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Short-term cyclosporine induces a remission of autoimmune hepatitis in children.

AbstractBACKGROUND/AIMS:
The current immunosuppressive treatment of patients with autoimmune hepatitis consists of prednisone and azathioprine. High doses of prednisone used to obtain the remission of the disease are associated with serious adverse effects. To avoid harmful consequences of prednisone therapy, we proposed to treat patients with oral cyclosporine to obtain the remission of the inflammatory process.
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Two patients were withdrawn from the study: one for non-compliance and the other for liver failure which did not improve with cyclosporine.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.
AuthorsF 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
JournalJournal of hepatology (J Hepatol) Vol. 30 Issue 2 Pg. 222-7 (Feb 1999) ISSN: 0168-8278 [Print] Netherlands
PMID10068099 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Inflammatory Agents
  • Immunosuppressive Agents
  • Cyclosporine
  • Alanine Transaminase
  • Azathioprine
  • Prednisone
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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