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 divided into control group （34 cases） and observation group （36 cases）. Control group received Methotrexate for injection by intravenous infusion， 10 mg every times， once a week； and also Tripterygium glycosides tablet， 10 mg every times， bid， po. Observation 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 incidence of adverse reactions was recorded. RESULTS： The effective rate in observation group was 85.71％， which was significantly 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 significant （P＜0.05 or P＜0.01）. And there was no significant difference in the adverse reactions in 2 groups （P＞0.05）. CONCLUSIONS： Feijin zhitong capsule combined with methotrexate and tripterygium glycosides has good efficacy and safety in the treatment of rheumatoid arthritis， it can reduce the inflammatory index level， improve symptom and sign.