Abstract: Objective To observe the efficacy and safety of different combination therapy of amethopterin and leflunomide(MTX+LEF) versus amethopterin, salazosulfapyridine and hydroxychloroquine(MTX+SSZ+HCQ) for patients with rheumatoid arthritis. Methods A total of 350 patents with RA were divided into two groups randomly, 180 patients were given MTX+LEF, and 170 patients given MTX+SSZ+HCQ, both for 12 weeks. Efficacy parameters including the time of early morning stiffness, engorgement index, functional disturbance index and erythrocyte sedimentation rate(ESR), C-reactive protein(CRP) and rheumatoid factor(RF) before and after the treatment were observed and the side effects of the therapies were recorded. Results All the parameters in both groups were improved after 4 weeks and 12 weeks treatment and for each group, the parameters were significantly different in different period after the treatment. Compared to MTX+SSZ+HCQ group, all the parameters of MTX+LEF group were better improved after 4 weeks treatment, and the improvement of ESR, RF kept predominant after 12 weeks treatment. The total efficacy analysis showed that MTX+LEF therapy was superior to MTX+SSZ+HCQ therapy, but no significant difference of the total efficacy was observed between the two groups after 12 weeks treatment. Conclusion Both DMARDs combination therapies were effective and safe, but the effect of combined therapy with MTX and LEF could appear earlier.

Key words: disease-modifying anti-rheumatic drugs, therapeutic alliance, rheumatoid arthritis