Chmielewska Barbara, Stelmasiak Zbigniew
Department and Clinic of Neurology, Medical University of Lublin.
Ann Univ Mariae Curie Sklodowska Med. 2002;57(1):226-36.
Previous reports justified positive impact of tiagabine, a new-generation antiepileptic drug on neuropsychological functioning as well as minimal risk of psychiatric exacerbations. In this prospective, open, observational, non-comparative, short-term--6 months' study we evaluated efficacy and tolerability of tiagabine as add-on in polytherapy in 30 young adults with both refractory epilepsy and mild or moderate mental retardation. About 40% of patients experienced improvement in seizure frequency of 50% or more and none complained of seizure deterioration. Overall seizure frequency fell down from a mean 9.9 at the baseline to 6.3 seizure days per month. The seizure rate was reduced from 14.9 to 9.2 per month after 24 weeks of add-on phase. Adjunctive tiagabine therapy appeared to be associated with reduction in overall seizure severity characteristics expressed as enhancement of mild seizures from 30 to 50% of patients and reduction in severe seizures from 30 to 16%. Responders reported an improvement in most health-related quality of life domains but mostly cognition, medication effects and social functioning. The majority (90%) of patients did not report additional adverse effects with tiagabine; the most common complains associated with central nervous system (vertigo, weakness, nervousness) were transient and did not cause discontinuation. Blood counts and liver functional tests did not show any clinically relevant changes. In this short-term observation tiagabine seemed to be a beneficial antiepileptic drug for mentally retarded patients with epilepsy as it decreased seizure frequency and severity, improved the patients' sense of the quality of life without enhancement of the risk of adverse effects in polytherapy.
先前的报告证实，新一代抗癫痫药物噻加宾对神经心理功能有积极影响，且精神症状加重的风险极小。在这项前瞻性、开放性、观察性、非对照、为期6个月的短期研究中，我们评估了噻加宾作为附加药物用于30名患有难治性癫痫以及轻度或中度智力障碍的年轻成年人联合治疗时的疗效和耐受性。约40%的患者癫痫发作频率改善了50%或更多，且无人抱怨癫痫发作恶化。总体癫痫发作频率从基线时的平均每月9.9次降至每月6.3天。附加治疗阶段24周后，癫痫发作率从每月14.9次降至9.2次。附加噻加宾治疗似乎与总体癫痫发作严重程度特征的降低有关，表现为轻度癫痫发作的患者比例从30%增至50%，重度癫痫发作的患者比例从30%降至16%。有反应的患者报告称，大多数与健康相关的生活质量领域有所改善，但主要是认知、药物作用和社会功能方面。大多数（90%）患者未报告噻加宾有额外的不良反应；与中枢神经系统相关的最常见主诉（眩晕、虚弱、紧张）是短暂的，未导致停药。血常规和肝功能检查未显示任何临床相关变化。在这项短期观察中，噻加宾似乎是一种对患有癫痫的智力障碍患者有益的抗癫痫药物，因为它降低了癫痫发作频率和严重程度，改善了患者的生活质量感，且未增加联合治疗中不良反应的风险。
