To study the clinical efficacy and safety of hericium erinaceus extract granules in the treatment of spleen deficiency syndrome after infection in children.Methods:A total of 106 children patients with spleen deficiency syndrome after infection in Shijiazhuang First Hospital of Hebei Province from Jan 2016 to Dec 2016 were divided into the control group (treatment of live combined Bifidbacterium and Lactobacillus tablets, 48 cases) and the observation group (based on control group, treatment of hericium erinaceus extract granules, 58 cases) according to the random number method.The total clinical efficacy, improvements of symptom scores, and curative effect on major symptoms during the treatment period in the two groups were compared.Results:Compared with the control group, the total effective rate of treatment was significantly increased in the observation group with statistical difference (96.6% vs 75.0%, χ2=10.64, P<0.05); There were no statistical difference in the symptom scores before treatment in two groups (8.6±0.7 vs 8.5±0.6, t=0.04, P>0.05); The symptom scores after treatment were significantly decreased in the observation group (0.4±0.1 vs 8.6±0.7, t=7.23, P<0.05) and the control group (4.2±0.6 vs 8.5±0.6, t=4.59, P<0.05) with statistical difference when compared with that before treatment; Compared with the control group, the symptom scores after treatment were significantly decreased in the observation group with statistical difference (0.4±0.1 vs 4.2±0.6, t=5.11, P<0.05); There were no abnormal changes in blood routine, urine routine, stool routine, liver and kidney function, myocardial enzyme and electrocardiogram in two groups.Conclusion:The treatment of hericium erinaceus extract granules can significantly increase the clinical efficacy of spleen deficiency syndrome after infection in children with higher treatment safety, and is worthy of clinical promotion.