| Background:Asthma is a common chronic respiratory disease affecting an estimated 360 million people world-widely.It is estimated that the number of cases will increase by 100 million in the next five years,with extremely adverse effects on human health.The number of asthmatic patients in China is about 30 million,and the number is increasing year by year.At present,western medicine mainly includes glucocorticoids,β-2 receptor agonists,leukotriene receptor antagonists,theophylline and anticholinergic drugs.In severe cases of bronchial asthma,external respiratory support is used to increase blood oxygen.However,conventional western medicine treatment fails to fundamentally solve the inducement and pathogenesis of asthma,which leads to asthma recurrence.Traditional Chinese medicine has advantages in treating asthma.YU is an important factor in the chronic duration of bronchial asthma and the key to treatment.Qi Yu Tan Ning Xue Yu is the important pathogenesis of asthma chronic disease progression,Jie Yu Su Fei is generated from Yu treatment and can effectively control the disease.Based on this theory and early clinical practice,combined with the ancient and modern literature and the experience of famous Chinese medicine experts,we generated Jie Yu Su Fei Decoction.Based on the preliminary study,this study intends to use randomized,controlled and prospective clinical study methods to evaluate Jie Yu Su Fei by reducing airway chronic inflammatory factors and airway hyper-response state in patients with chronic bronchial asthma.Objective:The aim of this research was to evaluate the efficacy and safety of Jie Yu Su Fei therapy in the treatment of chronic bronchial asthma,and to expand the idea of traditional Chinese medicine in the treatment of chronic bronchial asthma.Methods:A cross-sectional method was adopted in this study.Fifty patients with bronchial asthma in chronic persistent(syndrome type)stable stage were enrolled in the outpatient department of XiYuan Hospital from Aug 2020 to Jan 2021.They were randomly divided into two groups:the Jie Yu Su Fei Decoction group(N=25)and the control group(N=25).Jie Yu Su Fei Decoction was taken orally once a day,divided into two doses.Patients in the control group were graded according to the disease condition and treated according to the guidelines of GINA2020.The course of administration was 4 weeks.Before and after the experiment,the subjects’ asthma disease control grade,ACT score,symptom quantification index,anxiety and depression quantification index,lung function,serum inflammatory markers,blood,urine,feces,ECG,liver and kidney function,and possible adverse reactions were monitored and recorded.In the case of acute attack in the trial,according to the GINA2020 Global Strategy for asthma acute exacerbation of the conventional method of treatment(using relatively uniform Chinese and Western medicine treatment),to basically restore the condition to the level before the acute attack that is to stop treatment.Results:After treatment,the control grade of asthma condition in TCM group was significantly decreased,and ACT score was significantly increased,indicating that asthma condition was well controlled and the effect was significantly better than that of western medicine control group.As for the secondary efficacy indicators,the quantitative indicators of symptoms in both groups,such as asthma,chest sulking,shortness of breath,cough,sputum,and total scores of TCM syndromes,were all improved.There were significant differences before and after treatment in the Chinese medicine group and the improvement effect in the Chinese medicine group was better than that in the western medicine group.After treatment,the quantitative emotional indicators such as depression,anxiety and mood in the TCM group were significantly lower than those before treatment,and significantly different from those in the western medicine control group.The pulmonary function indexes(FEV1%,FVC,PEF),serum eosinophil and IgE levels in 2 groups before and after treatment showed no biologically significant changes.Safety comparison:No serious adverse events were observed during the trial.Conclusions:Jie Yu Su Fei therapy can significantly control asthma level,improve ACT score,improve symptom quantitative score,and the effect is obviously better than western medicine control.No significant changes were observed in the pulmonary function indexes and serum inflammatory biomarkers of patients during the trial,and no serious adverse events were observed.This study can provide a new theory and breakthrough point for the clinical treatment of chronic bronchial asthma. |
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