Center for Tumor-related Epilepsy, UOSD Psychiatry, Italy.
Epileptic Disord. 2012 Dec;14(4):388-97. doi: 10.1684/epd.2012.0542.
An open pilot study to evaluate the effect of pregabalin (PGB) as add-on therapy on seizure control, quality of life, and anxiety in patients with brain tumour-related epilepsy (BTRE).
We recruited 25 consecutive patients with BTRE and uncontrolled seizures. At baseline and during follow-up, patients underwent a complete physical and neurological examination and were evaluated using the QOLIE 31P (V2), EORTC QLQ C30, Adverse Events Profile, and Hamilton Anxiety Rating Scale (HAM-A). At baseline, a seizure diary was given.
During follow-up, 17 patients underwent chemotherapy, none underwent radiotherapy, 9 had disease progression, and 3 died. Mean duration of follow-up was 4.1 months. Mean PGB dosage was 279 mg/day. At baseline, mean weekly seizure frequency was 5.3 (±10) and at last available follow-up visit was 2.8±5. This difference was statistically significant (p=0.016). The responder rate was 76%. Ten patients dropped out; 4 as a result of seizure worsening, 1 as a result of unchanged seizure frequency, 3 as a result of a lack of compliance, and 2 as a result of side effects. Based on the QOLIE-31-P, a significant improvement of the subscale "seizure worry" (p=0.004) and a significant decrease in distress scores related to AEDs and social life (p=0.009 and p=0.008, respectively) were observed. A significant decrease in HAM-A score (p=0.002) was documented. CONCLUSIONS; These data indicate that PGB may represent a valid alternative as add-on treatment in this patient population, based on its efficacy on seizure control and anxiety.
本开放性试点研究旨在评估普瑞巴林(PGB)作为附加治疗对脑肿瘤相关性癫痫(BTRE)患者的癫痫控制、生活质量和焦虑的影响。
我们招募了 25 例连续的 BTRE 合并癫痫发作控制不佳的患者。在基线和随访期间,患者接受了全面的体格检查和神经系统检查,并使用 QOLIE 31P(V2)、EORTC QLQ C30、不良事件概况和汉密尔顿焦虑量表(HAM-A)进行评估。基线时,患者被给予一份癫痫发作日记。
在随访期间,17 例患者接受了化疗,无一例接受了放疗,9 例患者疾病进展,3 例患者死亡。平均随访时间为 4.1 个月。平均 PGB 剂量为 279mg/天。基线时,平均每周癫痫发作频率为 5.3(±10),最后一次随访时为 2.8±5。这一差异具有统计学意义(p=0.016)。应答率为 76%。10 例患者退出;4 例因癫痫发作恶化,1 例因癫痫发作频率无变化,3 例因缺乏依从性,2 例因不良反应而退出。根据 QOLIE-31-P,观察到“癫痫担忧”子量表显著改善(p=0.004),与 AED 和社会生活相关的困扰评分显著降低(p=0.009 和 p=0.008,分别)。HAM-A 评分显著降低(p=0.002)。
这些数据表明,基于 PGB 对癫痫控制和焦虑的疗效,PGB 可能是该患者人群的附加治疗的有效选择。