婴幼儿肝移植术后免疫抑制剂的有效性及安全性观察

Efficacy and Safety of Immunosuppressant in Infants after Liver Transplantation

目的:评价婴幼儿在肝移植术后使用免疫抑制剂的有效性和安全性。方法:回顾性查阅北京友谊医院2013年6月—2015年6月住院的婴幼儿肝移植84例,对免疫抑制剂使用情况及不良反应等进行统计分析。结果:肝移植术后初始他克莫司(FK506)给药剂量为(0.18±0.08)mg?kg^(-1)?d^(-1),经调整出院时有70例患儿延用二联方案,其中FK506给药剂量为(0.24±0.17)mg?kg^(-1)?d^(-1),FK506血药浓度范围控制在6~11μg·L^(-1)。住院期间术后患儿生存率89.3%,感染发生率71.43%,急性排斥反应发生率14.29%,发生急性排斥反应时FK506平均血药浓度为(5.69±2.38)μg·L^(-1),12例次中10例次(83.3%)<8μg·L^(-1)。FK506相关不良反应39例次,涉及患儿31人,发生率36.9%(31/84),其中胃肠道不良反应发生率15.48%,7.14%有中枢神经系统不良反应,8.3%出现转移酶升高,3.57%出现肾功能损害;发生不良反应时FK506平均血药浓度为(12.77±4.98)μg·L^(-1),39例次中有31例次(79.5%)>8.5·L^(-1)。结论:本研究中婴幼儿肝移植术后的免疫抑制剂使用较为安全有效,FK506初始给药剂量及血药浓度范围与成人有较大差异。

Objective： To investigate the efficacy and safety of immunosuppressant for infants after liver transplantation. Methods： A retrospective analysis was performed in 84 infants undergoing liver transplantation in our hospital during 2013.6~ 2015.6, and application and adverse reaction of immunosuppressant were analyzed. Results： All the infants have received tacrolimus combined with methylprednisolone, the initial dose of FK506 was（0.18±0.08） mg？kg^-1？d^-1. 70 patients kept using the same bigeminy immunosuppressant therapy at discharge, and the discharge dose of FK506 was（0.24±0.17） mg·kg^-1·？d^-1. The range of effective plasma concentration of FK506 was 6^-11μg·L^-1. Patient survival, infection rate and acute rejection were 89.3%, 71.43% and 14.29% respectively during the hospitalization period. The average blood concentration of FK506 was（5.69±2.38） μg·L^-1 when acute rejection occurred, and 10 in 12 cases（83.3%） were below 8 μg·L^-1. There were 39 cases drug adverse reaction which involved 31 infants, and the incidence of adverse reaction was 36.9%（31/84）. The incidence of gastrointestinal tract reaction, CNS reaction, transaminase elevation and renal dysfunction were 15.48%, 7.14%, 8.3% and 33.57%, respectively. The average blood concentration of FK506 was（12.77±4.98） μg·L^-1 when adverse reaction occurred, and 31 in 39 cases（79.5%） were over 8.5 μg·L^-1. Conclusion： The bigeminy immunosuppressant protocol based on tacrolimus is effective and safe in infants after liver transplantation, and there are some differences of the dosage and the effective plasma concentration of FK506 between infants and adults.