Piña-Garza Jesús Eric, Elterman Roy D, Ayala Ricardo, Corral Maria, Mikati Mohamad A, Piña-Garza Mary J, Warnock Clay R, Conklin Heather S, Messenheimer John A
Vanderbilt University, Nashville, Tennessee, USA.
J Child Neurol. 2008 Aug;23(8):853-61. doi: 10.1177/0883073808317348.
This open-label study was designed to evaluate the long-term tolerability and efficacy of lamotrigine in 1- to 24-month-old infants with partial seizures. The study enrolled both lamotrigine-naïve patients and patients who had been previously exposed to lamotrigine in a randomized, double-blind, placebo-controlled study. Patients (n = 204) received lamotrigine according to a dosing schedule that depended on prior experience with lamotrigine and concurrent antiepileptic drug therapy for up to 48 weeks or their second birthday, whichever occurred last. Total duration of lamotrigine exposure (which included exposure during the placebo-controlled study in lamotrigine-experienced patients) was >/=24 weeks in 92% of patients, >/=48 weeks in 70% of patients, and >/=72 weeks in 20% of patients. A total of 20 (10%) patients (8 lamotrigine-naïve patients and 12 lamotrigine-experienced patients) transitioned to lamotrigine monotherapy. The most common adverse events were pyrexia (45% of patients), upper-respiratory tract infection (28%), and ear infection (22%). The only adverse event considered reasonably attributable to study medication in >2% of patients was irritability (n = 10; 5% of patients). No cases of serious rash were reported. The median percent reduction from baseline in partial seizure frequency in the sample as a whole was 74%. Seizure frequency was reduced by >/=50% from pre-lamotrigine baseline in 62% of patients in the sample as a whole, 60% of the lamotrigine-naïve subgroup, and 63% of the lamotrigine-experienced subgroup. In the sample as a whole, 13% of patients were seizure free during the Treatment Phase. Investigators considered clinical status at the last clinic visit to be improved (mildly, moderately, or markedly) relative to prelamotrigine clinical status in 76% of patients (150/197) and to be unchanged in 19% (37/197). In this study-the first large prospective investigation of the long-term tolerability and efficacy of an antiepileptic drug in a patient population 2 years and younger-lamotrigine administered for up to approximately 72 weeks was well tolerated and associated with good seizure control.
这项开放性研究旨在评估拉莫三嗪对1至24个月大的部分性癫痫婴儿的长期耐受性和疗效。该研究纳入了未使用过拉莫三嗪的患者以及先前在一项随机、双盲、安慰剂对照研究中接触过拉莫三嗪的患者。患者（n = 204）根据给药方案接受拉莫三嗪治疗，该方案取决于先前使用拉莫三嗪的经验以及同时使用的抗癫痫药物治疗，最长可达48周或至其第二个生日，以较晚者为准。拉莫三嗪暴露的总时长（包括拉莫三嗪经验丰富的患者在安慰剂对照研究期间的暴露时长），92%的患者≥24周，70%的患者≥48周，20%的患者≥72周。共有20名（10%）患者（8名未使用过拉莫三嗪的患者和12名使用过拉莫三嗪的患者）转为拉莫三嗪单药治疗。最常见的不良事件为发热（45%的患者）上呼吸道感染（28%）和耳部感染（22%）。在超过2%的患者中，唯一被认为合理归因于研究药物的不良事件为易激惹（n = 10；5%的患者）。未报告严重皮疹病例。整个样本中部分性癫痫发作频率较基线降低的中位数百分比为74%。在整个样本中，62%的患者、未使用过拉莫三嗪亚组中的60%的患者以及使用过拉莫三嗪亚组中的63%的患者，癫痫发作频率较拉莫三嗪治疗前基线降低≥50%。在整个样本中，13%的患者在治疗阶段无癫痫发作。研究者认为，在末次门诊就诊时，76%的患者（150/197）的临床状态相对于拉莫三嗪治疗前有所改善（轻度、中度或显著改善），19%（37/197）的患者临床状态未改变。在这项研究中——这是首次针对2岁及以下患者群体中抗癫痫药物的长期耐受性和疗效进行的大型前瞻性研究——使用长达约72周的拉莫三嗪耐受性良好，且与良好的癫痫控制相关。
