| ObjectivesBenign childhood epilepsy with centro-temporal spikes(BECTS)is also called children benign Rolandic epilepsy and is the most common childhood epilepsy syndrome. It has typical clinical manifestations and electroencephalogram(EEG) features, it usually has a favourable outcome and seizures disappear during the teenage years. Although clinical seizures of BECTS are few and easy to control in most children, the seizures and frequent subclinical epileptiform discharge still cause cognitive impairment in children, affecting the life and learning. At present, antiepileptic drugs(AEDs) therapy is still the main antiepileptic method, so it is important to choose the right AEDs. Sodium valproate (VPA) is the most widely used first-line broad-spectrum traditional antiepileptic drugs, it is one of the firstly chosen AEDs in BECTS. Levetiracetam(LEV) is a new antiepileptic drug developed by UCB company of Belgium, because it has unique antiepileptic mechanism and better pharmacokinetic characteristics and efficient and safe clinical effects, it has became one of the most promising new antiepileptic drugs, and has been widely used in Occident and China. In recent years, studies have reported that LEV probably can improve cognitive function and quality of life in patients with epilepsy. In this study, we treat 60 children with newly diagnosed BECTS, who are given LEV and VPA as monotherapy, in comparison with VPA, to evaluate the efficacy and the effect on cognitive function of LEV in children with BECTS.Methods60 children with BECTS,37 males and 23 females, aged between 6 and 13 years, mean age 8.5±2.8 years, course of disease from 3 months to 3.5 years. Randomly divided into two groups, Treatment group (n=30) to LEV monotherapy, the initial treatment dose of 20mg/(kg.d), twice a day orally, every two weeks increase 10mg /(kg.d) gradually, maintenance dose 30～40 mg/(kg. d); control group (n=30) to VPA monotherapy, the initial treatment dose of 10 mg/(kg.d), once a day orally at night, every week increase 5 mg/(kg.d) gradually, maintenance dose 20-30 mg/(k g.d). Two groups reach maintenance dose within 4 weeks, following-up 16 weeks. Pre-treatment and treatment, two groups are examined with EEG and received test of P300 and WISC-CR. To evaluate clinical efficacy,EEG improvement,adverse reactions and effect on cognitive function of LEV and VPA. All experimental results are statistically analyzed with SPSS 15.0. Measurement data was reprensented with (?)±SD, using t-text; count data was inspected with chi-square text, P<0.05 indicates Statistical difference.Results1. Clinical efficacy 25(83.3%) with control completely,3(10.0%) with effective and 2(6.7%)with ineffective in 30 children in treatment group, total response rate is 93.3%;23(76.7%) with control completely,3(10.0%) with effective and 4(13.3%)with ineffective in 30 children in control group, total response rate is 86.7%. There is no significant difference in two groups(X2=0.19, P>0.05).2. EEG improvement EEG is reviewed after 8 weeks, epileptiform discharges disappeared in 5 children,9 are improved in EEG, epileptiform discharges decrease by 50%, the response rate is 46.7% in treatment group; epileptiform discharges disappeared in 2 children,4 are approved in EEG, epileptiform discharges decrease by 50%, the response rate is 13.3% in control group; there is significant difference in response rate (X2=4.8, P < 0.05). After 16 weeks, epileptiform discharges is disappeared in 12 children,11 are approved in EEG, and epileptiform discharges decrease by 50%, no improvement is discovered in 7 children, no deterioration, the total response rate is 78.3% in treatment group; epileptiform discharges is disappeared in 5 children,14 are approved in EEG, and epileptiform discharges decrease by 50%, no improvement is discovered in 10 children, epileptiform discharges is increased in 1 children, the total response rate is 63.3% in control group; There is no significant difference in response rate (X2=1.26,p>0.05); There is significant difference in control rate(X2=4.02, P<0.05), the treatment group is higher than the control group. 3. The effect on cognitive function:Pre-treatment there is no significant difference in latency and amplitude in two groups(P>0.05); After treatment with LEV for 16 weeks, the latency is shorten compared to pre-treatment and treatment with VPA(P < 0.05); There is no significant difference in amplitude in two groups pre-treatment compared to after treatment(P>0.05). Pre-treatment there is no significant difference in intelligence test in two groups(P>0.05); After treatment with LEV for 16 weeks, the scores of arithmetic,Vocabulary,coding and FIQ are improved compared to pre-treatment(P<0.05); After treatment with VPA for 16 weeks, the scores of block design,coding and PIQ are decreased compared to pre-treatment (P<0.05); there is significant difference in the scores of block design,coding,object and PIQ assembly in two groups(P<0.05), the treatment group is higher than the control group.4. Adverse reactions:During the increased doses, the incidence of adverse reactions is 30.0% in treatment group,36.7% in control group, there is no significant difference in two groups(X2=0.31, P>0.05); during maintenance treatment, the incidence of adverse reactions is 13.3% in treatment group,36.7% in control group, there is significant difference in two groups(X2=4.35, P<0.05).Conclusions1. LEV and VPA have favorable efficacy on controlling clinical onset in children with BECTS.2. LEV and VPA can improve EEG of children with BECTS, the improvement of EEG of LEV is earlier and more obvious.3. LEV can improve cognitive functions, VPA has slightly negative effect on cognitive functions.4. LEV has less adverse reactions, better tolerance and compliance.
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