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

作　　者：徐华 赵金玲 朱炜杰[1] XU Hua;ZHAO Jin-ling;ZHU Wei-jie(Department of Pediatrics,Affiliated Hospital of Jiangnan University,Wuxi 214000,Jiangsu Province,China)

机构地区：[1]江南大学附属医院儿科,江苏无锡214000

出　　处：《中国临床药理学杂志》2023年第23期3384-3387,共4页The Chinese Journal of Clinical Pharmacology

基　　金：江苏省自然科学基金面上基金资助项目(BK20201175)。

摘　　要：目的 观察吡仑帕奈片联合左乙拉西坦片治疗局灶性癫痫患儿的临床疗效及安全性。方法 将局灶性癫痫患儿按治疗方法分为对照组和试验组。对照组口服左乙拉西坦片,起始剂量为10 mg·kg^(-1)·d^(-1),用药1周后每周增加5~10 mg·kg^(-1)·d^(-1),持续4周后达到维持剂量30 mg·kg^(-1)·d^(-1),bid;试验组在对照组治疗的基础上,联合口服吡仑帕奈片,起始剂量为2 mg,每1~2周加量2 mg,单日口服剂量维持在4~8 mg,qd。2组患儿均治疗3个月。比较2组患儿的临床疗效、认知功能、神经功能、脑神经相关因子,以及药物不良反应的发生情况。结果 试验组入组98例,脱落4例,最终有94例纳入统计分析;对照组入组93例,脱落3例,最终有90例纳入统计分析。治疗后,试验组和对照组的总有效率分别为74.47%(70例/94例)和53.33%(48例/90例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的总智商分别为84.81±5.72和81.37±5.18,潜伏期分别为(1.33±0.21)和(1.52±0.24)s,波幅分别为(1.72±0.24)和(1.51±0.22)mV,脑源性神经营养因子分别为(17.29±3.06)和(20.01±3.25)μg·L^(-1),神经元特异性烯醇化酶分别为(18.26±3.12)和(21.74±3.53)μg·L^(-1),S100β分别为(13.74±2.26)和(16.85±2.89)μg·L^(-1),差异均有统计学意义(均P<0.05)。2组患儿的药物不良反应均以情绪烦躁、嗜睡、食欲缺乏为主。试验组和对照组的总药物不良反应发生率分别为10.64%和8.89%,差异无统计学意义(P>0.05)。结论 吡仑帕奈片联合左乙拉西坦片治疗儿童局灶性癫痫的临床疗效显著,其能显著改善患儿的认知功能、神经功能及脑神经相关因子水平,且不增加药物不良反应的发生率。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 2weeks,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±5.72and 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),S100βlevels 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 differ

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 

分 类 号：R971.6[医药卫生—药品]