Journal List > Korean J Pediatr Gastroenterol Nutr > v.5(2) > 1110430

Korean J Pediatr Gastroenterol Nutr. 2002 Sep;5(2):174-180. Korean.
Published online Sep 30, 2002.
Copyright © 2002 The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition
A Randomized, Double-Blind, Placebo-Controlled Trial of Early Ursodeoxycholic Acid Administration for Prevention of Total Parenteral Nutrition-Induced Hepatobiliary Complications
Yon Ho Choe, Nam Sun Beck, Ji Hee Kim,* Suk Hyang Lee, and Tae Sung Park
Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.
*Division of Pharmaceutical Services, Samsung Medical Center, Seoul, Korea.
Graduate School of Clinical Pharmacy, Sookmyung Women's University, Seoul, Korea.
Department of Statistics, Seoul National University, Seoul, Korea.


Ursodeoxycholic acid (UDCA) is known to decrease hepatic injury by promoting the biliary secretion of retained toxic endogenous bile acids in hepatobiliary diseases complicated by total parenteral nutrition (TPN). However, most studies have focused on treatment for complications after TPN. We investigated the preventive role of early administration of UDCA in TPN-induced hepatobiliary complications by a randomized, double-blind, placebo-controlled trial.


Between May 2000 and May 2002, thirteen patients, who were given TPN more than 10 days in the hospital, were assigned randomly to two groups. One was the case group (7 patients) who were given UDCA simultaneously with TPN regimen, and the other, the control group (6 patients) who were given placebo. Their age ranged from 1 day to 13 years. They were affected with diseases impossible for enteral nutrition, such as prematurity, cerebral palsy, chronic diarrhea, anorexia nervosa, pancreatitis, and cyclic vomiting. The duration of TPN ranged from 10 to 70 days. Hematologic parameters including liver function test were measured at regular intervals, and the duration, composition, administration rate, total calorie of TPN were recorded. The serum levels of total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase were compared between groups after cessation of the study.


The autoregressive coefficient of the control group was 0.4419 (p=0.0651) in bilirubin, -0.0431 (p=0.7923) in AST, 0.2398 (p=0.2416) in ALT, and 0.2459 (p=0.1922) in alkaline phosphatase by mixed procedure model when the parameters were referred to the case group.


The serum level of total bilirubin did not increase in comparison with that of the control group, but statistically insignificant, when both TPN and UDCA were administered simultaneously from the beginning.

Keywords: Ursodeoxycholic acid; Total parenteral nutrition; Hepatobiliary complication; prevention