OBJECTIVE:To observe the clinical efficacy and safety of Feijin zhitong capsule combined with methotrexate and tripterygium glycosides in the treatment of rheumatoid arthritis. METHODS:70 patients with rheumatoid arthritis were randomly di-vided into control group(34 cases)and observation group(36 cases). Control group received Methotrexate for injection by intrave-nous infusion,10 mg every times,once a week;and also Tripterygium glycosides tablet,10 mg every times,bid,po. Observa-tion group additionally received Feijin zhitong capsule,3 capsules every times,bid,po. The treatment course for both groups was 6 months. The clinical efficacy,symptoms and signs,erythrocyte sedimentation rate (ESR),rheumatoid factor (RF),C-reactive protein(CRP),interleukin(IL)-1,IL-6,IL-8 and TNF-α levels before and after treatment in 2 groups were observed,and the in-cidence of adverse reactions was recorded. RESULTS:The effective rate in observation group was 85.71%,which was significant-ly higher than control group(70.59%),the difference was statistically significant(P<0.05). After treatment,duration of morning stiffness,joint pain index,joint swelling index,joint tenderness index,ESR,RF,CRP,IL-1,IL-6,IL-8 and TNF-α in 2 groups were significantly lower than before,and observation group was lower than control group,the differences were statistically signifi-cant (P<0.05 or P<0.01). And there was no significant difference in the adverse reactions in 2 groups (P>0.05). CONCLU-SIONS:Feijin zhitong capsule combined with methotrexate and tripterygium glycosides has good efficacy and safety in the treat-ment of rheumatoid arthritis,it can reduce the inflammatory index level,improve symptom and sign.