OBJECTIVE： To systematically review the efficacy and safety of Jianpi shengxue granule alone or combined with iron supplement versus iron supplement alone in the treatment of iron deficiency anemia in children， and to provide evidence-based reference for iron deficiency anemia in children. METHODS： Retrieved from PubMed， Embase， Medline， Scifinder， Cochrane library， CJFD， VIP and Wanfang database during database establishment to Nov. 2018， RCT about efficacy and safety of Jianpi shengxue granule alone or combined with iron supplement （trial group） versus iron supplement alone （control group） in the treatment of iron deficiency anemia in children were collected. After the data were extracted from clinical studies that met the inclusion criteria， and the quality was evaluated with Cochrane System Evaluator Manual 5.1.0， Meta-analysis was conducted by using Rev Man 5.3 statistical software for total response rate， cure rate， the levels of hemoglobin （HB）， mean corpuscular volume （MCV）， mean corpuscular hemoglobin （MCH）， serum iron （SI）， serum ferritin （SF） elevation， the incidence of ADR. RESULTS： Totally 19 RCTs were enrolled， involving 2 259 patients. Results of Meta-analysis showed that total response rate [OR＝6.73， 95％CI （4.68， 9.68）， P＜0.001]， cure rate [OR＝2.51， 95％CI （2.06，3.06）， P＜0.001]， HB increased levels [MD＝8.91， 95％CI （6.13，11.68）， P＜0.001]， MCV increased levels [MD＝9.13， 95％CI （5.32，12.95）， P＜0.001]， MCH increased levels [MD＝2.95， 95％CI （1.75，4.15）， P＜0.001]， SI increased levels [MD＝3.66， 95％CI （2.77， 4.55）， P＜0.001]， SF increased levels [MD＝10.82， 95％CI （9.18，12.45）， P＜0.001] and the incidence of ADR [OR＝0.49， 95％CI （0.33，0.71）， P＝0.000 2] in trial group were all better than control group， with statistical significance. CONCLUSIONS： Jianpi shengxue granule alone or combined with iron supplement versus iron supplement alone can improve total response rate， cure rate， the levels of HB， MCV， MCH， SI and SF in children with iron deficiency anemia， and also decrease the incidence of ADR.