【目的】 探究益气温阳散结汤治疗肺部磨玻璃结节阳虚质患者的疗效及其对血清炎症因子、免疫功能的影响。【方法】选取沧州中西医结合医院呼吸科和治未病中心2020年1月至2024年6月收治的106例患者，采用随机数字表法将患者随机分为对照组和中药组，每组各 53例。对照组患者不予治疗，指导其随访方案；中药组患者给予益气温阳散结汤口服治疗 3个月。观察2组患者治疗前后中医证候积分、肺部磨玻璃结节最大直径、血清炎症因子[白细胞介素6（IL-6）、白细胞介素17A（IL-17A）、肿瘤坏死因子 α（TNF-α）]及免疫功能指标[外周血 T 细胞 CD3+、CD4+细胞百分比和 CD4+/CD8+比值]的变化情况，并评价2组患者的疗效和用药安全性。【结果】（1）脱落情况方面，研究期间，对照组脱落5例，中药组脱落3例，最终共纳入98例，其中对照组48例，中药组50例。（2）疗效方面，治疗3个月后，中药组的总有效率为46.00%（23/50），对照组为10.42%（5/48），组间比较（χ2检验），中药组的疗效显著优于对照组（P＜0.01）。（3）中医证候积分及肺部磨玻璃结节最大直径方面，治疗后，中药组的中医证候积分及肺部磨玻璃结节最大直径均较治疗前降低（P＜0.05），而对照组的中医证候积分及肺部磨玻璃结节最大直径均较治疗前无明显变化（P＞0.05）；组间比较，中药组对中医证候积分及肺部磨玻璃结节最大直径的降低幅度均明显优于对照组（P＜0.05）。（4）血清炎症因子方面，治疗后，中药组的血清IL-6、IL-17A、TNF-α水平均较治疗前明显降低（P＜0.05），而对照组的血清 IL-6、IL-17A、TNF-α 水平均无显著变化（P＞0.05）；组间比较，中药组对血清 IL-6、IL-17A、TNF-α水平的降低幅度均明显优于对照组（P＜0.05）。（5）T淋巴细胞亚群参数方面，治疗后，中药组的CD4+细胞百分比及CD4+/CD8+比值均较治疗前升高（P＜0.05），而对照组的CD3+、CD4+细胞百分比及CD4+/CD8+比值和中药组的CD3+细胞百分比均无显著变化（P＞0.05）；组间比较，中药组对CD4+细胞百分比及CD4+/CD8+比值的升高幅度均明显优于对照组（P＜0.05）。（6）安全性方面，中药组患者治疗期间无明显不良反应发生，具有较高的安全性。【结论】 益气温阳散结汤治疗肺部磨玻璃结节阳虚质患者疗效确切，可有效促进结节消减，改善患者临床症状，降低血清炎症因子水平，提高患者免疫功能，且安全性良好。

Objective To investigate the efficacy of Yiqi Wenyang Sanjie Decoction in the treatment of patients with pulmonary ground glass nodules and yang-deficiency constitution，and to observe its effect on serum inflammatory factors and immune function. Methods From January 2020 to June 2024，a total of 106 patients with pulmonary ground glass nodules and yang-deficiency constitution admitted to the Department of Respiratory Medicine and Preventive Treatment of Disease Center of Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine were selected. The patients were randomly divided into control group and Chinese medicine group by random number table method， with 53 cases in each group. The patients in the control group were only given follow-up without any intervention，and the patients in the Chinese medicine group were treated with Yiqi Wenyang Sanjie Decoction for 3 months. Before and after treatment， the two groups were observed in the changes of traditional Chinese medicine（TCM） syndrome scores， maximum diameter of pulmonary ground glass nodules， serum levels of inflammatory factors of interleukin-6（IL-6），interleukin-17A（IL-17A），and tumor necrosis factor-α（TNF-α），and levels of immune function indicators of peripheral blood CD3+ ，CD4+ cell percentage and CD4+ /CD8+ ratio. After treatment，the efficacy and safety of the two groups were evaluated. Results （1） During the trial，5 cases fell off from the control group and 3 cases fell off from the Chinese medicine group. A total of 98 cases were eventually included，and 48 cases were in the control group and 50 cases were in the Chinese medicine group. （2）After 3 months of treatment，the total effective rate of the Chinese medicine group was 46.00% （23/50），and that of the control group was 10.42%（5/48）. The intergroup comparison （tested by chi-square test） showed that the efficacy of the Chinese medicine group was significantly superior to that of the control group （P＜0.01）.（3）After treatment，the TCM syndrome score and the maximum diameter of pulmonary ground glass nodules in the Chinese medicine group were lowered （P＜0.05），while the TCM syndrome score and the maximum diameter showed no obvious changes compared with those at enrollment （P＞0.05）； the intergroup comparison showed that the reduction of TCM syndrome score and the maximum diameter of pulmonary ground glass nodules in the Chinese medicine group was significantly superior to that in the control group （P＜0.05）.（4） After treatment，the levels of serum inflammatory factors of IL-6，IL-17A and TNF-α in the Chinese medicine group were significantly lowered compared with those at enrollment （P＜0.05），while there was no significant change in serum IL-6，IL-17A and TNF-α levels of the control group （P＞0.05）；the intergroup comparison showed that the decrease of serum IL-6， IL-17A and TNF-α levels in the Chinese medicine group was significantly superior to that in the control group （P＜0.05）.（5）After treatment，the percentage of T lymphocyte subset CD4+ and the ratio of CD4+ /CD8+ in the Chinese medicine group were significantly increased compared with those at enrollment（P＜0.05），while there was no significant change in the percentage of CD3+，CD4+ cells and the ratio of CD4+ /CD8+ of the control group and in the percentage of CD3+ cells of the Chinese medicine group （P＞0.05）. The intergroup comparison showed that the increase of CD4+ percentage and CD4+ /CD8+ ratio in the Chinese medicine group was significantly superior to that in the control group （P＜0.05）.（6） There were no obvious adverse reactions occurring in the Chinese medicine group during the treatment，showing relatively high safety. Conclusion Yiqi Wenyang Sanjie Decoction exerts certain effect in the treatment of patients with pulmonary ground glass nodules and yang-deficiency constitution. It can effectively promote the reduction of nodules，relieve clinical symptoms，decrease serum levels of inflammatory factors，improve immune function，and has good safety.

R259

河北省中医药管理局2023年度中医药类科学研究计划项目（编号：2023252）