Randomized double - blind controlled clinical trial of leflunomide in the treatment of rheumatoid arthritis

Objective To study efficacy and safty of leflunomide (LEF) and methotrexate ( MTX) in the treatment of rheumatoid arthritis ( RA ). Methods In this random, double - blind, double - dummy, controlled, multicentric clinical trial, 70 patients with RA were allocated to received LEF (20 mg · d-1 , once a day) , 69 patients received MTX (15 mg · week , once a week) . Period of treatment is 12 weeks, part of cases may administrate drug for 24 weeks. Results The effective ratios of 12 weeks and 24 weeks in LEF group were 44. 28% (n =70)and 79. 36% (n =63) , respectively, the effective ratios of 12 and 24 weeks in MTX group were 49. 27% ( n = 69) ,74. 19% ( n = 62) , respectively. Through riddit analysis , the difference of curative effect between LEF and MTX had no signifi-cancy. Symptom , sign and join function of RA patients received LEF and MTX were ameliorated distinctly, the lever of ESR, CRP and RF were reduced. The ratio of adverse reactions of LEF and MTX were 17. 14% ( re = 12)and 31. 88% (n = 22) , respectively ( P 0. 05 ) . Conclusion Leflunomide is an effective and safe drug in treatment of RA.