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静脉和口服左乙拉西坦治疗疑似原发性脑肿瘤且有症状性癫痫发作的神经外科手术患者:HELLO 试验。

Intravenous and oral levetiracetam in patients with a suspected primary brain tumor and symptomatic seizures undergoing neurosurgery: the HELLO trial.

机构信息

Dr. Senckenberg Institute of Neurooncology, Johann Wolfgang Goethe University Frankfurt, Schleusenweg 2-16, 60528 Frankfurt, Germany.

出版信息

Acta Neurochir (Wien). 2012 Feb;154(2):229-35; discussion 235. doi: 10.1007/s00701-011-1144-9. Epub 2011 Sep 10.

DOI:10.1007/s00701-011-1144-9
PMID:21909835
Abstract

BACKGROUND

Levetiracetam (LEV) is a newer anticonvulsant with a favorable safety profile. There seem to be no relevant drug interactions, and an intravenous formulation is available. Therefore, LEV might be a suitable drug for the perioperative anticonvulsive therapy of patients with suspected brain tumors undergoing neurosurgery.

METHODS

In this prospective study (NCT00571155) patients with suspected primary brain tumors and tumor-related seizures were perioperatively treated with oral and intravenous LEV up to 4 weeks before and until 4 weeks after a planned neurosurgical procedure.

FINDINGS

Thirty patients with brain tumor-related seizures and intended neurosurgery were included. Three patients did not undergo the scheduled surgery after enrollment, and two patients were lost to follow-up. Therefore, 25 patients were fully evaluable. After initiation of therapy with LEV, 100% of the patients were seizure-free in the pre-surgery phase (3 days up to 4 weeks before surgery), 88% in the 48 h post-surgery phase and 84% in the early follow-up phase (48 h to 4 weeks post surgery). Treatment failure even after dose escalation to 3,000 mg/day occurred in three patients. No serious adverse events related to the treatment with LEV occurred.

CONCLUSION

Our data show the feasibility and safety of oral and intravenous LEV in the perioperative treatment of tumor-related seizures. Although this was a single arm study, the efficacy of LEV appears promising. Considering the side effects and interactions of other anticonvulsants, LEV seems to be a favorable option in the perioperative treatment of brain tumor-related seizures.

摘要

背景

左乙拉西坦(LEV)是一种新型抗癫痫药,具有良好的安全性。似乎没有相关的药物相互作用,且有可供静脉使用的制剂。因此,LEV 可能是拟行神经外科手术的疑似脑肿瘤患者围手术期抗癫痫治疗的合适药物。

方法

在这项前瞻性研究(NCT00571155)中,对疑似原发性脑肿瘤和肿瘤相关性癫痫发作的患者在计划神经外科手术前 4 周内开始给予口服和静脉 LEV 治疗,持续至术后 4 周。

结果

共纳入 30 例伴有脑肿瘤相关性癫痫发作和拟行神经外科手术的患者。3 例患者入组后未进行计划手术,2 例患者失访。因此,25 例患者可进行全面评估。开始 LEV 治疗后,100%的患者在术前阶段(手术前 3 天至 4 周)无癫痫发作,88%的患者在术后 48 小时内无癫痫发作,84%的患者在早期随访阶段(术后 48 小时至 4 周)无癫痫发作。尽管增加剂量至 3000mg/天,但仍有 3 例患者治疗失败。未发生与 LEV 治疗相关的严重不良事件。

结论

我们的数据表明,口服和静脉 LEV 用于肿瘤相关性癫痫的围手术期治疗是可行且安全的。尽管这是一项单臂研究,但 LEV 的疗效似乎很有前景。考虑到其他抗癫痫药物的副作用和相互作用,LEV 似乎是脑肿瘤相关性癫痫围手术期治疗的一个有利选择。

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