瘤手术中的发作预防:来自SPRING RCT的摘要
Michael D Jenkinson1, Helen Bulbeck2, Jade Carruthers3
1The Walton Centre NHS Foundation Trust and University of Liverpool, Liverpool, UK.
Health technology assessment (Winchester, England)
|March 9, 2026
概括
这项研究发现,预防性 levetiracetam 和 glioma 患者的标准护理之间的发作风险没有显著差异. 需要进一步的研究来确定抗发作药物在质瘤手术中的作用.
科学领域:
- 神经外科 神经外科
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 质瘤患者有很高的终身发作风险,通常是耐药的.
- 发作风险在外科手术期间,瘤进展期间和临近死亡时升级.
- 目前的指导方针不要求预防性抗发作药物治疗未经发作的质瘤患者接受手术.
研究的目的:
- 评估预防性 levetiracetam (手术前和手术后1年) 是否在接受手术的未经发作的质瘤患者中将发作风险降低50%以上.
- 与标准护理 (没有预防) 相比,评估预防性 levetiracetam 的成本效益.
- 调查预防性 levetiracetam 对生存,瘤复发和生活质量的影响.
主要方法:
- 一个双臂,多中心的第三期随机试验,涉及14个神经外科单位.
- 在疑似脑质瘤患者中,12个月的预防性 levetiracetam 与没有抗发作药物的比较.
- 主要结局 (12个月发作) 和次要结局 (发作时间,存活率,无进展存活率) 的治疗意图分析.
主要成果:
- 由于招募速度缓慢,该试验因94名参与者而提前结束,大大削弱了该研究的实力.
- 没有观察到12个月发作风险的显著差异:47%的 levetiracetam 组与41%的无预防组相比.
- 在没有预防的组 (2.5个月) 中,与 levetiracetam 组 (5.0个月) 相比,初次发作的中位时间更短.
结论:
- 缺乏实力的试验没有为这种患者群体中预防性 levetiracetam 的疗效或成本效益提供明确的证据.
- 预防性抗发作药物在质瘤手术中的作用尚不清楚.
- 需要进一步的最终试验来解决这个临床问题.
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