Gowda Vykuntaraju K, Romana Ayesha, Shivanna Niranjan H, Benakappa Naveen, Benakappa Asha
Division of Pediatric Neurology, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India. Correspondence to: Dr Vykuntaraju K Gowda, Division of Pediatric Neurology, Department of Pediatrics, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India.
Department of Pediatrics, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India.
Indian Pediatr. 2019 Aug 15;56(8):643-646.
To compare the efficacy and safety of intravenous Levetiracetam and Phenobarbitone in the treatment of neonatal seizures.
Open labelled, Randomized controlled trial.
Level III Neonatal Intensive Care Unit (NICU).
100 neonates (0-28 days) with clinical seizures.
If seizures persisted even after correction of hypoglycemia and hypocalcemia, participants were randomized to receive either Levetiracetam (20 mg/kg) or Phenobarbitone (20 mg/kg) intravenously. The dose of same drug was repeated if seizures persisted (20 mg/kg of Levetiracetam or 10 mg/kg of Phenobarbitone) and changeover to other drug occurred if the seizures persisted even after second dose of same drug.
Cessation of seizures with one or two doses of the first drug, and remaining seizure-free for the next 24 hours.
Seizures stoped in 43 (86%) and 31 (62%) neonates in Levetiracetam and Phenobarbitone group, respectively (RR 0.37; 95%CI 0.17, 0.80, P<0.01). 10 neonates had adverse reactions in the phenobarbitone group (hypotension in 5, bradycardia in 3 and requirement of mechanical ventilation in 2 neonates) while none had any adverse reaction in Levetiracatam group.
Levetiracetam achieves better control than Phenobarbitone for neonatal seizures when used as first-line antiepileptic drug, and is not associated with adverse drug reactions.
比较静脉注射左乙拉西坦和苯巴比妥治疗新生儿惊厥的疗效和安全性。
开放标签随机对照试验。
三级新生儿重症监护病房（NICU）。
100例临床诊断为惊厥的新生儿（0 - 28天）。
即使在低血糖和低钙血症纠正后惊厥仍持续的参与者，被随机分为静脉注射左乙拉西坦（20mg/kg）或苯巴比妥（20mg/kg）组。如果惊厥持续，则重复使用相同药物剂量（左乙拉西坦20mg/kg或苯巴比妥10mg/kg），若在第二剂相同药物治疗后惊厥仍持续，则换用另一种药物。
一剂或两剂首种药物治疗后惊厥停止，且在接下来24小时内无惊厥发作。
左乙拉西坦组和苯巴比妥组分别有43例（86%）和31例（62%）新生儿惊厥停止（相对危险度0.37；95%可信区间0.17, 0.80，P<0.01）。苯巴比妥组有10例新生儿出现不良反应（5例低血压，3例心动过缓，2例需要机械通气），而左乙拉西坦组无任何不良反应。
作为一线抗癫痫药物，左乙拉西坦在控制新生儿惊厥方面比苯巴比妥效果更好，且无药物不良反应。
