Objective To assess effectiveness and safety in rheumatoid arthritis （RA）patients treated with the indigenous leflunomide in comparison with Airohua produced by Cinkate Corp.
Methods A double blind and double dummy randomized controlled trial was conducted in the outpatient clinic of rheumatology. Fifty-six Chinese RA patients were divided into two groups who received either indigenous Leflunomide or Airohua of 20 mg daily and the two matching placebo tablets of Airohua or indigenous Leflunomide with the constant dose of Oxaprozin （0.4 g, qd） in the first 6 weeks. Clinical and laboratory data were collected every 6 weeks during 24 weeks of follow-up.
Results This study showed that the patients of both groups significantly improved on main variables except erythrocyte sedimentation rate （EXR） at the 12th week . The variables such as ESR, and the level of c-reaction protein in both groups at 24th week showed no statistical difference compared with those at the baseline. There were also no statistical difference in the clinical characteristics and laboratory findings between the two groups at the 12th week and 24th week （P 〉0. 05）. The effcacy of Airohua（37% ） was lower than that of indigenous Leflunomide（64% ） at the 12th week （P 〈0. 05 ） and slightly better than indigenous Leflunomide group at the 24 week （81.5% vs 77.3% , （ P 〉0. 05）. The administration of Airohua and indigenous leflunomide presented a similar pattern and frequency of adverse events. Serious adverse events such as interstitial pneumonitis, pulmonary infiltration, and liver impairment etc. were not reported in either group.
Conclusions The study shows that the indigenous Leflunomide has a superior therapeutic effect. Its efficacy and safety are similar to Airohua in the treatment of acfive RA patients in China.
Citation： JIANG Lindi ,CHEN Huiyong,YU Qiang,WANG Zhen. A Randomized, Double-blind Controlled Trial of Indigenous Leflunomide in the Treatment of Rheumatoid Arthritis. Chinese Journal of Evidence-Based Medicine, 2005, 05(10): 743-746. doi: Copy