用于治疗I型糖尿病的人类胰岛移植网络：来自瑞士 - 法国GRAGIL联盟（1999 - 2000年）的首批数据。罗纳 - 阿尔卑斯 - 日内瓦朗格汉斯岛移植研究小组
Human islet transplantation network for the treatment of Type I diabetes: first data from the Swiss-French GRAGIL consortium (1999-2000). Groupe de Recherche Rhin Rhĵne Alpes Genève pour la transplantation d'Ilots de Langerhans.
作者信息
Benhamou P Y, Oberholzer J, Toso C, Kessler L, Penfornis A, Bayle F, Thivolet C, Martin X, Ris F, Badet L, Colin C, Morel P
机构信息
Department of Endocrinology, University Hospital, Grenoble, France.
出版信息
Diabetologia. 2001 Jul;44(7):859-64. doi: 10.1007/s001250100571.
AIMS/HYPOTHESIS: Improvements in islet transplantation require clinical series large enough to implement controlled new strategies. The goal of this study was to demonstrate the feasibility of a multicentre network for islet transplantation in Type I (insulin-dependent) diabetic patients.
METHODS
The five centres (Besançon, Geneva, Grenoble, Lyon, Strasbourg) of the GRAGIL network allow pancreas procurement, recipient recruitment, transplantation procedure and follow-up. Islet isolation is, however, performed in one single laboratory (Geneva). Pancreata were procured in each of the five centres and transported to Geneva with an ischaemia time of less than 8 hours. Islets were isolated using a standard automated method. If the islet number was too low for a graft (< 6,000 Islet-equivalent/kg), islets were cultured up to 12 days until another isolation was possible. Islets were transplanted by percutaneous transhepatic intraportal injection. Immunosuppression consisted of cyclosporine, mycophenolate mofetil, steroids and an anti-interleukin 2 receptor antibody.
RESULTS
From March 1999 to June 2000, 56 pancreata procurements were performed with an average yield of 234500 islet-equivalent, with 32 preparations over 200000 islet-equivalent. Ten C-peptide negative Type I diabetic patients (5 men and 5 women, median age 44 years, median diabetes duration 29 years) with an established kidney graft (> 6 months) received 9,030 +/- 1,090 islet-equivalent/kg with a median purity of 63 %. The number of pancreata required for each graft was 1 (n = 5) or 2 (n = 5). At the completion of a 12 month follow-up, we observed 0% primary nonfunction, 50% graft survival and 20% insulin-independence.
CONCLUSIONS/INTERPRETATION: This study demonstrates the interest and the feasibility of a multicentre collaboration in human islet transplantation.
目的/假设：胰岛移植的改进需要足够大的临床系列研究来实施可控的新策略。本研究的目的是证明建立一个针对I型（胰岛素依赖型）糖尿病患者的胰岛移植多中心网络的可行性。
方法
GRAGIL网络的五个中心（贝桑松、日内瓦、格勒诺布尔、里昂、斯特拉斯堡）负责胰腺获取、受体招募、移植手术及随访。然而，胰岛分离在单一实验室（日内瓦）进行。五个中心分别获取胰腺，并在缺血时间少于8小时的情况下运送至日内瓦。采用标准自动化方法分离胰岛。如果胰岛数量对于移植来说过低（<6000胰岛当量/千克），则将胰岛培养长达12天，直至能够再次进行分离。通过经皮经肝门静脉注射进行胰岛移植。免疫抑制方案包括环孢素、霉酚酸酯、类固醇和抗白细胞介素2受体抗体。
结果
1999年3月至2000年6月，共进行了56次胰腺获取，平均产量为234500胰岛当量，其中32次制备的胰岛当量超过200000。10名C肽阴性的I型糖尿病患者（5名男性和5名女性，年龄中位数44岁，糖尿病病程中位数29年）已接受肾移植（>6个月），接受了9030±1090胰岛当量/千克的胰岛移植，纯度中位数为63%。每次移植所需的胰腺数量为1个（n = 5）或2个（n = 5）。在为期12个月的随访结束时，我们观察到原发性无功能发生率为0%，移植物存活率为50%，胰岛素独立性为20%。
结论/解读：本研究证明了人类胰岛移植多中心合作的意义及可行性。
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