Labiner David M, Ettinger Alan B, Fakhoury Toufic A, Chung Steve S, Shneker Bassel, Tatum Iv William O, Mitchell Miller J, Vuong Alain, Hammer Anne E, Messenheimer John A
Department of Neurology, University of Arizona, Tucson, Arizona 85724, USA.
Epilepsia. 2009 Mar;50(3):434-42. doi: 10.1111/j.1528-1167.2008.01792.x. Epub 2008 Nov 4.
To assess anger/hostility during treatment with lamotrigine adjunctive therapy versus levetiracetam adjunctive therapy in patients with partial seizures.
This randomized, double-blind, parallel-group study in adults with partial seizures included an 8-week escalation phase, during which adjunctive lamotrigine (n = 132) or adjunctive levetiracetam (n = 136) was titrated to a target dose, and a 12-week, double-blind maintenance phase, during which dosages of study medication and concomitant antiepileptic drugs were maintained. The primary endpoint was change from baseline to the end of the maintenance phase (week 20) in the Anger-Hostility subscale score of the Profile of Mood States (POMS).
Improvement with lamotrigine relative to levetiracetam was observed for mean +/- SD (standard deviation) change from baseline to the end of the maintenance phase (week 20) on the Anger-Hostility subscale (lamotrigine -2.0 +/- 8.2, levetiracetam -0.3 +/- 8.4; p = 0.024) (the primary endpoint); the Anger-Hostility subscale on weeks 5, 6, 7, 8, 9, 11, 12, 14, 16, 18, and 19; and the Total Mood Disturbance score on weeks 6, 7, 8, 9, 11, 12, 17, 19, and 20. Improvement (p < 0.05) with lamotrigine relative to levetiracetam was also observed on the POMS subscales Depression-Dejection, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. No difference in seizure frequency was observed between groups. The most common adverse events with both medications were headache and dizziness.
Adjunctive lamotrigine significantly improved Anger-Hostility subscale scores relative to adjunctive levetiracetam in patients with partial seizures at the end of 20 weeks. This difference was consistently observed throughout the treatment period. Similar improvement with lamotrigine versus levetiracetam was observed for other mood symptoms.
评估拉莫三嗪辅助治疗与左乙拉西坦辅助治疗对部分性癫痫患者愤怒/敌意情绪的影响。
这项针对成年部分性癫痫患者的随机、双盲、平行组研究包括一个为期8周的剂量递增阶段，在此期间将拉莫三嗪辅助治疗组（n = 132）或左乙拉西坦辅助治疗组（n = 136）滴定至目标剂量，以及一个为期12周的双盲维持阶段，在此期间维持研究药物和伴随使用的抗癫痫药物的剂量。主要终点是情绪状态量表（POMS）中愤怒-敌意分量表得分从基线到维持阶段结束（第20周）的变化。
在愤怒-敌意分量表上，从基线到维持阶段结束（第20周），拉莫三嗪相对于左乙拉西坦有改善，平均±标准差（标准差）变化为（拉莫三嗪 -2.0±8.2，左乙拉西坦 -0.3±8.4；p = 0.024）（主要终点）；在第5、6、7、8、9、11、12、14、16、18和19周的愤怒-敌意分量表；以及在第6、7、8、9、11、12、17、19和20周的总情绪紊乱得分。在POMS的抑郁-沮丧、活力-活动、疲劳-惰性和困惑-迷茫分量表上，拉莫三嗪相对于左乙拉西坦也有改善（p < 0.05）。两组间癫痫发作频率无差异。两种药物最常见的不良事件是头痛和头晕。
在20周结束时，对于部分性癫痫患者，拉莫三嗪辅助治疗相对于左乙拉西坦辅助治疗显著改善了愤怒-敌意分量表得分。在整个治疗期间均持续观察到这种差异。对于其他情绪症状，拉莫三嗪与左乙拉西坦相比也有类似改善。
