Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease.
BACKGROUND
Parenteral nutrition-associated liver disease can be a progressive and fatal entity in children with short-bowel syndrome. Soybean-fat emulsions provided as part of standard parenteral nutrition may contribute to its pathophysiology.


METHODS
We compared safety and efficacy outcomes of a fish-oil-based fat emulsion in 18 infants with short-bowel syndrome who developed cholestasis (serum direct bilirubin level of > 2 mg/dL) while receiving soybean emulsions with those from a historical cohort of 21 infants with short-bowel syndrome who also developed cholestasis while receiving soybean emulsions. The primary end point was time to reversal of cholestasis (3 consecutive measurements of serum direct bilirubin level of < or = 2 mg/dL).


RESULTS
Among survivors, the median time to reversal of cholestasis was 9.4 and 44.1 weeks in the fish-oil and historical cohorts, respectively. Subjects who received fish-oil-based emulsion experienced reversal of cholestasis 4.8 times faster than those who received soybean emulsions and 6.8 times faster in analysis adjusted for baseline bilirubin concentration, gestational age, and the diagnosis of necrotizing enterocolitis. A total of 2 deaths and 0 liver transplantations were recorded in the fish-oil cohort and 7 deaths and 2 transplantations in the historical cohort. The provision of fish-oil-based fat emulsion was not associated with essential fatty acid deficiency, hypertriglyceridemia, coagulopathy, infections, or growth delay.


CONCLUSIONS
Parenteral fish-oil-based fat emulsions are safe and may be effective in the treatment of parenteral nutrition-associated liver disease.
Gura
Kathleen M
KM
Department of Pharmacy, Children's Hospital Boston, Harvard Medical School, Boston, MA 02115, USA.
Lee
Sang
S
Valim
Clarissa
C
Zhou
Jing
J
Kim
Sendia
S
Modi
Biren P
BP
Arsenault
Danielle A
DA
Strijbosch
Robbert A M
RA
Lopes
Suzanne
S
Duggan
Christopher
C
Puder
Mark
M
D016022:Case-Control Studies; D002779:Cholestasis / Q000209:etiology* / Q000401:mortality / Q000628:therapy*; D015331:Cohort Studies; D005217:Fat Emulsions, Intravenous / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006776:Hospitals, Pediatric; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D053208:Kaplan-Meier Estimate; D017093:Liver Failure / Q000517:prevention & control; D008111:Liver Function Tests; D008297:Male; D010289:Parenteral Nutrition, Total / Q000009:adverse effects* / Q000379:methods; D011336:Probability; D012016:Reference Values; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D012778:Short Bowel Syndrome / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D013024:Soybean Oil / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D016896:Treatment Outcome
D005217:Fat Emulsions, Intravenous; D013024:Soybean Oil