Abstract | BACKGROUND/AIMS: METHODS: This is a pilot, multinational, multicenter, clinical trial involving children with autoimmune hepatitis. Thirty-two children were recruited, who according to international criteria were considered as having definite autoimmune hepatitis. Cyclosporine alone was administered for 6 months, followed by combined low doses of prednisone and azathioprine for 1 month, after which cyclosporine was discontinued. Biochemical remission of the disease was established by the follow-up of serum transaminase activity levels. Growth parameters and adverse effects of the treatment were recorded. RESULTS: Two patients were withdrawn from the study: one for non-compliance and the other for liver failure which did not improve with cyclosporine. Of the 30 remaining patients, 25 normalized alanine aminotransferase activity levels by 6 months and all the patients by 1 year of treatment. Z-scores for height showed a trend towards improvement during treatment. Adverse effects of cyclosporine were mild and disappeared during weaning off the medication. CONCLUSIONS:
Cyclosporine induced the biochemical remission of the hepatic inflammatory/necrotic process in children with autoimmune hepatitis, with few and well-tolerated adverse effects.
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Authors | F Alvarez, M Ciocca, C Cañero-Velasco, M Ramonet, M T de Davila, M Cuarterolo, T Gonzalez, P Jara-Vega, C Camarena, P Brochu, R Drut, E Alvarez |
Journal | Journal of hepatology
(J Hepatol)
Vol. 30
Issue 2
Pg. 222-7
(Feb 1999)
ISSN: 0168-8278 [Print] Netherlands |
PMID | 10068099
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Cyclosporine
- Alanine Transaminase
- Azathioprine
- Prednisone
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Topics |
- Adolescent
- Alanine Transaminase
(blood)
- Anti-Inflammatory Agents
(administration & dosage, adverse effects, therapeutic use)
- Azathioprine
(administration & dosage, therapeutic use)
- Child
- Child, Preschool
- Cyclosporine
(administration & dosage, adverse effects, therapeutic use)
- Drug Administration Schedule
- Drug Therapy, Combination
- Female
- Hepatitis, Autoimmune
(drug therapy, enzymology)
- Humans
- Immunosuppressive Agents
(administration & dosage, therapeutic use)
- Male
- Pilot Projects
- Prednisone
(administration & dosage, adverse effects, therapeutic use)
- Treatment Outcome
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