【目的】 观察自拟参芪补味汤（由黄芪人参汤化裁而来）治疗慢性阻塞性肺疾病（简称慢阻肺）稳定期肺脾气虚证患者的 临床疗效。【方法】 将 110例慢阻肺稳定期肺脾气虚证患者随机分为对照组和观察组，每组各 55例。对照组给予噻托溴铵吸 入粉雾剂吸入治疗，观察组在对照组的基础上给予参芪补味汤治疗，疗程为 3 个月。观察 2 组患者治疗前后肺功能指标 [第 1 秒用力呼气容积（FEV1）、用力肺活量（FVC）、一秒率（FEV1/FVC）]、改良英国医学研究学会呼吸困难指数（mMRC）评 分、6 min步行试验（6MWT）、慢阻肺患者自我评估测试（CAT）评分和中医证候积分的变化情况，并评价2组患者的临床疗效 和用药安全性。【结果】（1）脱落情况方面，研究过程中，观察组有1例患者剔除，2例患者脱落，对照组有3例患者脱落，最 终对照组和观察组各有52例患者纳入疗效统计。（2）疗效方面，治疗3个月后，观察组的总有效率为80.77%（42/52），对照组 为67.31%（35/52），组间比较（χ2检验），观察组的疗效略优于对照组，但差异无统计学意义（P＞0.05）。（3）肺功能指标方面， 治疗后，对照组的 FEV1、FEV1/FVC和观察组的 FEV1、FVC、FEV1/FVC均较治疗前明显改善（P＜0.05），且观察组对各项 肺功能指标的改善幅度均明显优于对照组（P＜0.05）。（4）6MWT 及 mMRC、CAT 评分方面，治疗后，2 组患者的 6MWT 及 mMRC、CAT评分均较治疗前明显改善（P＜0.05），且观察组的改善幅度均明显优于对照组（P＜0.05）。（5）中医证候积分方 面，治疗后，2 组患者的中医证候积分均较治疗前明显降低（P＜0.05），且观察组的降低幅度明显优于对照组（P＜0.05）。 （6）安全性方面，治疗过程中，2组患者均未发生明显不良反应，且患者的各项安全性指标均无异常变化。【结论】 在常规西 药治疗基础上联合参芪补味汤治疗慢阻肺稳定期肺脾气虚证患者疗效确切，可有效改善患者通气功能，缓解患者临床症状， 提高患者生活质量，延缓患者肺功能减退。

Objective To observe the clinical efficacy of self-formulated Shenqi Buwei Decoction（derived from Huangqi Renshen Decoction） in treating patients with stable chronic obstructive pulmonary disease（COPD） differentiated as lung-spleen qi deficiency syndrome. Methods A total of 110 patients with stable COPD differentiated as lung-spleen qi deficiency syndrome were randomly divided into a control group and an observation group，with 55 patients in each group. The control group was given Tiotropium Bromide Inhalation Powder for the inhalation treatment，and the observation group was given Shenqi Buwei Decoction on the basis of treatment for the control group， and the course of treatment covered 3 months. The changes of pulmonary function indicators of forced expiratory volume in one second（FEV1），forced vital capacity（FVC），and one-second rate of FEV1/ FVC，modified Medical Research Council index（mMRC）dyspnea scores，6-minute walk test（6MWT），COPD Assessment Test（CAT）scores，and traditional Chinese medicine（TCM）syndrome scores in the two groups were observed before and after treatment. After treatment， the clinical efficacy and safety of the two groups were evaluated. Results（1）During the trial，one patient was excluded and two patients fell off from the observation group，and three patients fell off from the control group. Eventually，52 patients in each of the two groups were included in the efficacy statistics.（2）After 3 months of treatment，the total effective rate of the observation group was 80.77%（42/52）and that of the control group was 67.31%（35/52）. The intergroup comparison（tested by chisquare test）showed that the therapeutic effect of the observation group was slightly superior to that of the control group，but the difference was not statistically significant（P＞0.05）.（3）In terms of indexes，After treatment， the levels of pulmonary function indicators of FEV1，FEV1/FVC in the control group and FEV1，FVC，FEV1/ FVC in the observation group were significantly improved compared with those before treatment（P＜0.05），and the improvement of FEV1， FVC， FEV1/FVC in the observation group was significantly superior to that in the control group（P＜0.05）.（4）After treatment， the 6MWT， mMRC and CAT scores of the two groups were significantly improved compared with those before treatment（P＜0.05），and the improvement in the observation group was significantly superior to that in the control group（P＜0.05）.（5）After treatment，the TCM syndrome scores of the two groups of patients were significantly decreased in comparison with those before treatment（P＜ 0.05），and the decrease in the observation group was significantly superior to that in the control group（P＜0.05）. （6）During the treatment process，no obvious adverse reactions occurred in the two groups of patients，there were no abnormal changes in the safety indicators，either. Conclusion On the basis of conventional western medicine treatment，the combined use of Shenqi Buwei Decoction exerts certain efficacy in the treatment of patients with stable COPD differentiated as lung-spleen qi deficiency syndrome. The combined therapy can effectively improve the ventilation function，relieve the clinical symptoms，improve the quality of life and delay the decline of lung function of the patients.

R259.63

国家自然科学基金区域创新重点项目（编号：U20A20398）