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ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R
Issue 11
Nov.  2018
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Clinical effect of fenofibrate combined with ursodeoxycholic acid in treatment of primary biliary cholangitis patients with poor response to ursodeoxycholic acid alone

DOI: 10.3969/j.issn.1001-5256.2018.11.020
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  • Published Date: 2018-11-20
  • Objective To investigate the clinical effect of fenofibrate combined with ursodeoxycholic acid ( UDCA) in the treatment of primary biliary cholangitis ( PBC) patients with poor response to UDCA alone. Methods A total of 67 PBC patients with poor response to UDCA who were treated in Xijing Hospital of Digestive Diseases, Air Force Medical University, from May 2009 to December 2017 were enrolled, and according to whether fenofibrate was used in addition, they were divided into combination treatment group with 33 patients and UDCA group with 34 patients. Related clinical data at baseline ( after one year of UDCA treatment) and at 6 and 12 months after treatment were collected, and the two groups were compared in terms of serum biochemical parameters, biochemical response, and GLOBE score after treatment. The t-test was used for comparison of normally distributed continuous data between two groups; the Mann-Whitney U test was used for comparison of continuous data with skewed distribution between two groups. The chi-square test or the Fisher's exact test was used for comparison of categorical data between groups. Results Compared with the UDCA group at 12 months after treatment, the combination treatment group had significant reductions in the serum levels of alkaline phosphatase ( ALP) , aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyl transpeptidase ( t = 3. 465, 2. 406, 2. 057 and 3. 208, P < 0. 001 and P = 0. 019, 0. 002, and 0. 044) .According to the Barcelona criteria and the Paris I/II criteria, the combination treatment group had a biochemical response rate of 54. 5% ( 18/15) , 36. 4% ( 12/21) , and 34. 3% ( 11/22) , respectively, and there was a significant difference in the evaluation results of the Barcelona criteria between the two groups ( t = 4. 349, P = 0. 037) . Compared with the UDCA group at 12 months after treatment, the combination treatment group had a significantly lower GLOBE score[0. 921 ( 0. 519 ~ 1. 657) vs 0. 498 (-0. 026 ~ 1. 027) , Z =-2. 007, P = 0. 045]and significantly higher 5-, 10-, and 15-year transplant-free survival rates ( Z =-2. 000, -2. 004 and-2. 009, P = 0. 045, 0. 045, and 0. 043) . Conclusion In patients with poor response to UDCA alone, fenofibrate combined with UDCA can significantly improve their blood biochemical parameters, especially the serum level of ALP. The combination treatment can also reduce the GLOBE score in patients with poor response and thus may help to improve long-term prognosis.

     

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