Department of Clinical Medicine, Division of Gastroenterology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
Eur Rev Med Pharmacol Sci. 2013 Oct;17(20):2718-20.
The aim of this study was to assess the long term effects of once-daily tacrolimus (OD-TAC) in a cohort of stable liver recipients converted from the twice daily tacrolimus (TD TAC), with a particular attention on the possible effects on renal function.
Between September 2008 and September 2010 conversion from TD-TAC to OD-TAC was proposed in adult stable liver transplant recipients who were followed as outpatients in our Transplant centre. Conversion from TC-TAC to OD-TAC was based on a 1 mg: 1 mg proportion. Tacrolimus through levels, laboratory parameters, metabolic disorders and any adverse events were evaluated at 1, 3, 6, 12 and 24 months after conversion. Renal function was evaluated using creatinine plasma levels and estimated glomerular filtration rate (GFR) derived from the Modification of Diet in Renal Disease (MDRD). Analysis of variance and t test for paired data were utilised for the comparison of the results obtained at the scheduled controls.
Sixty-five patients were enrolled in the study (50 males, 15 females, mean age 59±8 years). Median time since liver transplant (LT) was 39 months (range: 6 to 83 months). All patients were followed for a minimum of 12 months. Ninety per cent of patients stabilized their blood levels within 45 days. Liver function, glucose and plasma lipids concentration and arterial blood pressure remained stable during the study. Renal function improved during the 24 months of follow-up. No adverse events or acute rejection episodes were recorded during the study.
Considering the advantage on patient compliance, the equivalent efficacy and the adequate safety of OD-TAC formulation may represent a useful option in liver transplant patients, with a possible advantage on renal function.
本研究旨在评估将稳定的肝移植受者从每日两次的他克莫司（TD-TAC）转换为每日一次的他克莫司（OD-TAC）后的长期效果，特别关注其对肾功能的可能影响。
2008 年 9 月至 2010 年 9 月期间，我们建议在我们的移植中心接受门诊随访的稳定肝移植受者将 TD-TAC 转换为 OD-TAC。将 TC-TAC 转换为 OD-TAC 的基础是 1mg：1mg 的比例。在转换后 1、3、6、12 和 24 个月评估他克莫司的血药浓度、实验室参数、代谢紊乱和任何不良事件。使用血浆肌酐水平和改良肾脏病饮食（MDRD）衍生的估计肾小球滤过率（GFR）评估肾功能。使用方差分析和配对 t 检验比较预定对照时获得的结果。
本研究共纳入 65 例患者（50 例男性，15 例女性，平均年龄 59±8 岁）。肝移植后中位时间为 39 个月（范围：6-83 个月）。所有患者均至少随访 12 个月。90%的患者在 45 天内稳定了血药浓度。研究期间肝功能、血糖和血浆脂质浓度以及动脉血压保持稳定。肾功能在 24 个月的随访期间得到改善。研究期间未记录到任何不良事件或急性排斥反应。
考虑到患者依从性的优势、等效疗效和 OD-TAC 制剂的充分安全性，它可能是肝移植患者的一种有用选择，对肾功能可能有优势。
