Grosso S, Franzoni E, Coppola G, Iannetti P, Verrotti A, Cordelli D M, Marchiani V, Pascotto A, Spalice A, Acampora B, Morgese G, Balestri P
Pediatrics Department, University of Siena, Ospedale Santa Maria alle Scotte, Via M. Bracci, 53100 Siena, Italy.
Seizure. 2005 Jun;14(4):248-53. doi: 10.1016/j.seizure.2005.02.004.
The aim of this multicentric, prospective and uncontrolled study was to evaluate the efficacy and safety of levetiracetam in 110 children with refractory epilepsy, of whom 21 were less than 4 years old. After a median follow-up period of 7 months, levetiracetam administration was effective (responders with >50% decrease in seizure frequency) in 39% of children, of whom 10 (9%) became seizure-free. The efficacy was higher in patients with localization-related epilepsy (58% of responders) than in those with generalized epilepsy (37% of responders). Levetiracetam was well tolerated. The main side effects of somnolence and irritability occurred in 14% of patients. In one patient acute choreoathetosis occurred after few doses of levetiracetam. Overall, the adverse effects were not severe. Children younger than 4 years were particularly tolerant. In conclusion, the present study confirms that levetiracetam is effective and well tolerated as an add-on treatment in children with refractory epilepsy. Our preliminary data also indicate that levetiracetam may be a valid therapeutic option for epilepsy in infants and young children.
这项多中心、前瞻性且非对照研究的目的是评估左乙拉西坦对110例难治性癫痫患儿的疗效和安全性，其中21例年龄小于4岁。经过7个月的中位随访期后，39%的患儿使用左乙拉西坦有效（发作频率降低>50%的反应者），其中10例（9%）无癫痫发作。局灶性相关性癫痫患者的疗效（反应者占58%）高于全身性癫痫患者（反应者占37%）。左乙拉西坦耐受性良好。主要副作用嗜睡和易怒发生在14%的患者中。1例患者在服用几剂左乙拉西坦后出现急性舞蹈手足徐动症。总体而言，不良反应不严重。4岁以下儿童尤其耐受。总之，本研究证实左乙拉西坦作为难治性癫痫患儿的附加治疗有效且耐受性良好。我们的初步数据还表明左乙拉西坦可能是婴幼儿癫痫的有效治疗选择。
