培训课件-童癫痫的临床治疗.ppt

* Levision PM, et al. Neurocognitive effects of adjunctive letiracetam in children with partial-onset seizures: A randomized, double-blind, placebo-controlled, noninferiority trial Epilepsia. 2009; 50(11): 2377-2389 这是一项随机、双盲、安慰剂对照的左乙拉西坦对儿童和青少年患者认知功能影响的研究。经过12周治疗后，采用WRAML-2方法评价认知功能的变化。在总体记忆、视觉记忆、言语记忆和精神集中力等方面，左乙拉西坦都与安慰剂相似。 Summary Purpose:? Evaluate potential neurocognitive effects of adjunctive leveetiracetam in children with inadequately controlled partial-onset seizures (POS). Methods:? Randomized, double-blind, placebo-controlled, noninferiority safety study. Children (4–16?years; IQ ≥65) with ≥1 POS during 4?weeks before screening despite taking 1–2 antiepileptic drugs (AEDs) were randomized (2:1) to levetiracetam (20–60?mg/kg/day) or placebo for 12?weeks. Results:? Ninety-nine patients were randomized with 98 (Levetiracetam 64, placebo 34) in intent-to-treat (ITT) and 73 (Levetiracetam 46, placebo 27) in per protocol (PP) populations. Primary cognitive assessment was the Leiter International Performance Scale–Revised Attention and Memory Battery with the memory screen composite score change from baseline as the primary endpoint. PP Least Square Mean [LSM (standard error)] were 5.36 (1.78) for levetiracetam; 5.17 (2.33) for placebo; difference [two-sided 90% confidence interval (CI)] 0.19 (?4.69, 5.08). levetiracetam was noninferior to placebo because the 90% CI lower bound was greater than the defined noninferiority margin (?9.0). There were no statistically significant differences between groups in Wide Range Assessment of Memory and Learning-2 indexes and Leiter-R Examiner’s Rating Scale scores. Median reductions from baseline in weekly POS frequency were 91.5% versus 26.5% for letiracetam versus placebo; ≥50% responder rates: 62.5% versus 41.2%; seizure freedom rates: 46.9% versus 8.8% (ITT). Adverse events were reported by 89.1% letiracetam-treated and 85.3% placebo-treated patients; those reported by ≥10% letiracetam patients and more often with letirac