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Leflunomide for rheumatoid arthritis in phase Ⅱ clinical study

BAO Chun-de 1, CHEN Shun-le 1, LAO Zhi-ying 2, NI Li-qing 2, L*B Sui-feng 3, CHEN Jie 3, JIN Xia-huan 3, XIAO Fei 3 (1. Department of Rheumatology, Renji Hospital, SHANGHAI 200001, China; 2. Department of Rheumatology, Guanghua Hospital, SHANGHAI  
AIM: To assess efficacy and adverse reaction of leflunomide for rheumatoid arthritis in comparing with methotrexate (MTX). METHODS: One hundred and fifty patients were randomly assigned to receive leflunomide or MTX. Patients in leflunomide group were administered with leflunomide at 20 mg once daily and placebo of MTX at 6 tablets once weekly; those in MTX group took MTX at 15 mg once weekly and placebo of leflunomide at 2 tablets once daily. The therapeutic course was 24 wk. At the first 4-6 wk, oxaprozin could be used. RESULTS: The effective rates at 12 wk and 24 wk were 79 % and 90 % in leflunomide group respectively, 83 % and 84 % in MTX group respectively; the remarkably effective rates at 12 wk and 24 wk were 44 % and 80 % in leflunomide group respectively; 49 % and 72 % in MTX group respectively. No statistical differences on efficacy were demonstrated between two groups (P0.05). Leflunomide-related adverse reactions were observed: gastrointestinal symptoms, alopecia, skin rash and elevation of ALT etc, most of them were mild or moderate. The incidence of adverse reactions was 17 %, significantly lower than that in MTX group (32 %) (P0.05) and the severity was milder than that of MTX. CONCLUSION: Leflunomide is proved to be effective and well tolerated in the treatment of rheumatoid arthritis with less adverse reactions than MTX.
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