Abstract | BACKGROUND: METHODS: A 2.5-year, open label, crossover study, was designed to determine the effect of UDCA (15-20 mg/kg per day for 12 months, off for 6 months, and on again for 12 months) on clinical symptoms, biochemical test results, galactose and caffeine elimination half-lives (t1/2), and quantitative hepatic scintigraphy in 13 subjects aged 13.1 +/- 2.1 years (10 of whom completed the entire study), with intrahepatic cholestasis. RESULTS:
Pruritus improved with UDCA in the 6 patients with pruritus on entry into the study. At 12 months, there was a significant decline in ALT, gamma-glutamyl transpeptidase, and plasma levels of copper and manganese, with no further decline in these levels at 24 months. There were no changes in bilirubin or cholylglycine levels. After therapy was discontinued at 12 months, UDCA was restarted within 1 month in 9 of 12 patients in response to a doubling of ALT (n = 6) or worsening pruritus (n = 3). Galactose t1/2 increased after 12 months, with no further increases after 24 months of UDCA therapy, whereas caffeine t1/2 did not change. There were no significant changes in hepatic scintigraphy throughout the study. CONCLUSIONS:
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Authors | M R Narkewicz, D Smith, C Gregory, J L Lear, I Osberg, R J Sokol |
Journal | Journal of pediatric gastroenterology and nutrition
(J Pediatr Gastroenterol Nutr)
Vol. 26
Issue 1
Pg. 49-55
(Jan 1998)
ISSN: 0277-2116 [Print] United States |
PMID | 9443120
(Publication Type: Clinical Trial, Journal Article, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Caffeine
- Manganese
- Ursodeoxycholic Acid
- Copper
- gamma-Glutamyltransferase
- Alanine Transaminase
- Technetium Tc 99m Disofenin
- Galactose
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Topics |
- Adolescent
- Adult
- Alanine Transaminase
(blood)
- Caffeine
(metabolism)
- Child
- Child, Preschool
- Cholestasis, Intrahepatic
(diagnostic imaging, drug therapy, physiopathology)
- Copper
(blood)
- Cross-Over Studies
- Galactose
(metabolism)
- Half-Life
- Humans
- Liver
(physiopathology)
- Manganese
(blood)
- Radiography
- Technetium Tc 99m Disofenin
- Ursodeoxycholic Acid
(therapeutic use)
- gamma-Glutamyltransferase
(blood)
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