗粒治疗）和对照组（n = 251，给予中药安慰剂治疗）。在12个月的治疗期和12个月的随访期内评估急性加重（AE）、肺功能、临床症状、6分钟步行距离（6MWD）和呼吸困难情况。
总共432例患者完成试验，试验组和对照组分别有214例和218例。与对照组相比，早期治疗组的AE较少（p < 0.05），临床症状评分更好（p < 0.05），6MWD更长（p < 0.05），改良医学研究委员会（mMRC）评分更好（p < 0.05）。两组间用力肺活量（FVC）和第1秒用力呼气容积（FEV1%）无显著差异，但两组间2年内的FEV1及FEV1年下降率有显著差异（p < 0.05）。
中医治疗稳定期COPD可显著减少AE，增加6MWD，并缓解肺功能Ⅰ级和Ⅱ级患者的呼吸困难。FEV1得到改善，FEV1下降较慢表明在减轻疾病进展方面有潜在益处。
