| Objective:To evaluate the effects of Huanglong Zhike Granules on the control and improvement of symptoms of lung-kidney qi deficiency and phlegm-heat stagnation of lung syndrome in children with cough variable asthma(CVA),and to observe the safety of clinical application of Huanglong Zhike Granules.Methods:A stratified,randomized,double-blind,double-simulated,parallel controlled,multicenter clinical study was used.A total of 160 children were included and randomly divided into the experimental group and the control group according to a 1:1 ratio.The experimental group and the control group were given Huanglong Zhike Granules and Montelukast Sodium Chewable Tablets(Shun’erning)for 4 weeks.Compare the main index,secondary index and safety index.Results:1.Baseline comparability: A total of 160 children were included,including 80 in the experimental group and 80 in the control group.160 patients entered the total analysis data set(FAS),with 80 patients in the experimental group and 80 patients in the control group.Due to combined medication,drug compliance,case shedding and other reasons,147 patients finally entered the compliance data set(PPS),72 cases in the experimental group and 75 cases in the control group;160 patients entered the safety data set(SS),with 80 patients in the experimental group and 80 patients in the control group.All the patients who entered the FAS and PPS analysis had no significant difference in baseline demographic data(height,weight,age,sex,nationality,case source),medical history(medical history,course of disease,allergy/drug sensitivity history,allergen detection),combined diseases,combined drugs,etc.Except for gender PPS analysis,there was no significant difference(P>0.05),and the conclusions of FAS and PPS analysis were consistent.There was no significant difference in curative effect related indexes,disease control(activity limitation,night symptoms,relieving drug demand),cough severity,pulmonary function index forced expiratory volume in the first second(FEV1),forced vital capacity(FVC),FEV1/FVC and TCM syndrome scores between the two groups(P>0.05),all of which were comparable,and the conclusions of FAS and PPS analysis were consistent.2.Effectiveness analysis:The total disease control rate of the experimental group after 4weeks of treatment was 100.00%,and that of the control group was 98.67%.The rate difference and confidence interval between the two groups were 3.50%(-7.82%,14.82%).Logistic regression analysis showed that there was no significant difference in total control rate between the two groups(P>0.05).Taking-0.10 as the non-inferior cut-off value,the experimental group was not inferior to the control group,and the conclusions of FAS and PPS analysis were consistent.There was no significant difference in cough severity score,lung function test(FEV1,FVC,FEV1 predictive value),and TCM syndrome curative effect(total effective rate)between the two groups(P>0.05).The results of FAS and PPS analysis were consistent.3.Safety analysis:There were 2 adverse events in this study,all of which occurred in the control group.There were no serious adverse events,and 1 case was judged as an adverse reaction.There was no statistical difference in the incidence of adverse events and adverse reactions between the two groups(P>0.05).There were no significant differences in the laboratory test and functional test related indexes between the two groups(P>0.05).There were no significant differences in the baseline and post-treatment values of vital signs between the two groups(P>0.05).Conclusion:The total control rate of Huanglong Zhike Granule in treating children with cough variant asthma(lung and kidney qi deficiency,phlegm-heat stagnation in the lung syndrome)is not inferior to the control drug montelukast sodium chewable tablets.It can reduce the severity of cough,improve the lung and kidney-qi deficiency,phlegm-heat stagnation in the lung syndrome related symptoms,and the clinical application is safe. |
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