Bertsche Astrid, Neininger Martina P, Dahse Anna J, Syrbe Steffen, Bernhard Matthias K, Frontini Roberto, Kiess Wieland, Bertsche Thilo, Merkenschlager Andreas
Centre of Pediatric Research, University Hospital for Children and Adolescents, Liebigstraße 20a, 04103, Leipzig, Germany,
Eur J Pediatr. 2014 Jan;173(1):87-92. doi: 10.1007/s00431-013-2125-1. Epub 2013 Aug 11.
Since anticonvulsants such as valproate or oxcarbazepine have quite a disadvantageous profile of possible adverse drug events (ADEs), safer alternatives are being sought. The newer anticonvulsant levetiracetam is often considered advantageous. We performed a chart review of children and adolescents aged from 0.5 to 16.9 years, who had been started on an initial monotherapy with levetiracetam, valproate, or oxcarbazepine between 2007 and 2011, in order to analyze the therapy's failure rate during the first year. We differentiated failure of monotherapy due to a lack of effectiveness and due to ADEs. No psychometric tests were performed. Lack of effectiveness and inacceptable ADEs were assumed according to the judgment of physicians and families. Anticonvulsive monotherapy failed in 29/61 (48 %) levetiracetam patients and in 18/49 (37 %) valproate patients (for focal and generalized epilepsies; n.s.). This was caused by a lack of effectiveness in 25/61 (41 %) levetiracetam patients and in 11/49 (22 %) valproate patients (p ≤ 0.05). A modification of therapy due to ADEs was performed in 4/61 (7 %) levetiracetam patients and in 7/49 (14 %) valproate patients (n.s.). An anticonvulsive monotherapy failed in 21/42 (50 %) patients treated with levetiracetam and in 10/34 (29 %) patients treated with oxcarbazepine (for focal epilepsies; n.s.). Changes of monotherapy were caused by a lack of effectiveness in 17/42 (40 %) of levetiracetam patients and in 6/34 (18 %) of oxcarbazepine patients (p ≤ 0.05). ADEs leading to changes in therapy were reported for 4/42 (10 %) of levetiracetam and 4/34 (12 %) of oxcarbazepine patients (n.s.). An initial monotherapy of levetiracetam failed more frequently due to a lack of effectiveness than a monotherapy with valproate or oxcarbazepine. We found no significant difference in therapy failure due to ADEs.
由于丙戊酸盐或奥卡西平之类的抗惊厥药物可能引发的药物不良事件(ADEs)相当不利,因此人们正在寻找更安全的替代药物。新型抗惊厥药物左乙拉西坦通常被认为具有优势。我们对年龄在0.5至16.9岁之间、于2007年至2011年间开始接受左乙拉西坦、丙戊酸盐或奥卡西平初始单药治疗的儿童和青少年进行了病历审查,以分析治疗第一年的失败率。我们区分了因疗效不佳和因药物不良事件导致的单药治疗失败。未进行心理测试。疗效不佳和不可接受的药物不良事件是根据医生和家属的判断确定的。在左乙拉西坦治疗的61例患者中有29例(48%)抗惊厥单药治疗失败,丙戊酸盐治疗的49例患者中有18例(37%)失败(针对局灶性和全身性癫痫;无显著差异)。这是由于61例左乙拉西坦患者中有25例(41%)疗效不佳,49例丙戊酸盐患者中有11例(22%)疗效不佳(p≤0.05)。因药物不良事件而调整治疗的左乙拉西坦患者有4/61(7%),丙戊酸盐患者有7/49(14%)(无显著差异)。在接受左乙拉西坦治疗的42例患者中有21例(50%)抗惊厥单药治疗失败,接受奥卡西平治疗的34例患者中有10例(29%)失败(针对局灶性癫痫;无显著差异)。单药治疗的改变是由于42例左乙拉西坦患者中有17例(40%)疗效不佳,34例奥卡西平患者中有6例(18%)疗效不佳(p≤0.05)。报告因药物不良事件导致治疗改变的左乙拉西坦患者有4/42(10%),奥卡西平患者有4/34( 12%)(无显著差异)。左乙拉西坦初始单药治疗因疗效不佳而失败的频率高于丙戊酸盐或奥卡西平单药治疗。我们发现因药物不良事件导致的治疗失败无显著差异。