Beavis J, Kerr M, Marson A G
Wales College of Medicine, Cardiff University, Welsh Centre for Learning Disability, Meridian Court, North Road, Cardiff, Wales, UK, CF14 3BG.
Cochrane Database Syst Rev. 2007 Jul 18(3):CD005399. doi: 10.1002/14651858.CD005399.pub2.
The development of epilepsy in a person with intellectual disabilities is a common occurrence. In view of the fact that seizures in intellectually disabled people are often complex and refractory to treatment and that antiepileptic medication may have a profound effect upon behaviour in this patient group, it is evident that good quality randomised controlled trials are needed in this population.
The aim of our study was to assess the data available from randomised controlled trials of antiepileptic drug interventions in people with epilepsy and intellectual disabilities.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2006, Issue 4), MEDLINE OVID (1966 to October 2006), PsychInfo OVID (1806 to October 2006) and EMBASE OVID (1980 to April 2005).
Randomised controlled trials (RCTs) of pharmacological interventions for people with epilepsy and a learning disability. RCTs where inadequate methods of allocation concealment had been used were also included.
Two review authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. Outcome measures included the following.(1) Retention on treatment.(2) Seizure freedom.(3) Reduction in seizure frequency.(4) Seizure severity scales.(5) Global rating scales.(6) Behavioural outcomes.(7) Cognitive outcomes.(8) Adverse effects.(9) Quality of life.
Data were heterogenous and a descriptive analysis is presented. This review confirms that in the majority of cases where antiepileptic drugs (AEDs) were trialled in this population, moderate reduction in seizure frequency and occasional seizure freedom were obtained. In general it seems reasonable to say that AEDs proven effective in the general epilepsy population are also effective in refractory epilepsy in people with intellectual disability. It is not possible to comment on relative efficacy between medications making clinical choice decisions difficult. Clinical decision is also likely to be guided by concern over side effects. The quality of the studies does not aid clinicians greatly to this respect. In general it seems that in trial settings patients continue on treatment, in the majority of cases, and placebo groups often experience less in the way of side effects. Where side effects are experienced they appear similar to those seen in non-intellectual disability studies. One area of key concern is that of behavioural exacerbation. The majority of studies are unhelpful due to lack of or non-reliable measures in this area. However, where measured, little obvious impact on behaviour is seen in terms of behaviour disorder.
AUTHORS' CONCLUSIONS: In summary this review broadly supports the use of AEDs to reduce seizure frequency in people with refractory epilepsy and intellectual disability. The evidence suggests that side effects are similar to those in the general population and that behavioural side effects leading to discontinuation are rare but that other effects are under researched.
智力残疾者患癫痫很常见。鉴于智力残疾者的癫痫发作往往复杂且难以治疗,并且抗癫痫药物可能对该患者群体的行为产生深远影响,显然该人群需要高质量的随机对照试验。
我们研究的目的是评估从针对癫痫和智力残疾者的抗癫痫药物干预随机对照试验中获得的数据。
我们检索了Cochrane对照试验中央注册库(CENTRAL)(《Cochrane图书馆》2006年第4期)、MEDLINE OVID(1966年至2006年10月)、PsychInfo OVID(1806年至2006年10月)和EMBASE OVID(1980年至2005年4月)。
针对癫痫和学习障碍者的药物干预随机对照试验(RCTs)。也纳入了使用分配隐藏方法不充分的RCTs。
两位综述作者独立评估试验质量并提取数据。联系研究作者获取更多信息。结局指标包括以下方面。(1)治疗依从性。(2)无癫痫发作。(3)癫痫发作频率降低。(4)癫痫发作严重程度量表。(5)整体评定量表。(6)行为结局。(7)认知结局。(8)不良反应。(9)生活质量。
数据具有异质性,现进行描述性分析。本综述证实,在该人群中试验抗癫痫药物(AEDs)的大多数情况下,癫痫发作频率有中度降低,偶尔可实现无癫痫发作。一般来说,可以合理地说,在普通癫痫人群中已证明有效的AEDs在智力残疾的难治性癫痫中也有效。无法对药物之间的相对疗效进行评论,这使得临床选择决策困难。临床决策也可能受到对副作用担忧的指导。在这方面,研究质量对临床医生帮助不大。一般来说,在试验环境中,大多数情况下患者会继续接受治疗,安慰剂组的副作用通常较少。出现的副作用似乎与非智力残疾研究中所见的相似。一个关键关注领域是行为恶化。由于该领域缺乏或测量不可靠,大多数研究无帮助。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。
总之,本综述广泛支持使用AEDs来降低难治性癫痫和智力残疾者的癫痫发作频率。证据表明副作用与普通人群相似,导致停药的行为副作用很少见,但其他影响研究不足。