【目的】 评估朝夕补益法对慢性阻塞性肺疾病（COPD）稳定期肺肾亏虚证患者肺功能及复发率的影响。【方法】 选取 2023年1月至2023年8月在广州中医药大学第一附属医院重庆医院（重庆市北碚区中医院）就诊的COPD稳定期肺肾亏虚证的 患者90例，采用随机数字表法将患者随机分为对照组和治疗组，每组各45例。对照组单独使用氟替美维吸入剂治疗，治疗 组在对照组的基础上联合朝夕补益法（早上服用补中益气丸、晚上服用六味地黄丸）治疗，治疗时间均为3个月。观察2组患 者治疗前后中医证候积分、慢性阻塞性肺疾病评估测试（CAT）评分、血清镁离子（Mg2+ ）水平、肺功能指标[包括第1秒用力呼 气量占预计值的百分比（FEV1%）、每分钟最大通气量占预计值百分比（MVV%）、最大呼气流速（PEF）]的变化情况，于治疗 结束后评估临床疗效，并随访1年，比较2组患者1年内急性加重次数及住院次数。【结果】（1）脱落情况方面，研究期间6例 患者脱落，最终纳入84例，其中治疗组41例，对照组43例。（2）疗效方面，治疗3个月后，治疗组的总有效率为85.37%（35/41）， 对照组为69.77%（30/43），组间比较（χ2 检验），治疗组的疗效明显优于对照组（P＜0.01）。（3）量表评分方面，治疗后，2组患者 的中医证候积分及CAT评分均较治疗前降低（P＜0.01），且治疗组的降低幅度均明显优于对照组（P＜0.01）。（4）肺功能方面，治疗后，2组患者的 FEV1%、MVV%、PEF均较治疗前改善（P＜0.01），且治疗组的改善幅度均明显优于对照组（P＜0.05或 P＜0.01）。（5）血清Mg2+ 水平方面，治疗后，2组患者的血清Mg2+ 水平均较治疗前升高（P＜0.01），且治疗组的升高幅度明显优 于对照组（P＜0.01）。（6）随访情况方面，治疗后随访 1年，治疗组患者 1年内急性加重次数和住院次数均较对照组减少（P＜ 0.05）。【结论】 氟替美维吸入剂联合朝夕补益法能有效改善 COPD稳定期肺肾亏虚证患者的临床症状及肺功能，减少急性加 重和住院次数，具有良好的治疗效果。

Objective To evaluate the effects of morning-evening supplementing therapy，a therapy by tonification according to the alteration of daily yang-qi in the human body and the nature proposed by practitioner XUE Ji in Ming Dynasty，on the pulmonary function and recurrence rate in patients with stable chronic obstructive pulmonary disease（COPD） of lung-kidney deficiency type. Methods Ninety stable COPD patients with lung-kidney deficiency syndrome treated at Chongqing Hospital of the First Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2023 to August 2023 were equally randomized into two groups using a random number table，45 cases in the control group and 45 cases in the treatment group. Both groups received Fluticasone Furoate，Umeclidinium Bromide and Vilanterol Trifenatate Powder for Inhalation alone，and the treatment group received additional morning-evening supplementing therapy by using Buzhong Yiqi Pills in the morning and Liuwei Dihuang Pills in the evening. The treatment for the two groups covered 3 months. Before and after treatment， changes in the outcomes of traditional Chinese medicine（TCM） syndrome scores，COPD Assessment Test（CAT） scores，serum magnesium ion（Mg²⁺） level，and pulmonary function parameters [percentage of the forced expiratory volume in one second to the predicted volume（FEV1%）， percentage of maximum voluntary ventilation to the predicted volume（MVV%），and peak expiratory flow（PEF）] in the two groups were observed. After treatment， clinical efficacy was evaluated，and the frequency of acute exacerbation and hospitalization within one-year followup was compared in the two groups. Results（1） There were 6 patients falling off during the trial，and 84 cases were eventually included，with 41 cases in the treatment group and 43 cases in the control group.（2） After 3 months of treatment，the total effective rate of the treatment group was 85.37%（35/41），and that of the control group was 69.77%（30/43）. The intergroup comparison（tested by chi-square test） showed that the efficacy of the treatment group was significantly superior to that of the control group（P＜0.01）（. 3） After treatment，TCM syndrome scores and CAT scores in the two groups were lower than those before treatment（P＜0.01）， and the decrease in the treatment group was significantly superior to that in the control group（P＜0.01）.（4） After treatment，pulmonary function parameters of FEV1%， MVV% and PEF in the two groups were improved when compared with those before treatment（P＜0.01），and the improvement in the treatment group was superior to that in the control group （P＜0.05 or P＜0.01）.（5） After treatment，the serum Mg2+ level of the two groups was higher than that before treatment（P＜0.01），and the increase in the treatment group was superior to that in the control group（P＜0.01）. （6） The one-year follow-up after treatment showed that the frequency of acute exacerbation and hospitalization in the treatment group was decreased compared to that in the control group（P＜0.05）. Conclusion Fluticasone Furoate，Umeclidinium Bromide and Vilanterol Trifenatate Powder for Inhalation combined with morning-evening supplementing therapy significantly improves clinical symptoms and pulmonary function， and reduces acute exacerbations and hospitalizations in patients with stable COPD of lung-kidney deficiency type.

R259.63

重庆市科卫联合中医药科研项目（编号：2019zy023409）