Brandl U, Kurlemann G, Neubauer B, Rettig K, Schäuble Barbara, Schreiner A
Department of Neuropediatrics, University Hospital, Jena, Germany.
Neuropediatrics. 2010 Jun;41(3):113-20. doi: 10.1055/s-0030-1262839. Epub 2010 Sep 21.
This 12-week open label study explored cognitive and seizure outcomes of 53 children treated with topiramate (TPM). The digit symbol test and verbal learning memory test were administered at baseline and study endpoint. Topiramate was started either in monotherapy or add-on therapy. Overall, 57% of children experienced a ≥50% seizure reduction, 36% became seizure free and cognitive testing revealed no significant changes during TPM therapy. Due to the heterogeneity of the study population, post hoc analyses were added to compare patients in initial or conversion to TPM monotherapy as well as patients who continued add-on therapy. Verbal learning memory test parameters showed neither significant differences within any subgroup comparing baseline with endpoint nor significant differences between described subgroups except for one finding. The digit symbol test revealed no differences between each subgroup between baseline and endpoint. Comparing pre-post differences, TPM monotherapy was associated with better cognitive outcomes than treatment in add-on therapy. These results have to be interpreted with caution given the short study duration and the heterogeneity of the study population. Despite these limitations, our overall results suggest that treatment with topiramate is associated with improved seizure control without significant changes in cognitive functions at the low doses tested.
这项为期12周的开放标签研究探讨了53名接受托吡酯(TPM)治疗的儿童的认知和癫痫发作结果。在基线和研究终点进行了数字符号测试和言语学习记忆测试。托吡酯开始时采用单药治疗或联合治疗。总体而言,57%的儿童癫痫发作减少≥50%,36%的儿童癫痫发作停止,认知测试显示在TPM治疗期间没有显著变化。由于研究人群的异质性,增加了事后分析,以比较初始接受或转换为TPM单药治疗的患者以及继续联合治疗的患者。言语学习记忆测试参数在任何亚组中比较基线和终点时均未显示出显著差异,除了一项发现外,所述亚组之间也没有显著差异。数字符号测试显示基线和终点之间每个亚组之间没有差异。比较前后差异,TPM单药治疗比联合治疗的认知结果更好。鉴于研究持续时间短和研究人群的异质性,这些结果必须谨慎解释。尽管有这些局限性,但我们的总体结果表明,在所测试的低剂量下,托吡酯治疗与癫痫控制改善相关,而认知功能没有显著变化。