Stratta Robert J, Rogers Jeffrey, Orlando Giuseppe, Farooq Umar, Al-Shraideh Yousef, Doares William, Kaczmorski Scott, Farney Alan C
Wake Forest School of Medicine, Department of General Surgery , Medical Center Blvd, Winston-Salem, NC 27157 , USA +1 336 716 0548 ; +1 336 713 5055 ;
Expert Opin Biol Ther. 2014 Dec;14(12):1723-30. doi: 10.1517/14712598.2014.953049. Epub 2014 Aug 25.
BACKGROUND: The study purpose was to analyze midterm outcomes in a prospective trial of alemtuzumab (Alem) versus rabbit anti-thymocyte globulin (rATG) induction in simultaneous pancreas-kidney transplantation (SPKT). METHODS: From February 2005 to October 2008, 46 SPKTs (45 portal-enteric drainage) were prospectively randomized as part of a larger kidney transplant study to receive either single-dose Alem (30 mg intraoperatively) or multiple-dose rATG antibody induction (starting intraoperatively, minimum three doses administered) with tacrolimus/mycophenolate ± steroids. RESULTS: Of 222 kidney transplant patients enrolled in the study, 46 received SPKTs; 28 (61%) received Alem and 18 (39%) rATG induction. Follow-up ranged from 67 to 111 months (mean 80 months). There were no significant differences between the two groups in 5 years actual patient (86% Alem vs 89% rATG), kidney (82% Alem vs 61% rATG, p = 0.17) or pancreas (68% Alem vs 56% rATG) graft survival rates. Five years death-censored kidney (92% Alem vs 69% rATG, p = 0.09) and pancreas (76% Alem vs 56% rATG, p = 0.198) graft survival rates were slightly higher in patients receiving Alem. Acute rejection (21% Alem vs 44% rATG, p = 0.12) and major infection (39% Alem vs 67% rATG, p = 0.13) rates were slightly lower in the Alem group; cytomegalovirus infections were significantly lower (0 Alem vs 17% rATG, p = 0.05). The incidence of late acute rejection was low in both groups. There were no differences in early pancreas thrombosis (3.6% Alem vs 11% rATG), postoperative bleeding (11% Alem vs 0 rATG), other surgical complications, readmissions or freedom from steroids between groups. In patients with functioning grafts, 5 years mean serum creatinine (1.4 Alem vs 1.6 mg/dl rATG), calculated abbreviated modification of diet in renal disease glomerular filtration rate (55 Alem vs 52 ml/min/1.73 m(2) rATG), hemoglobin A1c (both 5.4%) and C-peptide (2.6 Alem vs 2.3 ng/ml rATG) levels were similar. CONCLUSIONS: Single-dose Alem and multiple-dose rATG induction provide similar midterm patient survival and graft functional outcomes with no major differences in morbidity or resource utilization.
背景：本研究旨在分析在同期胰肾联合移植（SPKT）中，使用阿仑单抗（Alem）与兔抗胸腺细胞球蛋白（rATG）进行诱导治疗的中期结果。 方法：2005年2月至2008年10月期间，作为一项更大规模肾移植研究的一部分，46例SPKT（45例采用门静脉-肠引流术）被前瞻性随机分组，接受单剂量Alem（术中30mg）或多剂量rATG抗体诱导治疗（术中开始，至少给予三剂），并联合使用他克莫司/霉酚酸酯±类固醇。 结果：在参与该研究的222例肾移植患者中，46例接受了SPKT；28例（61%）接受Alem诱导治疗，18例（39%）接受rATG诱导治疗。随访时间为67至111个月（平均80个月）。两组在5年实际患者生存率（Alem组为86%，rATG组为89%）、肾移植生存率（Alem组为82%，rATG组为61%，p = 0.17）或胰腺移植生存率（Alem组为68%，rATG组为56%）方面无显著差异。接受Alem治疗的患者，5年死亡截尾肾移植生存率（Alem组为92%，rATG组为69%，p = 0.09）和胰腺移植生存率（Alem组为76%，rATG组为56%，p = 0.198）略高。Alem组的急性排斥反应发生率（21% vs 44%，p = 0.12）和严重感染发生率（39% vs 67%，p = 0.13）略低；巨细胞病毒感染率显著更低（Alem组为0，rATG组为17%，p = 0.05）。两组晚期急性排斥反应的发生率均较低。两组在早期胰腺血栓形成（Alem组为3.6%，rATG组为11%）、术后出血（Alem组为11%，rATG组为0）、其他手术并发症、再次入院率或停用类固醇方面无差异。在移植肾功能良好的患者中，5年平均血清肌酐水平（Alem组为1.4，rATG组为1.6mg/dl）、计算得出的肾脏病饮食改良简化版肾小球滤过率（Alem组为55，rATG组为52ml/min/1.73m²）、糖化血红蛋白水平（均为5.4%）和C肽水平（Alem组为2.6，rATG组为2.3ng/ml）相似。 结论：单剂量Alem和多剂量rATG诱导治疗在中期患者生存率和移植肾功能结果方面相似，在发病率或资源利用方面无重大差异。
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