【摘要】 目的探索巴利昔单抗在小于2岁的ABO血型不相容儿童肝脏移植中的应用效果及其安全性。方法采用随机对照研究的方法,前瞻性收集2019年1月至2020年8月期间笔者所在医院的44例符合纳入标准的患儿,随机分为试验组与对照组,试验组术中及术后第4天使用巴利昔单抗免疫诱导,对照组不使用诱导治疗。比较2组肝移植受者肝移植术后并发症发生情况、术后3个月的供体特异性抗体(DSA)发生率以及随访期间的肝肾功能变化、生长发育情况和患儿存活情况。结果共44例患儿纳入本研究,其中试验组19例,对照组25例。2组患儿肝移植术后他克莫司使用剂量和他克莫司谷值浓度、血肌酐、血胱抑素、身高和体质量的变化趋势差别不大;肝移植术后的主要并发症,包括肺感染、巨细胞病毒血症、EBV病毒血症及肝移植术后3个月内血流感染发生率比较差异均无统计学意义(P>0.05),但试验组的急性细胞性排斥发生率低于对照组(P=0.04)。术后3个月时,试验组患儿的DSA阳性率(0,0/19)低于对照组(20.0%,5/25),差异有统计学意义(P=0.04)。所有患儿的术后中位随访时间为16.6个月(3.8～25.4个月)。随访期间对照组死亡2例,试验组和对照组的生存情况比较差异无统计学意义(P=0.24)。结论巴利昔单抗可安全应用于小于2岁的ABO血型不相容儿童的肝移植,不增加术后感染风险,且术后早期急性细胞性排斥反应发生率及术后3个月的DSA发生率均较低。更多还原

【Abstract】 Objective To compare the effect and safety of basiliximab in ABO incompatible pediatric liver transplant recipients. Methods ABO incompatible pediatric liver transplantation operated between January 2019 and August 2020 were studied. The patients were allocated randomized into two groups. Patients in experimental group were treated with basiliximab as immune induction therapy, but basiliximab was not used in patients of control group.Tacrolimus combined methylprednisolone were used after liver transplantation. The clinical characteristics, graft and recipient survival rate, rejection, infectious complications, and kidney functions after liver transplantation were observed.Donor specific antibody(DSA) was tested in 3 months after liver transplantation. The growth and development were assessed too after liver transplant. Results Fourty-four patients were enrolled in the study, including 19 patients in the experimental group and 25 patients in the control group. The median follow-up time was 16.6 months(3.8–25.4 months), and there were no statistically differences between the two groups in terms of age, sex, weight, pediatric endstage liver disease(PELD) score, and other basic conditions. There were no significant differences between the two groups in tacrolimus dose, tacrolimus trough concentration, kidney functions, height and weight growth after liver transplantation. There were no statistical differences in lung infection, blood stream infection within 3 months after liver transplantation, cytomegalovirus, EBV infection, graft/patient survival rate after liver transplantation(P>0.05).However, the acute rejection rate was lower and the DSA positive rate in 3 months after liver transplantation was lower in the experimental group(P<0.05). Conclusions Basiliximab can be safely used in ABO incompatible pediatric liver transplant recipients. Acute rejection rate and DSA positive rate after transplantation can be decreased with the use of basiliximab.更多还原