左乙拉西坦与苯妥英作为二线用药治疗儿童惊厥性癫痫持续状态的有效性及安全性的Meta分析

师睿; 阴怀清; 王转转

doi:10.7499/j.issn.1008-8830.2010066

PDF(1449 KB)

HTML

中国当代儿科杂志 ›› 2021, Vol. 23 ›› Issue (4) : 356-362. DOI: 10.7499/j.issn.1008-8830.2010066

论著·临床研究

左乙拉西坦与苯妥英作为二线用药治疗儿童惊厥性癫痫持续状态的有效性及安全性的Meta分析

师睿¹, 阴怀清², 王转转¹

作者信息 +

Efficacy and safety of levetiracetam versus phenytoin as second-line drugs for the treatment of children with convulsive status epilepticus: a Meta analysis

SHI Rui¹, YIN Huai-Qing², WANG Zhuan-Zhuan¹

Author information +

文章历史 +

摘要

目的系统评价左乙拉西坦（LEV）和苯妥英（PHT）作为二线用药治疗儿童惊厥性癫痫持续状态（CSE）的有效性及安全性。方法检索中英文电子数据库，纳入对比LEV和PHT作为二线用药治疗儿童CSE的有效性及安全性的随机对照试验。使用RevMan 5.3软件进行数据分析。结果纳入7个研究，共1 434名患儿。Meta分析结果显示，LEV组CSE的控制率高于PHT组（RR=1.12，95% CI：1.00~1.24，P=0.05）；24 h内癫痫复发率（RR=0.82，95% CI：0.22~3.11，P=0.77）和需要进一步抗癫痫药物治疗率（RR=0.97，95% CI：0.64~1.45，P=0.87）两组比较差异无统计学意义。两组不良事件发生率差异无统计学意义（RR=0.77，95% CI：0.55~1.09，P=0.15）。结论 LEV治疗儿童CSE的有效性优于PHT，且不增加不良反应的发生率。

Abstract

Objective To systematically evaluate the efficacy and safety of levetiracetam (LEV) versus phenytoin (PHT) as second-line drugs for the treatment of convulsive status epilepticus (CSE) in children. Methods English and Chinese electronic databases were searched for the randomized controlled trials comparing the efficacy and safety of LEV and PHT as second-line drugs for the treatment of childhood CSE. RevMan 5.3 software was used for data analysis. Results Seven studies with 1 434 children were included. The Meta analysis showed that compared with the PHT group, the LEV group achieved a significantly higher control rate of CSE (RR=1.12, 95%CI:1.00-1.24, P=0.05), but there was no significant difference between the two groups in the recurrence rate of epilepsy within 24 hours (RR=0.82, 95%CI:0.22-3.11, P=0.77) and the rate of further antiepileptic drug therapy (RR=0.97, 95%CI:0.64-1.45, P=0.87). There was no significant difference in the incidence rate of adverse events between the two groups (RR=0.77, 95%CI:0.55-1.09, P=0.15). Conclusions LEV has a better clinical effect than PHT in the treatment of children with CSE and does not increase the incidence rate of adverse events.

导出引用

师睿, 阴怀清, 王转转. 左乙拉西坦与苯妥英作为二线用药治疗儿童惊厥性癫痫持续状态的有效性及安全性的Meta分析[J]. 中国当代儿科杂志. 2021, 23(4): 356-362 https://doi.org/10.7499/j.issn.1008-8830.2010066

SHI Rui, YIN Huai-Qing, WANG Zhuan-Zhuan. Efficacy and safety of levetiracetam versus phenytoin as second-line drugs for the treatment of children with convulsive status epilepticus: a Meta analysis[J]. Chinese Journal of Contemporary Pediatrics. 2021, 23(4): 356-362 https://doi.org/10.7499/j.issn.1008-8830.2010066

参考文献

[1] Trinka E, Cock H, Hesdorffer D, et al. A definition and classification of status epilepticus:Report of the ILAE Task Force on Classification of Status Epilepticus[J]. Epilepsia, 2015, 56(10):1515-1523.
[2] Alldredge BK, Gelb AM, Isaacs SM, et al. A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus[J]. N Engl J Med, 2001, 345(9):631-637.
[3] Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus[J]. N Engl J Med, 2012, 366(7):591-600.
[4] Gaínza-Lein M, Sánchez Fernández I, Jackson M, et al. Association of time to treatment with short-term outcomes for pediatric patients with refractory convulsive status epilepticus[J]. JAMA Neurol, 2018, 75(4):410-418.
[5] Kapur J, Elm J, Chamberlain JM, et al. Randomized trial of three anticonvulsant medications for status epilepticus[J]. N Engl J Med, 2019, 381(22):2103-2113.
[6] Brophy GM, Bell R, Claassen J, et al. Guidelines for the evaluation and management of status epilepticus[J]. Neurocrit Care, 2012, 17(1):3-23.
[7] Brigo F, Bragazzi NL, Lattanzi S, et al. A critical appraisal of randomized controlled trials on intravenous phenytoin in convulsive status epilepticus[J]. Eur J Neurol, 2018, 25(3):451-463.
[8] Glauser T, Shinnar S, Gloss D, et al. Evidence-based guideline:treatment of convulsive status epilepticus in children and adults:report of the Guideline Committee of the American Epilepsy Society[J]. Epilepsy Curr, 2016, 16(1):48-61.
[9] Craig S. Phenytoin poisoning[J]. Neurocrit Care, 2005, 3(2):161-170.
[10] Appleton RE, Gill A. Adverse events associated with intravenous phenytoin in children:a prospective study[J]. Seizure, 2003, 12(6):369-372.
[11] Menon R, Radhakrishnan A, Radhakrishnan K. Status epilepticus[J]. J Assoc Physicians India, 2013, 61(8 Suppl):58-63.
[12] Minicucci F, Ferlisi M, Brigo F, et al. Management of status epilepticus in adults. Position paper of the Italian League against Epilepsy[J]. Epilepsy Behav, 2020, 102:106675.
[13] Nowack A, Malarkey EB, Yao J, et al. Levetiracetam reverses synaptic deficits produced by overexpression of SV2A[J]. PLoS One, 2011, 6(12):e29560.
[14] Walker MC, Patsalos PN. Clinical pharmacokinetics of new antiepileptic drugs[J]. Pharmacol Ther, 1995, 67(3):351-384.
[15] Weijenberg A, Brouwer OF, Callenbach PM. Levetiracetam monotherapy in children with epilepsy:a systematic review[J]. CNS Drugs, 2015, 29(5):371-382.
[16] Cormier J, Chu CJ. Safety and efficacy of levetiracetam for the treatment of partial onset seizures in children from one month of age[J]. Neuropsychiatr Dis Treat, 2013, 9:295-306.
[17] McTague A, Kneen R, Kumar R, et al. Intravenous levetiracetam in acute repetitive seizures and status epilepticus in children:experience from a children's hospital[J]. Seizure, 2012, 21(7):529-534.
[18] Hsia Y, Neubert A, Sturkenboom MC, et al. Comparison of antiepileptic drug prescribing in children in three European countries[J]. Epilepsia, 2010, 51(5):789-796.
[19] Glauser TA, Ayala R, Elterman RD, et al. Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures[J]. Neurology, 2006, 66(11):1654-1660.
[20] Legros B, Boon P, De Jonghe P, et al. Opinion of Belgian neurologists on antiepileptic drug treatment in 2006:Belgian study on epilepsy treatment (BESET-2)[J]. Acta Neurol Scand, 2009, 120(6):402-410.
[21] Li LJ, Zhang Y, Jia L, et al. Levetiracetam versus phenytoin for the treatment of established status epilepticus:a systematic review and meta-analysis of randomized controlled trials[J]. Seizure, 2020, 78:43-48.
[22] Senthil Kumar CS, Selvakumar P, Kowsik M. Randomized controlled trial of levetiracetam versus fosphenytoin for convulsive status epilepticus in children[J]. Pediatr Rev:Int J Pediatr Res, 2018, 5(4):237-242.
[23] Singh K, Aggarwal A, Faridi MMA, et al. IV levetiracetam versus IV phenytoin in childhood seizures:a randomized controlled trial[J]. J Pediatr Neurosci, 2018, 13(2):158-164.
[24] Dalziel SR, Borland ML, Furyk J, et al. Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT):an open-label, multicentre, randomised controlled trial[J]. Lancet, 2019, 393(10186):2135-2145.
[25] Lyttle MD, Rainford NEA, Gamble C, et al. Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE):a multicentre, open-label, randomised trial[J]. Lancet, 2019, 393(10186):2125-2134.
[26] Noureen N, Khan S, Khursheed A, et al. Clinical efficacy and safety of injectable levetiracetam versus phenytoin as second-line therapy in the management of generalized convulsive status epilepticus in children:an open-label randomized controlled trial[J]. J Clin Neurol, 2019, 15(4):468-472.
[27] Wani G, Imran A, Dhawan N, et al. Levetiracetam versus phenytoin in children with status epilepticus[J]. J Family Med Prim Care, 2019, 8(10):3367-3371.
[28] Nalisetty S, Kandasamy S, Sridharan B, et al. Clinical effectiveness of levetiracetam compared to fosphenytoin in the treatment of benzodiazepine refractory convulsive status epilepticus[J]. Indian J Pediatr, 2020, 87(7):512-519.
[29] National Institute for Health and Care Excellence. Epilepsies:diagnosis and management[EB/OL]. (2020-02-11)[2020-06-13]. https://www.nice.org.uk/guidance/cg137.
[30] McTague A, Martland T, Appleton R. Drug management for acute tonic-clonic convulsions including convulsive status epilepticus in children[J]. Cochrane Database Syst Rev, 2018, 1(1):CD001905.
[31] Sánchez Fernández I, Abend NS, Agadi S, et al. Gaps and opportunities in refractory status epilepticus research in children:a multi-center approach by the Pediatric Status Epilepticus Research Group (pSERG)[J]. Seizure, 2014, 23(2):87-97.
[32] Arican P, Gencpinar P, Cavusoglu D, et al. Levetiracetam monotherapy for the treatment of infants with epilepsy[J]. Seizure, 2018, 56:73-77.
[33] Wright C, Downing J, Mungall D, et al. Clinical pharmacology and pharmacokinetics of levetiracetam[J]. Front Neurol, 2013, 4:192.
[34] Nakamura K, Inokuchi R, Daidoji H, et al. Efficacy of levetiracetam versus fosphenytoin for the recurrence of seizures after status epilepticus[J]. Medicine (Baltimore), 2017, 96(25):e7206.