| Objective To evaluate the efficacy and safety of Pingchuanyiqi Particles in treating acute exacerbation of bronchial asthma(Qi Xu Han Xiao Zheng)through multi-center clinical study.Methods A multi-center,randomized,double-blind,placebo-controlled,parallel-group approach was used to enroll 300 asthma patients from 5 study units by 1:1 ratio.Patients were randomly treated with Pingchuanyiqi Particles or placebos.The main efficacy indicators were:(1)traditional Chinese medicine syndrome points;(2)lung function;(3)hormone use(number or rate)and dose.Secondary efficacy indicators include:(1)total score of TCM syndromes;(2)SABA dose;(3)number or rate of hospitalization due to acute exacerbation of asthma.(4)safety indicators:during the study period of the subjects,safety indicators such as vital signs,laboratory tests and adverse events were observed.SAS 9.10 statistical analysis software and the corresponding statistical analysis method were used to analyze the effectiveness indicators and safety indicators.ResultsThe actual group of 300 patients(150 cases for each group),30 cases off,20 cases removed.The number of cases distributed,demographic information(gender,age,marriage,weight and height),baseline status(disease severity,course of disease,duration of acute episode of asthma,TCM syndrome points,total points of TCM syndrome,lung function and maintenance therapy),asthma control influencing factors(smoking history,smoking,smoking time and smoking cessation time),there was no significant difference between treatment group and the placebo group(P>0.05).The balance between the two groups was good.ITT analysis showed:1,The analysis of the main TCM syndrome points showed that the main disease points of the treatment group and the placebo group on the 4th day,the 8th day of were both significantly lower than correspondent score before treatment The comparison between groups showed that there was no significant difference between the two groups(P>0.05)on the 4th day,but there was significant difference between the two groups(P<0.05)on the 8th day.Pingchuanyiqi particles on the main TCM syndrome points had improved.2,The analysis of pulmonary function showed:compared to the baseline,the lung function changes of the 4th day morning,the 4th day evening,and the 7th day morning,there have no statistically significant difference(P>0.05),but there was significant difference between the baseline and the 8th day morning(P<0.05).Pingchuanyiqi particles had an improving effect on pulmonary function in patients with bronchial asthma.3,The analysis of the total TCM syndromes points showed that the TCM syndrome points in the two groups was statistically significantly different compare to those before baseline,and the difference between the two groups was statistically significant(P<0.05).Pingchuanyiqi particles in the treatment of bronchial asthma in the process of improving shortness of breath,wheeze,fatigue,fear of cold,chest tightness,sputum difference was statistically significant(P<0.05).4,The analysis of the use of salbutamol showed that the amount of salbutamol(SABA)was significantly different from that of baseline(P<0.05)on the 3rd day to the 6th day and the 8th day after treatment.Pingchuanyiqi particles treat of bronchial asthma,can reduce the use of salbutamol.5,The study did not observe the use of systemic glucocorticoid and asthma due to acute exacerbation of asthma required hospitalization.6,There was no significant difference between the two groups in vital signs,physical examination,laboratory examination(blood routine,urine routine,liver and kidney function,electrocardiogram)(P>0.05).There was no serious adverse event occurred during the study.A total of 28 cases adverse events,among which 11 subjects(14 cases)came from Pingchuanyiqi group,12 subjects(14 cases)came from placebo group.There was no significant difference in the incidence of adverse events between the two groups(P>0.05).The adverse reactions associated with Pingchuanyiqi particles were:epigastric discomfort(2,1.4%),nausea(2,1.4%),diarrhea(1,0.7%),upper respiratory tract infection(1,0.7%),ALT increased(1,0.7%),TB increased(1,0.7%).There were 8 adverse events associated with Pingchuanyiqi particles,the rate was 5.8%.Conclusion This study showed that the Pingchuanyiqi Particles in the treatment of mild to moderate acute exacerbation of asthma(Qi Xu Han Xiao Zheng)was effective,safe and well tolerated. |
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