All biopsy specimens were formalin-fixed, paraffin-embedded and 10 extra unstained slides
were prepared Selleckchem Sunitinib locally that were sent to the CRN repository. Hematoxylin and eosin, Masson’s trichrome, and Perls’ iron stains were prepared by a central laboratory and reviewed centrally by the NASH CRN Pathology Committee, a group of nine hepatopathologists who were masked to all clinical and identifying data. Biopsies were scored by consensus during Pathology Committee meetings using the previously published NASH CRN NAFLD Activity Score (NAS) and fibrosis score.12 The characteristics of the adult patients (ages 18 and older) enrolled in the Database or the PIVENS trial were analyzed descriptively. Subjects were divided into three mutually exclusive
groups: (1) those with liver biopsies obtained within 6 months of clinical and laboratory data (contemporaneous liver biopsies), (2) those with the most recent liver biopsies obtained more than 6 months before clinical and laboratory data were obtained, and (3) those without an available liver biopsy. Cross-sectional analyses were then conducted of the first group of patients, that is, those who were enrolled in the Database or the PIVENS click here trial and had a liver biopsy within 6 months of their baseline clinical data. The two main outcomes studied were (1) the presence of definite NASH versus borderline or no NASH and (2) stage 3 (bridging) or stage 4 (cirrhosis) fibrosis scores versus lower stages. Secondary histological outcomes included the presence of one or more of the following features: (1) ≥ 34% steatosis, (2) ≥ grade 2 lobular inflammation, (3) portal inflammation, (4) any ballooning, (5) NAS ≥ 5, (6) any fibrosis, and (7)
cirrhosis. For these analyses, we examined the following basic predictor variables: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels; demographic factors including age, sex, race, and ethnicity; 上海皓元医药股份有限公司 anthropometrics including body mass index (BMI) and waist circumference; and the presence of comorbid conditions including hypertension and type 2 diabetes. We also examined additional clinical laboratory tests including: the AST/ALT ratio, gamma glutamyl transpeptidase (GGT), albumin, total protein, prothrombin time, platelet count, total cholesterol, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, triglycerides, hemoglobin A1c (HbA1c), fasting glucose and insulin as well as the homeostasis model assessment of insulin resistance (HOMA-IR) index, and titers of antinuclear (ANA), anti-smooth muscle (ASMA), and antimitochondrial (AMA) antibodies. To determine the factors associated with each outcome, binary and multiple logistic regression analyses were used and progressive models were built using AST and ALT alone (Model 1), Model 1 plus demographic information (Model 2), Model 2 plus comorbidities (Model 3), and finally Model 3 plus other standard laboratory studies (Model 4).