{"title":"左乙拉西坦与苯巴比妥治疗新生儿癫痫：系统综述和荟萃分析。","authors":"Jogender Kumar, Bharti Yadav, Jitendra Meena, Jaivinder Yadav, Jitendra Kumar Sahu","doi":"10.1007/s12098-023-04905-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To review whether levetiracetam is non-inferior to phenobarbitone as the first-choice antiseizure medication (ASM).</p><p><strong>Methods: </strong>The authors searched Medline, Embase, Web of Science, Scopus, and Cochrane Library for randomized controlled trials (RCTs) published until May 31, 2023. RCTs comparing the efficacy and safety of levetiracetam and phenobarbitone as first-line ASM in neonatal seizures were included. Random effects meta-analysis was performed, and the Risk of Bias version 2 tool was used for quality assessment.</p><p><strong>Results: </strong>Eleven RCTs enrolling 821 neonates [mostly term, with hypoxic-ischemic encephalopathy (HIE)] were included. There was no significant difference in seizure control between levetiracetam and phenobarbitone (10 RCTs, 786 participants; relative risk RR: 1.11; 95% CI: 0.79, 1.54; I<sup>2</sup>- 88%). Neonates in the levetiracetam group had a significantly lower incidence of hypotension (RR: 0.28; 95% CI: 0.09, 0.86), respiratory depression (RR: 0.36, 95% CI: 0.19, 0.66), and depressed sensorium (RR: 0.52, 95% CI: 0.27, 1.00). Three studies compared neurodevelopmental outcomes; however two of them were cross-over trials where infants received both drugs. Only one RCT enrolled pure cohorts and showed better neurodevelopment in the levetiracetam group at one month of age.</p><p><strong>Conclusions: </strong>With the limitation of very-low certainty evidence, the results of this systematic review suggest that levetiracetam may be non-inferior to phenobarbitone for managing neonatal seizures. Considering a better safety profile and marginally better neurodevelopment in the short term, levetiracetam may be considered an initial choice for managing neonatal seizures.</p><p><strong>Registration number: </strong>PROSPERO (CRD42023438018).</p>","PeriodicalId":13320,"journal":{"name":"Indian Journal of Pediatrics","volume":" ","pages":"29-41"},"PeriodicalIF":2.1000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Levetiracetam versus Phenobarbitone for Management of Neonatal Seizures: A Systematic Review and Meta-analysis.\",\"authors\":\"Jogender Kumar, Bharti Yadav, Jitendra Meena, Jaivinder Yadav, Jitendra Kumar Sahu\",\"doi\":\"10.1007/s12098-023-04905-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>To review whether levetiracetam is non-inferior to phenobarbitone as the first-choice antiseizure medication (ASM).</p><p><strong>Methods: </strong>The authors searched Medline, Embase, Web of Science, Scopus, and Cochrane Library for randomized controlled trials (RCTs) published until May 31, 2023. RCTs comparing the efficacy and safety of levetiracetam and phenobarbitone as first-line ASM in neonatal seizures were included. Random effects meta-analysis was performed, and the Risk of Bias version 2 tool was used for quality assessment.</p><p><strong>Results: </strong>Eleven RCTs enrolling 821 neonates [mostly term, with hypoxic-ischemic encephalopathy (HIE)] were included. There was no significant difference in seizure control between levetiracetam and phenobarbitone (10 RCTs, 786 participants; relative risk RR: 1.11; 95% CI: 0.79, 1.54; I<sup>2</sup>- 88%). Neonates in the levetiracetam group had a significantly lower incidence of hypotension (RR: 0.28; 95% CI: 0.09, 0.86), respiratory depression (RR: 0.36, 95% CI: 0.19, 0.66), and depressed sensorium (RR: 0.52, 95% CI: 0.27, 1.00). Three studies compared neurodevelopmental outcomes; however two of them were cross-over trials where infants received both drugs. Only one RCT enrolled pure cohorts and showed better neurodevelopment in the levetiracetam group at one month of age.</p><p><strong>Conclusions: </strong>With the limitation of very-low certainty evidence, the results of this systematic review suggest that levetiracetam may be non-inferior to phenobarbitone for managing neonatal seizures. Considering a better safety profile and marginally better neurodevelopment in the short term, levetiracetam may be considered an initial choice for managing neonatal seizures.</p><p><strong>Registration number: </strong>PROSPERO (CRD42023438018).</p>\",\"PeriodicalId\":13320,\"journal\":{\"name\":\"Indian Journal of Pediatrics\",\"volume\":\" \",\"pages\":\"29-41\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Indian Journal of Pediatrics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s12098-023-04905-1\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/11/8 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"PEDIATRICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian Journal of Pediatrics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s12098-023-04905-1","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/11/8 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PEDIATRICS","Score":null,"Total":0}
引用次数: 0
摘要
目的：评价左乙拉西坦作为首选抗癫痫药物（ASM）是否不劣于苯巴比妥。方法：作者检索Medline、Embase、Web of Science、Scopus和Cochrane Library，检索截至2023年5月31日发表的随机对照试验（RCT）。随机对照试验比较了左乙拉西坦和苯巴比妥作为一线ASM治疗新生儿癫痫的疗效和安全性。进行随机效应荟萃分析，并使用偏倚风险2版工具进行质量评估。结果：纳入了11项随机对照试验，共纳入821名新生儿[大部分为足月缺氧缺血性脑病（HIE）]。左乙拉西坦和苯巴比妥在癫痫控制方面没有显著差异（10项随机对照试验，786名参与者；相对风险RR:1.11；95%CI:0.79，1.54；I2-88%）。左乙拉西坦组新生儿低血压（RR:0.28；95%CI:0.09,0.86）、呼吸抑制（RR:0.36，95%CI:0.19,0.66）和感觉迟钝（RR:0.52，95%CI:0.27,0.00）的发生率显著降低。三项研究比较了神经发育结果；然而，其中两项是交叉试验，婴儿同时服用两种药物。只有一项随机对照试验纳入了纯队列，左乙拉西坦组在一个月大时表现出更好的神经发育。结论：由于确定性很低的证据的局限性，本系统综述的结果表明，左乙拉西坦在治疗新生儿癫痫发作方面可能不劣于苯巴比妥。考虑到更好的安全性和短期内稍好的神经发育，左乙拉西坦可能被认为是治疗新生儿癫痫的初步选择。注册号：PROSPERO（CRD42023438018）。
Levetiracetam versus Phenobarbitone for Management of Neonatal Seizures: A Systematic Review and Meta-analysis.
Objectives: To review whether levetiracetam is non-inferior to phenobarbitone as the first-choice antiseizure medication (ASM).
Methods: The authors searched Medline, Embase, Web of Science, Scopus, and Cochrane Library for randomized controlled trials (RCTs) published until May 31, 2023. RCTs comparing the efficacy and safety of levetiracetam and phenobarbitone as first-line ASM in neonatal seizures were included. Random effects meta-analysis was performed, and the Risk of Bias version 2 tool was used for quality assessment.
Results: Eleven RCTs enrolling 821 neonates [mostly term, with hypoxic-ischemic encephalopathy (HIE)] were included. There was no significant difference in seizure control between levetiracetam and phenobarbitone (10 RCTs, 786 participants; relative risk RR: 1.11; 95% CI: 0.79, 1.54; I2- 88%). Neonates in the levetiracetam group had a significantly lower incidence of hypotension (RR: 0.28; 95% CI: 0.09, 0.86), respiratory depression (RR: 0.36, 95% CI: 0.19, 0.66), and depressed sensorium (RR: 0.52, 95% CI: 0.27, 1.00). Three studies compared neurodevelopmental outcomes; however two of them were cross-over trials where infants received both drugs. Only one RCT enrolled pure cohorts and showed better neurodevelopment in the levetiracetam group at one month of age.
Conclusions: With the limitation of very-low certainty evidence, the results of this systematic review suggest that levetiracetam may be non-inferior to phenobarbitone for managing neonatal seizures. Considering a better safety profile and marginally better neurodevelopment in the short term, levetiracetam may be considered an initial choice for managing neonatal seizures.
期刊介绍：
Indian Journal of Pediatrics (IJP), is an official publication of the Dr. K.C. Chaudhuri Foundation. The Journal, a peer-reviewed publication, is published twelve times a year on a monthly basis (January, February, March, April, May, June, July, August, September, October, November, December), and publishes clinical and basic research of all aspects of pediatrics, provided they have scientific merit and represent an important advance in knowledge. The Journal publishes original articles, review articles, case reports which provide new information, letters in relation to published articles, scientific research letters and picture of the month, announcements (meetings, courses, job advertisements); summary report of conferences and book reviews.
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