Zou Li-Ping, Ding Chang-Huan, Fang Fang, Sin Ngai-Chuen, Mix Eilhard
Department of Neurology, Beijing Children's Hospital, Capital University of Medical Sciences, Beijing, China.
Clin Neuropharmacol. 2006 Nov-Dec;29(6):343-9. doi: 10.1097/01.WNF.0000236768.54150.8C.
This was a prospective open study to establish the efficacy, tolerability, and problems associated with the use of topiramate as first-choice drug in children with infantile spasms.
Open-label follow-up study, ranging from 24 to 36 months, of the cases of 54 patients with infantile spasms treated initially with topiramate as first-choice drug.
Thirty-one patients (57.4%) were seizure free for more than 24 months; 9 patients were treated with topiramate alone and 22 patients with topiramate plus nitrazepam and/or valproate. In 44 cases (81.4%), the reduction of seizure frequency from baseline was greater than 30%, whereas in 10 cases (18.6%), there was poor or no response. The average dosage applied was 5.2 mg/kg per day (maximum dosage, 26 mg/kg per day; minimum dosage, 1.56 mg/kg per day). Adverse events occurred in 14 patients (26%). They included poor appetite leading to anorexia, absence of sweating, and sleeplessness.
Topiramate proves to be an effective and safe first-choice drug not only as adjunctive but also as monotherapy of infantile spasms in children younger than 2 years.
这是一项前瞻性开放性研究，旨在确定托吡酯作为婴儿痉挛症患儿首选药物的疗效、耐受性及相关问题。
对54例最初以托吡酯作为首选药物治疗的婴儿痉挛症患儿进行了为期24至36个月的开放标签随访研究。
31例患者（57.4%）无癫痫发作超过24个月；9例患者仅接受托吡酯治疗，22例患者接受托吡酯加硝西泮和/或丙戊酸治疗。44例患者（81.4%）癫痫发作频率较基线降低超过30%，而10例患者（18.6%）反应不佳或无反应。平均用药剂量为每日5.2毫克/千克（最大剂量为每日26毫克/千克；最小剂量为每日1.56毫克/千克）。14例患者（26%）出现不良事件。包括食欲减退导致厌食、不出汗和失眠。
托吡酯不仅作为辅助治疗，而且作为2岁以下儿童婴儿痉挛症的单一疗法，被证明是一种有效且安全的首选药物。
