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在台湾的一家医疗中心进行的一项回顾性图表审查显示,比较奥卡西平口服液在婴儿和癫痫儿童中的疗效和耐受性。

A comparison of the efficacy and tolerability of oxcarbazepine oral suspension between infants and children with epilepsy: a retrospective chart review at a single medical center in Taiwan.

机构信息

Departments of Pediatrics, E-Da Hospital and I-Shou University, Kaohsiung, Taiwan.

出版信息

Paediatr Drugs. 2014 Feb;16(1):83-9. doi: 10.1007/s40272-013-0049-x.

Abstract

BACKGROUND

Few clinical studies have assessed the efficacy and safety of oxcarbazepine (OXC) oral suspension in Asian pediatric patients and particularly in infants. The aim of this study was to investigate and compare the efficacy, tolerability, and side effects of OXC oral suspension in Taiwanese infants and children with various types of epilepsy.

METHODS

A retrospective review of the efficacy, tolerability, and side effects of OXC oral suspension in a tertiary medical center in Taiwan was conducted and included children (1-9 years old) and infants (<1 year old) diagnosed with epilepsy, which was classified into idiopathic partial, symptomatic partial, or multifocal subtypes. The OXC oral suspension (Trileptal(®); Novartis) was given in a gradual dose titration, from an initial 7.5 mg/kg/day to 30 mg/kg/day within 1 month in all cases.

RESULTS

A total of 20 infants and 38 children were identified. There were no statistically significant differences between the children and infants in efficacy (75 vs. 82 %, p = 0.734) and adverse effects (30 vs. 21 %, p = 0.525) after OXC oral suspension treatment. The efficacy was significantly correlated with the epilepsy subtype (p < 0.01) and the number of combined antiepileptic drugs (AEDs) before OXC treatment (p < 0.01) in both groups. The patients with idiopathic and symptomatic partial epilepsy responded better to OXC oral suspension than those with multifocal epilepsy.

CONCLUSIONS

OXC oral suspension is effective and well tolerated in both infants and children with partial epilepsy in Taiwan. Treatment efficacy was related to epilepsy subtype and number of combined AEDs before OXC treatment. Monotherapy had an excellent therapeutic response in partial epilepsy but not in multifocal epilepsy.

摘要

背景

很少有临床研究评估奥卡西平(OXC)口服混悬液在亚洲儿科患者中的疗效和安全性,尤其是在婴儿中。本研究旨在调查和比较 OXC 口服混悬液在台湾各种类型癫痫的婴儿和儿童中的疗效、耐受性和副作用。

方法

对台湾一家三级医学中心的 OXC 口服混悬液疗效、耐受性和副作用进行回顾性分析,纳入年龄为 1-9 岁的儿童和<1 岁的婴儿,诊断为癫痫,分为特发性部分性、症状性部分性或多灶性亚型。OXC 口服混悬液(Trileptal®;诺华)以逐渐滴定剂量给予,所有患者在 1 个月内从初始 7.5 mg/kg/天增加至 30 mg/kg/天。

结果

共确定 20 例婴儿和 38 例儿童。OXC 口服混悬液治疗后,儿童和婴儿的疗效(75% vs. 82%,p=0.734)和不良反应(30% vs. 21%,p=0.525)无统计学差异。两组中,疗效与癫痫亚型(p<0.01)和 OXC 治疗前联合使用抗癫痫药物(AEDs)的数量(p<0.01)显著相关。特发性和症状性部分性癫痫患者对 OXC 口服混悬液的反应优于多灶性癫痫患者。

结论

OXC 口服混悬液在台湾部分性癫痫的婴儿和儿童中有效且耐受良好。治疗效果与癫痫亚型和 OXC 治疗前联合使用 AEDs 的数量有关。在部分性癫痫中,单药治疗有极好的疗效,但在多灶性癫痫中则不然。

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