The goal of the study was to assess the safety and efficacy of ursodeoxycholic acid drug (UDCA) Ursodez for primary biliary cirrhosis patients (PBC).
Materials and methods. The study included 7 women aged 44 to 71 years with a history of PBC from 2 to 6 years. PBC was confirmed by biochemical, immunological (AMA) and instrumental methods. Ursodez was used as UDCA drug and was administered to each new patient included into the study at a dose of 15 mg / kg / day for 12 weeks. The parameters to be assessed included the clinical symptoms (weakness, itching) from 0 to 5 points, blood biochemical parameters (bilirubin, ALT, AST, GGT, alkaline phosphatase, cholesterol, total protein and its fractions) on the 4th, 8th and 12th weeks. Results. After 12 weeks of Ursodez trea tment, the patients noted decreased weakness; less itching was registered in 6 of 7 patients. Three patients with increased level of bilirubin before Ursodez treatment achieved normal level of this parameter on 12 week. Significant decrease in average GGT level was registered (from 154,3 ± 57,8 U / l to 62,8 ± 15,3 U / L (p < 0,05)). Other cholestasis parameters were not
significantly changed. Decreased activity of the inflammatory process was revealed. Average ALT level decreased from 1,9 ± 0,3N to 1,2 ± 0,1N (p < 0,05). Ursodez tolerability was comparable to that of the other drugs from this group.