2008 Update From the Collaborative Islet Transplant Registry
2008 Update From the Collaborative Islet Transplant Registry
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DOI：
10.1097/tp.0b013e3181913f6a
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发表时间：
2008-12-27
期刊：
影响因子：
6.2
通讯作者：
Wease, Steve
中科院分区：
文献类型：
--
作者：
Alejandro, Rodolfo;Barton, Franca B.;Wease, Steve
背景。本报告总结了向 NIDDK 和 JDRF 资助的协作胰岛移植登记处 (CITR) 报告的胰岛移植的主要疗效和安全性结果，该登记处是目前最全面的人对人胰岛移植数据收集方法。 CITR 自 1999 年以来收集并监测北美、欧洲和澳大利亚同种异体胰岛移植的综合数据。结果。截至 2008 年 4 月，CITR 登记处包括 325 名成年接受者，他们接受了来自 712 名捐赠者的 649 份胰岛输注。首次输注后 3 年，23% 的单独胰岛受者处于胰岛素非依赖性状态（11 周以上 = 2 周），29% 处于胰岛素依赖状态且可检测到 C 肽，26% 失去功能，22% 存在数据缺失。 70% 的人至少达到过一次 II 级，其中 71% 的人在 1 年后仍达到 II 级，52% 的人在 2 年后仍达到 II 级。较高的输注次数、较多的总胰岛当量输注数量、较低的移植前 HbA(1c) 水平、与移植中心相关的处理中心以及较大的胰岛尺寸是有利于主要结果的因素。在诱导期间使用达珠单抗或依那西普的方案具有较高的发生率 11 和较低的功能丧失率，这支持了当前的方法。第 1 年输注相关不良事件发生率为 0.71 事件/人年 (EPY)，而免疫抑制相关不良事件发生率为 0.87 EPY，此后均下降至低于 0.21 EPY。结论。临床胰岛移植需要使用临床上最相关的终点（例如血糖稳定和严重低血糖预防）进行评估。登记的累积结果证实了胰岛移植对 T1 糖尿病代谢控制具有无可争议的积极影响。
Background. This report summarizes the primary efficacy and the safety Outcomes of islet transplantation reported to the NIDDK and JDRF funded Collaborative Islet Transplant Registry (CITR), currently the most comprehensive collection of human-to-human islet transplant data.Methods. CITR collects and monitors comprehensive data on allogeneic islet transplantation in North America, Europe, and Australia since 1999.Results. As of April 2008, the CITR registry comprised 325 adult recipients of 649 islet infusions derived from 712 donors. At 3 years post-first infusion, 23% of islet-alone recipients were insulin independent (11 >= 2 weeks), 29% were insulin dependent with detectable C-peptide, 26% had lost function, and 22% had missing data. Seventy percent achieved II at least once, of whom 71% were still II 1 year later and 52% at 2 years. Higher number of infusions, greater number of total islet equivalents infused, lower pretransplant HbA(1c) levels, processing centers related to the transplant center, and larger islet size are factors that favor the primary outcomes. Protocols with daclizumab or etanercept during induction had higher rates of 11 and lower rates of function loss, which endorse the current approaches. Infusion-related adverse event incidence was 0.71 events/person-year (EPY) in year 1, whereas immunosuppression-related adverse event incidence was 0.87 EPY, both declining to less than 0.21 EPY thereafter.Conclusions. Clinical islet transplantation needs to be evaluated using the most clinically relevant endpoints such as glucose stabilization and severe hypoglycemia prevention. The cumulative results of the registry confirm the inarguably positive impact of islet transplantation on metabolic control in T1 diabetes.