Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh 160012, India.
J Trop Pediatr. 2021 Jan 29;67(1). doi: 10.1093/tropej/fmab008.
Phenobarbitone is used as a first-line drug for neonatal seizures. However, its poor short- and long-term safety profile is concerning. We aim to systematically synthesize the data on the efficacy and safety of phenobarbitone as a first-line agent and compare it against other anti-epileptic drugs (AEDs) in neonates.
Using keywords related to the study population (neonatal seizure) and intervention (phenobarbitone), we searched CENTRAL, Embase, PubMed and Web of Science until 15 December 2020. Randomized controlled trials (RCTs) comparing phenobarbitone with any other AED as first-line therapy for seizure control in the neonates were considered eligible. The random-effect meta-analysis was done using RevMan 5.3 software.
We screened through 443 records and identified nine eligible studies (719 participants). Five RCTs comparing phenobarbitone with levetiracetam did not find any difference in seizure control with the first dose [risk ratio (RR) 1.43, 95% CI 0.79-2.57] or adverse effects (RR 4.66; 95% CI 0.33-65.83). Two trials comparing phenobarbitone and phenytoin also did not find any difference in seizure control with the first dose (RR 2.09; 95% CI 0.31-14.03) and other outcomes. Only one RCT compared phenobarbitone and lorazepam and found lorazepam to be more efficacious in seizure control with the first dose (RR 0.71; 95% CI 0.53-0.94). Three trials compared neurodevelopmental outcomes, in which levetiracetam was better in two, whereas one did not find any difference.
Phenobarbitone is at least as efficacious and safe as other drugs like phenytoin and levetiracetam. The data over the long-term neurodevelopmental outcome are lacking. The existing evidence is insufficient to recommend other drugs over phenobarbitone.
苯巴比妥被用作新生儿癫痫的一线药物。然而，其短期和长期安全性不佳令人担忧。我们旨在系统地综合关于苯巴比妥作为一线药物的疗效和安全性的数据，并将其与其他抗癫痫药物（AEDs）在新生儿中的疗效进行比较。
使用与研究人群（新生儿癫痫）和干预措施（苯巴比妥）相关的关键词，我们检索了 CENTRAL、Embase、PubMed 和 Web of Science，检索时间截至 2020 年 12 月 15 日。我们将比较苯巴比妥与任何其他 AED 作为新生儿控制癫痫发作的一线治疗药物的随机对照试验（RCTs）纳入研究。使用 RevMan 5.3 软件进行随机效应荟萃分析。
我们筛选了 443 条记录，确定了 9 项符合条件的研究（719 名参与者）。5 项比较苯巴比妥与左乙拉西坦的 RCT 研究发现，首次用药时控制癫痫发作方面无差异[风险比（RR）1.43，95%置信区间（CI）0.79-2.57]或不良反应（RR 4.66；95% CI 0.33-65.83）。两项比较苯巴比妥与苯妥英的试验也未发现首次用药时控制癫痫发作（RR 2.09；95% CI 0.31-14.03）和其他结局方面有差异。只有一项 RCT 比较了苯巴比妥和劳拉西泮，发现劳拉西泮在首次用药时控制癫痫发作更有效（RR 0.71；95% CI 0.53-0.94）。三项试验比较了神经发育结局，其中左乙拉西坦在两项试验中更好，而另一项试验未发现任何差异。
苯巴比妥与其他药物（如苯妥英和左乙拉西坦）一样有效且安全。长期神经发育结局的数据缺乏。现有证据不足以推荐其他药物替代苯巴比妥。
