The EMMES Corporation, Rockville, MD 20850, USA.
Cell Transplant. 2009;18(7):753-67. doi: 10.3727/096368909X470874. Epub 2009 Sep 28.
As of October 1, 2007, 25 North American medical institutions and one European islet transplant center reported detailed information to the Registry on 315 allograft recipients, of which 285 were islet alone (IA) and 30 were islet after kidney (IAK). Of the 114 IA recipients expected at 4 years after their last infusion, 12% were insulin independent, 16% were insulin dependent with detectable C-peptide, 40% had no detectable C-peptide, and 32% had missing C-peptide data or were lost to follow-up. Of the IA recipients, 72% achieved insulin independence at least once over 3 years and multiple infusions. Factors associated with achievement of insulin independence included islet size >1.0 expressed as IEQs per islet number [hazard ratio (HR) = 1.5, p = 0.06], additional infusions given (HR = 1.5, p = 0.01), lower pretransplant HbA(1c) (HR = 1.2 each %-age unit, p = 0.02), donor given insulin (HR = 2, p = 0.003), daclizumab given at any infusion (HR = 1.9, p = 0.06), and shorter cold storage time (HR = 1.04, p = 0.03), mutually adjusted in a multivariate model. Severe hypoglycemia prevalence was reduced from 78-83% preinfusion to less than 5% throughout the first year post-last infusion, and to 18% adjusted for missing data at 3 years post-last infusion. In Year 1 post-first infusion for IA recipients, 53% experienced a Grade 3-5 or serious adverse event (AE) and 35% experienced a severe AE related to either an infusion procedure or immunosuppression. In Year 1 post-first infusion, 33% of IA subjects and 35% of IAK subjects had an AE related to the infusion procedure, while 35% of IA subjects and only 27% of IAK subjects had an AE related to the immunosuppression therapy. Five deaths were reported, of which two were classified as probably related to the infusion procedure or immunosuppression, and 10 cases of neoplasm, of which two were classified as probably related to the procedure or immunosuppression. Islet transplantation continues to show short-term benefits of insulin independence, normal or near normal HbA(1C) levels, and sustained marked decrease in hypoglycemic episodes.
截至 2007 年 10 月 1 日，北美 25 家医疗机构和 1 家欧洲胰岛移植中心向登记处报告了 315 名同种异体移植受者的详细信息，其中 285 名为单纯胰岛移植（IA），30 名为胰岛联合肾移植（IAK）。在最后一次输注后 4 年，预计有 114 名 IA 受者达到 12%的胰岛素独立性，16%的胰岛素依赖但可检测到 C 肽，40%的 C 肽不可检测，32%的 C 肽数据缺失或失访。在 IA 受者中，72%的人在 3 年以上的多次输注中至少达到了一次胰岛素独立性。与实现胰岛素独立性相关的因素包括胰岛大小>1.0，以每胰岛数表达的 IEQs（风险比[HR] = 1.5，p = 0.06），给予额外的输注（HR = 1.5，p = 0.01），移植前糖化血红蛋白（HbA1c）水平较低（每单位 HR = 1.2%，p = 0.02），供体给予胰岛素（HR = 2，p = 0.003），任何输注时给予达珠单抗（HR = 1.9，p = 0.06），冷保存时间较短（HR = 1.04，p = 0.03），在多变量模型中相互调整。在最后一次输注后的第一年，严重低血糖的发生率从输注前的 78-83%降至<5%，调整缺失数据后，3 年时降至 18%。在 IA 受者的首次输注后第一年，53%的患者发生了 3-5 级或严重不良事件（AE），35%的患者发生了与输注过程或免疫抑制相关的严重 AE。在首次输注后第一年，33%的 IA 受试者和 35%的 IAK 受试者发生了与输注过程相关的 AE，而 35%的 IA 受试者和 27%的 IAK 受试者发生了与免疫抑制治疗相关的 AE。报告了 5 例死亡，其中 2 例可能与输注过程或免疫抑制有关，10 例发生了肿瘤，其中 2 例可能与该过程或免疫抑制有关。胰岛移植继续显示出短期的胰岛素独立性、正常或接近正常的 HbA1C 水平以及低血糖发作的持续显著减少的益处。
