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移植前补充左旋肉碱对肝移植受者原发性移植物功能障碍的影响:一项前瞻性、随机、安慰剂对照临床试验。

Effects of pre-transplant L-carnitine supplementation on primary graft dysfunction in liver transplant recipients: a pilot, randomized, placebo-controlled clinical trial.

作者信息

Khajeh Behrouz, Dashti-Khavidaki Simin, Nasiri-Toosi Mohsen, Mohammadi Keyhan, Jafari Atefeh

机构信息

Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, I.R. Iran.

Liver Transplantation Research Center, Tehran University of Medical Sciences, Tehran, I.R. Iran.

出版信息

Res Pharm Sci. 2019 Dec 11;14(6):504-514. doi: 10.4103/1735-5362.272537. eCollection 2019 Dec.

Abstract

Primary graft dysfunction (PGD) and non-function (PNF) happen in 8.7-24.7% and 0.9-7.2% of liver transplant recipients, respectively. These phenomena increase treatment cost and patients' death. This study assessed the effect of L-carnitine supplementation on the incidences of PNF/PGD in liver transplant recipients. This randomized, placebo-controlled, clinical trial was performed on adult liver transplant recipients. Patients took L-carnitine syrup 500 mg three times daily or placebo from the time of including in transplant waiting list until the day of transplant surgery (median 14 days, 1-192 days). Thirty-three patients in L-carnitine and 39 patients in placebo group completed the study. Although not statistically significant, PNF and PGD happened less frequently among recipients in L-carnitine compared with placebo group (3% 12.8% for PNF; 15.2% 30.8% for PGD). Alanine aminotransferase (ALT) and aspartate aminotransferase were lower in L-carnitine group at day 3 after transplantation. ALT declined more significantly within 48 h after transplantation in L-carnitine arm (median 120.50 79 IU/L; = 0.03). One-month patients' survival was significantly higher in L-carnitine versus placebo group (97% 74.4%; = 0.008). The rates of PNF and PGD in L-carnitine group were approximately one-fourth and one-half of placebo group respectively. One-month patients' survival was higher in L-carnitine group.

摘要

原发性移植肝无功能(PNF)和原发性移植肝失功(PGD)分别发生在8.7%-24.7%和0.9%-7.2%的肝移植受者中。这些现象增加了治疗成本和患者死亡率。本研究评估了补充L-肉碱对肝移植受者PNF/PGD发生率的影响。这项随机、安慰剂对照的临床试验是在成年肝移植受者中进行的。患者从被列入移植等待名单之时起至移植手术当天(中位数为14天,范围1-192天),每日三次服用500mg L-肉碱糖浆或安慰剂。L-肉碱组的33例患者和安慰剂组的39例患者完成了研究。虽然无统计学意义,但与安慰剂组相比,L-肉碱组受者中PNF和PGD的发生频率较低(PNF为3%对12.8%;PGD为15.2%对30.8%)。移植后第3天,L-肉碱组的丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶较低。L-肉碱组在移植后48小时内ALT下降更为显著(中位数为120.50对79 IU/L;P=0.03)。L-肉碱组1个月时患者生存率显著高于安慰剂组(97%对74.4%;P=0.008)。L-肉碱组的PNF和PGD发生率分别约为安慰剂组的四分之一和二分之一。L-肉碱组1个月时患者生存率更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c773/6937745/10c476181ea0/RPS-14-504-g001.jpg

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