左乙拉西坦品牌药转为非专利药后对癫痫患儿的临床疗效和不良反应分析

Analysis of clinical efficacy and adverse effects of levetiracetam in children with epilepsy after switching from brand-named drug to generic drug

摘要

目的 前瞻性观察左乙拉西坦(LEV)由品牌药转换为非专利药后对癫痫患儿的临床疗效和不良反应变化。方法 以2019年4月至2020年12月在西安交通大学第二附属医院儿科就诊的196例癫痫患儿为研究对象,收集其从LEV品牌药转换为非专利药治疗前后的临床资料,并根据转换后疾病发作情况分为发作增加组、发作减少组及发作无变化组.分析转换前后各组LEV血药浓度、癫痫发作情况、不良反应及转换后发作增加患儿的临床特征。结果 转换前LEV血药浓度为(8.09±2.42)μg/mL,转换后血药浓度为(8.28±2.17)μg/mL,经比较差异无统计学意义(t=0.521,P=0.831).转换前LEV治疗剂量/血药浓度比值为(3.44±1.10)L/kg,转换后治疗剂量/血药浓度比值为(3.77±1.59)L/kg,经比较差异无统计学意义(t=0.723,P=0.762).转换前LEV的治疗有效率为81.05%(154/190),转换为非专利药后有效率为75.79%(144/190),经比较差异无统计学意义(χ²=1.555,P=0.212).发病年龄小及联合治疗的患儿在转换后可能会出现发作增加,LEV品牌药转换为非专利药后,未见出现新的不良反应。结论 LEV品牌药转为非专利药后对癫痫患儿治疗安全有效,对发病年龄小及联合治疗的患儿需要重点关注.

Abstract

Objective To prospectively observe changes in clinical efficacy and adverse effects of levetiracetam (LEV) in children with epilepsy after switching from brand-named drug to generic drug. Methods 196 children with epilepsy who were treated in Pediatric Outpatient Department and Inpatient Department of The Second Affiliated Hospital of Xi′an Jiaotong University over a period from April 2019 to December 2020 were selected as study subjects. According to seizure frequency after switching, they were divided into increased seizure group, decreased seizure group and no change in seizure group. The clinical data of the children with epilepsy before and after LEV switching from brand-named drug to generic drug were collected. The LEV plasma concentration, seizure frequency, adverse effect before and after switching and the clinical features of those children with increased seizure frequency after switching were analyzed and compared between the two groups. Results The LEV plasma concentration was 8.09±2.42 μg/mL before switching and 8.28±2.17 μg/mL after switching, there was no statistical difference (t=0.521, P>0.05). The LEV therapeutic dose/plasma concentration ratio was 3.44±1.10 L/kg before switching and 3.77±1.59 L/kg after switching, there was no statistical difference (t=0.723, P>0.05). The effective rate was 81.05% (154/190) before switching and 75.79% (144/190) after switching, and also there was no statistical difference (χ²=1.555, P>0.05). These children who had young age of onset and received combination therapy may presented with increased seizure frequency after switching, and no new adverse effects were seen after LEV switching from brand-named drug to generic drug. Conclusion LEV is still safe and effective for treatment of the children with epilepsy after switching from brand-named drug to generic drug. However, we need to focus on those children who have young age of onset and receive combination therapy.

关键词

左乙拉西坦 / 非专利药 / 转换 / 抗惊厥药物 / 血药浓度 / 有效率

Key words

levetiracetam / generic drug / switching / anticonvwlsant drug / plasma concentration / effective rate

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基金资助

陕西省重点研发计划(S2021GYFGYBSFG0695)