van Engelen B G, Renier W O, Weemaes C M, Gabreels F J, Meinardi H
Institute of Neurology, University Hospital Nijmegen, The Netherlands.
Epilepsy Res. 1994 Dec;19(3):181-90. doi: 10.1016/0920-1211(94)90061-2.
The purpose of this study is to ascertain possible efficacy and to understand possible mechanisms of action of intramuscular or intravenous immunoglobulin (IVIg) in the treatment of intractable epilepsy, through a review of all identifiable articles on this topic. In 24 studies, none with a placebo controlled design, 368 patients with epilepsy receiving IVIg were identified. Patients' ages ranged from < 1 to 35 years, mean 7.3 years. Female/male ratio was 0.6. All patients were reported to suffer from intractable epilepsy. The average percentage of patients with an IgG2 deficiency was 25%. The total dose of IVIg varied between 0.3 and 6.8 g/kg for a period of 0.15 to 12 months. Whenever reported, adverse effects of IVIg were minimal. None of the studies reported the need of cessation of IVIg administration due to adverse effects. On the average, the mean clinical seizure reduction and the mean EEG improvement were 52% and 45%, respectively. On the average the percentage of patients with complete seizure remission and the percentage of patients with behavioral improvement were 23% and 63%, respectively. Cumulative meta-analysis of the identified articles is not possible due to the lack of controlled studies, the heterogeneity of the available studies, and the possible publication bias of unpublished negative data. Given these pitfalls, this literature study nevertheless allows some conclusions: (i) There is no formal proof of efficacy of IVIg treatment in epilepsy, and the present review underscores the need of controlled clinical trials before firm conclusions concerning efficacy can be drawn. The uncontrolled clinical observations discussed in this 'state-of-the-art' review generate suggestive evidence at best. They suggest that IVIg might be effective in some patients with intractable epilepsy, and may be considered as a safe add-on medication in various types of idiopathic and symptomatic intractable epilepsy. (ii) Review of the literature did not help in explaining intractable epilepsy or the mechanism of action of IVIg, but did permit some inferences that could serve to design future clinical and experimental approaches to IVIg administration in epilepsy.
本研究的目的是通过回顾关于该主题的所有可识别文章,确定肌肉注射或静脉注射免疫球蛋白(IVIg)治疗难治性癫痫的可能疗效,并了解其可能的作用机制。在24项研究中,均无安慰剂对照设计,共识别出368例接受IVIg治疗的癫痫患者。患者年龄范围为<1岁至35岁,平均7.3岁。女性/男性比例为0.6。据报道,所有患者均患有难治性癫痫。IgG2缺乏患者的平均百分比为25%。IVIg的总剂量在0.3至6.8 g/kg之间,治疗时间为0.15至12个月。只要有报道,IVIg的不良反应就很轻微。没有一项研究报告因不良反应而需要停止IVIg给药。平均而言,临床癫痫发作减少的平均值和脑电图改善的平均值分别为52%和45%。平均而言,癫痫完全缓解的患者百分比和行为改善的患者百分比分别为23%和63%。由于缺乏对照研究、现有研究的异质性以及未发表的阴性数据可能存在的发表偏倚,无法对已识别文章进行累积荟萃分析。鉴于这些缺陷,本文献研究仍然可以得出一些结论:(i)没有正式证据证明IVIg治疗癫痫的疗效,本综述强调在得出关于疗效的明确结论之前需要进行对照临床试验。本“最新综述”中讨论的非对照临床观察最多只能产生提示性证据。它们表明IVIg可能对一些难治性癫痫患者有效,并且可以被视为各种类型的特发性和症状性难治性癫痫的一种安全附加药物。(ii)文献回顾无助于解释难治性癫痫或IVIg的作用机制,但确实允许进行一些推断,这些推断可用于设计未来在癫痫中使用IVIg的临床和实验方法。