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.

IF 4.8 2区 医学 Q1 PHARMACOLOGY & PHARMACY Frontiers in Pharmacology Pub Date : 2025-01-17 eCollection Date: 2024-01-01 DOI:10.3389/fphar.2024.1507996
Aziz Eghbali, Aygin Eghbali, Neda Ashayeri, Fatemeh Fadayi, Kazem Ghaffari, Ali Ghasemi
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Abstract

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.

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口服左旋肉碱对儿童急性淋巴细胞白血病患者治疗维持期肝酶的影响:一项随机临床试验研究
背景:鉴于肝脏疾病和随后的肝酶升高是化疗药物治疗白血病患者最常见的并发症之一,本研究旨在评估口服左旋肉碱补充对儿童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:在本临床试验中,100例年龄在bb0 ~ 5岁的儿童患者经知情同意后分为两组。参与者被随机分为左旋肉碱组和安慰剂组。左肉碱组患者给予左肉碱糖浆50 mg/kg,每日3次(每8 h一次)。患者接受左肉碱糖浆治疗2个月,并测定丙氨酸转氨酶(ALT)、天冬氨酸转移酶(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)、部分凝血活酶时间(PTT)水平。结果:左肉碱组在研究期间AST、ALT、总胆红素、GGT的平均变化有统计学意义(P < 0.05),而安慰剂组无统计学意义(P < 0.05)。两组间ALP、直接胆红素、PT、PTT水平无显著差异。左旋肉碱组的副作用发生率明显高于安慰剂组(18% vs 4%, P = 0.025)。结论:本研究结果提示,60天左旋肉碱治疗可提高肝酶水平,从而预防ALL治疗期间肝损害的程度。根据我们的研究结果,补充左旋肉碱可能对儿科ALL患者在治疗维持阶段的肝酶水平有有益的影响。临床试验注册:https://irct.behdasht.gov.ir/search/result?query=IRCT20201107049296N2,标识符IRCT20201107049296N2。
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来源期刊
Frontiers in Pharmacology
Frontiers in Pharmacology PHARMACOLOGY & PHARMACY-
CiteScore
7.80
自引率
8.90%
发文量
5163
审稿时长
14 weeks
期刊介绍: Frontiers in Pharmacology is a leading journal in its field, publishing rigorously peer-reviewed research across disciplines, including basic and clinical pharmacology, medicinal chemistry, pharmacy and toxicology. Field Chief Editor Heike Wulff at UC Davis is supported by an outstanding Editorial Board of international researchers. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
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