To investigate the clinical effects and the action mechanism of Jianpi Shengxue Granules on iron-deficiency anemia in the patients with rheumatoid arthritis.Methods:A total of 87 cases of iron-deficiency anemia with rheumatoid arthritis admitted to Department of Traditional Chinese Medicine of Renmin Hospital of Wuhan University were randomly into a treatment group(n＝47)and a control group(n＝40).All patients were treated with methotrexate and leflunomide tablets.The control group was given Funaide oral liquid and the treatment group was treated with Jianpi Shengxue Granules.After 8 weeks of continuous treatment，the changes of TCM syndrome scores，blood biochemical and ferritin index，rheumatoid factor(RF)，erythrocyte sedimentation rate(ESR)，C-reactive protein(CRP)level，and the effect of basic drug treatment and adverse reactions were observed.Results:After treatment，the TCM syndrome score，RF，ESR，CRP，total iron binding level in the treatment group were significantly lower than those in the control group(P<0.05)，while the RBC，Hb，MCV，MCH，MCHC，serum iron were significantly higher the control group(P<0.05).There was no significant difference in the adverse reactions and curative effects of basic drugs between the 2 groups(P>0.05).Conclusion:Jianpi Shengxue Granules have good curative effects on iron-deficiency anemia in patients with rheumatoid arthritis.