乙琥胺、丙戊酸钠或拉莫三嗪用于儿童及青少年失神发作。
Ethosuximide, sodium valproate or lamotrigine for absence seizures in children and adolescents.
作者信息
Posner E B, Mohamed K, Marson A G
机构信息
Royal Victoria Infirmary, Department of Child Health, Queen Victoria Road, Newcastle-upon-Tyne, UK NE1 4LP.
出版信息
Cochrane Database Syst Rev. 2005 Oct 19(4):CD003032. doi: 10.1002/14651858.CD003032.pub2.
BACKGROUND
Absence seizures are brief epileptic seizures which present in childhood and adolescence. They are characterised by sudden loss of awareness and an electroencephalogram (EEG) typically shows generalised spike wave discharges at three cycles per second. Ethosuximide, valproate and lamotrigine are currently used to treat absence seizures. This review aims to determine the best choice of anticonvulsant for a child with typical absence seizures.
OBJECTIVES
To review the evidence for the effects of ethosuximide, valproate and lamotrigine as treatments for children and adolescents with absence seizures, when compared with placebo or each other.
SEARCH STRATEGY
We searched the Cochrane Epilepsy Group's Specialised Register (March 2005), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to March 2005) and EMBASE (1988 to March 2005). No language restrictions were imposed. In addition, we contacted Sanofi Winthrop, Glaxo Wellcome (now GlaxoSmithKline) and Parke Davis (now Pfizer), manufacturers of sodium valproate, lamotrigine and ethosuximide respectively.
SELECTION CRITERIA
Randomised parallel group monotherapy or add-on trials which include a comparison of any of the following in children or adolescents with absence seizures: ethosuximide; sodium valproate; lamotrigine or placebo.
DATA COLLECTION AND ANALYSIS
Outcome measures were: (1) proportion of individuals seizure free at 1, 3, 6, 12 and 18 months post randomisation; (2) people with a 50% or greater reduction in seizure frequency; (3) normalisation of EEG and/or negative hyperventilation test and (4) adverse effects. Data were independently extracted by two review authors. Results are presented as relative risks (RR) with 95% confidence intervals (95% CI).
MAIN RESULTS
Five small trials were found, four of them were of poor methodological quality. One trial (29 participants) compared lamotrigine with placebo using a response conditional design. Individuals taking lamotrigine were significantly more likely to be seizure free than participants taking placebo during this short trial. Another trial compared lamotrigine with sodium valproate, the study lacked power to detect the difference in efficacy. Three studies compared ethosuximide, but because of diverse study designs and populations studied, we decided not to pool results in a meta-analysis. None of these studies found a difference between valproate and ethosuximide with respect to seizure control, but confidence intervals were wide and the existence of important differences could not be excluded.
AUTHORS' CONCLUSIONS: Although ethosuximide, lamotrigine and valproate are commonly used to treat people with absence seizures we have insufficient evidence to inform clinical practice, and the few trials included in this review were of poor methodological quality and did not have sufficient number of participants. More trials of better quality are needed.
背景
失神发作是儿童期和青春期出现的短暂癫痫发作。其特征为突然意识丧失,脑电图(EEG)通常显示每秒三次的广泛性棘波放电。乙琥胺、丙戊酸盐和拉莫三嗪目前用于治疗失神发作。本综述旨在确定治疗典型失神发作儿童的最佳抗惊厥药物选择。
目的
比较乙琥胺、丙戊酸盐和拉莫三嗪与安慰剂或相互之间治疗儿童和青少年失神发作的效果证据。
检索策略
我们检索了Cochrane癫痫组专业注册库(2005年3月)、Cochrane对照试验中央注册库(CENTRAL)(Cochrane图书馆2005年第1期)、MEDLINE(1966年至2005年3月)和EMBASE(1988年至2005年3月)。未设语言限制。此外,我们联系了分别生产丙戊酸钠、拉莫三嗪和乙琥胺的赛诺菲·温思罗普公司、葛兰素威康公司(现为葛兰素史克公司)和帕克·戴维斯公司(现为辉瑞公司)。
入选标准
随机平行组单药治疗或附加治疗试验,包括对患有失神发作的儿童或青少年进行以下任何一种比较:乙琥胺;丙戊酸钠;拉莫三嗪或安慰剂。
数据收集与分析
结局指标为:(1)随机分组后1、3、6、12和18个月无发作个体的比例;(2)发作频率降低50%或更多的人;(3)脑电图正常化和/或过度换气试验阴性;(4)不良反应。数据由两位综述作者独立提取。结果以相对风险(RR)及95%置信区间(95%CI)表示。
主要结果
共找到5项小型试验,其中4项方法学质量较差。一项试验(29名参与者)采用反应条件设计比较拉莫三嗪与安慰剂。在这项短期试验中,服用拉莫三嗪的个体比服用安慰剂的参与者无发作的可能性显著更高。另一项试验比较拉莫三嗪与丙戊酸钠,该研究缺乏检测疗效差异的效力。三项研究比较了乙琥胺,但由于研究设计和研究人群多样,我们决定不将结果合并进行荟萃分析。这些研究均未发现丙戊酸盐和乙琥胺在癫痫控制方面存在差异,但置信区间较宽,不能排除存在重要差异的可能性。
作者结论
尽管乙琥胺、拉莫三嗪和丙戊酸盐常用于治疗失神发作患者,但我们没有足够的证据为临床实践提供参考,本综述纳入的少数试验方法学质量较差且参与者数量不足。需要更多高质量的试验。