PDF(Pubmed)
Abstract：
UNASSIGNED: Although levetiracetam and phenytoin are widely used antiseizure medications (ASM) in neonates, their efficacy on seizure freedom is unclear. We evaluated electroencephalographic (EEG) seizure freedom following sequential levetiracetam and phenytoin in neonatal seizures unresponsive to phenobarbital.
UNASSIGNED: We recruited neonates born ≥35 weeks and aged <72 h who had continued electrographic seizures despite phenobarbital, from three Indian hospitals, between 20 June 2020 and 31 July 2022. The neonates were treated with intravenous levetiracetam (20 mg/kg x 2 doses, second line) followed by phenytoin (20 mg/kg x 2 doses, third line) if seizures persisted. The primary outcome was complete seizure freedom, defined as an absence of seizures on EEG for at least 60 min within 40 min from the start of infusion.
UNASSIGNED: Of the 206 neonates with continued seizures despite phenobarbital, 152 received levetiracetam with EEG. Of these one EEG was missing, 47 (31.1%) were in status epilepticus, and primary outcome data were available in 145. Seizure freedom occurred in 20 (13.8%; 95% CI 8.6%-20.5%) after levetiracetam; 16 (80.0%) responded to the first dose and 4 (20.0%) to the second dose. Of the 125 neonates with persisting seizures after levetiracetam, 114 received phenytoin under EEG monitoring. Of these, the primary outcome data were available in 104. Seizure freedom occurred in 59 (56.7%; 95% CI 46.7%-66.4%) neonates; 54 (91.5%) responded to the first dose and 5 (8.5%) to the second dose.
UNASSIGNED: With the conventional doses, levetiracetam was associated with immediate EEG seizure cessation in only 14% of phenobarbital unresponsive neonatal seizures. Additional treatment with phenytoin along with levetiracetam attained seizure freedom in further 57%. Safety and efficacy of higher doses of levetiracetam should be evaluated in well-designed randomised controlled trials.
UNASSIGNED: National Institute for Health and Care Research (NIHR) Research and Innovation for Global Health Transformation (NIHR200144).
UNASSIGNED: We recruited neonates born ≥35 weeks and aged <72 h who had continued electrographic seizures despite phenobarbital, from three Indian hospitals, between 20 June 2020 and 31 July 2022. The neonates were treated with intravenous levetiracetam (20 mg/kg x 2 doses, second line) followed by phenytoin (20 mg/kg x 2 doses, third line) if seizures persisted. The primary outcome was complete seizure freedom, defined as an absence of seizures on EEG for at least 60 min within 40 min from the start of infusion.
UNASSIGNED: Of the 206 neonates with continued seizures despite phenobarbital, 152 received levetiracetam with EEG. Of these one EEG was missing, 47 (31.1%) were in status epilepticus, and primary outcome data were available in 145. Seizure freedom occurred in 20 (13.8%; 95% CI 8.6%-20.5%) after levetiracetam; 16 (80.0%) responded to the first dose and 4 (20.0%) to the second dose. Of the 125 neonates with persisting seizures after levetiracetam, 114 received phenytoin under EEG monitoring. Of these, the primary outcome data were available in 104. Seizure freedom occurred in 59 (56.7%; 95% CI 46.7%-66.4%) neonates; 54 (91.5%) responded to the first dose and 5 (8.5%) to the second dose.
UNASSIGNED: With the conventional doses, levetiracetam was associated with immediate EEG seizure cessation in only 14% of phenobarbital unresponsive neonatal seizures. Additional treatment with phenytoin along with levetiracetam attained seizure freedom in further 57%. Safety and efficacy of higher doses of levetiracetam should be evaluated in well-designed randomised controlled trials.
UNASSIGNED: National Institute for Health and Care Research (NIHR) Research and Innovation for Global Health Transformation (NIHR200144).
摘要：
■尽管左乙拉西坦和苯妥英在新生儿中广泛使用抗癫痫药物（ASM），它们对癫痫发作自由的疗效尚不清楚.我们评估了左乙拉西坦和苯妥英序贯治疗对苯巴比妥无反应的新生儿癫痫发作后的脑电图（EEG）癫痫发作。
我们招募了出生≥35周且年龄<72小时的新生儿，尽管苯巴比妥，但仍有持续的脑电图癫痫发作，来自三家印度医院，2020年6月20日至2022年7月31日。新生儿静脉注射左乙拉西坦（20mg/kg×2剂量，第二行），然后是苯妥英（20mg/kgx2剂量，第三行)如果癫痫发作持续存在。主要结果是完全癫痫发作自由，定义为在输注开始后的40分钟内至少60分钟内没有脑电图癫痫发作。
■在206例尽管苯巴比妥仍持续癫痫发作的新生儿中，152例接受左乙拉西坦伴脑电图。其中一个脑电图丢失了，47例（31.1％）处于癫痫持续状态，和主要结局数据在145.左乙拉西坦后20例(13.8%;95%CI8.6%-20.5%)出现癫痫发作自由;16例(80.0%)对第一剂有反应,4例(20.0%)对第二剂有反应。在左乙拉西坦后持续发作的125例新生儿中，114例脑电图监测下接收苯妥英。其中,主要结局数据来自104例.59例（56.7％；95％CI46.7％-66.4％）新生儿出现癫痫发作自由；54例（91.5％）对第一剂有反应，5例（8.5％）对第二剂有反应。
■使用常规剂量，左乙拉西坦仅在14%的苯巴比妥无反应的新生儿癫痫发作中与脑电图立即停止有关。苯妥英和左乙拉西坦的额外治疗进一步获得了57％的癫痫发作自由。高剂量左乙拉西坦的安全性和有效性应在精心设计的随机对照试验中进行评估。
■国家卫生与护理研究所（NIHR）全球卫生转型研究与创新（NIHR200144）。
我们招募了出生≥35周且年龄<72小时的新生儿，尽管苯巴比妥，但仍有持续的脑电图癫痫发作，来自三家印度医院，2020年6月20日至2022年7月31日。新生儿静脉注射左乙拉西坦（20mg/kg×2剂量，第二行），然后是苯妥英（20mg/kgx2剂量，第三行)如果癫痫发作持续存在。主要结果是完全癫痫发作自由，定义为在输注开始后的40分钟内至少60分钟内没有脑电图癫痫发作。
■在206例尽管苯巴比妥仍持续癫痫发作的新生儿中，152例接受左乙拉西坦伴脑电图。其中一个脑电图丢失了，47例（31.1％）处于癫痫持续状态，和主要结局数据在145.左乙拉西坦后20例(13.8%;95%CI8.6%-20.5%)出现癫痫发作自由;16例(80.0%)对第一剂有反应,4例(20.0%)对第二剂有反应。在左乙拉西坦后持续发作的125例新生儿中，114例脑电图监测下接收苯妥英。其中,主要结局数据来自104例.59例（56.7％；95％CI46.7％-66.4％）新生儿出现癫痫发作自由；54例（91.5％）对第一剂有反应，5例（8.5％）对第二剂有反应。
■使用常规剂量，左乙拉西坦仅在14%的苯巴比妥无反应的新生儿癫痫发作中与脑电图立即停止有关。苯妥英和左乙拉西坦的额外治疗进一步获得了57％的癫痫发作自由。高剂量左乙拉西坦的安全性和有效性应在精心设计的随机对照试验中进行评估。
■国家卫生与护理研究所（NIHR）全球卫生转型研究与创新（NIHR200144）。
