Ursodeoxycholic Acid in the Prevention of Pediatric Parenteral Nutrition-associated Cholestasis

소아 총정맥영양의 간담도계 합병증에 대한 Ursodeoxycholic acid의 예방효과에 대한 연구

  • Kim, Ji Hee (Division of Pharmaceutical Services, Samsung Medical Center) ;
  • Min, Myung Sook (Division of Pharmaceutical Services, Samsung Medical Center) ;
  • In, Yong Won (Division of Pharmaceutical Services, Samsung Medical Center) ;
  • Shon, Kie Ho (Division of Pharmaceutical Services, Samsung Medical Center) ;
  • Choi, Kyung Eob (Division of Pharmaceutical Services, Samsung Medical Center) ;
  • Choe, Yon Ho (Department of Pediatrics, Samsung Medical Center) ;
  • Beck, Nam Sun (Department of Pediatrics, Samsung Medical Center) ;
  • Lee, Suk Hyang (Graduate School of Clinical Pharmacy, Sookmyung Women's University) ;
  • Park, Tae Sung (Department of Statistics, Seoul National University)
  • 김지희 (삼성서울병원 약제부) ;
  • 민명숙 (삼성서울병원 약제부) ;
  • 인용원 (삼성서울병원 약제부) ;
  • 손기호 (삼성서울병원 약제부) ;
  • 최경업 (삼성서울병원 약제부) ;
  • 최연호 (삼성서울병원 소아과) ;
  • 백남선 (삼성서울병원 소아과) ;
  • 이숙향 (숙명여자대학교 임상약학대학원) ;
  • 박태성 (서울대학교 자연대학 계산통계학과)
  • Published : 2005.06.01

Abstract

Cholestatic liver disease is a frequent complication of prolonged parenteral nutrition, especially in premature infants. Numerous factors have been cited as contributing to TPN associated cholestasis. However the exact etiology remains obscure. Ursodeoxycholic acid (UDCA) has been reported to be beneficial far children and adults with various chronic cholestatic liver disease. The aim of this prospective, randomized, double-blind, placebo-controlled study was to determine the preventive effects of UDCA administration during TPN. Seventeen pediatric patients (8 boys and 9 girls) undergoing TPN were assigned randomly to two groups, UDCA and placebo group. UDCA group (n=9) received 15 mg/kg/day UDCA and placebo group (n=8) received 15 mg/kg/day placebo enterally during the TPN period. Liver function tests (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase) were per-formed before TPN and weekly or three times a week. The patients' weights, complete blood count, composition of TPN, and the infusion rate of TPN and lipid were monitored everyday. Calcium and phosphate were monitored twice a week. Between the UDCA and placebo groups, there were no differences in weight at the onset of TPN, birth weight, duration of TPN, respiratory distress syndrome associated with prematurity, age at the onset of TPN, gestational age, the number of days the patients received antibiotics, the number of patients received enteral nutritions and the composition of TPN. In contrast, there was a significant difference between the UDCA and placebo groups in alanine aminotransferase levels during TPN. It doesn't seem that UDCA administration during TPN correlates directly with improvement of liver function. But the preventive administration of UDCA may be effective in reducing liver enzyme, alanine aminotransferase and has no adverse effects.

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