Grosso S, Cordelli D M, Franzoni E, Coppola G, Capovilla G, Zamponi N, Verrotti A, Morgese G, Balestri P
Pediatrics Department, University of Siena, Italy.
Seizure. 2007 Jun;16(4):345-50. doi: 10.1016/j.seizure.2007.02.004. Epub 2007 Mar 26.
The aim of this multicentric, retrospective, and uncontrolled study was to evaluate the efficacy and safety of levetiracetam (LEV) in 81 children younger than 4 years with refractory epilepsy. At an average follow-up period of 9 months, LEV administration was found to be effective in 30% of patients (responders showing more than a 50% decrease in seizure frequency) of whom 10 (12%) became seizure free. This efficacy was observed for focal (46%) as well as for generalized seizures (42%). In addition, in a group of 48 patients, we compared the initial efficacy (evaluated at an average of 3 months of follow-up) and the retention at a mean of 12 months of LEV, with regard to loss of efficacy (defined as the return to the baseline seizure frequency). Twenty-two patients (46%) were initial responders. After a minimum of 12 months of follow-up, 9 of 48 patients (19%) maintained the improvement, 4 (8%) of whom remained seizure free. A loss of efficacy was observed in 13 of the initial responders (59%). Maintained LEV efficacy was noted in patients with focal epilepsy and West syndrome. LEV was well tolerated. Adverse events were seen in 18 (34%) patients. The main side effects were drowsiness and nervousness. Adverse events were either tolerable or resolved in time with dosage reduction or discontinuation of the drug. We conclude that LEV is safe and effective for a wide range of epileptic seizures and epilepsy syndromes and, therefore, represents a valid therapeutic option in infants and young children affected by epilepsy.
这项多中心、回顾性且非对照研究的目的是评估左乙拉西坦（LEV）对81名4岁以下难治性癫痫儿童的疗效和安全性。在平均9个月的随访期内，发现LEV治疗对30%的患者有效（反应者癫痫发作频率降低超过50%），其中10名（12%）患者癫痫发作停止。局灶性发作（46%）和全身性发作（42%）均观察到了这种疗效。此外，在一组48名患者中，我们比较了LEV的初始疗效（平均随访3个月时评估）和平均12个月时的疗效维持情况，涉及疗效丧失（定义为癫痫发作频率恢复到基线水平）。22名患者（46%）为初始反应者。经过至少12个月的随访，48名患者中有9名（19%）维持了改善，其中4名（8%）患者癫痫发作停止。13名初始反应者（59%）出现了疗效丧失。在局灶性癫痫和韦斯特综合征患者中观察到了LEV疗效的维持。LEV耐受性良好。18名（34%）患者出现了不良事件。主要副作用为嗜睡和紧张。不良事件要么可以耐受，要么通过减少剂量或停药及时缓解。我们得出结论，LEV对广泛的癫痫发作和癫痫综合征是安全有效的，因此，对于受癫痫影响的婴幼儿来说是一种有效的治疗选择。
