title: Use of non-invasive parameters of non-alcoholic steatohepatitis and liver fibrosis in daily practice--an exploratory case-control study.
abstract: BACKGROUND
  Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of a metabolic syndrome. To date, liver biopsy has been the gold standard used to differentiate between simple steatosis and steatohepatitis/fibrosis. Our aim was to compare the relevance of serum non-invasive parameters and scoring systems in the staging of liver fibrosis and non-alcoholic steatohepatitis (NASH) in patients with NAFLD.
  
  
  RESULTS
  A total of 112 consecutive patients diagnosed with NAFLD were included. A liver biopsy was performed on 56 patients. The Kleiner score was used for the staging and grading of the histology. Non-invasive parameters for fibrosis (hyaluronic acid; AST/ALT; fibrosis scoring indexes OELF, ELF, BARD score, APRI, NAFLD fibrosis score); and inflammation (M30 and M65 cytokeratin-18 fragments) were measured and calculated. The same analyses were performed in 56 patients diagnosed with NAFLD, who were not indicated for liver biopsy. Based on the liver histology, NASH was diagnosed in 38 patients; simple steatosis in 18 patients. A cut-off value of 750 U/L of serum M65 discriminated patients with and without NASH with a 80% sensitivity and 82% specificity (95% CI:57-95). Fibrosis stage F0-F2 was present in 39 patients; F3-F4 in 17 patients. Serum concentrations of hyaluronic acid were higher in patients with advanced fibrosis (p<0.01); a cut-off value of 25 µg/l discriminated patients with F3-F4 with a 90% sensitivity and 84% specificity from those with F0-F2 (95% CI:59-99). When applying the non-invasive criteria to those patients without a liver biopsy, NASH could only be diagnosed in 16%; however, advanced fibrosis could be diagnosed in 35% of them.
  
  
  CONCLUSIONS
  In patients with NAFLD, non-invasive serum parameters with a high accuracy can differentiate those patients with NASH and/or advanced fibrosis from those with simple steatosis. A substantial portion of those patients not indicated for liver biopsy might have undiagnosed advanced fibrosis.
authors.affiliation: Charles University in Prague, 1st Faculty of Medicine, 4th Department of Internal Medicine, Prague, Czech Republic.
authors.forename: Karel
authors.initials: K
authors.lastname: Dvorak
authors.affiliation: Charles University in Prague, 1st Faculty of Medicine, Department of Pathology, Prague, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Stritesky
authors.affiliation: Charles University in Prague, 1st Faculty of Medicine, 4th Department of Internal Medicine, Prague, Czech Republic.
authors.forename: Jaromir
authors.initials: J
authors.lastname: Petrtyl
authors.affiliation: Charles University in Prague, 1st Faculty of Medicine, 4th Department of Internal Medicine, Prague, Czech Republic; Charles University in Prague, 1st Faculty of Medicine, Institute of Medical Biochemistry and Laboratory Diagnostics, Prague, Czech Republic.
authors.forename: Libor
authors.initials: L
authors.lastname: Vitek
authors.affiliation: Charles University in Prague, 1st Faculty of Medicine, 4th Department of Internal Medicine, Prague, Czech Republic.
authors.forename: Renata
authors.initials: R
authors.lastname: Sroubkova
authors.affiliation: Charles University in Prague, 1st Faculty of Medicine, Institute of Medical Biochemistry and Laboratory Diagnostics, Prague, Czech Republic.
authors.forename: Martin
authors.initials: M
authors.lastname: Lenicek
authors.affiliation: Charles University in Prague, 1st Faculty of Medicine, 4th Department of Internal Medicine, Prague, Czech Republic.
authors.forename: Vaclav
authors.initials: V
authors.lastname: Smid
authors.affiliation: Charles University in Prague, 1st Faculty of Medicine, 3rd Department of Internal Medicine, Prague, Czech Republic.
authors.forename: Martin
authors.initials: M
authors.lastname: Haluzik
authors.affiliation: Charles University in Prague, 1st Faculty of Medicine, 4th Department of Internal Medicine, Prague, Czech Republic.
authors.forename: Radan
authors.initials: R
authors.lastname: Bruha
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000737:chemistry; D007249:Inflammation / Q000473:pathology; D008099:Liver / Q000473:pathology*; D008103:Liver Cirrhosis / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000473:pathology*; D011446:Prospective Studies; D012372:ROC Curve; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index
chemical_list: D006820:Hyaluronic Acid