奥卡西平治疗儿童癫癎的临床随访研究

Clinical observation of oxcarbazepine on the children with epilepsy

目的探讨奥卡西平治疗儿童癫痈部分性发作及难治性癫癎的临床疗效和安全性。方法2005—2006年上海新华医院小儿神经科收治癫痈患者52例，其中新诊断和未经治疗癫癎部分性发作患者37例为单药治疗组；15例为既往经2种以上抗癫癎药正规治疗，发作仍未控制者为添加治疗组。起始剂量5-10mg／（kg·d），每日2次口服，每5—7d，增加5-10mg／（kg·d），目标剂量20-40mg／（kg·d）。观察期为6个月至2年，进行自身对照开放性研究，观察其疗效、安全性及依从性，分析剂量与不同年龄及疗效的关系。结果单药治疗组有效率为（控制＋显效＋有效）89．19％，控制率为67、57％，退出率为2．70％；难治组有效率为46．67％，控制率为13．33％，退出率为26．67％。共5例退出，1例因皮疹退出，4例因发作未能控制而退出。小于4岁患儿的平均剂量较年长儿显著增高（P〈0．05）。发作减少50％以上的病例的平均剂量较发作减少50％以下者显著增高（P〈0、05）。21．15％的病例发生不良反应，包括困倦、头晕、乏力、皮疹等，无低钠血症发生。结论奥卡西平治疗儿童部分性癫痈疗效显著，对难治性癫癎的也有一定的疗效，临床应用依从性良好，不良反应较少，安全性好。

Objective To evaluate the efficacy and safety of oxcarbazepine （ OXC ） in the treatment of the childhood partial seizure （ PS ） or intractable Epilepsy （ IE ）. Methods 52 patients were divided into two groups. 37 newly diagnosed patients who had never accepted standard therapy entered mono-therapy group,and 15 patients who have had more than two anti-epileptic drugs（AEDs） regularity with uncontrol served as add-on therapy group. The initial dose was 5 - 10 mg/（ kg · d） ,every 5 to 7 days the dose was increased 5 - 10mg / mg/（ kg · d） ,and the maintenance dose was 20 -40 mg/（ kg · d）, （ given twice per day）. With the open-label auto-control method,we follow up the efficacy,the tolerability and the safety of OXC during the 6 months to 2 years of the treatment both in the monothrapy group and the add-on therapy group, and we analyze the relationship of the efficacy according the dosage and the age. Results The effective rate and the withdraw rate were 86.48% and 2. 7%, respectively,25 of 37 （ 67.56% ） patients achieved seiz seizure-free in monotherapy group. In add on therapy group,the effective and withdraw rate were 46. 67% and 26. 67% ,respectively,2 of 15 （ 13.00% ） patients achieved seizure free. 5 patients exited ,4 patients because of uncomplete seizure control and 1 patient because of skin rash. The mean dose in the 〈 4 year group was significantly higher compared with the older age groups （P =0. 03）. In the group which seizure was reduced/〉50% required a significantly higher mean dose compared to the group which seizure was reduced 〈50% （ P =0. 029）. Ten patients （21.15%） reported adverse events,such as drowsiness,dizziness,rash. For the most part,these adverse events tended to be transient. No hyponatrem!a was observed. Conclusion These findings suggest that OXC monotherapy is significantly effective in children with PS. And partly effective in IE. It is well tolerated, safety, and the adverse events is transient dose-dependent.