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

Efficacy and safety of switching from brand-name to domestic generic levetiracetam in children with epilepsy

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。

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.