Efficacy and safety of spleen aminopeptide oral lyophilized powder in ameliorating liver injury in infants and children with human cytomegalovirus infection: a single-center study in China.

BACKGROUND: Liver injury is both very common in infants and children and associated with low immune function. This study aimed to investigate the effect of spleen aminopeptide oral lyophilized powder (SAOLP) on liver injury in infants and children with human cytomegalovirus (HCMV) infection. METHODS: In this prospective observational study, 217 infants and children with both liver damage and HCMV infection who were admitted to the Department of Pediatric Gastroenterology, Children's Hospital of Nanjing Medical University between July 2018 and May 2020 were investigated. The median age of patients was 0.75 years (0.36-3.77 years), with 105 male and 112 female participants. All 217 patients received ursodeoxycholic acid (UDCA) and/or reduced glutathione (GDC) therapy. Of these 217 patients, 114 also received SAOLP. Liver function, cellular immunity levels, HCMV antibody titer, and HCMV-DNA load values were measured 1 day before treatment, and on the second and fourth week after treatment. RESULTS: After 4 weeks, patients treated with SAOLP showed median levels of serum alanine aminotransferase (ALT), total bilirubin (TB), and direct bilirubin (DB) which were significantly lower than those seen in patients who did not receive it. In addition, the percentage of CD4+ cells was significantly higher in those treated with SAOLP in comparison to those treated with UDCA and/or GDC alone. The number of positive HCMV-immunoglobin M (IgM) patients was also sharply decreased in the group receiving SAOLP. CONCLUSIONS: The addition of SAOLP to UDCA and/or GDC therapy may significantly relieve liver injury and reduce the jaundice index by enhancing immune function and anti-HCMV infection ability in infants and children.