The random and comparative study on therapeutic effect and safety between Levetiracetam and Phenobarbitaladministration for neonatal seizures / 中华实用儿科临床杂志

ABSTRACT

Objective To randomly compare the therapeutic effect and safety between Levetiracetam (LEV) and Phenobarbital (PB) in the treatment of neonatal seizures.Methods A total of 61 infants with acute convulsion were randomly divided into 2 groupsLEV group (n =30) and PB group (n =31) during January 2013 to December 2014 in Urumqi Children's Hospital.All neonates received routine management including etiology treatment and adverse drug reaction monitoring.In the LEV group,subjects received oral formulation of LEV with initial loading dose 30 mg/kg,followed by 15 mg/kg twice a day.If the seizures were not controlled completely,PB treatment was added until seizures were completed controlled.If seizures were controlled quickly,the dose of PB was gradually reduced and LEV was used as monotherapy.The subjects in PB group received intramuscular or intravenous injection of PB with 10 mg/kg as the first dose,then 5 mg/(kg · d) oral PB was administered,if seizures were not controlled,LEV treatment was added,then dose of PB was gradually reduced until seizures were controlled completely,and then patients were switched to LEV monotherapy gradually.The drug adverse reactions were observed.Results (1) After LEV or PB monotherapy,66.7％ (20/30 cases) and 54.8％ (17/31 cases) of the subjects obtained sustainable seizure free respectively.Although,there was a higher control ratio in LEV group,but no significant difference was observed between the 2 groups (P ＞0.05).(2) LEV group (16/30 cases,53.33％) had higher rapid seizure control ratio with seizure controlled within 24 h after first dosage administration than that of PB group (8/31 cases,25.80％),and there was significant difference (x2 =4.841,P =0.028).Further more,if adding the cases who had to change to use another comparative one (LEV or PB) due to their seizures failure control with the first one treated,LEV group (21/44 cases,47.72％) still had higher rapid seizure control ratio in total patients than that of PB group(10/41 cases,24.39％),and there was significant difference (x2 =4.988,P =0.026).(3) Eight cases who changed to LEV after PB as the first treatment drug failed obtained sustainable seizure free.(4) One case in PB group with transient urinary retention was observed but the symptom disappeared 36 h after PB withdrawal,and no significant drug adverse reaction was observed in LEV group.Conclusion LEV is more rapid and safe for seizure control of neonates than PB.