他克莫司
医学
巴利昔单抗
临床终点
泌尿科
随机对照试验
钙调神经磷酸酶
肝移植
免疫抑制
移植
外科
胃肠病学
内科学
作者
Guhan Venkatakrishnan,Manikandan Kathirvel,Binoj Sivasankara Pillai Thankamony Amma,A. Muraleedharan,Johns Shaji Mathew,Christi Titus Varghese,Krishnanunni Nair,Shweta Mallick,Madhu S. Durairaj,Unnikrishnan Gopalan,Dinesh Balakrishnan,Sudheer Othiyil Vayoth,S Sudhindran
出处
期刊:Hpb
[Elsevier]
日期:2024-02-01
卷期号:26 (2): 171-178
标识
DOI:10.1016/j.hpb.2023.10.017
摘要
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.
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