基于“气虚络损”思想探讨金宁丸治疗慢性阻塞性肺疾病稳定期的临床研究

A Clinical Study on the Treatment of Stable Chronic Obstructive Pulmonary Disease with Jinning Pill Based on the Concept of “Qi Deficiency and Collateral Damage”

摘要: 目的：旨在中医“气虚络损”理论指导下，自拟金宁丸治疗慢阻肺的有效性与安全性，初步探究药物作用机制，助力中医药学术成果转化，为慢阻肺患者提供简便效廉的补充治疗选择，优化慢阻肺中西医结合治疗方案。方法：选取2025年2月~2026年4月十堰市中医医院肺病科收治的64例气虚痰瘀型慢阻肺稳定期患者为研究对象，采用随机数字表法分为治疗组与对照组，各32例。对照组予以西医常规规范化干预治疗，治疗组在对照组基础上加用金宁丸口服治疗，两组患者均连续干预2个月。分别于干预前、干预1月、干预2月记录中医证候积分、6分钟步行试验(6MWT)、改良呼吸困难指数(mMRC)、慢阻肺评估测试(CAT)、肺功能指标(FEV1%, FEV1/FVC)、血清炎症因子(IL-6, IL-10)、T淋巴细胞亚群(CD4⁺, CD8⁺, CD4⁺/CD8⁺)、急性发作次数与BODE指数，同时观察两组干预期间不良事件发生情况。结果：干预前，两组患者中医证候、肺功能、运动耐力、炎症免疫等各项基线指标对比无统计学差异(P > 0.05)，组间具备可比性；干预1月、2月后，两组患者各项功能指标均较治疗前显著改善，且治疗组患者中医症状、肺功能、运动耐力、生活质量、炎症免疫平衡及远期预后改善幅度显著优于对照组，组间数据差异均具有统计学意义(P < 0.05)。两组干预期间均无严重不良事件发生，轻微不适发生率对比无统计学差异(P > 0.05)。结论：基于“气虚络损”理论运用金宁丸联合西医常规治疗，可有效改善慢阻肺稳定期患者中医证候与肺功能，提升运动耐力与生活质量，调节机体炎症及免疫失衡，减少急性发作风险，且干预方式安全可靠、无明显不良反应，临床疗效显著优于单纯西医常规治疗，值得临床推广。

Abstract: Objective: Under the guidance of the traditional Chinese medicine (TCM) theory of “qi deficiency and collateral damage”, this study aims to investigate the efficacy and safety of self-developed Jinning Pill in the treatment of chronic obstructive pulmonary disease (COPD), preliminarily explore the mechanism of drug action, facilitate the transformation of TCM academic achievements, provide a convenient, effective, and inexpensive complementary treatment option for COPD patients, and optimize the integrated TCM and Western medicine treatment regimen for COPD. Methods: Sixty-four patients with COPD in stable phase of qi deficiency and phlegm-blood stasis type admitted to the Pulmonary Disease Department of Shiyan Hospital of Traditional Chinese Medicine from February 2025 to April 2026 were selected as the research subjects. They were divided into a treatment group and a control group using a random number table method, with 32 cases in each group. The control group received standard Western medicine intervention therapy, while the treatment group received additional Jinning Pill oral treatment on top of the control group’s therapy. Both groups underwent continuous intervention for 2 months. TCM symptom scores, 6-minute walk test (6MWT), modified Modified Borg Dyspnea Scale (mMRC), COPD Assessment Test (CAT), pulmonary function indicators (FEV1%, FEV1/FVC), serum inflammatory factors (IL-6, IL-10), T lymphocyte subsets (CD4⁺, CD8⁺, CD4⁺/CD8⁺), frequency of acute exacerbations, and BODE index were recorded before, one month after, and two months after intervention. The occurrence of adverse events during the intervention period was also observed in both groups. Results: Before intervention, there were no statistical differences in baseline indicators such as TCM symptoms, pulmonary function, exercise tolerance, and inflammatory immunity between the two groups (P > 0.05), indicating comparability between the groups. After one and two months of intervention, both groups showed significant improvements in various functional indicators compared to before treatment. The treatment group exhibited significantly better improvements in TCM symptoms, pulmonary function, exercise tolerance, quality of life, inflammatory immune balance, and long-term prognosis than the control group, with statistically significant differences between the groups (P < 0.05). No serious adverse events occurred during the intervention period in both groups, and there was no statistical difference in the incidence of mild discomfort between the groups (P > 0.05). Conclusion: The use of Jinning Pill combined with standard Western medicine therapy based on the “qi deficiency and collateral damage” theory can effectively improve TCM symptoms and pulmonary function in patients with stable COPD, enhance exercise tolerance and quality of life, regulate inflammatory and immune imbalances in the body, reduce the risk of acute exacerbations, and the intervention method is safe and reliable with no significant adverse reactions. The clinical efficacy is significantly better than that of standard Western medicine therapy alone, making it worthy of clinical promotion.