Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.
Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research centre, Kochi, India.
Hepatol Int. 2020 Dec;14(6):1075-1082. doi: 10.1007/s12072-020-10109-y. Epub 2020 Dec 5.
The role of N-acetylcysteine (NAC) in improving outcomes following live donor liver transplantation (LDLT) is not well established. We designed a randomized double-blind placebo-controlled trial to study the role of NAC infusion in recipients undergoing LDLT.
We assigned 150 patients who underwent LDLT by computer-generated random sequence on 1:1 ratio to either NAC group or placebo group. Patients in the NAC group received NAC infusion which was started at beginning of graft implantation at an initial loading dose of 150 mg/kg/h over 1 h, followed by 12.5 mg/kg/h for 4 h and then at 6.25 mg/kg/h continued for 91 h. Placebo group received normal saline. The primary endpoint was composite occurrence of acute kidney injury (AKI) and early allograft dysfunction (EAD) in the recipient. Secondary endpoints included levels of bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, INR, primary graft non-function, intraoperative bleeding, post-transplant hospital stay and in-hospital mortality.
The composite endpoint did not show any significant difference between the NAC and placebo group (21.3% vs 29.3%, p = 0.35). Peak AST (425.65 IU/L vs 702.24 IU/L, p = 0.02) and peak ALT (406.65 IU/L vs 677.99 IU/L, p = 0.01) levels were significantly lower in the study group. Time to normalization of transaminases was also significantly low in the study group.
Perioperative NAC infusion following LDLT resulted in significantly lower postoperative AST and ALT levels. Rapid normalization of transaminases was also observed. This, however, did not translate to improvement in AKI or EAD.
N-乙酰半胱氨酸（NAC）在改善活体肝移植（LDLT）后结局中的作用尚未得到充分证实。我们设计了一项随机、双盲、安慰剂对照试验，以研究 NAC 输注在接受 LDLT 的受者中的作用。
我们通过计算机生成的随机序列将 150 名接受 LDLT 的患者按 1:1 的比例随机分为 NAC 组或安慰剂组。NAC 组患者在开始进行供体植入时开始输注 NAC，初始负荷剂量为 150mg/kg/h，持续 1 小时，然后以 12.5mg/kg/h 持续 4 小时，然后以 6.25mg/kg/h 持续 91 小时。安慰剂组患者接受生理盐水。主要终点是受体发生急性肾损伤（AKI）和早期移植物功能障碍（EAD）的复合发生率。次要终点包括胆红素、天冬氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）、肌酐、INR、原发性移植物无功能、术中出血、移植后住院时间和院内死亡率。
NAC 和安慰剂组的复合终点无显著差异（21.3% vs 29.3%，p=0.35）。研究组的峰值 AST（425.65IU/L vs 702.24IU/L，p=0.02）和峰值 ALT（406.65IU/L vs 677.99IU/L，p=0.01）水平显著降低。研究组转氨酶正常化的时间也明显缩短。
LDLT 术后 NAC 输注可显著降低术后 AST 和 ALT 水平。也观察到转氨酶的快速正常化。然而，这并没有转化为 AKI 或 EAD 的改善。
