国产和进口左乙拉西坦代谢率、有效性和安全性比较  

作　　者：刘翠敏 陈昊宇 冯常强[1] 陈卫佳 陈钇均 王莹[1] 吴刚 

机构地区：[1]浙江省台州医院,317000 [2]温州医科大学,325035

出　　处：《浙江临床医学》2024年第10期1507-1508,共2页Zhejiang Clinical Medical Journal

基　　金：浙江省公益技术研究基金项目(LGD20H310002)。

摘　　要：目的比较国产和进口左乙拉西坦(Levetiracetam,LEV)两种药物在癫痫患者体内血药浓度、有效性和安全性。方法收集服用国产或进口LEV药物的癫痫患者血液样本96例,其中国产药组62例,进口药组34例。采用高效液相检测样本的血药浓度。以服药前后癫痫发作次数为指标,观察两种药物的疗效和不良反应。结果国产LEV血药浓度值为9.32(6.57)μg/mL,进口LEV血药浓度值为9.5(6.68)μg/mL。国产LEV症状改善者56例,总有效率为90.3%;进口LEV症状改善者30例,总有效率为88.2%;两者不良反应发生率分别为14.5%和14.7%,差异均无统计学意义(P>0.05)。结论国产和进口LEV在癫痫患者体内代谢、有效性及安全性方面均无差异,为国产LEV的临床应用推广提供依据。Objective To compare the blood drug concentration,efficacy,and safety of domestic and imported Levetiracetam(LEV)in epilepsy patients.Methods Collect blood samples from 96 epilepsy patients taking domestic or imported LEV drugs,including 62 domestic cases and 34 imported cases,and use high-performance liquid chromatography to detect the blood drug concentration of patients.Observe the efficacy and adverse reactions of two drugs based on the number of epileptic seizures before and after medication.Results The domestic LEV blood concentration value was 9.32(6.57)μg/mL,and the imported LEV blood concentration value is 9.5(6.68)μg/mL.56 cases of domestically produced LEV showed improvement in symptoms,with a total clinical effective rate of 90.3%.30 cases showed improvement in imported LEV symptoms,with a total clinical effective rate of 88.2%.The incidence of adverse reactions for the two was 14.5%and 14.7%,respectively,there was no statistically significant differe nce.Conclusion There is no difference in metabolism,therapeutic efficacy,and safety betw een domestic and imported LEV in epilepsy patients,providing r eference for the clinical application of domestic LEV.

关 键 词：左乙拉西坦 国产 进口 疗效 代谢 不良反应 

分 类 号：R969[医药卫生—药理学]