Ruangkanchanasetr Prajej, Sanohdontree Natthi, Supaporn Thanom, Sathavarodom Nattapol, Satirapoj Bancha
Division of Nephrology, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.
Division of Endocrinology, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.
Ann Transplant. 2016 Dec 16;21:765-774. doi: 10.12659/aot.900638.
BACKGROUND Post-transplantation diabetes mellitus is a major metabolic adverse effect of tacrolimus (TAC). The objective of this study was to determine if the conversion from tacrolimus twice-daily (TAC-BID) to extended-release tacrolimus once-daily (TAC-OD) in stable renal transplant recipients had any effect on beta cell function (HOMA-b), insulin resistance (HOMA-IR), patient preference, and expense. MATERIAL AND METHODS Twenty-eight renal transplant recipients were recruited and converted from TAC-BID to TAC-OD at the same dose. Primary outcomes were beta cell function and insulin resistance in stable renal transplant recipients at 4, 8, and 16 weeks after conversion. Secondary outcomes were patient satisfaction and expense of medication. RESULTS No significant change in the HOMA-β and HOMA-IR was found in any of the 28 renal transplant recipients. However, HOMA-β increased from 60 (37.33, 109.71) to 78.5 (44.3, 108.4) (p=0.02) in 15 patients who had the conversion within 4 years after renal transplantation. In multivariate regression analysis, the conversion from TAC-BID to TAC-OD significantly increased HOMA-b at 4 months at 1.21 mIU/mmol (95%CI 0.54-1.88 mIU/mmol, p=0.01) in this subgroup. The renal transplant recipients reported the conversion was more satisfactory and cost of treatment was comparable. CONCLUSIONS In short-term follow-up, conversion from TAC-BID to TAC-OD is safe in stable renal transplant recipients and might be beneficial in term of improved beta cell function in the early years after renal transplantation. The conversion caused comparable cost and was preferred by renal transplant recipients.
移植后糖尿病是他克莫司(TAC)的一种主要代谢不良反应。本研究的目的是确定稳定的肾移植受者从每日两次他克莫司(TAC - BID)转换为每日一次缓释他克莫司(TAC - OD)是否对β细胞功能(HOMA - b)、胰岛素抵抗(HOMA - IR)、患者偏好和费用有任何影响。
招募了28名肾移植受者,并以相同剂量从TAC - BID转换为TAC - OD。主要结局是转换后4周、8周和16周时稳定的肾移植受者的β细胞功能和胰岛素抵抗。次要结局是患者满意度和药物费用。
28名肾移植受者中,HOMA -β和HOMA - IR均未发现显著变化。然而,在肾移植后4年内进行转换的15名患者中,HOMA -β从60(37.33,109.71)增加到78.5(44.3,108.4)(p = 0.02)。在多变量回归分析中,在该亚组中,从TAC - BID转换为TAC - OD在4个月时显著增加HOMA - b,增加幅度为1.21 mIU/mmol(95%CI 0.54 - 1.88 mIU/mmol,p = 0.01)。肾移植受者报告转换更令人满意,且治疗费用相当。
在短期随访中,稳定的肾移植受者从TAC - BID转换为TAC - OD是安全的,并且在肾移植后的早期可能有利于改善β细胞功能。这种转换导致的费用相当,且为肾移植受者所偏好。