Repeated administration of a vitamin preparation containing glycocholic acid in patients with hepatobiliary disease.
BACKGROUND
Until now, hydrophilic and lipophilic vitamin preparations had to be administered separately during total parenteral nutrition. By addition of glycocholic acid, a vitamin supplement (Cernevit, Baxter, Heidelberg, Germany) was developed that combines all vitamins into one vial. However, little information exists about possible consequences of bile acid administration such as glycocholic acid, especially if liver disease is pre-existing.


OBJECTIVE
To evaluate the effects of total parenteral nutrition with a vitamin preparation containing high doses of glycocholic acid in patients with and without liver disease.


METHODS
In a prospective, randomized-controlled trial, 74 patients, 36 of them with hepatobiliary disease, received total parenteral nutrition for 16 +/- 11 days, either with Cernevit or control vitamin supplements. Patients were closely monitored for clinical and biochemical parameters including serum bile acid profiles measured by high-performance liquid chromatography.


RESULTS
Serum glycocholic acid increased in patients with liver disease treated with Cernevit, whereas total bile acids did not significantly change. Other liver function tests remained stable during treatment. No adverse events during Cernevit administration were noted except for a reversible slight increase of transaminases in one patient.


CONCLUSIONS
Cernevit was well tolerated after repeated dosing, even in patients with severe liver disease. Apart from standard controls of liver biochemistry, no specific surveillance is necessary during treatment with Cernevit.
Rifai
K
K
Department of Gastroenterology, Hepatology and Endocrinology, Medical School Hannover, Hannover, Germany. rifai.k@gmx.de
Ockenga
J
J
Manns
M P
MP
Bischoff
S C
SC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001647:Bile Acids and Salts / Q000097:blood; D001660:Biliary Tract Diseases / Q000628:therapy*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D005260:Female; D006000:Glycocholic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008107:Liver Diseases / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010289:Parenteral Nutrition, Total / Q000379:methods*; D011446:Prospective Studies; D016896:Treatment Outcome; D014815:Vitamins / Q000008:administration & dosage*
D001647:Bile Acids and Salts; D014815:Vitamins; D006000:Glycocholic Acid