Abstract：Objective：To observe the clinical effect of Jianpi Zhixie Prescription combined with tuina on diarrhea in children with spleen deficiency syndrome. Methods：A total of 96 cases of children with diarrhea with spleen deficiency syndrome were divided into the observation group and the control group according to the random number table method， with 48 cases in each group. The control group was given the oral administration of Montmorillonite Powder and Bifidobacterium Quadruple Viable Tablets， and the observation group was additionally treated with Jianpi Zhixie Prescription combined with tuina based on the treatment of the control group. Both groups were treated for 2 weeks. The defecation frequency，traditional Chinese medicine (TCM) syndrome scores and immune function indexes before and after treatment， as well as the clincal symptom improvement time (the disappearance time of abdominal pain，the stop time of diarrhea，the time for defecation returning to normal) were compared between the two groups；the clinical effects and safety in the two groups were evaluated. Results： The total effective rate in the observation group was higher than that in the control group (P＜0.05)，the disappearance time of abdominal pain，the stop time of diarrhes，and the time for defecation returning to normal were shortened when compared with those in the control group (P＜0.05). After treatment， defecation frequency and TCM syndrome scores in the two groups were decreased when compared with those before treatment (P＜0.05)， and CD4+ levels and CD4+/CD8+ were increased (P＜0.05)； the defecation frequency and TCM syndrome score in the observation group were lower than those in the control group (P＜0.05)， and CD4+ level and CD4+/CD8+ were higher than those in the control group (P＜0.05). Before and after treatment，there was no significant difference being found in the comparison of CD8+ levels between the two groups (P＞0.05). There was no obvious adverse reaction in the two groups. Conclusion：Jianpi Zhixie Prescription combined with tuina has a definite curative effect in the treatment of diarrhea in children with spleen deficiency syndrome， which can reduce clinical symptoms， accelerate the improvement of diarrhea symptoms and regulate immune function，with high safety.