补中益气汤辅助ICS/LABA/LAMA三联疗法治疗稳定期COPD的临床对照研究

Clinical control study of Buzhong Yiqi decoction combined with ICS/LABA/LAMA triple therapy in the treatment of stable COPD

目的探讨补中益气汤辅助ICS/LABA/LAMA三联疗法治疗稳定期慢性阻塞性肺疾病(COPD)的疗效与安全性。方法将2018年1月至2019年12月海南省第三人民医院收治的稳定期COPD患者116例随机分为对照组和观察组,每组各58例,前者用ICS/LABA/LAMA三联疗法,后者在此基础上增加补中益气汤辅助治疗。治疗12周后进行评估。结果干预后两组患者的病情均有明显好转,且观察组的6 min步行距离更长(P<0.05),肺功能(包括FEV_(1)、FVC、FEV_(1)/FVC)更好(P<0.05)。同时,观察组的生活质量和肺纤维化的改善更好。不良反应两组差异无统计学意义(P>0.05)。结论补中益气汤辅助ICS/LABA/LAMA三联疗法治疗稳定期COPD可提升患者的运动功能、肺功能、生活质量、改善患者肺纤维化状态,不良反应与ICS/LABA/LAMA三联疗法无明显差异。

Objective To explore the efficacy and safety of Buzhong Yiqi decoction combined with ICS/LABA/LAMA triple therapy in the treatment of stable chronic obstructive pulmonary disease(COPD). Methods A total of 116 patients with stable COPD admitted to the Third People’s Hospital of Hainan Province from January 2018 to December 2019 were randomly divided into the control group and the observation group, with 58 cases in each group. The former group was treated with ICS/LABA/LAMA triple therapy, and the latter group was supplemented with Buzhong Yiqi decoction. Assessment was performed after 12 weeks of treatment. Results After intervention, the condition of patients in both groups improved significantly, and the observation group had a longer 6-minute walking distance(P<0.05) and better lung function(including FEV_(1), FVC, FEV_(1)/FVC)(P<0.05).Meanwhile, the observation group had better quality of life(SGRQ-C score) and improvement of pulmonary fibrosis(P<0.05). There was no significant difference in adverse reactions between the two groups(P>0.05).Conclusion Buzhong Yiqi decoction combined with ICS/LABA/LAMA triple therapy in the treatment of stable COPD could improve the motor function, lung function, quality of life and pulmonary fibrosis status of patients.There is no significant difference in adverse reactions between the two therapies.