左乙拉西坦单药治疗脑性瘫痪并癫婴幼儿的疗效

Effect of Levetiracetam Monotherapy for Epilepsy Combined with Cerebral Palsy in Toddler

目的观察左乙拉西坦(LEV)单药治疗脑性瘫痪(脑瘫)并癫婴幼儿的疗效和不良反应。方法将78例新诊断癫婴幼儿根据Gesell发育量表和临床诊断分为脑瘫组(n=37)和发育正常组(n=41)。应用LEV进行治疗,采用开放、前瞻、短期(8周)的临床试验研究。2组患儿均给予LEV,从10 mg.kg-1.d-1开始,分2次口服,每7 d加量1次,每次加量10 mg.kg-1.d-1,直至达到发作控制或目标剂量50 mg.kg-1.d-1,加量期为4周。以治疗前4周的发作次数为基础,与加量结束后的发作次数进行比较以判断疗效,并观察治疗过程中的不良反应。结果脑瘫组37例患儿均完成为期8周的临床观察,发育正常组41例中8例退出研究。脑瘫组19例完全控制,显效7例,有效6例,无效5例,总有效率86.5%,完全控制率51.4%;发育正常组33例完全控制17例,显效6例,有效5例,无效5例,总有效率84.8%,完全控制率51.5%。二组总有效率、完全控制率比较均无统计学差异(Pa>0.05)。78例中发生不良反应者26例(占33.3%)。发育正常组发生烦躁及行为改变11例,食欲减退、睡眠增多各2例,呕吐1例,其中4例因烦躁及行为改变退出观察;脑瘫组出现呕吐4例,食欲减退3例,睡眠增多2例,一过性皮疹1例,未见烦躁等不良反应。不良反应均于加量期出现,加量期后减轻或消失。未见体质量、血常规、尿常规及肝、肾功能改变。结论 LEV对合并癫的脑瘫婴幼儿疗效较好,且无严重不良反应,适合在合并癫的脑瘫患儿中应用。

Objective To observe the efficacy and adverse effects of levetiracetam（LEV） monotherapy in epileptic combined with cerebral palsy in toddler.Methods Seventy-eight newly diagnosed epileptic toddlers were divided into cerebral palsy group（n=37） and normal developmental group（n=41） according to the Gesell Developmental Scale and the clinical diagnosis.LEV was utilized for the open,prospective,short-term（8 weeks） clinical trials to interprete the efficacy and adverse effects in these toddlers.All the patients were initiated with oral administration of LEV at the dose of 10 mg·kg-1·d-1,which was evenly divided into twice daily.Titration was made as once a week at the dose 10 mg·kg-1·d-1 to seizure free or the objective dose of 50 mg ·kg-1·d-1 within 4 weeks.The therapeutic effects were assessed by comparing the 4 weeks seizure frequency between pre-titration and post-titration.Adverse effects were examined throughout the whole study.Results Children in cerebral palsy group were completed through the 8-week clinical observation,however,8 cases of 41 toddlers in the normal developmental group were dropped out during the clinical trial.In the cerebral palsy group,19 cases were seizure free,7 significant effective,6 cases were effective and 5 cases were ineffective,total effective rate was 86.5%,and seizure free rate was 51.4%;amongst the 33 cases who completed the trial in the normal developmental group,17 cases were seizure free,6 cases were significant effective,5 cases were effective and 5 ineffective,total effective rate was 84.8%,and seizure free rate was 51.5%,there was no significant difference in the total effective rate and seizure free rate between the 2 groups（Pa0.05）.Twenty-six cases（accounting for 33.3%） of all children,developed adverse effects.Adverse effects in 16 children in normal developmental group（39.0%） were irritability and behavioral changes in 11 cases,loss of appetite in 2 cases,drowsiness in 2 cases and vomiting in 1 case,and 4 children were dropped out from the study due to irritability and behavioral change;10 children of the cerebral group（27.0%） developed vommiting in 4 cases,loss of appetite in 3 cases,drowsiness in 2 cases and transient rash in 1 case,and no adverse effect of irritation and behavioral changes was found.All of the adverse effects emerged during the titration period and disappeared thereafter in the children who completed the study.No change was found in the examination of body weight,complete blood cell,urine,heptic and renal function.Conclusions LEV shows a relatively good effects and no severe side effects on epileptic toddlers with cerebral palsy and can be widely used for seizure control in children with cerebral palsy.