Cramer J A, Arrigo C, Van Hammée G, Gauer L J, Cereghino J J
Departments of Psychiatry and Neurology, Yale University School of Medicine, New Haven, Connecticut, USA.
Epilepsia. 2000 Jul;41(7):868-74. doi: 10.1111/j.1528-1157.2000.tb00255.x.
To evaluate the short-term effect of levetiracetam (LEV; UCB L059) as add-on therapy on health-related quality of life in the treatment of refractory partial-onset seizures.
Patients were enrolled in protocol UCB N132 if they had >/=12 partial-onset seizures with or without secondary generalization during the 12-week baseline period with a minimum of two seizures every 4 weeks. Randomization was made to placebo, LEV 1,000 mg, or LEV 3,000 mg, with sample size based on seizure frequency reduction. The 31-item Quality of Life in Epilepsy (QOLIE-31) questionnaire was completed by 246 patients at the end of baseline and at 18-week follow-up, or earlier if withdrawn.
Significant differences were found among the three treatment groups for Seizure Worry (p = 0. 0003), Overall Quality of Life (p = 0.04), and Cognitive Functioning domains (p = 0.01), as well as the Total Score (p = 0.009). Responders (>/=50% partial onset seizure reduction) had significant improvements in all areas, except Medication Effect, compared with nonresponders (all p > 0.006). Clinically noticeable improvement (>/=10% change from baseline to follow-up) was perceived by LEV 3, 000 mg responders in all areas, except Emotional Well-Being, by LEV 1,000 mg responders in 5 of 9 areas, and by placebo responders in 2 of 9 areas.
Addition of LEV to standard medication seems to have a positive impact on health-related quality of life, particularly among responders in this short-term study. These exploratory analyses require additional studies to evaluate long-term changes in a larger population.
评估左乙拉西坦（LEV；UCB L059）作为附加疗法治疗难治性部分性发作癫痫对健康相关生活质量的短期影响。
如果患者在12周的基线期内有≥12次部分性发作，无论有无继发性全身性发作，且每4周至少发作两次，则纳入UCB N132方案。随机分为安慰剂组、1000 mg左乙拉西坦组或3000 mg左乙拉西坦组，样本量基于发作频率降低情况确定。246例患者在基线期结束时和18周随访时，或提前退出研究时，完成了31项癫痫生活质量（QOLIE - 31）问卷。
三个治疗组在癫痫担忧（p = 0.0003）、总体生活质量（p = 0.04）、认知功能领域（p = 0.01）以及总分（p = 0.009）方面存在显著差异。与无反应者相比，有反应者（部分性发作减少≥50%）在所有领域均有显著改善，但药物疗效领域除外（所有p>0.006）。3000 mg左乙拉西坦组有反应者在所有领域均有临床显著改善（从基线到随访变化≥10%），情绪健康领域除外；1000 mg左乙拉西坦组有反应者在9个领域中的5个领域有改善；安慰剂组有反应者在9个领域中的2个领域有改善。
在标准药物治疗中添加左乙拉西坦似乎对健康相关生活质量有积极影响，尤其是在这项短期研究中的有反应者中。这些探索性分析需要更多研究来评估更大人群中的长期变化。
