Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.
Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.
HPB (Oxford). 2024 Feb;26(2):171-178. doi: 10.1016/j.hpb.2023.10.017. Epub 2023 Oct 26.
To compare the safety and efficacy of once-daily tacrolimus (ODT) versus twice-daily tacrolimus (BDT) in adult live donor liver transplantation (LDLT).
In this open-labelled randomized trial, 174 adult patients undergoing LDLT were randomized into ODT or BDT, combined with basiliximab induction and mycophenolate mofetil (steroid-free regimen). Tacrolimus was started at a total dose of 1 mg and the trough level was aimed at 3-7 ng/ml. The primary endpoint was eGFR at 1,3- and 6 months post-transplant, using CKD- EPI equation. Secondary endpoints included biopsy-proven acute rejection (BPAR), metabolic complications, post-operative bilio-vascular complications and patient survival.
There was no statistically significant difference in eGFR between the two groups at 6 months (ODT -96 ± 19, BDT -91 ± 21, p value-0.164). BPAR was comparable (18/84 in ODT, 19/88 in BDT, p value-0.981). For a similar dosage of tacrolimus, the median trough tacrolimus levels attained were significantly lower for ODT than BDT during the first-month post-transplant (p value-0.001). Metabolic complications due to immunosuppression, post-operative bilio-vascular complications and patient survival was similar between the two groups at 6 months.
Once-daily tacrolimus has similar renal safety and efficacy as twice-daily tacrolimus when used in combination with basiliximab induction and mycophenolate in adult LDLT.
比较成人活体肝移植（LDLT）中每日一次他克莫司（ODT）与每日两次他克莫司（BDT）的安全性和疗效。
在这项开放标签的随机试验中，174 名接受 LDLT 的成年患者被随机分为 ODT 或 BDT 组，联合巴利昔单抗诱导和霉酚酸酯（无激素方案）。他克莫司起始剂量为 1 毫克，目标谷浓度为 3-7ng/ml。主要终点为移植后 1、3 和 6 个月的估算肾小球滤过率（eGFR），采用 CKD-EPI 方程。次要终点包括活检证实的急性排斥反应（BPAR）、代谢并发症、术后肝胆并发症和患者生存。
两组在 6 个月时的 eGFR 无统计学差异（ODT-96±19，BDT-91±21，p 值-0.164）。BPAR 发生率相似（ODT 组 18/84，BDT 组 19/88，p 值-0.981）。在相同剂量的他克莫司下，移植后第一个月 ODT 的中位他克莫司谷浓度明显低于 BDT（p 值-0.001）。在 6 个月时，两组之间因免疫抑制引起的代谢并发症、术后肝胆并发症和患者生存率相似。
在成人 LDLT 中，与巴利昔单抗诱导和霉酚酸酯联合使用时，每日一次他克莫司与每日两次他克莫司具有相似的肾安全性和疗效。
