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目的 采用对照试验评价妥泰治疗婴儿痉挛 (West综合征 )的疗效和安全性。方法 将 30例West综合征患儿随机分组 ,15例为妥泰观察组 ,另 15例为对照组。观察组中 5例为妥泰单药治疗者 ,10例为妥泰和硝基安定联合应用者。结果 观察组住院期间接受妥泰治疗的平均剂量是 4 2mg/ (kg·d) ,最大剂量 7.1mg/ (kg·d)。 15例患儿发作均得到不同程度的控制 ,其中 12例在院期间发作完全控制。平均随访 2 2～ 2 4个月。 12例在院期间发作被完全控制的患儿 ,出院后又出现发作的 9例 ,其中出院 1个月内发作的有 3例 ,2～ 3个月发作的6例。住院期间未完全控制的 3例和出院后又出现发作的 9例患儿在增加妥泰剂量后 ,随访 2 4个月 ,随访时平均发作次数是 0 3～ 1 0次 /月 ,妥泰的平均剂量 6 .6mg/ (kg·d) ,最小剂量 1 2mg/ (kg·d) ,最大剂量 12 5mg/ (kg·d)。随访至 2 4个月 ,妥泰观察组 15例中 ,发作完全控制 6个月以上有 5例 ,其中 3例 2 4个月没有发作 ;有效 8例 ,无效或放弃 2例。结论 妥泰作为一种新型抗癫疒间 药物 ,对症状性婴儿痉挛有较好的疗效 ,安全、副作用少 ;与硝基安定联合应用可以减少药物的副作用和药物剂量。
Objective To evaluate the efficacy and safety of topiramate in the treatment of infantile spasms (West syndrome). Methods Thirty children with West syndrome were randomly divided into three groups: 15 cases of Topotec group and 15 cases of control group. Five patients in the observation group were treated with Topiramate, and 10 were topiramate and nitrazepam. Results The average dose of topiramate in the observation group during hospitalization was 42 mg / (kg · d) and the maximum dose was 7.1 mg / (kg · d). 15 cases of children with seizures have different degrees of control, of which 12 cases were completely controlled during the attack in the hospital. The average follow-up 2 2 ~ 2 4 months. Of the 12 children who underwent complete control of their seizures during the hospital period, 9 were reported to have seizures after discharged from hospital, including 3 in 1 month after discharge and 6 in 2 to 3 months. During the period of follow-up, the average number of seizures was 0 3 ~ 10 times per month after 3 months of incomplete control in hospitalization and 9 cases of seizures after discharged from hospital. The average dose of 6. 6mg / (kg · d), the minimum dose of 12mg / (kg · d), the maximum dose of 125mg / (kg · d). During the follow-up period to 24 months, in the top-observation group of 15 cases, there were 5 cases with complete control over 6 months, of which 3 cases did not attack in 24 months; 8 cases were effective, 2 cases were invalid or abandoned. Conclusions Topotecan, as a new antiepileptic drug, has good curative effect on the symptomatic infantile spasms with less side effects and less side effects and dose of the drug when used in combination with nitrazepam.