在胰岛移植登记处中，与 1 型糖尿病合并严重低血糖的胰岛单独移植受者 5 年结局良好相关的因素。
Factors associated with favourable 5 year outcomes in islet transplant alone recipients with type 1 diabetes complicated by severe hypoglycaemia in the Collaborative Islet Transplant Registry.
机构信息
Schulze Diabetes Institute and Department of Surgery, University of Minnesota, Minneapolis, MN, USA.
The EMMES Company, LLC, Rockville, MD, USA.
出版信息
Diabetologia. 2023 Jan;66(1):163-173. doi: 10.1007/s00125-022-05804-4. Epub 2022 Oct 6.
AIMS/HYPOTHESIS: Islet transplantation has been studied in small cohorts of recipients with type 1 diabetes complicated by severe hypoglycaemic events (SHEs). We determined factors associated with favourable outcomes in a large cohort of recipients reported to the Collaborative Islet Transplant Registry (CITR).
METHODS
In 398 non-uraemic islet transplant alone (ITA) recipients with type 1 diabetes and SHEs, transplanted between 1999 and 2015 and with at least 1 year follow-up, we analysed specified favourable outcomes against each of all available characteristics of pancreas donors, islet grafts, recipients and immunosuppressive regimens, as well as immunosuppression and procedure-related serious adverse events (SAEs).
RESULTS
Four factors were associated with the highest rates of favourable outcomes: recipient age ≥35 years; total infused islets ≥325,000 islet equivalents; induction immunosuppression with T cell depletion and/or TNF-α inhibition; and maintenance with both mechanistic target of rapamycin (mTOR) and calcineurin inhibitors. At 5 years after the last islet infusion, of the recipients meeting these four common favourable factors (4CFF; N=126), 95% were free of SHEs, 76% had HbA <53 mmol/mol (7.0%), 73% had HbA <53 mmol/mol (7.0%) and absence of SHEs, and 53% were insulin independent, significantly higher rates than in the remaining recipients (<4CFF; N=272). The incidence of procedural and immunosuppression-related SAEs per recipient that resulted in sequelae, disability or death was low in both the 4CFF (0.056 per person) and <4CFF (0.074 per person) groups.
CONCLUSIONS/INTERPRETATION: In recipients with type 1 diabetes complicated by SHEs, islet transplantation meeting 4CFF protected 95% from SHEs at 5 years after the last islet infusion and exerted a large and significant benefit on glycaemic control, with an acceptable safety profile for this subgroup of type 1 diabetes.
目的/假设：胰岛移植已在伴有严重低血糖事件（SHEs）的 1 型糖尿病小队列受者中进行了研究。我们在向协作胰岛移植登记处（CITR）报告的大型受者队列中确定了与良好结局相关的因素。
方法
在 1999 年至 2015 年间接受非尿毒症胰岛单独移植（ITA）且伴有 SHEs 的 398 例 1 型糖尿病且至少随访 1 年的患者中，我们针对胰腺供体、胰岛移植物、受者和免疫抑制方案的所有可用特征，以及免疫抑制和程序相关严重不良事件（SAE），分析了特定的良好结局。
结果
有四个因素与最佳结局的发生率最高相关：受者年龄≥35 岁；输注的总胰岛≥325000 胰岛当量；诱导免疫抑制采用 T 细胞耗竭和/或 TNF-α 抑制；以及维持使用雷帕霉素（mTOR）和钙调神经磷酸酶抑制剂。在最后一次胰岛输注后 5 年，符合这四个常见有利因素（4CFF；N=126）的受者中，95%无 SHEs，76%HbA<53mmol/mol（7.0%），73%HbA<53mmol/mol（7.0%）且无 SHEs，53%胰岛素依赖，明显高于其余受者（<4CFF；N=272）。在 4CFF（每人 0.056）和<4CFF（每人 0.074）两组中，导致后遗症、残疾或死亡的程序和免疫抑制相关 SAE 的发生率均较低。
结论/解释：在伴有 SHEs 的 1 型糖尿病受者中，符合 4CFF 的胰岛移植可在最后一次胰岛输注后 5 年内保护 95%的患者免受 SHEs 影响，并对血糖控制产生显著的、重要的益处，对 1 型糖尿病的这一亚组具有可接受的安全性。
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