丙戊酸单药或联合用药治疗儿童癫痫的临床研究  

Clinical trial of monotherapy or combination therapy with valproate in children with epilepsy

作　　者：饶欣[1] 林玮玮[1] 曾大勇[1] 林希[2] RAO Xin;LIN Wei-wei;ZENG Da-yong;LIN Xi(Department of Pharmacy,The First Affiliated Hospital of Fujian Medical University,Fuzhou 350005,Fujian Province,China;Department of Pediatrics,The First Affiliated Hospital of Fujian Medical University,Fuzhou 350005,Fujian Province,China)

机构地区：[1]福建医科大学附属第一医院药学部,福建福州350005 [2]福建医科大学附属第一医院儿科,福建福州350005

出　　处：《中国临床药理学杂志》2020年第10期1212-1215,共4页The Chinese Journal of Clinical Pharmacology

基　　金：福建省卫生计生青年科研课题基金资助项目(2016-1-56);福建省卫生计生中青年骨干人才培养课题基金资助项目(2016-ZQN-38)。

摘　　要：目的观察丙戊酸钠(VPA)单药治疗及联合其他常用抗癫痫药治疗儿童癫痫的临床疗效及安全性。方法将153例患儿分为A组64例、B组27例、C组47例、D组9例和E组6例。A组给予口服VPA 20~30 mg·kg^-1·d^-1;B,C,D和E组在A组治疗的基础上,分别给予口服奥卡西平(OXC)20~30 mg·kg^-1·d^-1,左乙拉西坦(LEV)20~60 mg·kg^-1·d^-1,拉莫三嗪(LTG)2~10 mg·kg^-1·d^-1和托吡酯(TDM)3~6 mg·kg^-1·d^-1。5组患儿每日给药2次,均治疗6个月以上。比较5组患儿的临床疗效,以及药物不良反应的发生情况。结果治疗后,A,B,C,D和E组的总有效率分别为68.75%(44例/64例),88.89%(24例/27例),85.11%(40例/47例),77.78%(7例/9例)和83.33%(5例/6例),B,C组的总有效率和A组比较,差异均有统计学意义(均P<0.05)。A和B组的VPA平均血药浓度分别为(66.68±20.37)和(57.33±17.62)μg·mL^-1,差异有统计学意义(P<0.05)。5组患儿的药物不良反应均以肝功能异常和血红蛋白降低为主。A,B,C,D和E组的总药物不良反应发生率分别为18.75%,18.52%,23.40%,11.11%和50.00%,A组的发生率与其余4组比较,差异均无统计学意义(均P>0.05)。结论VPA单药治疗癫痫患儿的临床效果不理想,需要联合药物治疗,可考虑联用OXC或LEV,但是长期联用OXC需适当增加VPA的剂量,且抗癫痫药联合使用并不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of sodium valproate(VPA)single drug therapy and combined with other antiepileptic drugs in the treatment of epilepsy in children.Methods A total of 153 children were divided into A group(64 cases),B group(27 cases),C group(47 cases),D group(9 cases)and E group(6 cases).A group was given oral administration of VPA 20-30 mg·kg^-1·d^-1.B,C,D and E groups received oral administration of oxcarbazepine(OXC)20-30 mg·kg^-1·d^-1,levetiracetam(LEV)20-60 mg·kg^-1·d^-1,lamotrigine(LTG)2-10 mg·kg^-1·d^-1 and topiramate(TDM)3-6 mg·kg^-1·d^-1,respectively,on the basis of A group.Five groups were treated for at least 6 months with twice a day.The clinical efficacy and adverse drug reactions of 5 groups were compared.Results After treatment,the total effective rates of A,B,C,D and E groups were 68.75%(44 cases/64 cases),88.89%(24 cases/27 cases),85.11%(40 cases/47 cases),77.78%(7 cases/9 cases)and 83.33%(5 cases/6 cases)with significant differences between A group and B,C groups(all P<0.05).The average concentrations of VPA in A and B groups were(66.68±20.37)and(57.33±17.62)μg·m L^-1 with significant difference(P<0.05).The adverse drug reactions of five groups were abnormal liver function and decrease of hemoglobin.The total incidences of adverse drug reactions in A,B,C,D and E groups were 18.75%,18.52%,23.40%,11.11%and 50.00%,there were no significant differences between A group and B,C,D,E groups(all P>0.05).Conclusion The effect of VPA single drug treatment is not ideal,the combination of OXC or LEV may be considered,but the long-term combined use of OXC needs to increase the dose of VPA appropriately.The combination of antiepileptic drugs did not increase the incidence of adverse drug reactions.

关 键 词：丙戊酸钠 儿童 癫痫 血药浓度 联合用药 

分 类 号：R971.6[医药卫生—药品]