奥卡西平混悬液治疗儿童局灶性癫癎的临床研究

Clinical efficacy of oxcarbazepine suspension in children with focal epilepsy

目的探讨奥卡西平混悬液治疗儿童局灶性癫癎的疗效及安全性。方法选取2009年10月至2011年12月118例新诊断的局灶性发作癫癎患儿,年龄为2～14岁,随机分为2组:试验组60例,口服奥卡西平(OXC)混悬液;对照组58例,口服卡马西平(CBZ)片,用药后比较其疗效及安全性。结果试验组在用药后13、26周的有效率分别为75%和72%,完全控制分别为53%和50%;对照组在用药后13、26周的有效率分别为71%和66%;完全控制分别50%和43%。两组用药后13、26周的疗效差异无统计学意义(P>0.05)。用药后26周,试验组不良反应发生率为18%,对照组不良反应发生率为40%,明显高于试验组,差异有统计学意义(P<0.05)。结论 OXC混悬液单药治疗2～14岁新诊断的儿童局灶性发作癫癎的疗效与CBZ片相当,且不良反应较少,安全性好。

Objective To investigate the clinical efficacy and safety of oxcarbazepine （OXC） suspension in children with focal epilepsy. Methods A total of 118 children aged 2 - 14 years, who were newly diagnosed with focal epilepsy between October 2009 and December 2011, were randomly divided into experimental group （n = 60） and control group （n = 58 ）. The experimental group was treated with an orally suspension of OXC and the control group was orally administered with carbamazepine （CBZ） tablets. The two treatment regimens were compared in terms of clinical efficacy and safety. Results After 13 and 26 weeks of treatment, the experimental group had response rates of 75% and 72% respectively and seizure-free rates of 53% and 50%, and the control group had response rates of 71% and 66% and seizure-free rates of 50% and 43% respectively. There were no significant differences in the clinical efficacy between the two groups （ P 〉 O. 05 ）. After 26 weeks of treatment, the adverse event rates of the experimental and control groups were 18% and 40% respectively, with a significant difference between the two groups （P 〈 0.05 ）. Conclusions OXC suspension has a comparable clinical efficacy to that of CBZ tablets in children aged 2 - 14 years who are newly diagnosed with focal epilepsy, but OXC suspension causes fewer adverse events and has higher safety.