Cramer Joyce A, Van Hammée Geneviève
Department of Psychiatry, Yale University School of Medicine, 950 Campbell Avenue (Room 7-127), West Haven, CT 06516, USA.
Epilepsy Behav. 2003 Apr;4(2):118-23. doi: 10.1016/s1525-5050(03)00004-0.
Health-related quality of life (HRQOL) of patients taking levetiracetam (LEV) was evaluated in long-term follow-up. Short-term assessments compared LEV and placebo add-on therapy in an 18-week clinical trial, with long-term follow-up for a mean of 4.1 years. The QOLIE-31 was expanded to assess distress associated with each domain, change, and priority of importance of each domain. Significant improvements were observed at short-term in patients starting with LEV (N=66), whereas patients initially randomized to placebo (N=35) were unchanged. Improvement observed in LEV starters remained stable long-term. Placebo starters reached the same level of improvement in HRQOL at long-term. Correlations between the QOLIE-31-P distress items and domain items indicated that distress was significantly lower when HRQOL was better (P<0.0001, all domains). At long-term, highest-priority QOLIE-31-P domains were Social Functioning, Cognitive Function, and Overall QOL. Thus, gains in HRQOL were maintained during long-term LEV treatment, whether LEV was initiated early or late. Patient distress and importance of domains are useful data in determining how treatments impact on HRQOL.
在长期随访中评估了服用左乙拉西坦（LEV）患者的健康相关生活质量（HRQOL）。在一项为期18周的临床试验中对左乙拉西坦和安慰剂附加疗法进行了短期评估，并进行了平均4.1年的长期随访。对癫痫生活质量量表-31（QOLIE-31）进行扩展，以评估与每个领域相关的痛苦、变化以及每个领域重要性的优先级。开始服用左乙拉西坦的患者（N = 66）在短期内有显著改善，而最初随机分配到安慰剂组的患者（N = 35）则无变化。在左乙拉西坦起始治疗的患者中观察到的改善在长期内保持稳定。长期来看，安慰剂起始治疗的患者在HRQOL方面达到了相同的改善水平。癫痫生活质量量表-31-痛苦项目（QOLIE-31-P）与领域项目之间的相关性表明，当HRQOL较好时，痛苦显著降低（P < 0.0001，所有领域）。长期来看，癫痫生活质量量表-31-痛苦项目优先级最高的领域是社会功能、认知功能和总体生活质量。因此，无论左乙拉西坦是早期还是晚期开始使用，在长期左乙拉西坦治疗期间HRQOL的改善都得以维持。患者的痛苦和领域的重要性是确定治疗如何影响HRQOL的有用数据。
