Clinical Observation And Mechanism Of Action Of Jianpi Zhuyun Recipe In The Treatment Of Children With Atopic Dermatitis

Objective:1.The research is based upon the pathogenesis theory of "imbalance between drying and dampness induced by transportation dysfunction of spleen".The purpose of the research is to objectively assess the clinical efficacy of Jianpi Zhuyun Fang and to provide a scientific basis for the treatment of AD(atopic dermatitis,AD)using Jianpi Zhuyun Fang,through the observation of the severity of pediatric patients' conditions before and after treatment according to changes in SCORAD(scoring Atopic Dermatitis,SCORAD),clinical symptoms scoring systems,quality of life scores,etc.2.Through the proteomics technology,the protein target and biological mechanism of Jianpi Zhuyun Fang in the treatment of AD were explored to provide basis for clinical diagnosis,treatment and research.Methods:Study 1.Clinical observation of Jianpi Zhuyun Fang in the treatment of pediatric atopic dermatitisClinical Observation of Treating Children with AD with Jianpi Zhuyun Fang.This exploratory trial uses a randomized,single-blind,placebo-controlled approach to observe the clinical efficacy of the Jianpi Zhuyun Fang in treating children with AD.A total of 44 children is enrolled.They are randomly divided into two groups of 22 children each;a treatment group and a placebo group.The treatment group is being treated under Jianpi Zhuyun Fang twice a day orally.The placebo group is being given placebo twice a day orally.The treatment period is eight weeks for both.After which,the improvements and any adverse reactions from Jianpi Zhuyun Fang are evaluated by using SCORAD and quality of life scores,etc.before and after the treatment.Study 2.The Effect of Jianpi Zhuyun Fang on Proteomics in Children with ADQuantitative proteomics was used to analyze the serum samples of the children before and after the treatment of Jianpi Zhuyun Fang,in order to find different proteins in different groups.Through bioinformatics analysis of differentially expressed proteins,the biological pathways and molecular targets related to drug action were searched,and the molecular mechanism of Jianpi Zhuyun Fang,in treating atopic dermatitis was explained at the protein level.Results:Study 1.Clinical Observation of Treating Children with AD with Jianpi Zhuyun Fang1.Enrollment and Exclusion:44 subjects are enrolled in the research;22 subjects are enrolled in the treatment group and 22 subjects are enrolled in the placebo group.Two subjects are excluded from each group due to lack of post-treatment data.These four patients are not involved in the statistical analysis of efficacy.The final study has 40 effective cases,20 from the treatment group and 20 from the placebo group.2.Skin Lesions Comparison of SCORAD:Comparisons of pre-treat ment and post-treatment SCORAD within the same group(treatment group or placebo group)both have differences that are statistically significant(P<0.05).Data within the treatment group became statistically significant after one week of treatment(P<0.05);data within the placebo group became statistically significant after six weeks of treatment(P<0.05).There is no significant difference in the SCORAD scores between the two groups before treatment(P>0.05).After 8 weeks of treatment,there is a statistically significant difference between the groups(P<0.05);the clinical effect of the treatment group is more positive than that of the placebo group.(2)In terms of symptom scores,there were significant differences in the scores of symptom scores before and after treatment within the two groups(P<0.05).There is no significant difference in the scores of clinical symptoms between the two groups before treatment(P>0.05).A fter 8 weeks of treatment,the difference between the two groups became statistically significant(P<0.05).The treatment group improved the clinical symptoms better than the placebo group.3.Comparison of quality of life index score:The difference in the quality of life scores before and after the treatment in the treatment group is statistically significant(P<0.05).There is no significant difference in the quality of life scores before and after the treatment within the placebo group(P>0.05).There is a statistically significant difference in the scores(P<0.05)between the two groups.The treatment group improved the quality of life of the children better than the placebo group.4.Effectiveness Comparison:Of the 20 patients in the treatment group,2 patients completely recover,12 patients experience improvements,6 patients do not see any improvements.The total effective rate is 70%Of the 20 patients in the placebo group,none recovers,4 patients experienced improvements,16 do not see any improvements.The total effective rate is 20%.When comparing the total effective rate between the two groups,the difference is statistically signific.ant(P<0.05),and the total effective rate of the treatment group was significantly better than that of the placebo group.5.Safety Considerations:Of the total of 44 children with AD included in the study,4 of which are excluded because of no post-treatment data.There are 40 subjects remaining in the two groups,,and no obvious adverse reactions occur during the study.One child in each group develops a cold symptom during the study period.It was determined that there is no causal relationship with the treatment itself.There is no other adverse events among other patients.Study 2.The Effect of Jianpi Zhuyun Fang on Proteomics in Children with Atopic Dermatitis1.The serum proteomics of children before treatment(DB)and after treatment(DA)were analyzed by mass spectrometry.A total of 252 proteins were identified,of which 232 were identified in DB group and 219 were identified in DA group.According to the differen ce of protein expression level more than 1.5 times,101 differential proteins were identified between the two groups.2.Bioinformatics analysis of differentially expressed proteins revealed that the mechanism of Jianpi Zhuyun Fang's pharmacodynamics might be related to many biological pathways,such as complement and coagulation cascade pathway,inflammatory reaction,cell adhesion etc.Conclusion:1.Based on the results of this study,Jianpi Zhuyun Fang can effectively improve SCORAD scores and quality of life index scores,relieve symptoms,and improve the quality of life in children with AD.It is an effective and highly safe prescription for the treatment of AD.2.This study explored the biological mechanism of Jianpi Zhuyun Fang on the level of protein,suggesting that the drugs may have therapeutic effects on AD mainly by regulating congenital or acquired immune response and improving epidermal barrier function.