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目的分析左乙拉西坦(LEV)单药或联合用药治疗婴儿癫的长程保留率。方法回顾性分析2006年7月至2007年6月应用LEV治疗的婴儿癫患儿的临床资料。结果 60例服用LEV的癫患儿,部分性发作20例,全面性发作19例,癫综合征21例,其中难治性癫21例。23例LEV单药治疗,37例以LEV作为添加药物联合治疗。LEV首剂量10 mg/kg·d,每日2次口服,每周加量10 mg/kg,加量调整直至取得最佳疗效和耐受性。LEV治疗6个月、1年、2年、3年及4年的保留率分别为95.0%、75.0%、60.0%、51.7%和38.3%。最主要停药原因为缺乏疗效(43.2%)。COX回归模型提示,病程>1个月(RR=2.91,95%CI:1.16~7.30)及难治性癫(RR=2.30,95%CI:1.22~4.32)是患儿停药的危险因素(P均<0.05)。患儿服药后发作频率较基线水平明显减少(P<0.01)。至随访结束,23例未停药患儿中,有效率100%,完全缓解率69.57%。主要不良反应为倦怠乏力(56.0%),其余为睡眠增多、烦躁不安等。结论 LEV单药或联合用药治疗婴儿癫具有较好的长程保留率、良好的疗效及耐受性。
Objective To analyze the long-term retention rate of levodisetine (LEV) monotherapy or combination therapy in the treatment of infantile epilepsy. Methods The clinical data of children with epilepsy treated with LEV from July 2006 to June 2007 were retrospectively analyzed. Results 60 cases of epilepsy children taking LEV, 20 cases of partial seizures, 19 cases of comprehensive seizures, 21 cases of epilepsy syndrome, including refractory epilepsy in 21 cases. 23 cases of LEV monotherapy, 37 cases of LEV as an additional drug combination therapy. LEV first dose of 10 mg / kg · d, 2 times a day orally, weekly dose of 10 mg / kg, dosage adjustments until the best efficacy and tolerability. The retention rates of LEV for 6 months, 1 year, 2 years, 3 years and 4 years were 95.0%, 75.0%, 60.0%, 51.7% and 38.3% respectively. The main reason for discontinuation of the lack of efficacy (43.2%). COX regression model suggested that the disease duration> 1 month (RR = 2.91, 95% CI: 1.16-7.30) and refractory epilepsy (RR = 2.30, 95% CI: 1.22-4.32) (P <0.05). The frequency of seizures in children with medication was significantly lower than baseline (P <0.01). To the end of follow-up, 23 cases of non-stop children, the effective rate was 100%, the complete remission rate was 69.57%. The main adverse reactions were fatigue (56.0%), the rest were increased sleep, restlessness and so on. Conclusion LEV alone or in combination therapy for epilepsy in infants has better long-term retention, good efficacy and tolerability.