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氨苯砜治疗耐药性部分发作性癫痫患者的安全性和耐受性:一项开放标签试验。

Safety and tolerability of dapsone for the treatment of patients with drug-resistant, partial-onset seizures: an open-label trial.

机构信息

Neurology Division, National Institute of Neurology and Neurosurgery, Mexico City, Mexico.

出版信息

Neurol Sci. 2011 Dec;32(6):1063-7. doi: 10.1007/s10072-011-0612-6. Epub 2011 May 17.

Abstract

Dapsone has shown anti-convulsive properties in animal models of epilepsy. In the present study, we tested the safety and tolerability of dapsone as adjunctive therapy in adult patients with drug-resistant partial-onset seizures. Twenty-two adult patients with drug-resistant partial-onset seizures were included. After a 3-month baseline period, patients received dapsone 100 mg per day, for a 3-month evaluation period. Plasma concentrations of anti-epileptic drugs (AEDs) did not significantly change during the study. No alteration of mean clinical laboratory values was observed. The reported adverse events were: mild methemoglobinemia (50%), headache (31.8%), paleness (27.3%) and somnolence (4.5%).Sixteen of 22 patients reduced their seizure frequency in more than 50% as a result of dapsone treatment. Three subjects remained seizure-free during the entire dapsone treatment period. This open-label study of adjunctive dapsone therapy at 100 mg/day suggests that dapsone is safe, and well-tolerated in adults with drug-resistant partial-onset seizures.

摘要

氨苯砜在癫痫动物模型中表现出抗惊厥特性。在本研究中,我们测试了氨苯砜作为附加疗法在耐药性部分发作性癫痫成人患者中的安全性和耐受性。纳入了 22 名耐药性部分发作性癫痫的成年患者。在 3 个月的基线期后,患者接受每天 100mg 的氨苯砜治疗,进行 3 个月的评估期。研究期间,抗癫痫药物(AEDs)的血浆浓度没有明显变化。未观察到平均临床实验室值的改变。报告的不良事件为:轻度高铁血红蛋白血症(50%)、头痛(31.8%)、苍白(27.3%)和嗜睡(4.5%)。由于氨苯砜治疗,22 名患者中有 16 名的癫痫发作频率降低了 50%以上。3 名受试者在整个氨苯砜治疗期间保持无癫痫发作。这项每日 100mg 氨苯砜辅助治疗的开放性研究表明,氨苯砜在耐药性部分发作性癫痫的成人中是安全且耐受良好的。

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