Comparison of efficacy and safety between valproic acid monotherapy and valproic acid in combination with oxcarbazepine for treatment of children with epilepsy
10.3760/cma.j.issn.1008-5734.2014.05.003
- VernacularTitle: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
- Author:
Ti ZHANG
1
;
Jingkai ZHOU
;
Mei LIU
;
Shuang LI
;
Limei ZHAO
;
Yu CHEN
Author Information
1. 中国医科大学附属盛京医院药学部, 沈阳,110004
- Publication Type:Journal Article
- Keywords:
Valproic acid;
Oxcarbazepine;
Treatment outcome;
Safety;
Patient compliance
- From:
Adverse Drug Reactions Journal
2014;(5):264-268
- CountryChina
- Language:Chinese
-
Abstract:
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 in children with CDR of 5-13(μg·kg)/( ml·mg)was higher than that in children with CDR of 1-5(μg·kg)/(ml·mg)(P <0.05). Conclusions The efficacy,safety and compliance of VPA in combination with OXC treatment is better than that of VPA monotherapy in children with epilepsy. Age and the plasma concentration maybe the risk factors of adverse reactions and liver function abnormalities.