1.上海中医药大学附属曙光医院呼吸科(上海 201203)
张一乐,男,硕士,主治医师,主要从事中西医结合呼吸系统疾病的临床研究工作
张炜,主任医师,教授,博士研究生导师;E-mail:zhangw1190@sina.com
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张一乐, 史苗颜, 孙萌, 等. 补肾益肺方对慢性阻塞性肺疾病稳定期患者气道黏液高分泌及肺功能影响的临床研究[J]. 上海中医药杂志, 2021,55(12):69-73.
Yile ZHANG, Miaoyan SHI, Meng SUN, et al. Clinical study on effect of Bushen Yifei Decoction on airway mucus hypersecretion and lung function in patients with chronic obstructive pulmonary disease in the stable stage[J]. Shanghai Journal of Traditional Chinese Medicine, 2021,55(12):69-73.
张一乐, 史苗颜, 孙萌, 等. 补肾益肺方对慢性阻塞性肺疾病稳定期患者气道黏液高分泌及肺功能影响的临床研究[J]. 上海中医药杂志, 2021,55(12):69-73. DOI: 10.16305/j.1007-1334.2021.1911036.
Yile ZHANG, Miaoyan SHI, Meng SUN, et al. Clinical study on effect of Bushen Yifei Decoction on airway mucus hypersecretion and lung function in patients with chronic obstructive pulmonary disease in the stable stage[J]. Shanghai Journal of Traditional Chinese Medicine, 2021,55(12):69-73. DOI: 10.16305/j.1007-1334.2021.1911036.
目的,2,观察补肾益肺方对慢性阻塞性肺疾病(简称“慢阻肺”)稳定期患者气道黏液高分泌及肺功能的影响。,方法,2,将90例慢阻肺稳定期肺肾两虚型患者随机分为治疗组与对照组,每组45例。两组均予常规用药(沙美特罗替卡松粉吸入剂),治疗组加用补肾益肺方治疗,对照组加用中药安慰剂治疗。两组疗程均为12个月,观察年急性加重次数,比较肺功能相关指标第一秒用力呼气容积(FEV,1,)、第一秒用力呼气容积占用力肺活量的百分比(FEV,1,/FVC%)、第一秒用力呼气容积占预计值的百分比(FEV,1,%)以及诱导痰液黏蛋白(MUC5AC)、痰液性状评分、外周血中性粒细胞弹性蛋白酶(NE)水平的变化情况。,结果,2,①最终85例患者完成了试验,治疗组43例,对照组42例。②两组年急性加重次数比较,差异有统计学意义(,P,<,0.05)。③组间治疗6个月比较,治疗组FEV,1,、FEV,1,/FVC%、FEV,1,%水平明显优于对照组(,P,<,0.05);组间治疗12个月比较,治疗组FEV,1,、FEV,1,/FVC%、FEV,1,%水平明显优于对照组(,P,<,0.05)。④组间治疗6个月比较,治疗组痰液MUC5AC、痰液性状评分、外周血NE水平明显低于对照组(,P,<,0.05);组间治疗12个月比较,治疗组痰液MUC5AC、痰液性状评分、外周血NE水平明显低于对照组(,P,<,0.05)。⑤试验期间,两组均未出现严重不良反应事件,安全性指标也未见异常。,结论,2,补肾益肺方联合沙美特罗替卡松粉吸入剂治疗慢阻肺稳定期的疗效较好且安全,可更加明显地减少患者年急性加重次数,改善其肺功能及痰液性状,改善气道黏液高分泌,从而延缓肺功能的减退。
Objective,2,To investigate the effect of Bushen Yifei Decoction on airway mucus hypersecretion and lung function in patients with chronic obstructive pulmonary disease (COPD) in the stable stage.,Methods,2,Ninety patients with lung and kidney deficiency syndrome in the stable stage of COPD were randomly divided into the treatment group (,n,=45) and the control group (,n,=45). Both groups were administered with conventional medication (salmeterol xinafoate and fluticasone propionate powder for inhalation). The treatment group was additionally administered with Bushen Yifei Decoction, while the control group was administered with the placebo of traditional Chinese herbal medicine (TCHM). The course of treatment in both groups was 12 months. The annual frequency of acute exacerbations was observed, and changes in lung function-related indicators like FEV,1, FEV,1,/FVC% and FEV,1,%, as well as the changes in levels of MUC5AC, scores of sputum nature, and levels of peripheral blood neutrophil elastase (NE) were compared.,Results,2,①Finally 85 patients completed the trial, 43 cases in the treatment group and 42 cases in the control group. ②There was significant difference in the annual frequency of acute exacerbations between the two groups (,P,<,0.05). ③According to the inter-group comparisons after 6 months of treatment, the levels of FEV,1, FEV,1,/FVC% and FEV,1,% in the treatment group were significantly better than those in the control group (,P,<,0.05); According to the inter-group comparisons after 12 months of treatment, the levels of FEV,1, FEV,1,/FVC% and FEV,1,% in the treatment group were significantly better than those in the control group (,P,<,0.05). ④According to the inter-group comparisons after 6 months of treatment, the level of sputum MUC5AC, the score of sputum nature, and the level of peripheral blood NE in the treatment group were significantly lower than those in the control group (,P,<,0.05); According to the inter-group comparisons after 12 months of treatment, the level of sputum MUC5AC, the score of sputum nature, and the level of peripheral blood NE in the treatment group were significantly lower than those in the control group (,P,<,0.05). ⑤During the trial, there were no serious adverse events in both groups, and no abnormality in safety indicators were found.,Conclusion,2,Bushen Yifei Decoction combined with salmeterol xinafoate and fluticasone propionate powder for inhalation is effective and safe in treating chronic obstructive pulmonary disease in stable stage, which can significantly reduce patients’ annual acute exacerbation frequency, improve their lung function, sputum nature and airway mucus hypersecretion, and delay the decline of lung function.
慢性阻塞性肺疾病补肾益肺方中药沙美特罗替卡松粉吸入剂中性粒细胞弹性蛋白酶气道黏液高分泌肺功能
chronic obstructive pulmonary diseaseBushen Yifei Decoctiontraditional Chinese herbal medicinesalmeterol xinafoate and fluticasone propionate powder for inhalationneutrophil elastaseairway mucus hypersecretionlung function
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