Abstract
BackgroundBiopsy is the usual gold standard for liver steatosis assessment. The aim of this study was to identify a panel of biomarkers (SteatoTest), with sufficient predictive values, for the non-invasive diagnosis of steatosis in patients with or without chronic liver disease. Biomarkers and panels were assessed in a training group of consecutive patients with chronic hepatitis C and B, alcoholic liver disease, and non-alcoholic fatty liver disease, and were validated in two independent groups including a prospective one. Steatosis was blindly assessed by using a previously validated scoring system.Results310 patients were included in the training group; 434 in three validation groups; and 140 in a control group. SteatoTest was constructed using a combination of the 6 components of FibroTest-ActiTest plus body mass index, serum cholesterol, triglycerides, and glucose adjusted for age and gender. SteatoTest area under the ROC curves was 0.79 (SE = 0.03) in the training group; 0.80 (0.04) in validation group 1; 0.86 (0.03) in validation group 2; and 0.72 (0.05) in the validation group 3 – all significantly higher than the standard markers: γ-glutamyl-transpeptidase or alanine aminotransferase. The median SteatoTest value was 0.13 in fasting controls; 0.16 in non-fasting controls; 0.31 in patients without steatosis; 0.39 in grade 1 steatosis (0–5%); 0.58 in grade 2 (6–32%); and 0.74 in grade 3–4 (33–100%). For the diagnosis of grade 2–4 steatosis, the sensitivity of SteatoTest at the 0.30 cut-off was 0.91, 0.98, 1.00 and 0.85 and the specificity at the 0.70 cut-off was 0.89, 0.83, 0.92, 1.00, for the training and three validation groups, respectively.ConclusionSteatoTest is a simple and non-invasive quantitative estimate of liver steatosis and may reduce the need for liver biopsy, particularly in patients with metabolic risk factor.
Highlights
Biopsy is the usual gold standard for liver steatosis assessment
Patients A total of 2,272 subjects were analyzed (Figure 1), being 884 subjects included in the biomarker validation study, distributed as follows: 310 patients in the training group; 171 in the validation group 1; 201 in the validation group 2; 62 in the validation group 3; and 140 subjects in the control group
According to the low predictive values of ALT, GGT and ultrasonography, as well as the risk and the variability of liver biopsy, the previous strategy could be improved by using better biomarkers of steatosis, such as ST, combined
Summary
Biopsy is the usual gold standard for liver steatosis assessment. The aim of this study was to identify a panel of biomarkers (SteatoTest), with sufficient predictive values, for the non-invasive diagnosis of steatosis in patients with or without chronic liver disease. Biomarkers and panels were assessed in a training group of consecutive patients with chronic hepatitis C and B, alcoholic liver disease, and non-alcoholic fatty liver disease, and were validated in two independent groups including a prospective one. Fatty liver disease involves the accumulation of triglycerides in hepatocytes, apoptosis, hepatocellular ballooning, Mallory's hyaline, necrosis of hepatocytes, lobular inflammation [5,6], small hepatic vein obliteration [7] and often fibrosis with possible progression to cirrhosis, hepatocellular cancer and liver-related death [1,4,8,9]. Non-alcoholic fatty liver disease (NAFLD) is an adaptive response of the liver to insulin resistance. The natural progression of insulin resistance and endogenous noxious insults (such as free radical production, mitochondrial dysfunction, endotoxin) which are, at least in part, related to the presence of excessive fat in the liver, can trigger the development of non-alcoholic steatohepatitis (NASH). NASH itself can induce a fibrogenic response that can result in cirrhosis [5,6]
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