左乙拉西坦治疗小儿癫痫的疗效和安全性临床随访研究
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摘要
目的：通过随访研究左乙拉西坦（LEV）治疗不同类型癫癎小儿过程中，患儿临床症状、脑电图及药物不良反应等项目的变化，评价该药的疗效和安全性，为临床小儿神经内科医生提供更为可靠的新型抗癫癎药物(AEDs)应用方法和依据。
方法：选取山西省儿童医院小儿神经内科专科门诊自2009年10月~2011年3月收治的应用LEV单药或添加治疗的100例癫癎患儿为研究对象，采用开放性自身对照随访研究方法。100例患儿均进行LEV口服治疗，服药前向家长详细交待药物的可能疗效和不良反应，征得患儿家长同意，接受药物治疗。LEV给药起始剂量为每日10mg/kg，分两次口服，每周增加上述剂量1次，3~4周增加至目标剂量每日20~40mg/kg，随访6~24个月。服药前均进行脑电图、影像学（头颅CT或MRI）、血常规、肝肾功能检查。服药1个月复查血常规、肝肾功能，以后每3~6个月复查一次。每3个月复查脑电图1次，主要观察治疗前后的痫样放电变化情况。以发作频率减少的百分率和脑电图痫样放电的变化情况作为疗效判断标准，观察治疗前后发作频率的变化、脑电图改变，并记录治疗过程中不良反应的发生情况，评价疗效和安全性。
结果:100例入选的癫癎患儿，失访4例。（1）临床发作控制：发作完全控制的为49例(49/96)，占51%；有效27例(27/96)，占28.1%；无效17例(17/96)，占17.8%；加重3例(3/96)，占3.1%。总有效率为79.1%。（2）脑电图：痫样放电完全消失22例，减少50%以上8例，减少25%-49%6例，无变化3例，增加3例。（3）不良事件：少数患儿出现包括情绪异常14.6%（14/96）,乏力7.3%（7/96）,嗜睡6.3%（6/96），皮疹1%（1//96）等不良反应。未发现严重过敏及血液系统抑制、肝肾功能异常等不良反应。2例因不良反应停药。
结论：左乙拉西坦治疗小儿各类型癫癎具有良好的疗效和安全性，在改善患儿脑电图方面疗效显著，是一个值得在小儿癫癎治疗中推广应用的新型广谱抗癫癎药物。
Objective
Through the follow-up study of Levetiracetam(LEV) in the treatment of children with different types of epilepsies,changes of clinical symptoms, electroencephalogram (EEG) and adverse events were observed. To research the efficacy and safety of LEV therapy in children with different types of epilepsies,and to provide more reliable methods and evidences for Pediatric neural physician in the application of Antiepileptic Drugs(AEDs).
Methods
100cases of children with epilepsy receiving LEV therapy from Shanxi Children's Hospital between September2009and March2011were investigated in our subject.The method of self-controlled and open-label research was performed.Before LEV was intaken orally for children,possible efficency and adverse reactions were detailed told to parents to consent the permission. The LEV treatment initiated at the dose of10mg·kg-1·d-1,which was divided into twice daily,the same amounts were added continuously once a week,until the objective dose of20-40mg·kg-1·d-1within3-4weeks.Observation lasted for6-24months.Before taking the medicine,EEGs,Imaging examination(CT/MRI),Blood routine,Kidney and liver function examinations were done.Recheck blood routine and Kidney and liver function examinations after a month for the first time,then every3-6months.EEG was reexaminated every3months and attention is paid to the changes. Reduction of the percentage of frequency of attacks and EEGs changes as the judgment standard curative effect,to observe before and after treatment attack frequency changes, eeg changes.Recording the adverse reaction conditions,to evaluate the efficacy and safety.
Results
Among100children,96patients were followed up.(1)Clinical attacks control:49cases(51%) achieved seizure-free,27children(28.1%) had at least50%reduction in seizures but not100%,17cases(17.8%) had inefficacy and3cases(3.1%) had aggravation.The total effective rate was79.1%.(2)EEG:the epileptic discharges in22children disappear,8decrease more than50%, 6decrease25%-49%,3show no changes in epileptic discharges and3increases.(3)Adverse events:The adverse events happened in few cases,including mood and behavioral changes(14.6%),asthenia(7.3%),somnolence(6.3%),and skin rashes(1%).Not found serious allergies and blood, kidney and liver function abnormal system depression and other adverse reaction.2cases withdrew the treatment for side effects.
Conclusion
Levetiracetam is of well efficacy and safety, especially in improving EEGs.As a new antiepileptic drug,LEV has a promising future in clinical use for children with types of epilepsies.
方法：选取山西省儿童医院小儿神经内科专科门诊自2009年10月~2011年3月收治的应用LEV单药或添加治疗的100例癫癎患儿为研究对象，采用开放性自身对照随访研究方法。100例患儿均进行LEV口服治疗，服药前向家长详细交待药物的可能疗效和不良反应，征得患儿家长同意，接受药物治疗。LEV给药起始剂量为每日10mg/kg，分两次口服，每周增加上述剂量1次，3~4周增加至目标剂量每日20~40mg/kg，随访6~24个月。服药前均进行脑电图、影像学（头颅CT或MRI）、血常规、肝肾功能检查。服药1个月复查血常规、肝肾功能，以后每3~6个月复查一次。每3个月复查脑电图1次，主要观察治疗前后的痫样放电变化情况。以发作频率减少的百分率和脑电图痫样放电的变化情况作为疗效判断标准，观察治疗前后发作频率的变化、脑电图改变，并记录治疗过程中不良反应的发生情况，评价疗效和安全性。
结果:100例入选的癫癎患儿，失访4例。（1）临床发作控制：发作完全控制的为49例(49/96)，占51%；有效27例(27/96)，占28.1%；无效17例(17/96)，占17.8%；加重3例(3/96)，占3.1%。总有效率为79.1%。（2）脑电图：痫样放电完全消失22例，减少50%以上8例，减少25%-49%6例，无变化3例，增加3例。（3）不良事件：少数患儿出现包括情绪异常14.6%（14/96）,乏力7.3%（7/96）,嗜睡6.3%（6/96），皮疹1%（1//96）等不良反应。未发现严重过敏及血液系统抑制、肝肾功能异常等不良反应。2例因不良反应停药。
结论：左乙拉西坦治疗小儿各类型癫癎具有良好的疗效和安全性，在改善患儿脑电图方面疗效显著，是一个值得在小儿癫癎治疗中推广应用的新型广谱抗癫癎药物。
Objective
Through the follow-up study of Levetiracetam(LEV) in the treatment of children with different types of epilepsies,changes of clinical symptoms, electroencephalogram (EEG) and adverse events were observed. To research the efficacy and safety of LEV therapy in children with different types of epilepsies,and to provide more reliable methods and evidences for Pediatric neural physician in the application of Antiepileptic Drugs(AEDs).
Methods
100cases of children with epilepsy receiving LEV therapy from Shanxi Children's Hospital between September2009and March2011were investigated in our subject.The method of self-controlled and open-label research was performed.Before LEV was intaken orally for children,possible efficency and adverse reactions were detailed told to parents to consent the permission. The LEV treatment initiated at the dose of10mg·kg-1·d-1,which was divided into twice daily,the same amounts were added continuously once a week,until the objective dose of20-40mg·kg-1·d-1within3-4weeks.Observation lasted for6-24months.Before taking the medicine,EEGs,Imaging examination(CT/MRI),Blood routine,Kidney and liver function examinations were done.Recheck blood routine and Kidney and liver function examinations after a month for the first time,then every3-6months.EEG was reexaminated every3months and attention is paid to the changes. Reduction of the percentage of frequency of attacks and EEGs changes as the judgment standard curative effect,to observe before and after treatment attack frequency changes, eeg changes.Recording the adverse reaction conditions,to evaluate the efficacy and safety.
Results
Among100children,96patients were followed up.(1)Clinical attacks control:49cases(51%) achieved seizure-free,27children(28.1%) had at least50%reduction in seizures but not100%,17cases(17.8%) had inefficacy and3cases(3.1%) had aggravation.The total effective rate was79.1%.(2)EEG:the epileptic discharges in22children disappear,8decrease more than50%, 6decrease25%-49%,3show no changes in epileptic discharges and3increases.(3)Adverse events:The adverse events happened in few cases,including mood and behavioral changes(14.6%),asthenia(7.3%),somnolence(6.3%),and skin rashes(1%).Not found serious allergies and blood, kidney and liver function abnormal system depression and other adverse reaction.2cases withdrew the treatment for side effects.
Conclusion
Levetiracetam is of well efficacy and safety, especially in improving EEGs.As a new antiepileptic drug,LEV has a promising future in clinical use for children with types of epilepsies.
引文
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