Abstract：
OBJECTIVE: To compare levetiracetam and phenytoin as prophylaxis for the short-term development of status epilepticus (SE) during care of pediatric patients with acute severe traumatic brain injury (TBI).
METHODS: Nonprespecified secondary analysis using propensity score matching.
METHODS: We used the Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT NCT04077411) dataset (2014-2017).
METHODS: Patients less than 18 years old with Glasgow Coma Scale Score less than or equal to 8 who received levetiracetam or phenytoin as a prophylactic anticonvulsant therapy.
METHODS: None.
RESULTS: Of the 516 total patients who qualified for the case-control study, 372 (72.1%) patients received levetiracetam, and 144 (27.9%) received phenytoin. After propensity score matching, the pair-matched analysis with 133 in each group failed to identify an association between levetiracetam versus phenytoin use and occurrent of SE (3.8% vs. 0.8%, p = 0.22), or mortality (i.e., in-hospital, 30-d and 60-d). However, on closer inspection of the statistical testing, we cannot exclude the possibility that selecting levetiracetam rather than phenytoin for prophylaxis was associated with the following: up to a mean difference of 7.3% greater prevalence of SE; up to a mean difference of 13.9%, 12.1%, and 13.9% greater mortality during the hospital stay, and 30-, and 60-days after hospital arrival, respectively. Last, analysis of 6 months Glasgow Outcome Scale Extended score in those without premorbid comorbidities, there was an association between favorable outcomes and use of phenytoin rather than levetiracetam prophylaxis.
CONCLUSIONS: In ADAPT, the decision to use prophylactic levetiracetam versus phenytoin failed to show an association with occurrence of subsequent SE, or mortality. However, we are unable to exclude the possibility that selecting levetiracetam rather than phenytoin for prophylaxis was associated with greater prevalence of SE and mortality. We are unable to make any recommendation about one prophylactic anticonvulsant medication over the other, but recommend that further larger, contemporary studies in severe pediatric TBI are carried out.
METHODS: Nonprespecified secondary analysis using propensity score matching.
METHODS: We used the Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT NCT04077411) dataset (2014-2017).
METHODS: Patients less than 18 years old with Glasgow Coma Scale Score less than or equal to 8 who received levetiracetam or phenytoin as a prophylactic anticonvulsant therapy.
METHODS: None.
RESULTS: Of the 516 total patients who qualified for the case-control study, 372 (72.1%) patients received levetiracetam, and 144 (27.9%) received phenytoin. After propensity score matching, the pair-matched analysis with 133 in each group failed to identify an association between levetiracetam versus phenytoin use and occurrent of SE (3.8% vs. 0.8%, p = 0.22), or mortality (i.e., in-hospital, 30-d and 60-d). However, on closer inspection of the statistical testing, we cannot exclude the possibility that selecting levetiracetam rather than phenytoin for prophylaxis was associated with the following: up to a mean difference of 7.3% greater prevalence of SE; up to a mean difference of 13.9%, 12.1%, and 13.9% greater mortality during the hospital stay, and 30-, and 60-days after hospital arrival, respectively. Last, analysis of 6 months Glasgow Outcome Scale Extended score in those without premorbid comorbidities, there was an association between favorable outcomes and use of phenytoin rather than levetiracetam prophylaxis.
CONCLUSIONS: In ADAPT, the decision to use prophylactic levetiracetam versus phenytoin failed to show an association with occurrence of subsequent SE, or mortality. However, we are unable to exclude the possibility that selecting levetiracetam rather than phenytoin for prophylaxis was associated with greater prevalence of SE and mortality. We are unable to make any recommendation about one prophylactic anticonvulsant medication over the other, but recommend that further larger, contemporary studies in severe pediatric TBI are carried out.
摘要：
目的：比较左乙拉西坦和苯妥英钠预防急性重型颅脑损伤（TBI）患儿短期癫痫持续状态（SE）的作用。
方法：使用倾向评分匹配的非预设二次分析。
方法：我们使用了急性小儿TBI试验（ADAPTNCT04077411）数据集（2014-2017）中的方法和决定。
方法：接受左乙拉西坦或苯妥英作为预防性抗惊厥治疗的18岁以下格拉斯哥昏迷评分小于或等于8的患者。
方法：无。
结果：在符合病例对照研究资格的516名患者中，372例（72.1%）患者接受左乙拉西坦，144人(27.9%)接受苯妥英治疗。在倾向得分匹配后，每组133个配对分析未能确定左乙拉西坦与苯妥英使用和当前SE之间的关联(3.8%与0.8%,p=0.22),或死亡率(即，在医院,30-d和60-d)。然而,仔细检查统计检验，我们不能排除选择左乙拉西坦而不是苯妥英进行预防与以下情况相关的可能性：SE患病率平均差异高达7.3％;平均差异高达13.9％，12.1%,住院期间死亡率增加13.9%，30-,医院到达后60天，分别。最后,分析6个月格拉斯哥结果量表扩展评分在那些没有病前合并症，有利的结局与使用苯妥英而不是左乙拉西坦之间存在关联.
结论：在适应中，使用预防性左乙拉西坦与苯妥英的决定未能显示与后续SE的发生有关，或死亡率。然而,我们无法排除选择左乙拉西坦而不是苯妥英进行预防与更高的SE患病率和死亡率相关的可能性.我们无法对一种预防性抗惊厥药物提供任何建议，但建议更大，在严重的儿科TBI进行当代研究。
方法：使用倾向评分匹配的非预设二次分析。
方法：我们使用了急性小儿TBI试验（ADAPTNCT04077411）数据集（2014-2017）中的方法和决定。
方法：接受左乙拉西坦或苯妥英作为预防性抗惊厥治疗的18岁以下格拉斯哥昏迷评分小于或等于8的患者。
方法：无。
结果：在符合病例对照研究资格的516名患者中，372例（72.1%）患者接受左乙拉西坦，144人(27.9%)接受苯妥英治疗。在倾向得分匹配后，每组133个配对分析未能确定左乙拉西坦与苯妥英使用和当前SE之间的关联(3.8%与0.8%,p=0.22),或死亡率(即，在医院,30-d和60-d)。然而,仔细检查统计检验，我们不能排除选择左乙拉西坦而不是苯妥英进行预防与以下情况相关的可能性：SE患病率平均差异高达7.3％;平均差异高达13.9％，12.1%,住院期间死亡率增加13.9%，30-,医院到达后60天，分别。最后,分析6个月格拉斯哥结果量表扩展评分在那些没有病前合并症，有利的结局与使用苯妥英而不是左乙拉西坦之间存在关联.
结论：在适应中，使用预防性左乙拉西坦与苯妥英的决定未能显示与后续SE的发生有关，或死亡率。然而,我们无法排除选择左乙拉西坦而不是苯妥英进行预防与更高的SE患病率和死亡率相关的可能性.我们无法对一种预防性抗惊厥药物提供任何建议，但建议更大，在严重的儿科TBI进行当代研究。
