Abstract | BACKGROUND: METHODS: Centers in the United States and the Soviet Union participated in this randomized, controlled, double-blind trial designed to evaluate the effectiveness and safety of orally administered methotrexate. Patients received one of the following treatments each week for six months: 10 mg of methotrexate per square meter of body-surface area (low dose), 5 mg of methotrexate per square meter (very low dose), or placebo. The use of prednisone (less than or equal to 10 mg per day) and two nonsteroidal antiinflammatory drugs was also allowed. RESULTS: The 127 children (mean age, 10.1 years) had a mean duration of disease of 5.1 years; 114 qualified for the analysis of efficacy. According to a composite index of several response variables, 63 percent of the children who received low-dose methotrexate improved, as compared with 32 percent of those in the very-low-dose group and 36 percent of those in the placebo group (P = 0.013). As compared with the placebo group, the low-dose group also had significantly larger mean reductions from base line in the number of joints with pain on motion (-11.0 vs. -7.1), the pain-severity score (-19 vs. -11.5), the number of joints with limited motion (-5.4 vs. -0.7), and the erythrocyte sedimentation rate (-19.0 vs. -6 mm per hour). In the methotrexate groups only three children had the drug discontinued because of mild-to-moderate side effects; none had severe toxicity. CONCLUSIONS:
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Authors | E H Giannini, E J Brewer, N Kuzmina, A Shaikov, A Maximov, I Vorontsov, C W Fink, A J Newman, J T Cassidy, L S Zemel |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 326
Issue 16
Pg. 1043-9
(Apr 16 1992)
ISSN: 0028-4793 [Print] United States |
PMID | 1549149
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Prednisone
- Methotrexate
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Topics |
- Administration, Oral
- Adolescent
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage)
- Arthritis, Juvenile
(drug therapy, physiopathology)
- Blood Sedimentation
- Child
- Child, Preschool
- Double-Blind Method
- Drug Resistance
- Drug Therapy, Combination
- Female
- Humans
- Male
- Methotrexate
(administration & dosage, adverse effects, therapeutic use)
- Patient Compliance
- Prednisone
(administration & dosage)
- Prospective Studies
- Range of Motion, Articular
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