Tian Y-F, Tsai C-S, Lee P-C, Chu S-H, Chien Y-S, Loong C-C, Chen C-H, Wu M-S, Chu S-H, Lian J-D
Division of General Surgery, Chi Mei Medical Center, Chia Nan University of Pharmacy & Science, Tainan, Taiwan.
Transplant Proc. 2012 Apr;44(3):661-6. doi: 10.1016/j.transproceed.2012.01.099.
Posttransplant new-onset diabetes mellitus (NODM) is an important complication among patients receiving immunosuppressants. It has a considerable impact on chronic allograft dysfunction. Calcineurin inhibitors have been implicated in the development of posttransplant NODM. Since high-risk candidates also undergo transplantation, prevention and control of posttransplant NODM is important. A 3-year postmarketing surveillance study is currently underway in Taiwan to evaluate the incidence and risk factors leading to development of NODM among de novo and maintenance solid-organ transplant patients receiving cyclosporine (CsA)-based immunosuppressive therapy. Concomitant therapy consisted of basiliximab, mycophenolate mofetil or enteric-coated mycophenolate sodium, and corticosteroids. Diabetes was diagnosed according to the American Diabetes Association criteria. This 6-month protocol-defined interim analysis included 101 patients (84 de novo, 17 maintenance) who received renal (n = 77), liver (n = 13), or heart (n = 11) transplantation. At the end of 6 months, 8/101 (7.92%) patients experienced NODM. The mean time to NODM was 3.05 months. No significant difference was observed between NODM and non-NODM patients for risk factors: age, body mass index, blood pressure, gender, high-density lipoproteins/triglycerides hdl/tg, and anti-hepatitis C virus. The composite endpoint of biopsy-proven acute rejection, graft loss, or death was reached in four patients, with a mean time to event of 3.81 months. Infections were noted in 34 subjects but, no malignancies. Among 389 adverse events reported in 91 patients (90.1%), the majority were of mild to moderate severity. Two deaths were reported: heart transplant recipients with acute rejection and cytomegalovirus meningitis with respiratory failure. Long-term enrollment with follow-up evaluation of these NODM patients up to 3 years will help evaluate the NODM incidence rates and exact graft survival and overall survival rates of CsA-treated transplant patients in Taiwan.
移植后新发糖尿病（NODM）是接受免疫抑制剂治疗患者的一种重要并发症。它对慢性移植器官功能障碍有相当大的影响。钙调神经磷酸酶抑制剂与移植后NODM的发生有关。由于高风险患者也会接受移植手术，因此预防和控制移植后NODM很重要。台湾目前正在进行一项为期3年的上市后监测研究，以评估接受基于环孢素（CsA）的免疫抑制治疗的初发和维持性实体器官移植患者中NODM的发生率及发病风险因素。联合治疗包括巴利昔单抗、霉酚酸酯或肠溶型霉酚酸钠，以及皮质类固醇。根据美国糖尿病协会标准诊断糖尿病。这项为期6个月的方案定义的中期分析纳入了101例患者（84例初发，17例维持性），他们接受了肾移植（n = 77）、肝移植（n = 13）或心脏移植（n = 11）。在6个月末，101例患者中有8例（7.92%）发生了NODM。发生NODM的平均时间为3.05个月。在NODM患者和非NODM患者之间，未观察到以下风险因素存在显著差异：年龄、体重指数、血压、性别、高密度脂蛋白/甘油三酯（HDL/TG）以及抗丙型肝炎病毒。4例患者达到了经活检证实的急性排斥反应、移植器官丢失或死亡的复合终点，事件发生的平均时间为3.81个月。34例患者出现感染，但未发生恶性肿瘤。在91例患者（90.1%）报告的389例不良事件中，大多数为轻度至中度严重程度。报告了2例死亡：心脏移植受者发生急性排斥反应，以及巨细胞病毒性脑膜炎伴呼吸衰竭。对这些NODM患者进行长达3年的长期入组及随访评估，将有助于评估台湾接受CsA治疗的移植患者的NODM发生率以及确切的移植器官存活率和总生存率。
