左乙拉西坦的国产仿制药替换治疗儿童癫痫的疗效及安全性研究

doi:10.7499/j.issn.1008-8830.2111033

摘要
图/表
参考文献(22)
相关文章 (15)
点击分布统计
下载分布统计

全文: PDF (547 KB) [HTML]
输出: BibTeX | EndNote (RIS) 背景资料

摘要目的评价左乙拉西坦的国产仿制药替换原研药进口左乙拉西坦治疗儿童癫痫的疗效及安全性。方法回顾性分析2019年5月至2020年12月在广东省人民医院住院或门诊接受左乙拉西坦的国产仿制药替换治疗的154例癫痫患儿的临床资料，分析比较左乙拉西坦的国产仿制药替换原研药治疗的效果及安全性。结果 154例患儿基线期癫痫控制率为77.3%（119/154），替换治疗6个月后癫痫控制率达83.8%（129/154），差异有统计学意义（P<0.05）。基线期与替换治疗6个月后癫痫发作频率比较差异无统计学意义（P>0.05）。替换治疗后无效患儿出现难治性癫痫比例高于有效患儿（P<0.05）。替换治疗前，仅1例患儿（0.6%）出现嗜睡；替换治疗后，3例患儿（1.9%）观察到轻度药物不良反应，包括头晕、嗜睡、易激惹、脾气暴躁，与替换治疗前比较差异无统计学意义（P>0.05）。结论左乙拉西坦的国产仿制药替换原研药进口左乙拉西坦治疗儿童癫痫是安全有效的，值得推广，但是需要更多的前瞻性随机对照试验来证实。

	服务

	把本文推荐给朋友
	加入我的书架
	加入引用管理器
	E-mail Alert
	RSS
	作者相关文章
	梁明娟
	邱炜凤
	张静雯
	黎雪萍
	石港安
	翟琼香
	张宇昕
	陈志红

关键词 ：癫痫, 左乙拉西坦, 仿制药, 原研药, 替换治疗, 儿童

Abstract：Objective To study the efficacy and safety of domestic generic levetiracetam in replacement of brand-name levetiracetam in the treatment of children with epilepsy. Methods A retrospective analysis was performed on the medical data of 154 children with epilepsy who received domestic generic levetiracetam in the inpatient or outpatient service of Guangdong Provincial People's Hospital from May 2019 to December 2020. Domestic generic levetiracetam and brand-name levetiracetam were compared in terms of efficacy and safety. Results For these 154 children, the epilepsy control rate was 77.3% (119/154) at baseline. At 6 months after switching to domestic generic levetiracetam, the epilepsy control rate reached 83.8% (129/154), which showed a significant increase (P<0.05). There was no significant change in the frequency of seizures from baseline to 6 months after switching (P>0.05). The incidence of refractory epilepsy in children with no response after switching treatment was significantly higher than that in children with response (P<0.05). Before switching, only 1 child (0.6%) experienced somnolence, while after switching, 3 children (1.9%) experienced mild adverse drug reactions, including dizziness, somnolence, irritability, and bad temper. Conclusions Switching from brand-name to generic levetiracetam is safe and effective and holds promise for clinical application, but more prospective randomized controlled trials are required in future.

Key words： Epilepsy Levetiracetam Generic drug Brand-name drug Switching treatment Child

收稿日期: 2021-11-07

通讯作者: 陈志红，女，副主任医师。Email：765136277@qq.com。 E-mail: 765136277@qq.com

作者简介: 梁明娟，女，硕士研究生，住院医；

引用本文:

梁明娟,邱炜凤,张静雯等. 左乙拉西坦的国产仿制药替换治疗儿童癫痫的疗效及安全性研究[J]. 中国当代儿科杂志, 2022, 24(3): 285-289.

LIANG Ming-Juan,QIU Wei-Feng,ZHANG Jing-Wen et al. Efficacy and safety of switching from brand-name to domestic generic levetiracetam in children with epilepsy[J]. CJCP, 2022, 24(3): 285-289.

链接本文:

http://www.zgddek.com/CN/10.7499/j.issn.1008-8830.2111033 或 http://www.zgddek.com/CN/Y2022/V24/I3/285

	1 中国抗癫痫协会. 临床诊疗指南—癫痫病分册[M]. 2版. 北京: 人民卫生出版社, 2015.
	Abou-Khalil B. Levetiracetam in the treatment of epilepsy[J]. Neuropsychiatr Dis Treat, 2008, 4(3): 507-523. PMID: 18830435. PMCID: PMC2526377. DOI: 10.2147/ndt.s2937.
	Heaney DC, Sander JW. Antiepileptic drugs: generic versus branded treatments[J]. Lancet Neurol, 2007, 6(5): 465-468. PMID: 17434101. DOI: 10.1016/S1474-4422(07)70105-9.
	Perucca E, Albani F, Capovilla G, et al. Recommendations of the Italian League against Epilepsy working group on generic products of antiepileptic drugs[J]. Epilepsia, 2006, 47 Suppl 5: 16-20. PMID: 17239100. DOI: 10.1111/j.1528-1167.2006.00871.x.
	Hensler K, Uhlmann C, Porschen T, et al. Generic substitution of antiepileptic drugs—a survey of patients' perspectives in Germany and other German-speaking countries[J]. Epilepsy Behav, 2013, 27(1): 135-139. PMID: 23416284. DOI: 10.1016/j.yebeh.2012.12.029.
	6 国务院办公厅. 国务院办公厅关于印发国家组织药品集中采购和使用试点方案的通知国办发〔2019〕2号[J]. 中国制药信息, 2019(3): 7-10.
	Markoula S, Chatzistefanidis D, Gatzonis S, et al. Brand-to-generic levetiracetam switch in patients with epilepsy in a routine clinical setting[J]. Seizure, 2017, 48: 1-6. PMID: 28363098. DOI: 10.1016/j.seizure.2017.03.012.
	Gha-Hyun L, Dae SJ. Brand name to generic substitution of levetiracetam in patients with epilepsy[J]. Seizure, 2018, 60: 127-131. PMID: 29960217. DOI: 10.1016/j.seizure.2018.06.020.
	9 王艳, 赵新利, 谭军, 等. 左乙拉西坦佐治儿童难治性癫痫的疗效[J]. 新乡医学院学报, 2013, 30(12): 972-974.
	Chaluvadi S, Chiang S, Tran L, et al. Clinical experience with generic levetiracetam in people with epilepsy[J]. Epilepsia, 2011, 52(4): 810-815. PMID: 21426334. PMCID: PMC4500114. DOI: 10.1111/j.1528-1167.2011.03025.x.
	Fitzgerald CL, Jacobson MP. Generic substitution of levetiracetam resulting in increased incidence of breakthrough seizures[J]. Ann Pharmacother, 2011, 45(5): e27. PMID: 21521860. DOI: 10.1345/aph.1P765.
	Lang JD, Kostev K, Onugoren MD, et al. Switching the manufacturer of antiepileptic drugs is associated with higher risk of seizures: a nationwide study of prescription data in Germany[J]. Ann Neurol, 2018, 84(6): 918-925. PMID: 30298621. DOI: 10.1002/ana.25353.
	Shaw SJ, Hartman AL. The controversy over generic antiepileptic drugs[J]. J Pediatr Pharmacol Ther, 2010, 15(2): 81-93. PMID: 22477799. PMCID: PMC3018179.
	Privitera MD, Welty TE, Gidal BE, et al. Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial[J]. Lancet Neurol, 2016, 15(4): 365-372. PMID: 26875743. DOI: 10.1016/S1474-4422(16)00014-4.
	Vossler DG, Anderson GD, Bainbridge J. AES position statement on generic substitution of antiepileptic drugs[J]. Epilepsy Curr, 2016, 16(3): 209-211. PMID: 27330454. PMCID: PMC4913860. DOI: 10.5698/1535-7511-16.3.209.
	16 Medicines and Healthcare products Regulatory Agency. Antiepileptic drugs: new advice on switching between different manufacturers' products for a particular drug[EB/OL]. (2014-12-11)[2020-10-07]. https://www.gov.uk/drug-safety-update/antiepileptic-drugs-new-advice-on-switching-between-different-manufacturers-products-for-a-particular-drug.
	Bosak M, S?owik A, Turaj W. Safety of switching from brand-name to generic levetiracetam in patients with epilepsy[J]. Drug Des Devel Ther, 2017, 11: 2287-2291. PMID: 28814836. PMCID: PMC5546726. DOI: 10.2147/DDDT.S138270.
	Reimers A, Olsson P, Nilsson J, et al. Impact of generic substitution on levetiracetam serum concentration—a prospective study in an outpatient setting[J]. Epilepsy Res, 2017, 134: 54-61. PMID: 28595756. DOI: 10.1016/j.eplepsyres.2017.04.017.
	Trimboli M, Russo E, Mumoli L, et al. Brand-to-generic levetiracetam switching: a 4-year prospective observational real-life study[J]. Eur J Neurol, 2018, 25(4): 666-671. PMID: 29322654. DOI: 10.1111/ene.13568.
	Vari MS, Pinto F, Mencaroni E, et al. Safety of overnight switch from brand-name to generic levetiracetam[J]. Clin Drug Investig, 2016, 36(1): 87-91. PMID: 26507620. DOI: 10.1007/s40261-015-0351-1.
	Fanella M, Morano A, Fattouch J, et al. Switch from originator to equivalent drug in the era of generic antiepileptic drugs: study of Keppra versus Epitiram clinical equivalence[J]. Clin Neuropharmacol, 2017, 40(6): 239-242. PMID: 28976412. DOI: 10.1097/WNF.0000000000000250.
	Peterson GM. Generic substitution of antiepileptics: need for a balanced view[J]. CNS Spectr, 2011, 16(8): 169-175. PMID: 24725557. DOI: 10.1017/S109285291200034X.