肺康颗粒治疗COPD稳定期肺脾两虚证患者的临床研究

The Clinical Research of Feikang Granules in Pulmonosplenic Asthenia Patients with Chronic Obstructive Pulmonary Disease

目的评价肺康颗粒对慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)稳定期肺脾两虚证患者临床疗效、肺功能、外周血转移生长因子-β1(TGF-β1)的影响及其安全性。方法选取稳定期COPD肺脾两虚证患者60例,按简单随机化方法将其分为对照组(n=30)和治疗组(n=30)。对照组给予茶碱缓释片0.2g,口服,1次/12h,按需使用沙丁胺醇气雾剂;治疗组在对照组基础上加用肺康颗粒,口服,每天1次,2组疗程均为3个月。观察治疗前后患者的临床症状、肺功能、外周血TGF-β1及常规实验室指标。结果治疗后,治疗组在临床症状改善、减低外周血TGF-β1蛋白表达方面与对照组比较,差异有统计学意义(P<0.05);2组各项肺功能指标与同组治疗前比较,差异有统计学意义(P<0.05);但2组间各项肺功能指标比较,差异无统计学意义(P>0.05)。治疗过程中未发生明显不良反应。结论肺康颗粒治疗COPD稳定期肺脾两虚证患者疗效确切,并对改善肺功能、减轻气道重塑有一定作用。

Objective To investigate the effect and safety of Feikang granules on clinical efficacy,pulmonary function and the transforming growth factor-β1（TGF-β1）in pulmonosplenic asthenia patients with chronic obstructive pulmonary disease（COPD）.Methods 60 cases of pulmonosplenic asthenia patients with COPD were equally randomized into a treatment group and a control group.The patients in the treatment group took the Feikang granules once a day,took 0.2g of theophylline,every 12 hours,and used salbutamol aerosol as needed.The patients in the control group took 0.2g of theophylline,every 12 hours,and used salbutamol aerosol as needed.The period of treatment was 3months for both groups.The clinical symptoms,pulmonary function,TGF-β1and routine laboratory tests were observed before and after the treatment.Results Compared with the control group,the treatment group had significant differences（P〈0.05）in improving clinical symptoms and TGF-β1expression.The index of pulmonary function of both two groups had significant differences（P〈0.05）from that of before treatment;however,there were no significant difference（P〉0.05）between the two groups after treatment.No obvious adverse reactions were found in the two groups.Conclusion Feikang granules have definitive effect for the treatment of pulmonosplenic asthenia patients with COPD,and it has certain effect on improving pulmonary function and relieving airway remodeling.