Alleviating Effects of Ursodeoxycholic Acid in Children with Acute Hepatitis A Infection: A Randomized Clinical Trial

摘要

Objectives: Ursodeoxycholic acid (UDCA) is a secondary hydrophilic bile acid with alleviating effects on liver enzymes. This study aimed to investigate the effect of UDCA on the improvement of liver enzymes in children with hepatitis A infection. Methods: In this randomized clinical trial, 152 patients were randomly allocated to either intervention (UDCA) or control (no drug) group. Liver enzymes were measured six times within six months post-therapy. Statistical tests were carried out using SPSS 19 software. Results: The mean ALT level reduced from 1296.7 ± 1236 IU/L to 15.4 ± 3 IU/L in the UDCA group after six months. ALT also reduced from 1062.3 ± 959 IU/L to 16.4 ± 5 IU/L in the control group. The ratio of patients with normal ALT levels was significantly higher in the UDCA group (n = 61, 80.3%) than in the control group (n = 51, 68%) two months post-therapy (P = 0.06). The mean level of AST reduced from 983.8 ± 1036 IU/L to 19.4 ± 5 IU/L in the UDCA group and from 981.8 ± 1177 IU/L to 22.8 ± 7 IU/L in the control group. The ratio of patients with normal AST levels was significantly higher in the UDCA group than in the control group one month (n = 34, 44.7% vs. n = 20, 26.7%, respectively; P = 0.02), two months (n = 51, 67.1% vs. n = 31, 41.3%, respectively; P = 0.001), and three months (n = 66, 86.8% vs. n = 56, 74.7%, respectively; P = 0.04) post-therapy. Six months post-therapy, all the patients reached normal AST and ALT levels in both groups. Conclusions: Our results indicated that UDCA accelerated achieving biochemical response in children with acute hepatitis A.