| Autor: |
M A, van Rossum, T J, Fiselier, M J, Franssen, A H, Zwinderman, R, ten Cate, L W, van Suijlekom-Smit, W H, van Luijk, R M, van Soesbergen, N M, Wulffraat, J C, Oostveen, W, Kuis, P F, Dijkstra, C F, van Ede, B A, Dijkmans |
| Rok vydání: |
1998 |
| Předmět: |
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| Zdroj: |
Arthritis and rheumatism. 41(5) |
| ISSN: |
0004-3591 |
| Popis: |
To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA).We conducted a 24-week randomized, placebo-controlled, double-blind, multicenter study of patients with active JCA of both oligoarticular and polyarticular onset. Patients were treated with a dosage of 50 mg/kg/day of SSZ (maximum 2,000 mg/day) or placebo. The efficacy variables were joint scores, physician's, parents', and patient's overall assessments, and laboratory parameters of inflammation.Of the 69 patients enrolled, 52 (75%) completed the trial. Six patients (18%) withdrew from the placebo group, and 11 (31%) withdrew from the SSZ group (P = 0.18). In the intention-to-treat analysis of end point efficacy, between-group differences were significant for the overall articular severity score (P = 0.02), all global assessments (P = 0.01), and the laboratory parameters (P0.001). Adverse events occurred more frequently in the SSZ group and were the main reason for withdrawal (P0.001), but in all instances, these events were transient or reversible upon cessation of treatment.The results of this first placebo-controlled study show that SSZ is effective and safe in the treatment of children with oligoarticular- and polyarticular-onset JCA, although it was not well tolerated in one-third of the patients. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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