中国临床药理学杂志2023，Vol.39Issue(23)：3384-3387,4.DOI:10.13699/j.cnki.1001-6821.2023.23.009
吡仑帕奈联合左乙拉西坦治疗局灶性癫痫患儿的临床研究
Clinical trial of pirampanil combined with levetiracetam in the treatment of children with focal epilepsy
摘要
Abstract
Objective To observe the clinical efficacy and safety of pirampanil tablets combined with levetiracetam tablets in the treatment of children with focal epilepsy.Methods The children with focal epilepsy were divided into control group and treatment group according to treatment method.Control group took levetiracetam tablets orally,the initial dose was 10 mg·kg-1·d-1,and after 1 week of administration,5-10 mg·kg-1·d-1 was increased weekly,and the maintenance dose was 30 mg·kg-1·d-1 after 4 weeks,bid.On the basis of control group,treatment group was combined with oral pirampanil tablets,the initial dose was 2 mg,and the additional dose was 2 mg every 1 to 2 weeks,and the daily oral dose was maintained at 4 to 8 mg,qd.Two groups were treated for 3 months.The clinical efficacy,cognitive function,neurological function,cranial nerve related factors and adverse drug reactions were compared between the two groups.Results In the treatment group,98 cases were enrolled,4 cases dropped out,and 94 cases were finally included in the analysis;in the control group,93 cases were enrolled,3 cases dropped out,and 90 cases were finally included in the analysis.After treatment,the total effective rates of treatment and control groups were 74.47％(70 cases/94 cases)and 53.33％(48 cases/90 cases)with significant difference(P＜0.05).After treatment,the total IQ of treatment and control groups were 84.81±5.72 and 81.37±5.18,the latency was(1.33±0.21)and(1.52±0.24)s,the amplitude was(1.72±0.24)and(1.51±0.22)mV,brain-derived neurotrophic factor levels were(17.29±3.06)and(20.01±3.25)μg·L-1,neuron-specific enolase levels were(18.26±3.12)and(21.74±3.53)μg·L-1,S100β levels were(13.74±2.26)and(16.85±2.89)µg·L-1,and the differences were statistically significant(all P＜0.05).The adverse drug reactions of the two groups were emotional irritability,lethargy and lack of appetite.The total incidences of adverse drug reactions in the treatment and control groups were 10.64％and 8.89％,without significant difference(P＞0.05).Conclusion Pirampanel tablets combined with levetiracetam tablet have a definitive clinical efficacy in the treatment of children with focal epilepsy,which can significantly improve the cognitive function,neurological function and the level of cranial nerve related factors,without increasing the incidence of adverse drug reactions.关键词
吡仑帕奈片/左乙拉西坦片/局灶性癫痫/患儿/临床疗效/安全性评价Key words
pirampanide tablet/levetiracetam tablet/focal epilepsy/child patient/clinical efficacy/safety evaluation分类
医药卫生引用本文复制引用
徐华,赵金玲,朱炜杰..吡仑帕奈联合左乙拉西坦治疗局灶性癫痫患儿的临床研究[J].中国临床药理学杂志,2023,39(23):3384-3387,4.基金项目
江苏省自然科学基金面上基金资助项目(BK20201175) （BK20201175）
