CAJ | 학술논문

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HbAlc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,HbAlc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7d.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.
목적:평고신생저이도이식치료1형당뇨병방법적안전성화유효성.방법:소유22례병인균접수경간동맥신생저이도이식치료,이식후병인접수다충면역억제치료방안；제1조14례병인사용배포균소、효식화갑기강적송룡,몰유접수저C태검측；제2조2례병인지사용배포균소화효식,제3조6례병인적면역억제방안시OKT3、타극막사、서라막사화갑기강적송룡.재이식치료전화이식후1년,병인진행료혈당、외원성이도소용량、당화혈홍단백、저내원성반전록병독(PERV)화간공능적평고,제2조화제3조적8례병인접수료혈청저C태검측.6례병인재이식후4～6년진행료복사.결과:제1조14례병인이식후이도소용량감소화HbAlc수평강저.제2조2례병인재이식후대사지표몰유변화,저C태검측음성.제3조적6례병인재이식3개월이후,이도소용량균감소,HbAlc정상,6례병인혈청균검측도유의의적저C태.기중2례병인접수료제2차신생저이도이식,1례병인단잠탈리이도소치료7d.소유병인재이식후균미출현엄중불량반응,몰유PERV감염적증거.6례병인재신생저이도이식4～6년후접수검사,차6례병인균재접수이식치료1년후정지면역억제치료,복사시6례병인균접수이도소치료.기중4례병인엄격한제당적섭입,2례병인위자유음식；저2례병인중,유1례출현2차동증,유경도당뇨병시망막병변；1례출현1차유우급성위장염도치적동증；기여4례균미출현임하병발증.6례병인재차접수PERV검측균위음성.결론:이충이도가이재인체내존활병발휘기공능,몰유발현엄중불량반응.
Objective To ascertain the safety and function of the transplantation of neonatal pig islets (NPIs) for diabetic patients.Methods NPIs were injected into the hepatic artery of 22 patients.After the transplantation,the patients were treated with a multiple drug immunosuppressive regimens.The first 14 patients were treated with cyclosporine (CsA),mycophenolate mofetil (MMF) and prednisolon,and porcine C-peptide was not monitored,the following 2 patients were given cyklosporin and MMF only,while the next 6 patients were given a quadruple drug regimen consisting of OKT3,takrolimus,sirolimus and prednisolon.The blood glucose levels,exogenous insulin requirement,HbA1c,porcine endogenous retrovirus (PERV) and liver function were assessed before and after NPI transplantation.The serum porcine C peptide were monitored in last 8 patients.Results The first 14 patients required less insulin and the HbAlc dropped after the transplantation.In the 2 subsequent patients,the metabolic parameters remained unchanged and monitor of porcine C-peptide was negative.Insulin requirements were reduced in all 6 patients,and HbAlc was normalized 3 months after the transplantation.Significant levels of porcine C-peptide were detected in the patient serum.Two of the patients were given a second injection of NPIs,and one of them became insulin independent for 7 d.No serious adverse events were noted after the transplantation.There was no evidence of PERV transmission.Six out of the 22 patients were followed up for 4-6 years after the NPIs injection,immunosuppressive treatment was stopped 1 year after the transplantation.The patients started to take insulin at the time of follow up.Four patients restricted the intake of sugar,while the other 2 did not.One patient had ketoacidosis twice and slight diabetic retinopathy,and another patient had ketoacidosis induced by acute gastroenteritis.The remaining 4 patients did not have any complications.Assays for PERV were again negative.Conclusion Xenogenic islets can survive and function in the human body.No serious adverse events are noted.