Bruce D S, Sollinger H W, Humar A, Sutherland D E, Light J A, Kaufman D B, Alloway R R, Lo A, Stratta R J
Department of Transplantation, University of Chicago, IL 60637, USA.
Transplantation. 2001 Nov 27;72(10):1637-43. doi: 10.1097/00007890-200111270-00010.
We report an experience with 71 simultaneous kidney-pancreas transplant (SKPT) recipients receiving daclizumab induction in combination with tacrolimus (TAC), mycophenolate mofetil (MMF), and steroids. The mean follow-up time was 5.9+/-2.5 (SD) months (range 0.5-11 months). The study population included 47 males (65%) and 24 females (35%) with a mean age of 40+/-8 years. The mean pretransplant duration of diabetes and dialysis were 25+/-8 and 1.5+/-0.9 years (34 hemodialysis, 16 peritoneal dialysis), respectively. Mean HLA match was 1.2+/-1.5, with one patient receiving a second transplant. The mean cold ischemic times for the kidney and the pancreas were 15+/-5 and 16+/-4 hr, respectively. Six-month patient, kidney, and pancreas graft survival and rejection rates were 97, 96, 93, and 35%, respectively. There were two deaths, one due to fungal infection and the other due to a cardiac event. There were three kidney graft losses, two immunological, and one death with function. Of the five pancreas graft losses, two were due to infection, one immunological, one thrombosis, and one death with function. The patient population was then stratified according to the number of daclizumab doses: 4-5 doses (n=45) or 1-3 doses (n=26). There were no differences in patient and kidney graft survival rates, 98 vs. 96%, and 92 vs. 92%, respectively. However, there was a trend toward improved pancreas graft survival in the group receiving 4-5 doses (96%) compared with 1-3 doses (85%), P=0.07. Although more patients receiving 1-3 doses had rejection (54%) than patients receiving 4-5 doses (24%), there was no dose response relationship between the total number of doses or the adjusted total mg/kg dose and time to rejection. All patients with functioning grafts have good renal and pancreas allograft function at 6 and 12 months. The overall incidence of major infection was 27% and there were no differences in the incidence of infection between the two groups. No major adverse events were attributed to daclizumab use. In conclusion, excellent short-term outcomes were noted in this retrospective, multicenter survey of initial experience with daclizumab induction in combination with TAC, MMF, and steroids in SKPT recipients. Optimal dosing strategies for SKPT recipients remain to be determined.
我们报告了71例同时接受肾胰腺移植(SKPT)的受者使用达利珠单抗诱导联合他克莫司(TAC)、霉酚酸酯(MMF)和类固醇的经验。平均随访时间为5.9±2.5(标准差)个月(范围0.5 - 11个月)。研究人群包括47名男性(65%)和24名女性(35%),平均年龄为40±8岁。移植前糖尿病和透析的平均持续时间分别为25±8年和1.5±0.9年(34例血液透析,16例腹膜透析)。平均HLA配型为1.2±1.5,1例患者接受了二次移植。肾脏和胰腺的平均冷缺血时间分别为15±5小时和16±4小时。6个月时患者、肾脏和胰腺移植物的存活率及排斥率分别为97%、96%、93%和35%。有2例死亡,1例死于真菌感染,另1例死于心脏事件。有3例肾脏移植物丢失,2例因免疫因素,1例伴有功能的死亡。在5例胰腺移植物丢失中,2例因感染,1例因免疫因素,1例因血栓形成,1例伴有功能的死亡。然后根据达利珠单抗剂量数对患者群体进行分层:4 - 5剂(n = 45)或1 - 3剂(n = 26)。患者和肾脏移植物存活率无差异,分别为98%对96%和92%对92%。然而,与接受1 - 3剂(85%)相比,接受4 - 5剂的组胰腺移植物存活率有改善趋势(96%),P = 0.07。虽然接受1 - 3剂的患者排斥反应发生率(54%)高于接受4 - 5剂的患者(24%),但剂量总数或调整后的总mg/kg剂量与排斥反应时间之间无剂量反应关系。所有移植物功能良好的患者在6个月和12个月时肾脏和胰腺同种异体移植物功能均良好。主要感染的总体发生率为27%,两组感染发生率无差异。未发现因使用达利珠单抗导致的重大不良事件。总之,在这项关于SKPT受者使用达利珠单抗诱导联合TAC、MMF和类固醇的初始经验的回顾性多中心调查中,观察到了出色的短期结果。SKPT受者的最佳给药策略仍有待确定。