同种异体胰岛移植治疗1型糖尿病1O例及随访观察3年的临床研究

Allograft islets transplantation for type 1 diabetes mellitus and 3-year follow-up： 10 cases report

目的评估同种异体胰岛移植治疗1型糖尿病的3年随访结果。方法对10例1型糖尿病患者（T1DM）施行同种异体胰岛移植。以Liberase酶消化，COBE2991型专用胰岛细胞分离机分离及连续密度梯度纯化，获取高纯度与高活性的胰岛。采用经皮肝门静脉穿刺，胰岛悬液重力输注，将短期培养的胰岛经门静脉移植到肝脏内。术后采用兔抗人T淋巴细胞免疫球蛋白（ATG）、注射用依那西普联合应用他克莫司＋吗替麦考酚酯的改良Edmonton免疫抑制方案，随访3年，定期监测受者血糖、C肽与糖化血红蛋白的水平。结果随访36个月，6例完全撤除胰岛素治疗，4例胰岛索用量较术前减少60％以上。术后血糖稳定维持在正常水平，C肽均在正常范围内，糖化血红蛋白基本正常，肝肾功能稳定维持正常，无胰岛移植并发症发生。结论同种异体胰岛移植治疗1型糖尿病3年期临床疗效较好，手术简捷，创伤小，安全性高，远期疗效尚需进一步观察。

Objective To evaluate the 3-year follow-up outcomes of allograft islet transplantation for type 1 diabetes mellitus （T1DM）. Method Ten cases of T1DM were subjected to islet transplantations. The pancreases were digested by Liberase collagenase enzyme and islets with high activity were purified using continuous gradients of Ficoll-diatrizoic acid on a refrigerated COBE 2991 centrifuge. Cultured islets were infused by minimally invasive surgical approach to the liver via portal vasculature. After islet cell transplantation, a modified Edmonton immunosuppresion protocol containing antithymocyte globulin （ATG） and Etanercept, tacrolimus and mycophenolate mofetil was used, and the changes in blood glucose, C peptide and glycate hemoglobin were monitored regularly during a follow-up period of 3 years. Result The glucocorticoid-free irnmunosuppressive regimen was used. During the follow-up period of 36 months; 6 recipients remained insulin-independent. The dosage of insulin decreased by 60% in 4 patients. The levels of blood glucose and HbA1c were all within normal range and liver and renal functions were normal. C-peptide level was normal. No complications related to islet infusion were observed. Conclusion Medium-term clinical effect of islet transplantation is effective and safe for treating T1DM.