Abstract：
BACKGROUND: This study aimed to compare the efficacy and safety of basiliximab (BAS) versus a single dose of anti-thymocyte globulin (r-ATG) induction therapy in pediatric kidney transplant recipients (KTRs).
METHODS: This single-center retrospective comparative cohort study included all pediatric KTRs from May 2013 to April 2018 and followed up to 12 months. In the first period, all recipients received BAS, while from May 2016, a single 3 mg/kg dose of r-ATG was instituted. Maintenance therapy consisted of a calcineurin inhibitor plus prednisone plus azathioprine or mycophenolate.
RESULTS: A total of 227 patients were included (BAS, n = 113; r-ATG, n = 114). The main combination of immunosuppressive drugs was tacrolimus, prednisone, and azathioprine in both groups (87% vs. 88%, p = .718). Patients receiving r-ATG showed superior survival-free of the composite endpoint (acute rejection, graft loss, or death; 76% vs. 61%, p = .003; HR 2.08, 1.29-3.34, p = .003) and lower incidence of biopsy-proven acute rejection (10% vs. 21%, p = .015). There was no difference in the overall incidence of CMV infection (33% vs. 37%, p = .457), PTLD (1% vs. 3%, p = .309), 30-day hospital readmissions (24% vs. 23%, p = .847), and kidney function at 12 months (86 ± 29 vs. 84 ± 30 mL/min/1.73m2, p = .614).
CONCLUSIONS: These data suggest that induction therapy with a single 3 mg/kg dose of r-ATG is associated with higher efficacy for preventing acute rejection and similar safety profile compared to BAS.
METHODS: This single-center retrospective comparative cohort study included all pediatric KTRs from May 2013 to April 2018 and followed up to 12 months. In the first period, all recipients received BAS, while from May 2016, a single 3 mg/kg dose of r-ATG was instituted. Maintenance therapy consisted of a calcineurin inhibitor plus prednisone plus azathioprine or mycophenolate.
RESULTS: A total of 227 patients were included (BAS, n = 113; r-ATG, n = 114). The main combination of immunosuppressive drugs was tacrolimus, prednisone, and azathioprine in both groups (87% vs. 88%, p = .718). Patients receiving r-ATG showed superior survival-free of the composite endpoint (acute rejection, graft loss, or death; 76% vs. 61%, p = .003; HR 2.08, 1.29-3.34, p = .003) and lower incidence of biopsy-proven acute rejection (10% vs. 21%, p = .015). There was no difference in the overall incidence of CMV infection (33% vs. 37%, p = .457), PTLD (1% vs. 3%, p = .309), 30-day hospital readmissions (24% vs. 23%, p = .847), and kidney function at 12 months (86 ± 29 vs. 84 ± 30 mL/min/1.73m2, p = .614).
CONCLUSIONS: These data suggest that induction therapy with a single 3 mg/kg dose of r-ATG is associated with higher efficacy for preventing acute rejection and similar safety profile compared to BAS.
摘要：
背景：本研究旨在比较巴利昔单抗（BAS）与单剂量抗胸腺细胞球蛋白（r-ATG）诱导疗法在小儿肾移植受者（KTRs）中的疗效和安全性。
方法：这项单中心回顾性比较队列研究包括2013年5月至2018年4月的所有儿科KTR，随访12个月。在第一阶段，所有收件人都收到了BAS，而从2016年5月起,采用单一剂量3mg/kg的r-ATG.维持治疗包括钙调磷酸酶抑制剂加泼尼松加硫唑嘌呤或霉酚酸酯。
结果：共纳入227例患者（BAS，n=113;r-ATG,n=114)。免疫抑制药物的主要组合是他克莫司，泼尼松,和硫唑嘌呤在两组中(87%vs.88%,p=.718）。接受r-ATG的患者表现出优于复合终点(急性排斥反应，移植物丢失，或死亡；76%vs.61%,p=.003；HR2.08，1.29-3.34，p=.003），活检证实的急性排斥反应发生率较低（10％vs.21%,p=.015）。CMV感染的总体发生率没有差异(33%vs.37%,p=.457)，PTLD（1%vs.3%,p=.309)，30天再次住院（24%vs.23%,p=.847)，和12个月时的肾功能（86±29vs.84±30mL/min/1.73m2，p=.614）。
结论：这些数据表明，与BAS相比，使用单次3mg/kg剂量的r-ATG的诱导治疗具有更高的预防急性排斥反应的功效和相似的安全性。
方法：这项单中心回顾性比较队列研究包括2013年5月至2018年4月的所有儿科KTR，随访12个月。在第一阶段，所有收件人都收到了BAS，而从2016年5月起,采用单一剂量3mg/kg的r-ATG.维持治疗包括钙调磷酸酶抑制剂加泼尼松加硫唑嘌呤或霉酚酸酯。
结果：共纳入227例患者（BAS，n=113;r-ATG,n=114)。免疫抑制药物的主要组合是他克莫司，泼尼松,和硫唑嘌呤在两组中(87%vs.88%,p=.718）。接受r-ATG的患者表现出优于复合终点(急性排斥反应，移植物丢失，或死亡；76%vs.61%,p=.003；HR2.08，1.29-3.34，p=.003），活检证实的急性排斥反应发生率较低（10％vs.21%,p=.015）。CMV感染的总体发生率没有差异(33%vs.37%,p=.457)，PTLD（1%vs.3%,p=.309)，30天再次住院（24%vs.23%,p=.847)，和12个月时的肾功能（86±29vs.84±30mL/min/1.73m2，p=.614）。
结论：这些数据表明，与BAS相比，使用单次3mg/kg剂量的r-ATG的诱导治疗具有更高的预防急性排斥反应的功效和相似的安全性。
