Huang Xiaolei, Lin Wenjia, Wang Jiayin, Liu Chubin, Wei Guan, Wang Jiawei, Wang Chaoyang
Department of Emergency, The Second Attached Hospital of Fujian Medical University, Quanzhou, Fujian, China.
Department of Neurosurgery, The Second Attached Hospital of Fujian Medical University, Quanzhou, Fujian, China.
Int J Neurosci. 2025 Jul;135(7):787-796. doi: 10.1080/00207454.2024.2332959. Epub 2024 Mar 27.
To observe the efficacy and safety of sodium valproate (VPA) compared to levetiracetam (LEV) in the treatment of severe traumatic brain injury (sTBI).
In this blind, prospective study, eighty-four sTBI patients who had craniotomy from August 2021 to August 2023 were randomly split into two groups through random number table method: LEV and VPA, each with 42 patients. Both received comprehensive treatment post-craniotomy. LEV group: LEV injection on surgery day, transitioning to LEV tablets from day two. VPA group: VPA injection on surgery day, switching to VPA extended-release tablets from day two. The study compared hospital stay, neurological function, clinical outcomes, seizures, and drug reactions between groups.
The length of hospital stay showed no significant difference between the LEV and VPA groups. Both groups demonstrated improved neurological function post-treatment (NIHSS and BI scores), with no significant between-group differences. Clinical outcomes at 3 months post-treatment were similar in both groups. Seizure occurrence within 3 months after treatment showed no significant difference between the LEV (19.05%) and VPA (23.81%) groups. However, the VPA group experienced a significantly higher rate of drug-related adverse reactions (40.48%) compared to the LEV group (21.43%).
Both VPA and LEV are effective in treating sTBI, showing no significant difference in improving neurological function, daily life abilities, treatment outcomes, and seizure occurrence. However, VPA treatment exhibited a significantly higher incidence of drug-related adverse reactions compared to LEV, indicating that LEV might be a safer option for sTBI treatment.
观察丙戊酸钠(VPA)与左乙拉西坦(LEV)治疗重型颅脑损伤(sTBI)的疗效及安全性。
在这项前瞻性盲法研究中,将2021年8月至2023年8月行开颅手术的84例sTBI患者通过随机数字表法随机分为两组:LEV组和VPA组,每组42例。两组术后均接受综合治疗。LEV组:手术日给予LEV注射液,术后第2天改为LEV片剂。VPA组:手术日给予VPA注射液,术后第2天改为VPA缓释片。比较两组的住院时间、神经功能、临床结局、癫痫发作及药物反应。
LEV组和VPA组的住院时间无显著差异。两组治疗后神经功能均有改善(NIHSS和BI评分),组间无显著差异。两组治疗后3个月的临床结局相似。治疗后3个月内癫痫发作发生率在LEV组(19.05%)和VPA组(23.81%)之间无显著差异。然而,VPA组药物相关不良反应发生率(40.48%)显著高于LEV组(21.43%)。
VPA和LEV治疗sTBI均有效,在改善神经功能、日常生活能力、治疗结局及癫痫发作方面无显著差异。然而,VPA治疗的药物相关不良反应发生率显著高于LEV,表明LEV可能是治疗sTBI更安全的选择。