Walker Lauren, Pirmohamed Munir, Marson Anthony G
Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
Cochrane Database Syst Rev. 2013 Jun 27(6):CD009945. doi: 10.1002/14651858.CD009945.pub2.
Epilepsy is a common neurological disorder made particularly disabling in the 30% of patients who do not achieve freedom from seizures despite multiple trials of antiepileptic drugs (AEDs). Experimental and clinical evidence supports a role for inflammatory pathway activation in the pathogenesis of epilepsy which, if effectively targeted by immunomodulatory interventions, highlights a potentially novel therapeutic strategy.
To evaluate the efficacy and tolerability of immunomodulatory interventions as additional therapy in focal epilepsy syndromes in adults.
We searched the Cochrane Epilepsy Group Specialised Register (2 August 2012), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2012, Issue 7), MEDLINE (Ovid, 1946 to July week 3, 2012), the World Health Organization's International Clinical Trials Registry (2 August 2012), ClinicalTrials.gov (2 August 2012) and the Current Controlled Trials International Standard Randomised Controlled Trial Number Register (2 August 2012). There were no language restrictions. We reviewed the bibliographies of retrieved studies to search for additional reports of relevant studies.
Randomised controlled trials of add-on immunomodulatory drug interventions for the treatment of focal epilepsy in adults (aged over 16 years).
Three review authors independently assessed trial quality and extracted data. The primary outcomes were 50% or greater reduction in seizure frequency and seizure freedom; the secondary outcomes included serious and commonly occurring adverse effects, allergy, withdrawal and quality of life assessment.
We identified one study involving both children and adults (n=61) that assessed the effect of intravenous immunoglobulin (IVIG) as add-on therapy for the treatment of epilepsy. The authors found no significant difference between IVIG and placebo for the primary outcomes of seizure freedom or 50% or greater reduction in seizure frequency. The study reported a statistically significant effect for global blind assessment (rating scale involving multiple seizure-related parameters) in favour of IVIG. Secondary outcomes including adverse effects and allergies were not demonstrated.
AUTHORS' CONCLUSIONS: It is not possible to draw any conclusions about the role of immunomodulatory interventions in reducing seizure frequency or the safety of these agents in adults with epilepsy. Further randomised controlled trials are needed.
癫痫是一种常见的神经系统疾病,在30%的患者中,尽管多次试用抗癫痫药物(AEDs),仍无法实现无癫痫发作,这使其致残性尤为突出。实验和临床证据支持炎症途径激活在癫痫发病机制中起作用,如果通过免疫调节干预有效靶向该途径,则突出了一种潜在的新治疗策略。
评估免疫调节干预作为成人局灶性癫痫综合征辅助治疗的疗效和耐受性。
我们检索了Cochrane癫痫小组专业注册库(2012年8月2日)、Cochrane对照试验中央注册库(CENTRAL,Cochrane图书馆2012年第7期)、MEDLINE(Ovid,1946年至2012年7月第3周)、世界卫生组织国际临床试验注册库(2012年8月2日)、ClinicalTrials.gov(2012年8月2日)以及当前对照试验国际标准随机对照试验编号注册库(2012年8月2日)。没有语言限制。我们查阅了检索到的研究的参考文献,以寻找相关研究的其他报告。
针对成人(16岁以上)局灶性癫痫治疗的免疫调节药物辅助干预的随机对照试验。
三位综述作者独立评估试验质量并提取数据。主要结局为癫痫发作频率降低50%或更多以及无癫痫发作;次要结局包括严重和常见的不良反应、过敏、撤药及生活质量评估。
我们确定了一项涉及儿童和成人(n = 61)的研究,该研究评估了静脉注射免疫球蛋白(IVIG)作为癫痫辅助治疗的效果。作者发现,在无癫痫发作或癫痫发作频率降低50%或更多的主要结局方面,IVIG与安慰剂之间无显著差异。该研究报告称,在全局盲法评估(涉及多个与癫痫发作相关参数的评分量表)方面,IVIG有统计学意义上的显著效果。未证实包括不良反应和过敏在内的次要结局。
关于免疫调节干预在降低癫痫发作频率中的作用或这些药物在癫痫成人患者中的安全性,无法得出任何结论。需要进一步的随机对照试验。