中药治疗AECOPD风险窗的疗效和安全性：一项多中心随机对照试验

IF 6.7 1区医学 Q1 CHEMISTRY, MEDICINAL

Phytomedicine Pub Date : 2025-06-06 DOI:10.1016/j.phymed.2025.156903

Jiansheng Li , Hailong Zhang , Huanrong Ruan , Guixiang Zhao , Hailang He , Congxia Hou , Weixu Sun , Shuaihui Hou , Xiaozhuang Liu , Ya Li

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引用次数: 0

摘要

慢性阻塞性肺疾病（AECOPD）急性加重可显著加速疾病进展并显著增加死亡风险。AECOPD的风险窗口（AECOPDRW）代表急性加重和恢复到稳定阶段之间的时间。中药治疗COPD疗效显著，但中药治疗AECOPDRW尚未得到高质量临床研究的验证。目的探讨CM辨证治疗AECOPDRW的临床疗效。研究设计：一项多中心、随机、双盲、安慰剂对照的平行试验。方法纳入336名符合条件的受试者。两组均以常规治疗为基础。实验组给予中医辨证论治的中药颗粒治疗，对照组给予中药颗粒形式的安慰剂治疗。干预疗程8周，随访26周。主要结局是急性加重发生率和在AECOPDRW期间记录的COPD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、随访期间CAT评分、肺功能、mMRC量表、临床症状量表和生活质量评估工具。结果8周时，实验组患者急性加重风险及CAT评分显著降低，组间风险比（RR）为0.375(95%可信区间[CI]: 0.150 ~ 0.935；p = 0.027)，平均差值（MD）为-2.476分(95% CI: -3.281 ~ -1.671；p & lt;0.001)。26周时，实验组急性加重风险组间比较差异有统计学意义(RR: 0.519；95% CI: 0.282 ~ 0.953；P = 0.030)。实验组首次加重时间（97.63±35.90）明显长于对照组（66.11±25.25）(MD: 31.517 (95% CI: 14.720 ~ 48.314；p & lt;0.001)。两组在风险窗口期和随访期间的急性加重再入院率相似。随访26周后，实验组CAT评分较对照组降低2.046分(p <；0.001)。此外，在整个研究过程中，实验组的mMRC评分、FEV1和FVC值均显著降低(p <；0.05)。研究期间，实验组患者咳嗽、咳痰、疲劳等临床症状评分均显著低于对照组(p <；0.05)。对于SGRQ、mCOPD-PRO和mESQ-COPD，我们的结果表明CM在很多方面都有更好的优势。结论CM治疗AECOPDRW在进一步降低急性加重发生率、延长至初始急性加重间隔、缓解临床症状、提高生活质量方面具有较高的疗效和安全性。

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Efficacy and safety of Chinese medicine in treating risk window of AECOPD: A multicenter randomized controlled trial

Background

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.

Purpose

To assess the clinical effect of CM syndrome differentiation treatment for patients with AECOPDRW.

Study design

A multicenter, randomized, double-blind, placebo-controlled parallel trial.

Methods

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.

Results

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 FEV₁ 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.

Conclusion

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.

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来源期刊

Phytomedicine 医学-药学

CiteScore

10.30

自引率

5.10%

发文量

670

审稿时长

91 days

期刊介绍： Phytomedicine is a therapy-oriented journal that publishes innovative studies on the efficacy, safety, quality, and mechanisms of action of specified plant extracts, phytopharmaceuticals, and their isolated constituents. This includes clinical, pharmacological, pharmacokinetic, and toxicological studies of herbal medicinal products, preparations, and purified compounds with defined and consistent quality, ensuring reproducible pharmacological activity. Founded in 1994, Phytomedicine aims to focus and stimulate research in this field and establish internationally accepted scientific standards for pharmacological studies, proof of clinical efficacy, and safety of phytomedicines.