丙戊酸及其与奥卡西平联用治疗儿童癫痫的疗效和安全性比较  

Comparison of efficacy and safety between valproic acid monotherapy and valproic acid in combination with oxcarbazepine for treatment of children with epilepsy

作　　者：张媞[1] 周敬凯 刘美[1] 李爽[1] 肇丽梅[1] 陈愉[2] 

机构地区：[1]中国医科大学附属盛京医院药学部,沈阳110004 [2]中国医科大学附属盛京医院呼吸科,沈阳110004

出　　处：《药物不良反应杂志》2014年第5期264-268,共5页Adverse Drug Reactions Journal

基　　金：国家自然科学基金（81302857）;辽宁省自然科学基金（2013021079）

摘　　要：目的：考查单用丙戊酸（ VPA）以及VPA与奥卡西平（ OXC）联用治疗儿童癫痫的有效性、安全性和依从性。方法收集2012年10月至2013年10月就诊于中国医科大学附属盛京医院、应用VPA（ VPA组）或VPA联合OXC（ VPA＋OXC组）治疗、连续用药2个月以上且随访满1年的癫痫患儿的病历资料进行回顾性分析，记录并比较2组患儿的用药情况[ VPA日剂量、OXC日剂量、VPA标准化血药浓度（ CDR）、用药依从性（以药物保留率评价）]、癫痫控制情况和药物不良反应（ ADR）发生情况。结果共208例患儿纳入研究。VPA组105例，男性62例，女性43例，年龄1-15岁，平均（6.8±3.4）岁；VPA＋OXC组103例，男性60例，女性43例，年龄1-15岁，平均（7.4±3.5）岁。VPA 组与 VPA ＋ OXC 组 VPA 日剂量、CDR、药物保留率差异均无统计学意义[（507±207）mg比（498±164）mg，（4.2±2.3）（μg·kg）/（ml·mg）比（4.3±1.6）（μg·kg）/（ml· mg），81.9%比79.6%，均P〉0.05）]；随访1年时，VPA＋OXC组有效率明显优于VPA组[82.5%（85/103）比61.9%（65/105），P〈0.05）。随访1年期间VPA组与VPA＋OXC组ADR症状和肝功能异常发生率差异均无统计学意义[13.3%（14/105）比15.5%（16/103），4.8%（5/105）比6.8%（7/103），均P〉0.05]。但将患儿按年龄分组比较，则显示1-10岁患儿2组ADR发生率和VPA＋OXC组肝功能异常发生率均高于11-15岁患儿（均P〈0.05）；按VPA血药浓度分组比较，CDR为5-13（μg·kg）/（ ml·mg）的患儿ADR症状和肝功能异常发生率均高于CDR为1-5（μg·kg）/（ ml·mg）的患儿。结论 OXC与VPA联用治疗儿童癫痫疗效优于单用VAP，同时具有良好的安全性和依从性。患儿年龄和VPA血药浓度可能是发生ADR症状和肝功能异常的危险因素。Objective To investigate the efficacy,safety and compliance of valproic acid（ VPA） monotherapy and VPA in combination with oxcarbazepine（ OXC）in children with epilepsy. Methods A retrospective analysis of clinical data of children with epilepsy,treated in Shengjing Hospital of China Medical University from October 2012 to October 2013 was performed. The patients were treated with VPA （ VPA group）or VPA in combination with OXC（ VPA＋OXC group）continuously for more than 2 months and were followed up for 1 year. The situation of drug use[ VPA daily dose,OXC daily dose,concentration dose ratio（ CDR ） of VPA,medication compliance（ evaluated by retention raty ）],situation of epilepsy control and occurrence of adverse reactions were recorded and compared. Results A total of 208 children were included in the study,105 children were in the VPA group,62 male cases and 43 female cases,aged 1 to 15 years,mean（6. 8 ± 3. 4）years;103 children were in the VPA＋OXC group,60 male cases and 43 female cases,aged 1 to 15 years,mean（7. 4 ± 3. 5）years. There was no significant difference in VPA daily dose,CDR,and the retention rate[（507 ± 207）mg vs.（498 ± 164）mg,（4. 2 ± 2. 3）（μg·kg）/（ml·mg）vs.（4. 3 ± 1. 6）（μg·kg）/（ml·mg）,81. 9% vs. 79. 6%,respectively,P〉0. 05）]. At one year follow-up,the efficacy rate in the VPA＋OXC group[82. 5%（85/103）]was significantly higher than that in the VPA group[61. 9%（65/105）]（P〈0. 05）. During one year of follow-up,there was no significant difference in liver function abnormalities and adverse reactions in the VPA and VPA＋OXC groups[13. 3%（14/105）vs. 15. 5%（16/103）,4. 8%（5/105）vs. 6. 8%（7/103）,respectively,P〉0. 05]. But the incidence of adverse reactions in the 2 groups and the liver function abnormalities in the VPA＋OXC group in children aged from 1 to 10 years were higher than that aged from 11 to 15 years（P〈0. 05）;the incidence of adverse reactions and liver function abnormalities i

关 键 词：丙戊酸 奥卡西平 治疗效果 安全性 病人依从 

分 类 号：R742.1[医药卫生—神经病学与精神病学]