All data extracted.

BackgroundThe inflammatory response is the main pathophysiological basis of stable chronic obstructive pulmonary disease (COPD). It is a key factor that leads to frequent exacerbations and disease progression. Suppressing the inflammatory response can improve pulmonary function, prognosis, and quality of life in stable COPD patients.ObjectiveTo evaluate the effect of Qingjin Huatan decoction (QJHTD) on pulmonary function and inflammatory mediators in stable COPD patients.MethodsRandomized controlled trials (RCTs) on the treatment of stable COPD with QJHTD were retrieved from nine Chinese and English electronic databases up to June 30, 2024. The quality of the studies was assessed using the Cochrane Risk of Bias Tool and the modified Jadad scale. Statistical analysis, sensitivity analysis, and publication bias assessment were performed using Stata 17.0 software.ResultsA total of 16 RCTs involving 1,228 stable COPD patients were included. Compared to standard treatment, QJHTD significantly improved pulmonary function, with increases in FEV1 (MD = 0.32, 95% CI [0.25, 0.38], p = 0.000), FVC (MD = 0.30, 95% CI [0.22, 0.37], p = 0.000), FEV1/FVC (MD = 5.58, 95% CI [4.81, 6.34], p = 0.000), and PaO2 (MD = 9.62, 95% CI [6.17, 13.08], p = 0.000), and a decrease in PaCO2 (MD = -9.12, 95% CI [–11.96, –6.28], p = 0.000). QJHTD also significantly suppressed the expression of inflammatory mediators, including TNF-α (MD = –7.47, 95% CI [–10.59, –4.34], p = 0.000), IL-6 (MD = -4.33, 95% CI [–6.17, –2.48], p = 0.000), and hs-CRP (MD = –9.11, 95% CI [–11.02, –7.20], p = 0.000). Additionally, QJHTD improved clinical efficacy (RR = 4.60, 95% CI [3.09, 6.86], p = 0.000) without increasing the incidence of adverse reactions (RR = 1.60, 95% CI [0.69, 2.46], p = 0.42).ConclusionThe current evidence suggests that QJHTD, as an adjunct therapy to standard treatment, may significantly improve pulmonary function, reduce inflammatory mediators, and enhance clinical efficacy in patients with stable COPD, with a favorable safety profile. However, these findings should be interpreted with caution due to several limitations, including small sample sizes, high heterogeneity among studies, and methodological weaknesses such as lack of blinding. More rigorously designed, high-quality, multicenter trials are needed to confirm these results.

**背景** 炎症反应是稳定期慢性阻塞性肺疾病（chronic obstructive pulmonary disease, COPD）的主要病理生理学基础，亦是导致患者病情频繁急性加重与疾病进展的关键因素。抑制炎症反应可改善稳定期COPD患者的肺功能、预后及生活质量。
**目的** 评价清金化痰汤（Qingjin Huatan decoction, QJHTD）对稳定期COPD患者肺功能与炎症介质的影响。
**方法** 检索截至2024年6月30日的9家中英文电子数据库中，关于清金化痰汤治疗稳定期COPD的随机对照试验（randomized controlled trial, RCT）。采用Cochrane偏倚风险工具与改良Jadad量表对纳入研究的质量进行评价。使用Stata 17.0软件完成统计学分析、敏感性分析及发表偏倚评估。
**结果** 共纳入16项随机对照试验，涉及1228例稳定期COPD患者。与标准治疗相比，清金化痰汤可显著改善患者肺功能：第一秒用力呼气容积（forced expiratory volume in one second, FEV1，均数差=0.32，95%置信区间[0.25, 0.38]，P=0.000）、用力肺活量（forced vital capacity, FVC，均数差=0.30，95%置信区间[0.22, 0.37]，P=0.000）、第一秒用力呼气容积占用力肺活量百分比（FEV1/FVC，均数差=5.58，95%置信区间[4.81, 6.34]，P=0.000）及动脉血氧分压（PaO2，均数差=9.62，95%置信区间[6.17, 13.08]，P=0.000）均显著升高，动脉血二氧化碳分压（PaCO2，均数差=-9.12，95%置信区间[-11.96, -6.28]，P=0.000）显著降低。清金化痰汤还可显著抑制炎症介质的表达，包括肿瘤坏死因子-α（tumor necrosis factor-α, TNF-α，均数差=-7.47，95%置信区间[-10.59, -4.34]，P=0.000）、白细胞介素-6（interleukin-6, IL-6，均数差=-4.33，95%置信区间[-6.17, -2.48]，P=0.000）及高敏C反应蛋白（high-sensitivity C-reactive protein, hs-CRP，均数差=-9.11，95%置信区间[-11.02, -7.20]，P=0.000）。此外，清金化痰汤可提升临床疗效（相对危险度=4.60，95%置信区间[3.09, 6.86]，P=0.000），且未增加不良反应发生率（相对危险度=1.60，95%置信区间[0.69, 2.46]，P=0.42）。
**结论** 现有证据表明，清金化痰汤作为标准治疗的辅助疗法，可显著改善稳定期COPD患者的肺功能、降低炎症介质水平并提升临床疗效，且安全性良好。但本研究结论需谨慎解读，因纳入研究存在诸多局限性，包括样本量较小、研究间异质性较高，以及缺乏盲法等方法学缺陷。未来需开展设计更严谨、高质量的多中心试验以验证本研究结果。