Asgarshirazi Masoumeh, Shariat Mamak, Sheikh Mahdi
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Hepatobiliary Pancreat Dis Int. 2017 Jun;16(3):296-302. doi: 10.1016/s1499-3872(16)60142-x.
Liver injury associated with antiepileptic drugs accounts for a large proportion of drug-induced liver injuries (DILI) in children. Although withdrawal of the causative agent is the only proved treatment for DILI, in some clinical situations it is not possible. Recent studies have reported promising results of using hepatoprotective drugs with antioxidant actions for the management of DILI. This study aimed to evaluate the efficacy of folic acid versus silymarin treatment in relation to decreasing liver enzymes in patients with DILI due to antiepileptic therapy.
This randomized, open-label, clinical trial evaluated 55 children with epilepsy who were on antiepileptic treatment and experienced DILI. The children were randomized to receive either silymarin (5 mg/kg per day) or folic acid (1 mg per day) for one month and were followed up for three months.
Liver enzymes significantly decreased in both groups. The decrease trend in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were stronger in the folic acid group compared to silymarin group (P=0.04 and P=0.007, respectively). At the end of the study patients in the folic acid group had significantly lower ALT (P=0.04), AST (P=0.02), and gamma-glutamyl transferase (GGT) (P<0.001) levels and also higher percentage of normal ALT (30.7% vs 3.4%, P=0.009) and AST (42.3% vs 0%, P<0.001), and GGT (23.1% vs 0%, P=0.008) values compared to the patients in the silymarin group. No rebound elevations in ALT, AST and GGT levels or adverse reactions were noted in neither of the study groups.
Although both treatments were safe and effective in decreasing liver enzymes, folic acid seems to be superior to silymarin in the management of DILI.
与抗癫痫药物相关的肝损伤在儿童药物性肝损伤（DILI）中占很大比例。尽管停用致病药物是唯一被证实的DILI治疗方法，但在某些临床情况下无法做到。最近的研究报告了使用具有抗氧化作用的保肝药物治疗DILI取得了有前景的结果。本研究旨在评估叶酸与水飞蓟宾治疗对降低抗癫痫治疗所致DILI患者肝酶的疗效。
这项随机、开放标签的临床试验评估了55名接受抗癫痫治疗并发生DILI的癫痫儿童。这些儿童被随机分为接受水飞蓟宾（每日5mg/kg）或叶酸（每日1mg）治疗1个月，并随访3个月。
两组肝酶均显著降低。与水飞蓟宾组相比，叶酸组丙氨酸氨基转移酶（ALT）和天冬氨酸氨基转移酶（AST）的下降趋势更强（分别为P=0.04和P=0.007）。研究结束时，叶酸组患者的ALT（P=0.04）、AST（P=0.02）和γ-谷氨酰转移酶（GGT）（P<0.001）水平显著更低，正常ALT（30.7%对3.4%，P=0.009）、AST（42.3%对0%，P<0.001）和GGT（23.1%对0%，P=0.008）值的百分比也高于水飞蓟宾组患者。两个研究组均未观察到ALT、AST和GGT水平的反弹升高或不良反应。
尽管两种治疗在降低肝酶方面均安全有效，但在DILI的管理中，叶酸似乎优于水飞蓟宾。
