Objective To prospectively observe changes in clinical efficacy and adverse effects of levetiracetam(LEV)in children with epilepsy after switching from brand-named drug to generic drug.Methods 196 children with epilepsy who were treated in Pediatric Outpatient Department and Inpatient Department of The Second Affiliated Hospital of Xi'an Jiaotong University over a period from April 2019 to December 2020 were selected as study subjects.According to seizure frequency after switching,they were divided into increased seizure group,decreased seizure group and no change in seizure group.The clinical data of the children with epilepsy before and after LEV switching from brand-named drug to generic drug were collected.The LEV plasma concentration,seizure frequency,adverse effect before and after switching and the clinical features of those children with increased seizure frequency after switching were analyzed and compared between the two groups.Results The LEV plasma concentration was 8.09±2.42μg/mL before switching and 8.28±2.17μg/mL after switching,there was no statistical difference(t=0.521,P＞0.05).The LEV therapeutic dose/plasma concentration ratio was 3.44±1.10L/kg before switching and 3.77±1.59L/kg after switching,there was no statistical difference(t=0.723,P＞0.05).The effective rate was 81.05％(154/190)before switching and 75.79％(144/190)after switching,and also there was no statistical difference(x2=1.555,P＞0.05).These children who had young age of onset and received combination therapy may presented with increased seizure frequency after switching,and no new adverse effects were seen after LEV switching from brand-named drug to generic drug.Conclusion LEV is still safe and effective for treatment of the children with epilepsy after switching from brand-named drug to generic drug.However,we need to focus on those children who have young age of onset and receive combination therapy.
维普
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