CAJ | 학술논문

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。
목적：고사단용병무산（ VPA）이급VPA여오잡서평（ OXC）련용치료인동전간적유효성、안전성화의종성。방법수집2012년10월지2013년10월취진우중국의과대학부속성경의원、응용VPA（ VPA조）혹VPA연합OXC（ VPA+OXC조）치료、련속용약2개월이상차수방만1년적전간환인적병력자료진행회고성분석，기록병비교2조환인적용약정황[ VPA일제량、OXC일제량、VPA표준화혈약농도（ CDR）、용약의종성（이약물보류솔평개）]、전간공제정황화약물불량반응（ ADR）발생정황。결과공208례환인납입연구。VPA조105례，남성62례，녀성43례，년령1~15세，평균（6.8±3.4）세；VPA+OXC조103례，남성60례，녀성43례，년령1~15세，평균（7.4±3.5）세。VPA 조여 VPA + OXC 조 VPA 일제량、CDR、약물보류솔차이균무통계학의의[（507±207）mg비（498±164）mg，（4.2±2.3）（μg·kg）/（ml·mg）비（4.3±1.6）（μg·kg）/（ml· mg），81.9%비79.6%，균P>0.05）]；수방1년시，VPA+OXC조유효솔명현우우VPA조[82.5%（85/103）비61.9%（65/105），P<0.05）。수방1년기간VPA조여VPA+OXC조ADR증상화간공능이상발생솔차이균무통계학의의[13.3%（14/105）비15.5%（16/103），4.8%（5/105）비6.8%（7/103），균P>0.05]。단장환인안년령분조비교，칙현시1~10세환인2조ADR발생솔화VPA+OXC조간공능이상발생솔균고우11~15세환인（균P<0.05）；안VPA혈약농도분조비교，CDR위5~13（μg·kg）/（ ml·mg）적환인ADR증상화간공능이상발생솔균고우CDR위1~5（μg·kg）/（ ml·mg）적환인。결론 OXC여VPA련용치료인동전간료효우우단용VAP，동시구유량호적안전성화의종성。환인년령화VPA혈약농도가능시발생ADR증상화간공능이상적위험인소。
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.