To analyze the clinical effects and possible mechanism of Huangqi Baizhu Decoction in the treatment of children with constipation of spleen deficiency syndrome，and to provide reference for the selection of TCM treatment schemes in the treatment of children with constipation of spleen deficiency syndrome.Methods:A total of 150 children with spleen deficiency constipation who were treated in The First Affiliated Hospital of Henan University of Chinese Medicine from January 2012 to January 2017 were included in the study.The patients were divided into a control group and an observation group with 75 cases in each group.The 2 groups of children and their parents were given health education，daily diet and living habits guidance，to help parents to establish children's defecation habits，to be treated with lactulose oral liquid.On the basis of the observation group，Huangqi Baizhu decoction was added to the treatment.Two groups of children were treated for 2 weeks for a course of treatment.The adverse drug reactions/side effects were collected and compared between the 2 groups.The changes of clinical symptom scores(defecation frequency，defecation time，stool characteristics，defecation difficulty)，aquaporin-8(AQP-8)，colon transit test score(CTT)，serum lymphocyte(CD3+，CD4+，CD8+，CD4+/CD8+)were evaluated before and after treatment were evaluated and compared.After completion of treatment，the clinical efficacy was evaluated and the total clinical efficiency was compared.Results:1)After 2 weeks of treatment，the frequency of defecation，defecation time，stool characteristics and difficulty scores of the 2 groups were significantly decreased than those before treatment，and the observation group was lower than those of the control group(P<005).2)AQP-8 and CTT scores of the 2 groups were decreased than those before treatment，and the observation group was lower than the control group(P<005).3)Lymphocyte CD3+、CD4+、CD4+/CD8+ of the 2 groups were significantly increased than those before treatment，and the observation group was higher than the control group(P<005).CD8+ was significantly decreased than before treatment，and the observation group was lower than the control group(P<005).4)The total clinical effective rate of the observation group was significantly higher than that of the control group(P<005).5)There was no significant difference in the rate of adverse drug reactions between the 2 groups(P>005).Conclusion:Huangqi Baizhu Decoction can effectively improve the immune function，AQP-8，CTT score of children with constipation of spleen deficiency syndrome，improve clinical constipation symptoms，promote clinical efficacy，and do not increase adverse drug reactions，which has a certain clinical value.