Objective:To evaluate the efficacy and safety of once-daily tacrolimus extended-release capsules (OD-TAC) in pediatric liver transplant recipients after conversion from twice-daily tacrolimus (TD-TAC).Methods:A retrospective analysis was performed on pediatric liver transplant recipients at Tianjin First Center Hospital between January 2014 and December 2020 who were converted from TD-TAC to OD-TAC with a follow-up of at least 12 months. After conversion, all patients received OD-TAC monotherapy. The daily dose conversion ratio from TD-TAC to OD-TAC ranged from 2∶1 to 1∶2. Clinical data including demographics, tacrolimus dosage, trough concentrations, liver function, and adverse events were collected. Continuous variables with normal distribution were expressed as Mean±SD and compared using independent-samples t-test or ANOVA; non-normally distributed variables were expressed as median ( Q1, Q3) and compared using Mann-Whitney U or Kruskal-Wallis H tests. Categorical variables were expressed as frequency and percentage, and compared using χ 2 test or Fisher's exact test. P<0.05 was considered statistically significant. Results:A total of 290 children were enrolled, including 140 males (48.3%) and 150 females (51.7%). The median age at transplantation was 7.34 (6.03, 12.34) months, and the median time to conversion was 36 (29, 48) months post-transplant. Tacrolimus daily doses at 3, 6, and 12 months after conversion were slightly higher than before conversion, but without statistical significance (all P>0.05). Trough tacrolimus levels at 6 and 12 months after conversion were 2.34±1.02 μg/L and 2.23±1.07 μg/L, respectively, both lower than pre-conversion (2.77±1.43 μg/L), with statistical significance ( P=0.02 and P<0.01). Serum creatinine levels at 6 and 12 months post-conversion were 2.63±0.63 mmol/L and 2.76±0.68 mmol/L, respectively, both higher than before conversion (2.57±1.90 mmol/L, P<0.05). Triglyceride level at 12 months post-conversion was 0.87±0.25 mmol/L, significantly lower than pre-conversion (1.05±0.55 mmol/L, P<0.05). Two patients developed transient bilirubin elevation at 3 months, and another two developed transient triglyceride elevation at 6 months; all recovered without intervention. No new-onset diabetes was observed during follow-up. Thirteen patients experienced acute rejection. One patient (0.3%) died three years after conversion due to hepatic venous outflow obstruction, while all others survived. Conclusion:In pediatric liver transplant recipients, OD-TAC provides comparable efficacy and safety to TD-TAC.

Objective:To evaluate the efficacy and safety of once-daily tacrolimus extended-release capsules (OD-TAC) in pediatric liver transplant recipients after conversion from twice-daily tacrolimus (TD-TAC).Methods:A retrospective analysis was performed on pediatric liver transplant recipients at Tianjin First Center Hospital between January 2014 and December 2020 who were converted from TD-TAC to OD-TAC with a follow-up of at least 12 months. After conversion, all patients received OD-TAC monotherapy. The daily dose conversion ratio from TD-TAC to OD-TAC ranged from 2∶1 to 1∶2. Clinical data including demographics, tacrolimus dosage, trough concentrations, liver function, and adverse events were collected. Continuous variables with normal distribution were expressed as Mean±SD and compared using independent-samples t-test or ANOVA; non-normally distributed variables were expressed as median ( Q1, Q3) and compared using Mann-Whitney U or Kruskal-Wallis H tests. Categorical variables were expressed as frequency and percentage, and compared using χ 2 test or Fisher's exact test. P<0.05 was considered statistically significant. Results:A total of 290 children were enrolled, including 140 males (48.3%) and 150 females (51.7%). The median age at transplantation was 7.34 (6.03, 12.34) months, and the median time to conversion was 36 (29, 48) months post-transplant. Tacrolimus daily doses at 3, 6, and 12 months after conversion were slightly higher than before conversion, but without statistical significance (all P>0.05). Trough tacrolimus levels at 6 and 12 months after conversion were 2.34±1.02 μg/L and 2.23±1.07 μg/L, respectively, both lower than pre-conversion (2.77±1.43 μg/L), with statistical significance ( P=0.02 and P<0.01). Serum creatinine levels at 6 and 12 months post-conversion were 2.63±0.63 mmol/L and 2.76±0.68 mmol/L, respectively, both higher than before conversion (2.57±1.90 mmol/L, P<0.05). Triglyceride level at 12 months post-conversion was 0.87±0.25 mmol/L, significantly lower than pre-conversion (1.05±0.55 mmol/L, P<0.05). Two patients developed transient bilirubin elevation at 3 months, and another two developed transient triglyceride elevation at 6 months; all recovered without intervention. No new-onset diabetes was observed during follow-up. Thirteen patients experienced acute rejection. One patient (0.3%) died three years after conversion due to hepatic venous outflow obstruction, while all others survived. Conclusion:In pediatric liver transplant recipients, OD-TAC provides comparable efficacy and safety to TD-TAC.