Li Jiansheng, Zhang Hailong, Ruan Huanrong, Zhao Guixiang, He Hailang, Hou Congxia, Sun Weixu, Hou Shuaihui, Liu Xiaozhuang, Li Ya
Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases co-constructed by Henan Province & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, China; National Regional Chinese Medicine (Lung Disease) Diagnostic and Treatment Centre of the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China; Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, China.
Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases co-constructed by Henan Province & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, China; National Regional Chinese Medicine (Lung Disease) Diagnostic and Treatment Centre of the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China; Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, China.
Phytomedicine. 2025 Aug;144:156903. doi: 10.1016/j.phymed.2025.156903. Epub 2025 Jun 6.
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) significantly accelerate disease progression and substantially increase mortality risk. The risk window of AECOPD (AECOPDRW) represents a time between acute exacerbation and recovery to a stable stage. Chinese medicine (CM) has shown significant therapeutic efficacy in COPD but CM treatment for AECOPDRW has not been validated by high-quality clinical studies.
To assess the clinical effect of CM syndrome differentiation treatment for patients with AECOPDRW.
A multicenter, randomized, double-blind, placebo-controlled parallel trial.
336 eligible participants were included to the study. Both groups were based on the conventional treatment as the baseline therapy. The experimental group was administered Chinese herbal medicine granules based on CM syndrome differentiation, whereas the control group received a placebo in the form of Chinese herbal medicine granules. The intervention course lasted for 8-week, while the follow-up for 26-week. Primary outcomes were incidences of acute exacerbation and COPD Assessment Test (CAT) scores recorded during AECOPDRW. Secondary outcomes were the timing of the first acute exacerbation, incidence of exacerbations, acute exacerbation readmission rate, severity of exacerbation, and CAT scores during follow-up, pulmonary function, mMRC scale, clinical symptom scale, and the quality of life assessment tools.
At 8-week, the risk of acute exacerbations and CAT score were significantly reduced in the experimental group between-group analysis with a risk ratio (RR) of 0.375(95 % confidence interval [CI]: 0.150 to 0.935; p = 0.027), and a mean difference (MD) of -2.476 score (95 % CI: -3.281 to -1.671; p < 0.001). At 26-week, experimental group showed statistically lower risk of acute exacerbation between-group analysis (RR: 0.519; 95 % CI: 0.282 to 0.953; p = 0.030). The first exacerbation time in the experimental group (97.63 ± 35.90) was statistically longer than in the control group (66.11 ± 25.25) (MD: 31.517 (95 % CI: 14.720 to 48.314; p < 0.001). The rates of acute exacerbation readmission were similar for both the groups during the risk window and follow-up period. After 26 weeks of follow-up, experimental group CAT score was reduced by 2.046 between-group analysis (p < 0.001). Furthermore, during the whole study, the experimental group showed significantly reduced in mMRC score, as well as FEV and FVC values (all p < 0.05). During study period, the experimental group had a significant reduce in clinical symptom scores, including cough, expectoration, and fatigue, than the control group (p < 0.05). Regarding to SGRQ, mCOPD-PRO and mESQ-COPD, our results demonstrated that CM had better advantages in many aspects.
Treatment of AECOPDRW with CM showed high efficacy and safety in significantly reducing further incidences of acute exacerbation, prolonging the interval to the initial acute exacerbation, alleviating the clinical symptoms, and improving the quality of life.
慢性阻塞性肺疾病急性加重（AECOPD）显著加速疾病进展并大幅增加死亡风险。AECOPD的风险窗口（AECOPDRW）指急性加重与恢复到稳定期之间的时间段。中医在慢性阻塞性肺疾病治疗中已显示出显著疗效，但中医对AECOPDRW的治疗尚未得到高质量临床研究的验证。
评估中医辨证治疗对AECOPDRW患者的临床疗效。
一项多中心、随机、双盲、安慰剂对照平行试验。
336名符合条件的参与者纳入本研究。两组均以常规治疗作为基础治疗。试验组根据中医辨证给予中药颗粒剂，而对照组接受中药颗粒剂形式的安慰剂。干预疗程持续8周，随访26周。主要结局为AECOPDRW期间记录的急性加重发生率和慢性阻塞性肺疾病评估测试（CAT）评分。次要结局为首次急性加重的时间、加重发生率、急性加重再入院率、加重严重程度以及随访期间的CAT评分、肺功能、改良英国医学研究委员会（mMRC）分级、临床症状评分和生活质量评估工具。
8周时，试验组组间分析显示急性加重风险和CAT评分显著降低，风险比（RR）为0.375（95%置信区间[CI]：0.150至0.935；p = 0.027），平均差值（MD）为-2.476分（95% CI：-3.281至-1.671；p < 0.001）。26周时，试验组组间分析显示急性加重风险在统计学上较低（RR：0.519；95% CI：0.282至0.953；p = 0.030）。试验组的首次加重时间（97.63±35.90）在统计学上长于对照组（66.11±... 25.25）（MD：31.517（95% CI：14.720至48.314；p < 0.001）。在风险窗口和随访期间，两组的急性加重再入院率相似。随访26周后，试验组组间分析显示CAT评分降低了2.046（p < 0.001）。此外，在整个研究期间，试验组的mMRC评分以及第一秒用力呼气容积（FEV）和用力肺活量（FVC）值显著降低（均p < 0.05）。在研究期间，试验组的临床症状评分，包括咳嗽、咳痰和疲劳，比对照组显著降低（p < 0.05）。关于圣乔治呼吸问卷（SGRQ）、慢性阻塞性肺疾病患者报告结局（mCOPD-PRO）和慢性阻塞性肺疾病欧洲生存质量量表（mESQ-COPD），我们的结果表明中医在许多方面具有更好的优势。
中医治疗AECOPDRW在显著降低急性加重的进一步发生率、延长至首次急性加重的间隔时间、缓解临床症状和改善生活质量方面显示出高疗效和安全性。
