Jackson Cerian F, Makin Selina M, Marson Anthony G, Kerr Michael
Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Clinical Sciences Centre for Research and Education, Lower Lane, Fazakerley, Liverpool, UK, L9 7LJ.
Cochrane Database Syst Rev. 2015 Sep 3;2015(9):CD005399. doi: 10.1002/14651858.CD005399.pub3.
The prevalence of epilepsy among people with intellectual disabilities is much higher than in the general population. Seizures in this population are often complex and refractory to treatment and antiepileptic medication may have a profound effect upon behaviour (Kerr 1997).This is an updated version of a Cochrane Review first published in Issue 3, 2007.
To assess the data available from randomised controlled trials (RCTs) of the efficacy of antiepileptic drug (AED) interventions in people with epilepsy and intellectual disabilities.
For the latest update of this review, we searched the Cochrane Epilepsy Group Specialised Register (2 September 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO) (2 September 2014), MEDLINE (Ovid, 1946 to 3 September 2014) and PsycINFO (EBSCOhost, 1887 to 3 September 2014).
Randomised and quasi-randomised controlled trials (RCTs) of pharmacological interventions for people with epilepsy and a learning disability.
Two review authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We assessed epilepsy/seizure, behavioural and cognitive outcomes, as well as quality of life and adverse effects.
We included 14 RCTs (1116 participants) in the present review. Data were heterogenous and a descriptive analysis is presented. In the majority of cases where antiepileptic drugs (AEDs) were trialled in this population, we found moderate reductions in seizure frequency in that there was a significantly higher rate of responders (reduction of 50% or more) in the treatment group compared with the placebo group, with some studies reporting a higher incidence of seizure freedom in the treatment group. In general, AEDs that are proven to be effective in the general epilepsy population are also effective for refractory epilepsy in people with intellectual disability. It is not possible to comment on the relative efficacy of medications, making clinical decisions difficult.In trial settings patients continued on treatment in the majority of cases. Placebo groups often experienced fewer adverse events. Where adverse events were experienced they appeared similar to those in the general population. The methods by which adverse events were recorded and reported appeared to be inconsistent, resulting in very large variation between studies. This is problematic as clinically relevant interpretation of these findings is limited.The quality of evidence provided in the present review is low to moderate. Additionally the majority of studies lacked or used non-reliable measures of behavioural exacerbation. However, where measured, little obvious impact on behaviour was seen in terms of behaviour disorder.
AUTHORS' CONCLUSIONS: This review broadly supports the use of AEDs to reduce seizure frequency in people with refractory epilepsy and intellectual disability. The evidence suggests that adverse events are similar to those in the general population and that behavioural adverse events leading to discontinuation are rare; however, other adverse effects are under-researched.
智力残疾人群中癫痫的患病率远高于普通人群。该人群的癫痫发作往往较为复杂且难以治疗,抗癫痫药物可能会对行为产生深远影响(克尔,1997年)。这是一篇Cochrane系统评价的更新版本,首次发表于2007年第3期。
评估抗癫痫药物(AED)干预对癫痫合并智力残疾患者疗效的随机对照试验(RCT)的现有数据。
为了本次系统评价的最新更新,我们检索了Cochrane癫痫专业组专门注册库(2014年9月2日)、通过Cochrane研究在线注册库(CRSO)检索Cochrane对照试验中心注册库(CENTRAL)(2014年9月2日)、MEDLINE(Ovid,1946年至2014年9月3日)以及PsycINFO(EBSCOhost,1887年至2014年9月3日)。
针对癫痫合并学习障碍患者的药物干预的随机和半随机对照试验(RCT)。
两位综述作者独立评估试验质量并提取数据。我们联系研究作者以获取更多信息。我们评估了癫痫/癫痫发作、行为和认知结局,以及生活质量和不良反应。
本综述纳入了14项RCT(1116名参与者)。数据具有异质性,现进行描述性分析。在该人群中试用抗癫痫药物(AED)的大多数情况下,我们发现癫痫发作频率有中度降低,即治疗组中反应者(降低50%或更多)的比例显著高于安慰剂组,一些研究报告治疗组中癫痫发作完全缓解的发生率更高。一般来说,在普通癫痫人群中被证明有效的AED对智力残疾患者的难治性癫痫也有效。无法对药物的相对疗效进行评论,这使得临床决策困难。在试验环境中,大多数情况下患者继续接受治疗。安慰剂组的不良事件通常较少。当出现不良事件时,它们似乎与普通人群中的相似。不良事件记录和报告的方法似乎不一致,导致研究之间存在很大差异。这存在问题,因为对这些结果的临床相关解释有限。本综述提供的证据质量低至中等。此外,大多数研究缺乏或使用不可靠的行为恶化测量方法。然而,在进行测量时,就行为障碍而言,对行为几乎没有明显影响。
本综述广泛支持使用AED来降低难治性癫痫合并智力残疾患者的癫痫发作频率。证据表明不良事件与普通人群中的相似,导致停药的行为不良事件很少见;然而,其他不良影响的研究不足。