Dupont S, Stefan H
Unité d’Epilepsie, Clinique Neurologique Paul Castaigne, Hôpital de la Salpêtrière, 47 Boulevard de l’Hôpital, Paris Cedex 13, France.
Acta Neurol Scand Suppl. 2012(194):29-35. doi: 10.1111/ane.12017.
Zonisamide is currently licensed in Europe and the USA for the adjunctive treatment of partial seizures (with or without secondary generalization) in adults, based on the results of four pivotal, randomized, double-blind, placebo-controlled trials. It is also licensed in Europe as monotherapy for adults with newly diagnosed partial epilepsy, based on the results of a randomized, double-blind, non-inferiority trial. Because clinical trials are conducted under tightly controlled conditions, using rigid dosing schedules and employing strict exclusion/exclusion criteria, there is a need for 'real-world' evidence of an antiepileptic drug's effectiveness and tolerability in clinical practice, where patients are much more diverse in terms of clinical characteristics and treatment is tailored to the individual's specific needs. Several studies have demonstrated that adjunctive treatment with zonisamide is effective when administered under everyday clinical practice conditions, with a favourable safety/tolerability profile similar to that observed in clinical trials. In the Zonisamid im Alltag Der Epilepsiepatienten (ZADE) study, almost 80% of patients showed a reduction in seizure frequency of ≥50% over a median follow-up of 18 weeks, and over one-third of patients became seizure free. Data from these clinical practice studies also indicate that zonisamide is effective and generally well tolerated when administered as a first-line adjunctive treatment and is associated with high retention rates and improvements in quality of life. Evidence from these clinical practice studies therefore complements data from zonisamide's clinical trial programme, providing pragmatic information on the likely benefits and risks of treatment under real-life conditions.
基于四项关键的随机、双盲、安慰剂对照试验结果，唑尼沙胺目前在欧洲和美国被批准用于成人部分性癫痫发作（伴或不伴继发全面性发作）的辅助治疗。基于一项随机、双盲、非劣效性试验结果，唑尼沙胺在欧洲也被批准用于新诊断的成人部分性癫痫的单药治疗。由于临床试验是在严格控制的条件下进行的，采用严格的给药方案并运用严格的纳入/排除标准，因此需要有抗癫痫药物在临床实践中的“真实世界”有效性和耐受性证据，在临床实践中，患者的临床特征更加多样化，治疗是根据个体的特定需求进行定制的。多项研究表明，在日常临床实践条件下给予唑尼沙胺辅助治疗是有效的，其安全性/耐受性良好，与临床试验中观察到的情况相似。在“癫痫患者日常生活中的唑尼沙胺（ZADE）”研究中，近80%的患者在中位随访18周期间癫痫发作频率降低了≥50%，超过三分之一的患者癫痫发作停止。这些临床实践研究的数据还表明，唑尼沙胺作为一线辅助治疗药物使用时是有效的，并且一般耐受性良好，与高保留率和生活质量改善相关。因此，这些临床实践研究的证据补充了唑尼沙胺临床试验项目的数据，提供了关于在现实生活条件下治疗可能的益处和风险的实用信息。
