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静脉注射免疫球蛋白:一项针对伦诺克斯-加斯托综合征患儿的单盲试验。

Intravenous immunoglobulin: a single-blind trial in children with Lennox-Gastaut syndrome.

作者信息

Illum N, Taudorf K, Heilmann C, Smith T, Wulff K, Mansa B, Platz P

机构信息

Department of Paediatrics, Rigshospitalet, Copenhagen, Denmark.

出版信息

Neuropediatrics. 1990 May;21(2):87-90. doi: 10.1055/s-2008-1071468.

Abstract

The antiepileptic effect of intravenous immunoglobulin (Sandoglobulin, Sandoz) was investigated in Lennox-Gastaut syndrome by an add-on, placebo-controlled, single-blind trial. Ten patients, aged 4-14 years, with insufficient response to conventional anticonvulsive therapy received placebo and Sandoglobulin 400 mg/kg two times each with an interval of two weeks. The washout period was four weeks and the total observation period 14 weeks, during which parents daily registered number and type of seizures. EEG, in vitro lymphocyte transformation tests and concentrations of immunoglobulins including IgG subclasses were evaluated before and after active treatment. Two children showed an immediate reduction in their high-frequency and invariable seizure activity from 42% to 100% and a less abnormal EEG. In addition, general well-being and intellectual performance was improved. The strongest response was observed in one child with a concomitant finding of a low level of IgG2, the only abnormal immunologic test in this study. The remaining 8 children, who had either a high or a low but variable seizure frequency showed no immediate change as EEG and their general condition was unaffected. We conclude that intravenous immunoglobulin had an immediate and pronounced effect on break-through seizure activity and a simultaneous neurophysiologic effect in 20% of our patients with Lennox-Gastaut syndrome. The effect was not confined to patients with immunologic abnormalities.

摘要

通过一项附加的、安慰剂对照的单盲试验,研究了静脉注射免疫球蛋白(桑多球蛋白,山德士公司生产)对Lennox-Gastaut综合征的抗癫痫作用。10名年龄在4至14岁之间、对传统抗惊厥治疗反应不佳的患者接受了安慰剂和桑多球蛋白400mg/kg的治疗,每次间隔两周,各治疗两次。洗脱期为四周,总观察期为14周,在此期间家长每天记录癫痫发作的次数和类型。在积极治疗前后评估脑电图、体外淋巴细胞转化试验以及包括IgG亚类在内的免疫球蛋白浓度。两名儿童的高频和持续性癫痫活动立即从42%降至100%,脑电图异常程度减轻。此外,总体健康状况和智力表现有所改善。在一名伴有IgG2水平低的儿童中观察到最强反应,这是本研究中唯一异常的免疫学检查结果。其余8名癫痫发作频率高或低但不稳定的儿童,脑电图和总体状况未受影响,未见立即变化。我们得出结论,静脉注射免疫球蛋白对20%的Lennox-Gastaut综合征患者的突破性癫痫活动有即时且显著的作用,同时具有神经生理学效应。该效应并不局限于有免疫异常的患者。

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