奥卡西平混悬液治疗儿童癫痫的疗效和安全性的临床观察
Efficacy and safety of oxcarbazepine oral suspension in epileptic children: a clinical study

摘要：目的 观察奥卡西平(OXC)混悬液治疗不同类型儿童癫痫的疗效和安全性。方法 收集自2011年6月～2014年6月就诊于西安交通大学第一附属医院儿科及西安市儿童医院神经专科门诊服用OXC混悬液单药或添加治疗的83例癫痫患儿为研究对象，采用开放性自身对照研究方法。OXC混悬液起始剂量8～10mg/(kg？d)，每7d加药10mg/(kg？d)，直至最小有效量，一般维持剂量为20～40mg/(kg？d)。随访时间6～24个月。观察治疗前后发作频率变化,以发作频率减少的百分率作为疗效判定标准，记录不良反应以评价安全性。结果 入选83例患儿，5例退出。患儿服药后每3个月评价1次服药的疗效：第一阶段(服药第1、2、3月)完全控制率为41%，总体有效率为71.8%；第二阶段(服药第4、5、6月)完全控制率为46.2%，总体有效率为76.9%；第三阶段(服药第7、8、9月)完全控制率为59%，总体有效率为79.5%。各阶段药物疗效差异无统计学意义(P>0.05)。54例部分性发作完全控制率为59.3%，总有效率为79.6%，24例全面性发作控制率为45.8%，总有效率为62.5%，两组疗效差异无统计学意义(P>0.05)。43例单药治疗的发作控制率58.1%，总有效率79%，35例添加治疗的发作完全控制率40%，总有效率57.1%。<2岁24例发作完全控制率为41.7%，总有效率为62.5%；2～6岁54例发作控制率为59.3%，总有效率为83.3%。14例(17.95%)出现不良反应，表现为嗜睡、反应慢、情绪激动、皮疹、纳差、情绪激动、头晕、视物模糊，多数不良反应症状轻微且持续时间短。结论 OXC混悬液对儿童部分性及全面强直-阵挛癫痫具有较好疗效及安全性，不良反应小，依从性好。
ABSTRACT: Objective To study the efficacy and safety of oxcarbazepine (OXC) oral suspension on children with different kinds of epilepsy. Methods A total of 83 children with epilepsy were selected from the Pediatric Department of the First Affiliated Hospital of Xi’an Jiaotong University and Xi’an Children’ Hospital from June 2011 to June 2014. They were treated with OXC monotherapy or adjunctive therapy. Use open-label and self-contrast method. The initial dose of OXC was 8-10mg/(kg？d), and then was added 10mg/(kg？d) per 7 days until it reached the minimum effective dose. Generally, the maintenance dose was about 20-40mg/(kg？d). The follow-up duration was 6-12 months. Results 83 cases were eventually included and 5 cases withdrew. We elvaluated the efficacy every 3 months. The results were as follows: the first stage (1, 2, 3 months) resulted in a 41.0% of full control rate and a 71.8% of total effective rate; the second stage (4, 5, 6 months) resulted in a 46.2% of full control rate and a 76.9% of total effective rate; the third stage (7, 8, 9 months) resulted in a 59.0% of full control rate and a 79.5% of total effective rate. There were no significant differences in the efficacy of the three stages. 54 cases with partial seizures resulted in a 59.3% of full control rate and a 79.6% of total effective rate; 24 cases with generalized seizure resulted in a 45.8% of full control rate and a 62.5% of total effective rate. There was no statistical significant difference in the efficacy of the two seizure types. 43 cases with monotherapy resulted in a 58% of full control rate and a 79% of total effective rate, 35 cases with add-on therapy resulted in a 40.0% of full control rate and a 57.1% of total effective rate. 24 cases with < 2 resulted in a 41.7% of full control rate and a 62.5% of total effective