title: Case-control study on prednisolone combined with ursodeoxycholic acid and azathioprine in pure primary biliary cirrhosis with high levels of immunoglobulin G and transaminases: efficacy and safety analysis.
abstract: To the best of our knowledge, this is the first study to address the use of glucocorticoids in the comparatively special population of pure primary biliary cirrhosis (PBC) patients who have high levels of immunoglobulin G (IgG) and transaminases but do not have PBC-autoimmune hepatitis overlap syndrome. Ursodeoxycholic acid (UDCA) is now assumed to be the standard therapy for PBC patients. However, patients treated with UDCA still have a risk of progression to cirrhosis and end-stage liver disease. The most recent European Association for the Study of the Liver guidelines of 2009 declared that further studies on glucocorticoid therapy in this disease should be a priority. Therefore, we designed this 3-year longitudinal retrospective study, which might provide deep insight into the treatment for PBC.The aim of this study was to assess whether the combination of prednisolone, UDCA, and azathioprine was superior to UDCA alone in these PBC patients.Sixty patients were enrolled in this study. Thirty-one patients underwent UDCA monotherapy, and 29 patients were treated with prednisolone, UDCA, and azathioprine. We analyzed their biochemistries, immune parameters, liver synthetic function, and noninvasive assessments of liver fibrosis, as well as treatment efficacy and adverse effects at baseline and at 1, 3, 6, 12, 24, and 36 months.Alkaline phosphatase (ALP), γ-glutamyl transpeptidase, alanine aminotransferase, and aspartate aminotransferase levels and the aspartate aminotransferase-to-platelet ratio index (APRI) and S-index improved dramatically in both groups, whereas IgG levels only decreased in the combination group (all P < 0.05). Albumin (ALB) levels decreased in the UDCA group but increased with the combination treatment at 36 months. Significant differences between the 2 groups were observed at 36 months in ALP (P = 0.005), IgG (P = 0.002), ALB (P = 0.002), APRI (P = 0.015), and S-index (P = 0.020). Prednisolone combined with UDCA and azathioprine showed a higher efficacy based on our new criteria.The combination of prednisolone, UDCA, and azathioprine is superior to UDCA alone for the treatment of pure PBC patients with high levels of IgG and transaminases. Side effects were minimal or absent.
authors.affiliation: Centre for Liver Diseases and Department of Infectious Diseases (Y-QF, WJ, JL, Y-QD, YW, MY, G-QW), Peking University First Hospital, Xicheng District, Beijing; and Department of Infectious Diseases (D-XL), Sixth Hospital of Shenyang, Heping District, Shenyang, Liaoning, China.
authors.forename: Yu-Qing
authors.initials: YQ
authors.lastname: Fang
authors.forename: Dong-Xia
authors.initials: DX
authors.lastname: Lv
authors.forename: Wei
authors.initials: W
authors.lastname: Jia
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.forename: Yong-Qiong
authors.initials: YQ
authors.lastname: Deng
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.forename: Min
authors.initials: M
authors.lastname: Yu
authors.forename: Gui-Qiang
authors.initials: GQ
authors.lastname: Wang
mesh_terms: D000328:Adult; D001379:Azathioprine / Q000627:therapeutic use*; D016022:Case-Control Studies; D002756:Cholagogues and Choleretics / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008105:Liver Cirrhosis, Biliary / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use*; D000637:Transaminases / Q000097:blood*; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D002756:Cholagogues and Choleretics; D005938:Glucocorticoids; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D014580:Ursodeoxycholic Acid; D011239:Prednisolone; D000637:Transaminases; D001379:Azathioprine