Clinical study of sinomenine in combination with methotrexate for the treatment of active rheumatoid arthritis

Objective To evaluate the effect of sinomenine( SIN) and methotrexate( MTX) in treating active rheumatoid arthritis( RA). Methods Ninety patients with active RA were randomly divided into treatment group and control group,with 45 cases in each group. Treatment group was treated by SIN and MTX,and control group was treated by MTX,with the course of 6 months. We observed the standards of ACR20 and ACR50 and compared the morning stiffness,erythrocyte sedimentation rate( ESR),C-reactive protein( CRP) and rheumatoid factor( RF). The adverse effects were monitored. Results ① In treatment group,the rates of reaching the ACR20 and ACR50 were 86. 67% and 77. 78%,while in control group the rates were 60. 00% and 57. 78% respectively; The rates of reaching the ACR20 and ACR50 in treatment group were higher than that of the control group( P 0. 05). ② In each group,there were significant differences in morning stiffness,ESR,CRP and RF between before and after treatment( P 0. 05). After treatment,significant differences were found in morning stiffness,ESR,CRP and RF between the two groups( P 0. 05). ③ Ninety patients were enrolled for safety analysis. Mild adverse events occurred in 7patients( 15.6%) in treatment group,and eight patients( 17.8%) in control group developed mild adverse events. There was no difference in the incidence of adverse events between the two groups( P 0. 05). Conclusion Combined SIN and MTX can alleviate clinical symptoms of arthralgia and arthroncus,reduce the duration of morning stiffness in patients with active RA,and would not increase the incidence of adverse events.