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目的:评估新生猪胰岛移植治疗1型糖尿病方法的安全性和有效性。方法:所有22例病人均接受经肝动脉新生猪胰岛移植治疗,移植后病人接受多种免疫抑制治疗方案;第1组14例病人使用环孢菌素、骁息和甲基强的松龙,没有接受猪C肽检测;第2组2例病人只使用环孢菌素和骁息,第3组6例病人的免疫抑制方案是OKT3、他克莫司、西罗莫司和甲基强的松龙。在移植治疗前和移植后1年,病人进行了血糖、外源性胰岛素用量、糖化血红蛋白、猪内源性反转录病毒(PERV)和肝功能的评估,第2组和第3组的8例病人接受了血清猪C肽检测。6例病人在移植后4～6年进行了复查。结果:第1组14例病人移植后胰岛素用量减少和HbA1c水平降低。第2组2例病人在移植后代谢指标没有变化,猪C肽检测阴性。第3组的6例病人在移植3个月以后,胰岛素用量均减少,HbA1c正常,6例病人血清均检测到有意义的猪C肽。其中2例病人接受了第2次新生猪胰岛移植,1例病人短暂脱离胰岛素治疗7 d。所有病人在移植后均未出现严重不良反应,没有PERV感染的证据。6例病人在新生猪胰岛移植4～6年后接受检查,此6例病人均在接受移植治疗1年后停止免疫抑制治疗,复查时6例病人均接受胰岛素治疗。其中4例病人严格限制糖的摄入,2例病人为自由饮食;这2例病人中,有1例出现2次酮症,有轻度糖尿病视网膜病变;1例出现1次由于急性胃肠炎导致的酮症;其余4例均未出现任何并发症。6例病人再次接受PERV检测均为阴性。结论:异种胰岛可以在人体内存活并发挥其功能,没有发现严重不良反应。
PURPOSE: To evaluate the safety and efficacy of neonatal porcine islet transplantation for the treatment of type 1 diabetes. Methods: All 22 patients received transplanted hepatic piglet islets via islet transplantation. Patients underwent multiple immunosuppressive regimens after transplantation. In group 1, 14 patients received cyclosporin, scrotum and methylprednisolone, No C-peptide was detected in pigs; two patients in group 2 only used cyclosporine and scrotalin, and the immunosuppressive regimen in 6 patients in group 3 was OKT3, with tacrolimus, sirolimus and methylprednisolone Pine Patients were assessed for blood glucose, exogenous insulin, glycosylated hemoglobin, porcine endogenous retroviruses (PERV), and liver function 1 year prior to transplantation and 1 year after transplantation. Groups 2 and 3 The patient received the serum pig C-peptide test. Six patients were examined 4 to 6 years after transplantation. Results: In the first group of 14 patients, the amount of insulin and the level of HbA1c decreased after transplantation. Group 2 patients in 2 patients after transplantation no change in metabolic indicators, pig C peptide test negative. Six patients in group 3 had less insulin and had normal HbA1c after 3 months of transplantation, and all of the 6 patients had significant serum porcine C-peptide detected. Two of the patients received the second newborn piglet islet allograft, and one patient briefly left insulin for 7 days. All patients did not develop serious adverse reactions after transplantation, there is no evidence of PERV infection. Six patients were examined 4 to 6 years after transplantation of neonatal pig islets. All 6 patients stopped immunosuppressive therapy after 1 year of transplant. All 6 patients underwent insulin therapy during the review. Among them, 4 patients had severe restriction of sugar intake and 2 patients had free diet. One of 2 patients had ketosis and mild diabetic retinopathy in 1 patient and 1 patient had acute gastroenteritis Caused ketosis; the remaining 4 cases did not show any complications. Six patients were again tested negative for PERV. CONCLUSIONS: Heterologous islets can survive and function in the human body without any serious adverse reactions.