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左旋肉碱对肾移植受者移植肾功能延迟的保护作用:一项前瞻性、随机、双盲、安慰剂对照临床试验

Protective Effects of L-Carnitine Against Delayed Graft Function in Kidney Transplant Recipients: A Pilot, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

作者信息

Jafari Atefeh, Khatami Mohammad-Reza, Dashti-Khavidaki Simin, Lessan-Pezeshki Mahboob, Abdollahi Alireza, Moghaddas Azadeh

机构信息

Department of Clinical Pharmacy, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.

Nephrology Research Center, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

J Ren Nutr. 2017 Mar;27(2):113-126. doi: 10.1053/j.jrn.2016.11.002. Epub 2017 Jan 4.

DOI:10.1053/j.jrn.2016.11.002
PMID:28065453
Abstract

OBJECTIVE

Delayed graft function (DGF) is an early complication after deceased donor kidney transplantation with significant adverse effects on graft outcomes. Ischemia-reperfusion injury during transplantation is a major cause of DGF. Tissue concentrations of carnitine, an antioxidant and regulator of cellular energy supply, decrease in the kidney following ischemia-reperfusion insult. Based on promising animal data, this study evaluated the possible protective effect of L-carnitine against DGF.

DESIGN

This study is a pilot, randomized, double-blind, placebo-controlled clinical trial that was conducted on kidney transplantation patients in kidney transplant ward of Imam Khomeini hospital complex affiliated to Tehran University of Medical Sciences, Tehran, Iran.

SUBJECTS

Patients older than 14 years old undergoing their first kidney transplantation from a deceased donor were evaluated for eligibility to take part in this study. Fifty-six patients were randomly assigned to L-carnitine or placebo groups.

INTERVENTION

During this trial, 3 g of oral L-carnitine or placebo was administered in 3 divided doses each day for 4 consecutive days starting the day before kidney transplantation (i.e., days -1, 0, 1, and 2).

MAIN OUTCOME MEASURE

The need for dialysis within the first week after transplantation, serum creatinine and urine output were assessed daily. After hospital discharge, patients were followed for 3 months regarding organ function.

RESULTS

DGF incidence did not differ between the L-carnitine and placebo groups (18.51% vs. 23.8%, respectively; P = .68). Total allograft failure within 3 months after kidney transplantation happened in 6 patients in the placebo and 1 patient in the L-carnitine group (P = .05).

CONCLUSION

This study showed no protective effects of oral L-carnitine supplementation against DGF occurrence recipients; however, 3-month graft loss was lower in the L-carnitine supplemented group.

摘要

目的

移植肾功能延迟恢复(DGF)是尸体供肾移植后的一种早期并发症,对移植肾的预后有显著不良影响。移植过程中的缺血再灌注损伤是DGF的主要原因。肉碱是一种抗氧化剂和细胞能量供应调节剂,在肾脏缺血再灌注损伤后,其组织浓度会降低。基于有前景的动物实验数据,本研究评估了左旋肉碱对DGF的可能保护作用。

设计

本研究是一项前瞻性、随机、双盲、安慰剂对照临床试验,在伊朗德黑兰医科大学附属伊玛目霍梅尼医院综合大楼肾移植病房的肾移植患者中进行。

研究对象

对年龄大于14岁、接受首次尸体供肾肾移植的患者进行评估,以确定其参与本研究的资格。56例患者被随机分为左旋肉碱组或安慰剂组。

干预措施

在本试验中,从肾移植前一天(即第-1、0、1和2天)开始,连续4天每天分3次口服3g左旋肉碱或安慰剂。

主要观察指标

评估移植后第一周内透析的需求、每日血清肌酐和尿量。出院后,对患者的器官功能进行3个月的随访。

结果

左旋肉碱组和安慰剂组的DGF发生率无差异(分别为18.51%和23.8%;P = 0.68)。肾移植后3个月内,安慰剂组有6例患者发生移植肾完全失功,左旋肉碱组有1例患者发生移植肾完全失功(P = 0.05)。

结论

本研究表明,口服补充左旋肉碱对预防接受者发生DGF无保护作用;然而,补充左旋肉碱组的3个月移植肾丢失率较低。

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