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目的了解左乙拉西坦(LEV)添加治疗大田原综合征(OS)的疗效。方法采用开放性自身对照研究,对确诊OS且当抗癫药物治疗无效的患儿给予添加LEV口服治疗。共入组11例。男7例,女4例;年龄29～87 d。治疗剂量从10 mg·kg-1·d-1开始,每1～2周日剂量增加10 mg·kg-1,至维持剂量40～50 mg·kg-1·d-1,分2次口服。治疗前1周和治疗后1个月及每3个月分别评价临床发作及视频脑电图。治疗期间检测肝肾功能及血常规,密切随访不良反应。结果 1例(9.1%)因出现明显的烦躁症状,在服药2周停药,停药2 d后烦躁症状完全缓解;其余10例患儿平均随访时间16.3个月(7～28个月)。1例(9.1%)发作完全控制,7例(63.6%)发作减少>50%,2例(18.1%)无效,总有效率为72.7%。6例患儿(54.5%)精神运动发育滞后有不同程度减轻。坚持服药的10例患儿均未出现明显不良反应,治疗期间未见肝、肾功能及血常规有异常改变。结论 LEV添加治疗OS具有良好疗效及安全性,可以在临床中进一步推广,但尚需多中心随机双盲安慰剂对照试验进一步支持。
Objective To investigate the efficacy of levetiracetam (LEV) in the treatment of Haodahara syndrome (OS). Methods Open self-controlled study was conducted to treat children with confirmed OS who were ineffective in antiepileptic treatment with oral LEV supplementation. A total of 11 patients in the group. There were 7 males and 4 females, ranging in age from 29 to 87 days. The therapeutic dose was increased from 10 mg · kg-1 · d-1 to 10 mg · kg-1 every 1 to 2 weeks until the maintenance dose was 40 to 50 mg · kg-1 · d-1 . One week before treatment and one month after treatment and every three months, respectively, clinical evaluation and video EEG were evaluated. During the treatment of liver and kidney function tests and blood, close follow-up adverse reactions. Results One patient (9.1%) was relieved of symptoms of irritability after 2 weeks of medication. The symptoms of irritability were completely relieved after 2 days of discontinuation. The average follow-up time of the remaining 10 patients was 16.3 months (range, 7-28 months). One patient (9.1%) had complete control of the seizures, seven patients (63.6%) had seizures reduced by> 50%, two patients (18.1%) were ineffective and the total effective rate was 72.7%. Six children (54.5%) had different levels of psychomotor retardation. Adhere to medication in 10 cases of children showed no obvious adverse reactions, no liver, kidney function and blood routine abnormal changes during the treatment. Conclusions The therapeutic effect and safety of LEV in the treatment of OS are good and can be further popularized clinically. However, a multicenter randomized, double-blind, placebo-controlled trial is still needed.