Specchio Nicola, Boero Giovanni, Michelucci Roberto, Gambardella Antonio, Giallonardo Anna Teresa, Fattouch Jinane, Di Bonaventura Carlo, de Palo Alessia, Ladogana Marianna, Lamberti Paolo, Vigevano Federico, La Neve Angela, Specchio Luigi Maria
Division of Neurology, Bambino Gesù Children's Hospital, Roma, Italy.
Epilepsia. 2008 Apr;49(4):663-9. doi: 10.1111/j.1528-1167.2007.01523.x. Epub 2008 Feb 5.
A multicenter, prospective, long-term, open-label study to evaluate the effects of levetiracetam on electroencephalogram (EEG) abnormalities and photoparoxysmal response (PPR) of patients affected by juvenile myoclonic epilepsy (JME).
Forty-eight patients with newly diagnosed JME (10) or resistant/intolerant (38) to previous antiepileptic drugs (AEDs) were enrolled. After an 8-week baseline period, levetiracetam was titrated in 2 weeks to 500 mg b.i.d. and then increased to up to 3,000 mg/day. Efficacy parameters were based on the comparison and analysis of EEG interictal abnormalities classified as spikes-and-waves, polyspikes-and-waves, and presence of PPR. Secondary end point was evaluation of EEG and PPR changes as predictive factors of 12-month seizure freedom.
Overall, mean dose of levetiracetam was 2,208 mg/day. Mean study period was 19.3 +/- 11.5 months (range 0.3-38). During the baseline period, interictal EEG abnormalities were detected in 44/48 patients (91.6%) and PPR was determined in 17/48 (35.4%) of patients. After levetiracetam treatment, 27/48 (56.2%) of patients compared to 4/48 (8.3%) in the baseline period (p < 0.0001) had a normal EEG. Thirteen of 17 (76.4%) (p < 0.0003) patients showed suppression of PPR. Cumulative probability of days with myoclonia (DWM) 12-month remission was significantly higher (p < 0.05) in patients with a normal (normalized) EEG after levetiracetam treatment compared to those with an unchanged EEG.
Levetiracetam appeared to be effective in decreasing epileptiform EEG abnormalities, and suppressing the PPR in JME patients. This effect, along with a good efficacy and tolerability profile in this population further supports a first-line role for levetiracetam in the treatment of JME.
一项多中心、前瞻性、长期、开放标签研究，以评估左乙拉西坦对青少年肌阵挛性癫痫（JME）患者脑电图（EEG）异常和光阵发性反应（PPR）的影响。
纳入48例新诊断的JME患者（10例）或对先前抗癫痫药物（AEDs）耐药/不耐受的患者（38例）。经过8周的基线期后，左乙拉西坦在2周内滴定至500mg，每日两次，然后增加至最高3000mg/天。疗效参数基于对EEG发作间期异常的比较和分析，这些异常分为棘波和慢波、多棘波和慢波以及PPR的存在情况。次要终点是评估EEG和PPR变化作为12个月无癫痫发作预测因素的情况。
总体而言，左乙拉西坦的平均剂量为2208mg/天。平均研究期为19.3±11.5个月（范围0.3 - 38个月）。在基线期，44/48例患者（91.6%）检测到发作间期EEG异常，17/48例患者（35.4%）检测到PPR。左乙拉西坦治疗后，48例患者中有27例（56.2%）EEG正常，而基线期为4/48例（8.3%）（p < 0.0001）。17例患者中有13例（76.4%）（p < 0.0003）PPR得到抑制。与EEG无变化的患者相比，左乙拉西坦治疗后EEG正常（标准化）的患者12个月肌阵挛天数（DWM）缓解的累积概率显著更高（p < 0.05）。
左乙拉西坦似乎对减少JME患者的癫痫样EEG异常以及抑制PPR有效。这种效果，以及该人群中良好的疗效和耐受性，进一步支持左乙拉西坦在JME治疗中的一线作用。
