Analysis of effectiveness and safety of tacrolimus in infants after liver transplantation

Objective To evaluate the effectiveness and safety of immunosuppressive program including tacrolimus (FK506) in infants after liver transplantation. Methods The medical records of infants who underwent liver transplantation for biliary atresia and receiving the immunosuppressant of FK506 combined with methylprednisolone (MP) after operation in Beijing Friendship Hospital during June 2013 to September 2014 were collected. The infants' general clinical situation, recipient survival rate, survival rate of transplanted liver, transplant complication, acute rejection rate, and adverse reactions were recorded. The whole blood trough concentration of KF506 on day 3, 7, 15 and one month after medication and occurrence of rejection and adverse reactions were recorded. Results A total of 54 infants were enrolled into this study, 50% were boys. The children's age was 4-19 months, the median age was 8 months. Seven infants died within 14 to 45 days after liver transplantation. Both recipient survival rate and survival rate of transplanted liver were 87%. Three cases (5.6%) developed transplant complication on days 7-9 after operation, among them 2 cases had hepatic artery thrombosis and 1 case had bile leakage, respectively. Ten infants (18.5%) developed acute rejection on days 4-14 after operation. The incidence of adverse reaction during hospitalization was 35.2% (19/54). Twenty-five case-times adverse reactions involved 19 infants. There were 5 case-times of severe adverse reactions which involved 5 infants (3 cases died from epilepsia, increased creatinine, and heart failure, respectively; 2 cases recovered to normal from increased serum alanine aminotransferase after the treatment of liver protection). There were 20 case-times general adverse reactions (diarrhea, vomiting and skin rash etc.) which involved 17 infants. They all improved after symptomatic treatment. The mean blood concentration of FK506 on days 3, 7, 15 and one month after medication were (9.6±5.7), (8.7±4.5), (9.2±3.7) and (8.6±4.1) μg/L, respectively. The blood concentration of FK506 was 2.4-9.3 μg/L with an average concentration of (5.10±2.04)μg/L when acute rejection occurred and 6.2-23.9 μg/L with an average concentration of (11.67±3.58) μg/L when adverse reactions occurred. The average blood concentration of FK506 was(11.67±3.58)μg/L and the concentrations in 17 of 25 cases were over 10 μg/L. Conclusion FK506 at blood concentration 6.0-11.0 μg/L in infants used for immunosuppressive therapy after liver transplantation is relatively effective and safe. Key words: Infant; Liver transplantation; Tacrolimus; Patient safety