Comparison of efficacy of folic acid and silymarin in the management of antiepileptic drug induced liver injury:a randomized clinical trial  

作　　者：Masoumeh Asgarshirazi Mamak Shariat Mahdi Sheikh 

机构地区：[1]Department of Pediatrics,Vali-asr Hospital,Tehran University of Medical Sciences,Tehran,Iran [2]Maternal,Fetal and Neonatal Research Center,Tehran University of Medical Sciences,Tehran,Iran

出　　处：《Hepatobiliary & Pancreatic Diseases International》2017年第3期296-302,共7页国际肝胆胰疾病杂志（英文版）

基　　金：supported by a grant from the research deputy of Tehran University of Medical Sciences

摘　　要：BACKGROUND： 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 dinical situations it is not possible. Recent studies have reported promising results of using hepatoprotective drugs with antioxidant actions for the management of DILl. 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. METHODS： This randomized, open-label, clinical trial evalu- ated 55 children with epilepsy who were on antiepileptic treat- ment and experienced DILL 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. RESULTS： 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-glntamyl 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.CONCLUSION： Although both treatments were safe and effective in decreasing liver enzymes, folic acid seems to be superior to silymarin in the management of DILl.BACKGROUND： 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 dinical situations it is not possible. Recent studies have reported promising results of using hepatoprotective drugs with antioxidant actions for the management of DILl. 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. METHODS： This randomized, open-label, clinical trial evalu- ated 55 children with epilepsy who were on antiepileptic treat- ment and experienced DILL 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. RESULTS： 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-glntamyl 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.CONCLUSION： Although both treatments were safe and effective in decreasing liver enzymes, folic acid seems to be superior to silymarin in the management of DILl.

关 键 词：ANTICONVULSANT ANTIEPILEPTIC ENZYMES HEPATITIS HEPATOTOXICITY 

分 类 号：R575[医药卫生—消化系统]