口服左旋肉碱补充剂对小儿急性淋巴细胞白血病患者维持治疗阶段肝脏酶的影响：一项随机临床试验研究。
Effects of oral Lcarnitine supplementation on liver enzymes in pediatric acute lymphoblastic leukemia patients in the maintenance phase of treatment: a randomized clinical trial study.
作者信息
Eghbali Aziz, Eghbali Aygin, Ashayeri Neda, Fadayi Fatemeh, Ghaffari Kazem, Ghasemi Ali
机构信息
Clinical Research Development Center of Aliasghar Hospital, Iran University of Medical Sciences, Tehran, Iran.
School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
出版信息
Front Pharmacol. 2025 Jan 17;15:1507996. doi: 10.3389/fphar.2024.1507996. eCollection 2024.
BACKGROUND
Given that liver diseases and subsequent increases in liver enzymes are among the most frequent complications observed in leukemia patients treated with chemotherapeutic drugs, this study aimed to assess the impact of oral Lcarnitine supplementation on liver enzyme levels the maintenance phase of treatment for pediatric acute lymphoblastic leukemia (ALL) patients.
METHODS
In this clinical trial, 100 pediatric patients aged >5 years were divided into two groups after obtaining informed consent. The participants were randomly divided into the Lcarnitine and placebo groups. In the Lcarnitine group, patients received 50 mg/kg of Lcarnitine syrup three times a day (every 8 h). Patients were examined for 2 months to receive Lcarnitine syrup and to measure the levels of alanine aminotransferase (ALT), aspartate transferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), direct bilirubin, total bilirubin, prothrombin time (PT), and partial thromboplastin time (PTT).
RESULTS
The mean changes in AST, ALT, total bilirubin, and GGT during the study period were significant in the group treated with Lcarnitine (P < 0.05), although they were not significant in the placebo group (P > 0.05). Also, the levels of ALP, direct bilirubin, PT, and PTT were not significantly different between the two groups. The incidence of side effects was significantly higher in the Lcarnitine group than in the placebo group (18% vs 4%, P = 0.025).
CONCLUSION
The results of this study suggested that a 60-day Lcarnitine treatment can improve liver enzyme levels and thus prevent the extent of liver damage during the treatment of ALL. Based on the results of our study, Lcarnitine supplementation may have a beneficial effect on liver enzyme levels in pediatric ALL patients during the maintenance phase of treatment.
CLINICAL TRIAL REGISTRATION
https://irct.behdasht.gov.ir/search/result?query=IRCT20201107049296N2, identifier IRCT20201107049296N2.
背景
鉴于肝脏疾病以及随后肝酶升高是接受化疗药物治疗的白血病患者中最常见的并发症之一，本研究旨在评估口服补充左旋肉碱对小儿急性淋巴细胞白血病（ALL）患者治疗维持期肝酶水平的影响。
方法
在这项临床试验中，100名年龄大于5岁的小儿患者在获得知情同意后被分为两组。参与者被随机分为左旋肉碱组和安慰剂组。在左旋肉碱组中，患者每天三次（每8小时一次）接受50mg/kg的左旋肉碱糖浆。对患者进行2个月的观察，期间给予左旋肉碱糖浆并测量丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、碱性磷酸酶（ALP）、γ-谷氨酰转移酶（GGT）、直接胆红素、总胆红素、凝血酶原时间（PT）和部分凝血活酶时间（PTT）的水平。
结果
在研究期间，左旋肉碱治疗组的AST、ALT、总胆红素和GGT的平均变化具有统计学意义（P<0.05），而安慰剂组则无统计学意义（P>0.05）。此外，两组之间的ALP、直接胆红素、PT和PTT水平无显著差异。左旋肉碱组的副作用发生率显著高于安慰剂组（18%对4%，P=0.025）。
结论
本研究结果表明，60天的左旋肉碱治疗可改善肝酶水平，从而在ALL治疗期间预防肝损伤程度。基于我们的研究结果，补充左旋肉碱可能对小儿ALL患者治疗维持期的肝酶水平有有益影响。
临床试验注册
https://irct.behdasht.gov.ir/search/result?query=IRCT20201107049296N2，标识符IRCT20201107049296N2。
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