Chen Ruilin, Ni Kaiwen, Ji Conghua, Liu Zhongda, Yu Yali, Liu Gang, Yang Junchao, Wang Zhen
The First Clinical College of Zhejiang Chinese Medical University, Zhejiang Chinese Medical University, Hangzhou, China.
The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China.
Front Med (Lausanne). 2024 May 3;11:1289928. doi: 10.3389/fmed.2024.1289928. eCollection 2024.
Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease. Traditional Chinese Medicine (TCM) has shown promising potential in COPD treatment. and we conducted a multi-center RCT to evaluate the effectiveness of TCM-based therapy in stable COPD patients.
In this multicenter, double-blind RCT, a total of 200 patients were supposed to be assigned to either trial or control group randomly. Both groups received Tiotropium (18 μg) from month 0 to month 12. Trial group received additional TCM granules, while control group received a placebo from month 0 to month 6. Symptom assessment, total effective rate, lung function measurements, hospitalization rates, and quality of life were evaluated at month 0, month 6, and month 12. Adverse events were assessed at month 12.
Of the initial 105 patients (aged 40-80) who completed the study, 51 were in trial group and 54 were in control group. At month 6, significant differences were observed between two groups in total effective rate ( = 0.020), sputum score ( = 0.047), changes in FVC% ( = 0.047) and FEV1 ( = 0.046). At month 12, significant differences were observed in sputum score ( = 0.020), FVC ( = 0.042), and change in FEV1 ( = 0.013). Compared to baseline, they both demonstrated improvements in symptoms, acute exacerbation, lung function, quality of life, and exercise tolerance.
TCM treatment effectively improved total effective rate, sputum symptom, FVC%, FEV1, and exhibited prolonged efficacy in improving sputum symptoms and FEV1 in stable COPD patients.https://www.chictr.org.cn/showproj.html?proj=6029 identifier ChiCTR-TRC-13003531.
慢性阻塞性肺疾病（COPD）是一种常见、可预防且可治疗的疾病。中医在COPD治疗中已显示出有前景的潜力。我们开展了一项多中心随机对照试验（RCT）来评估基于中医的疗法对稳定期COPD患者的有效性。
在这项多中心、双盲RCT中，总共200名患者应被随机分配到试验组或对照组。两组在第0个月至第12个月均接受噻托溴铵（18μg）治疗。试验组在第0个月至第6个月额外接受中药颗粒治疗，而对照组接受安慰剂治疗。在第0个月、第6个月和第12个月评估症状、总有效率、肺功能测量、住院率和生活质量。在第12个月评估不良事件。
在最初完成研究的105名患者（年龄40 - 80岁）中，试验组有51名，对照组有54名。在第6个月时，两组在总有效率（P = 0.020）、痰液评分（P = 0.047）、用力肺活量百分比变化（P = 0.047）和第1秒用力呼气容积（FEV1）（P = 0.046）方面存在显著差异。在第12个月时，在痰液评分（P = 0.020）、用力肺活量（P = 0.042）和FEV1变化（P = 0.013）方面存在显著差异。与基线相比，两组在症状、急性加重、肺功能、生活质量和运动耐力方面均有改善。
中医治疗有效提高了总有效率、痰液症状、用力肺活量百分比、FEV1，并在改善稳定期COPD患者的痰液症状和FEV1方面显示出持久疗效。https://www.chictr.org.cn/showproj.html?proj=6029 标识符ChiCTR - TRC - 13003531。
