目的：观察益气活血消癥方对COPD稳定期患者的临床疗效及可能的作用机制。方法：将55例慢性阻塞性肺疾病稳定期患者随机分为治疗组28例，对照组27例。对照组给予西医常规治疗。治疗组在常规治疗的基础上加用益气活血消癥方治疗。两组疗程均为8周。治疗前后检测中医主要症状、中医证候评分、CAT、SpO2及治疗后检测血清因子（包括TGF-β1、smad2、smad3和smad7），然后评价主症总分、证候积分、CAT量表、SpO2及血清因子的疗效。结果：治疗8周后治疗组患者主症积分、中医证候积分、CAT均较治疗前明显降低，SpO2较前明显升高；且主症积分、肺气虚、脾气虚、痰阻症状评分、CAT值明显低于对照组，SpO2明显高于对照组。治疗组主症总分总有效率为53.57%，明显高于对照组的2.7%。治疗组治疗前后CAT差值d > 2分且高于对照组。治疗组血清TGF-β1、Smad3含量较对照组降低，Smad7含量较对照组升高，以上差异均有统计学意义（P < 0.05）。结论：益气活血消癥方治疗慢性阻塞性肺疾病稳定期患者不仅能改善患者症状、生活质量、慢性缺氧状态等，同时对于血清中TGF-β1/Smad信号通路上的相关蛋白也有影响，这可能是该方干预慢阻肺的分子生物学机制。该方以益气活血、消癥通络的治法从而影响“肺络微型癥瘕”形成，其聚散调节的关键点在于TGF-β1/Smad信号通路。同时，也反证了“微型癥瘕痹阻肺络”这一病机假说的合理性。

This study was aimed to explore the clinical effect of Yiqi Huoxue Xiaozheng Decoction on stable chronic obstructive pulmonary disease patients and its possible mechanism.A total of 55 stable COPD patients were randomlydivided into the treatment group（28）and the control group（27）.The control group was given conventional westernmedicine treatment and the treatment group was given conventional treatment western medicine treatment combined withYiqi Huoxue Xiaozheng Decoction. The patients were treated for 8 weeks.Before and after treatment, main symptoms,TCM syndromes, CAT and SpO2 of patients and serum factor including TGF-β1、smad2、smad3 and smad7 were examedafter treatment. Result: showed that after 8 weeks of treatment, the main symptom, TCM syndrome and CAT in thetreatment group were significantly lower than those before treatment, and SpO2 increased significantly compared with thatbefore. After treatment, main symptoms, lung qi deficiency, spleen qi deficiency, phlegm resistance symptoms and CATof the treatment group were significantly lower than those in the control group, and SpO2 was significantly higher than thatin the control group. The total effective rate of main symptom of the treatment group was 53.57%, which was significantlyhigher than that of the control group , and it was 2.7%. The difference of CAT before and after the treatment> 2 in thetreatment group was higher than that of the control group. The content of TGF- beta 1 and Smad3 in the treatment groupwas lower than that of the control group, and the content of Smad7 was higher than that of the control group.Thosedifference was statistically significant (P < 0.05). Conclusion: Yiqi Huoxue Xiaozheng Decoction can improve symptoms,quality of life and chronic hypoxia of stable COPD patients, While the decoction can influence the protein of TGF-beta 1/smad Signaling Pathway.That may be a molecular biological mechanism for the decoction to intervene the chronicobstructive pulmonary disease. Yiqi Huoxue Xiaozheng Decoction affects the formation of "lung collaterals microZhengjia" by yiqi huoxue xiaozheng tongluo. Its key point is TGF-β1/Smad signaling pathway. At the same time, it alsoreflects the rationality of the pathogenesis hypothesis of "micro Zhengjia blocks pulmonary collaterals".

北京市科技重大专项（Z1714100001017020）：基于“毒损肺络”理论采用中药干预小气道阻塞的多中心随机分组平行对照研究，负责人：王琦。