| Objectives:To evaluate the efficacy and safety of Bailing Capsule in the treatment of chronic bronchial asthma(deficiency syndrome).Method:A total of 70 subjects with chronic duration of asthma(deficiency of asthma syndrome)were recruited in the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine and randomly divided into a treatment group and a control group.On the basis of western medicine,the treatment group took Bailing capsules,2 capsules/time,3 times a day,the control group took Bailing capsules placebo,2 capsules/time,3 times a day,and the study period was 6 months.Record asthma control level,quality of life,asthma control test,lung function and safety index when leaving the group,record asthma control level,quality of life,asthma control test monthly,conduct safety check after 3 months of medication,and collect relevant research Data,through the observation of asthma control level,quality of life(AQLQ),lung function level,asthma control test(ACT),liver and kidney function and electrocardiogram to evaluate the effectiveness and safety of Bailing capsules.Result:1 Effectiveness(1)Comparison of asthma control: the asthma control rate of the treatment group increased from 40% to 93.3%,asthma was effectively controlled in 90% of patients during the study period,and asthma was not controlled in 10% of patients;the monthly asthma control rate of the control group was Between 42.4% and 78.8%,asthma was not effectively controlled in 36.4% of patients during the study period.With the increase of time,the control rate of the treatment group is higher than that of the control group,and the monthly asthma control rate of the treatment group is more than 80%,which is significantly higher than that before the study;The proportion of patients with complete control of asthma in the treatment group was higher than that in the control group,and the proportion of uncontrolled asthma was significantly lower than that in the control group.There was a statistical difference between the two groups(P<0.05).(2)Lung function: After continuous treatment with Bailing capsules for 6 months,the FEV1%,FEV1/FVC,and PEF% indexes of the treatment group did not improve significantly.Compared with the control group,the lung function indexes of the two groups were not statistically different Compared with the lung function of the two groups after treatment and before treatment,there was no statistical difference(P>0.05).(3)ACT comparison: The score of ACT enrollment in the treatment group was19.83±3.28 points,and after 3 months of treatment it was 24.60±0.86 points and remained stable.With the increase of treatment time,the score of the treatment group was higher than that of the control group;the score of the treatment group was significantly higher than that before the study,and the ACT score of the treatment group was at a high level from the third month;while the score of the control group was compared with that before the study No significant changes.Compared with the control group,the monthly score of the treatment group was improved,and the difference was statistically significant(P<0.05).(4)Comparison of quality of life: The average total quality of life score of the treatment group was significantly improved compared with the control group,of which the difference was statistically significant from the 4th month(P<0.05).The score of the treatment group with limited activity dimension was improved compared with the control group,and the difference was statistically significant after 4 months of medication(P<0.05);in the dimension of asthma symptoms,the score of the treatment group increased significantly,the control group remained stable,and the difference between the two groups Statistically significant(P<0.05);in the psychological dimension,the score of the treatment group gradually increased,the control group decreased,and increased after 6 months,of which the difference between the two groups was statistically significant in the 4th and 5th months(P<0.05);In the dimension of response to stimuli,the treatment group responded less to the stimulus,and the overall control group was more sensitive to the stimulus than the treatment group.Among them,there was a statistical difference between the third and 4th months(P<0.05);In terms of self-health evaluation,the score of the treatment group was higher than that of the control group after 3 months,and there was a statistical difference between the two groups in the 6th month(P<0.05).In addition to the stimuli response dimension,the treatment group scored higher in the activity-restricted dimension,symptom dimension,psychologicaldimension,and self-care dimension than the control group;with the increase of time,the treatment group in the activity-restricted dimension,symptoms both the dimension and the mental dimension have been improved compared with that before the study,and the dimension of concern for one's health has improved from the third month onwards.The control group has a significant improvement from the sixth month onwards,except for the mental dimension.No significant changes before the study.2 SecurityDuring the study period,neither group had any adverse reactions,and there were no significant changes in blood routine,liver and kidney items,and electrocardiogram(P>0.05).Conclusion:Bailing Capsule can effectively improve the level of asthma control,improve the quality of life,and improve the ACT score;Bailing Capsule has good safety. |
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