奥卡西平治疗儿童癫(癎)的临床随访研究

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目的探讨奥卡西平治疗儿童癫癎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癎患者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癎疗效显著,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 investigate the clinical efficacy and safety of oxcarbazepine in the treatment of partial seizures and refractory epilepsy in children. Methods From 2005 to 2006, 52 cases of epilepsy were admitted to Pediatrics Department of Shanghai Xinhua Hospital. Among them, 37 cases of newly diagnosed and untreated epileptic seizures were treated with monotherapy; 15 cases were previously treated with 2 or more kinds of antiepileptic drugs Formal drug treatment, seizures have not yet been controlled to add treatment group. The initial dose of 5 ~ 10mg / (kg · d), 2 times a day orally, every 5 ~ 7d, an increase of 5 ~ 10mg / (kg · d), the target dose of 20 ~ 40mg / (kg · d). The observation period was 6 months to 2 years. A self-controlled open-label study was conducted to observe its efficacy, safety and compliance. The relationship between dose and age and efficacy was analyzed. Results The effective rate was 89.19% (control + effective / effective) in monotherapy group, the control rate was 67.57%, the withdrawal rate was 2.70%; the refractory group was 46.67%, the control rate was 13.33% and the withdrawal rate was 26.67% . A total of 5 patients withdrew, 1 patient withdrawal due to rash, 4 patients due to the attack failed to control and exit. The average dose of children younger than 4 years old was significantly higher than that of the older children (P <0.05). The average dose of cases with more than 50% reduction of seizures was significantly higher than that of those with seizures decreased by 50% (P <0.05). Adverse reactions occurred in 21.15% of the cases, including sleepiness, dizziness, fatigue, rash, etc., without hyponatremia. Conclusion Oxcarbazepine treatment of children with partial epilepsy has a significant effect on refractory epilepsy also has some effect, good clinical compliance, less adverse reactions, good safety.
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