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目的描述1999至2010年在合作胰岛移植登记处(CITR)的伴有严重低血糖的1型糖尿病患者接受胰岛移植的主要疗效和安全性结果的趋势。研究设计与方法 CITR总共有677例胰岛单独移植或肾移植后胰岛移植的1型糖尿病患者用来分析五个主要的治疗结果和整体安全性,每年随访一次至移植后5年,以确定任何早期(1999-2002年)、中期(2003-2006年)或更近期(2007-2010年)的差异。结果胰岛移植3年后,不依赖胰岛素的比例分别提高到早期(1999-2002年,n=214)27%,中期(2003-2006年中,n=255)的37%和更近期(2007-2010年,n=208)44%(P=0.006各时期间年份比较;P=0.01,单独时期中年份比较)。提示胰岛移植功能的C-肽≥0.3ng/mL一直保留到更近期(P<0.001)。移植治疗在糖化血红蛋白减少和严重低血糖问题解决上表现出持久的长期效应。更近期的空腹血糖稳定性也呈现出改善。不良事件发生率也有轻度减少。胰岛再输注率更低:48%/年(2007-2010年)vs.60%～65%/年(1999-2006年)(P<0.01)。曾经达到过不依赖胰岛素程度的患者的胰岛移植功能持续时间更长(P<0.001)。结论由此得出CITR 2007-2010年间接受胰岛移植者的主要效应和安全性比在1999年至2006年的那些患者均得到改善,且伴随更少的胰岛再输注损伤和副反应。
Objective To describe the trends of the primary efficacy and safety outcomes of islet transplantation in type 1 diabetic patients with severe hypoglycemia at the Cooperative Islet Transplant Registry (CITR) from 1999 to 2010. Study Design and Methods CITR A total of 677 patients with type 1 diabetes who underwent islet transplantation or islet transplantation after kidney transplantation were used to analyze five major treatment outcomes and overall safety and were followed up annually until 5 years after transplantation to determine any early (1999-2002), medium (2003-2006) or more recent (2007-2010). Results After 3 years of islet transplantation, insulin-independent rates increased to 27% in the early (1999-2002, n = 214), 37% in the medium (n = 255 in 2003-2006) and more recently 2010, n = 208) 44% (P = 0.006 years comparisons over time; P = 0.01, comparison of middle ages in individual periods). C-peptide ≥ 0.3 ng / mL suggesting islet transplant function remained more recently (P <0.001). Transplantation therapy shows long-lasting long-term effects on glycohemoglobin reduction and the resolution of severe hypoglycemia. More recently, fasting plasma glucose stability has also shown to improve. There was also a slight decrease in the incidence of adverse events. The rate of islet reperfusion was lower: 48% / year (2007-2010) vs. 60% -65% / year (1999-2006) (P <0.01). The islet transplant function in patients who had previously achieved insulin-independent duration lasted longer (P <0.001). Conclusions It is concluded that the primary effect and safety of CITR recipients from 2007 to 2010 were improved over those from 1999 to 2006 with fewer islet reperfusion injury and side effects.