Objective: To observe the clinical effect of Xinrun Zhike granules in the treatment of children with cough variant asthma(CVA)of cold dryness injury lung syndrome,and to explore the efficacy and safety of Xinrun Zhike granules in the treatment of the disease.Methods: A total of 72 children with CVA were randomly divided into a treatment group and a control group.The children in the control group were treated with oral montelukast sodium chewable tablets and coptis oil(hospital preparation)applied to the dry skin and mucosa around the nasal cavity.The children in the treatment group took Xinrun Zhike granules on the basis of the control group.Both groups were treated for 14 days.Before and after treatment,the scores of each symptom,total score of main symptoms,total score of secondary symptoms,total score of TCM syndromes,simple cough evaluation test(CET),visual analogue scale(VAS)score of cough and absolute eosinophil count(EOS)were recorded.SPSS 26.0 statistical software was used to analyze the data and compare the differences between the data.Results: 1.A total of 3 cases dropped out(1 female in the treatment group and 1 male and 1 female in the control group),and 69 cases completed the study(35 cases in the treatment group and 34 cases in the control group).There were no significant differences in baseline data such as gender and age between the two groups(P>0.05).2.Comparison of two groups of children before and after treatment: After treatment,the scores of each symptom,total score of main symptoms,total score of secondary symptoms,total score of TCM syndromes,cough visual analogue scale(VAS),simple cough evaluation test(CET)and absolute eosinophil count(EOS)in the two groups were significantly lower than those before treatment,and the differences were statistically significant(P<0.05).3.Comparison between the two groups after treatment: the treatment group was better than the control group in improving cough and expectoration,and the difference was statistically significant(P<0.05);In terms of each secondary disease,the treatment group was superior to the control group in the improvement of dark or blue eyelids,dry pharynx and itching,the difference was statistically significant(P < 0.05),but there was no significant difference in dry mouth and nose,red lips or dry lips,and barbed nails(P>0.05);The treatment group was better than the control group in reducing the total score of main symptoms,the total score of secondary symptoms,the total score of TCM syndromes,VAS score,CET score and EOS count,and the differences were statistically significant(P<0.05).4.Efficacy evaluation: the effective rate was 91.40% in the treatment group and 79.40% in the control group,which was statistically significant(P<0.05).5.Safety evaluation: During the treatment,no adverse events occurred in the two groups,and the safety evaluation was level 1.Conclusions:Xinrun Zhike granules are significant in the treatment of children with cough variant asthma of cold dryness injury lung syndrome.Compared with the control group treated with montelukast sodium chewable tablets alone,the treatment with Xinrun Zhike granules is more effective in improving symptoms and reducing EOS count in children. |