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一项比较阿米替林与托吡酯预防儿童慢性每日头痛的随机试验。

A randomized trial comparing amitriptyline versus topiramate for the prophylaxis of chronic daily headache in pediatric patients.

机构信息

Division of Pediatric Neurology, Baskent University School of Medicine, Bahcelievler, Ankara, Turkey.

出版信息

Int J Neurosci. 2013 Aug;123(8):553-6. doi: 10.3109/00207454.2013.776048. Epub 2013 Mar 14.

Abstract

OBJECTIVE

the goal of this prospective and double-blind study was to compare the efficacy of amitriptyline and topiramate for the prevention of pediatric chronic daily headache (CDH).

RESEARCH DESIGN AND METHODS

fifty-seven children (aged 9-16 yr) diagnosed with CDH were randomly assigned to two groups: group A (n = 29 patients) received amitriptyline 0.5 mg/kg/d and group B (n = 28 patients) received topiramate 25 mg/d increasing up to 100 mg/d according to patient response. Treatment response was monitored for at least 4 months.

RESULTS

fifty-five percent of the patients in group A responded to amitriptyline and 61% of patients in group B responded to topiramate as defined by a reduction of more than 50% in monthly headache frequency. There was no significant difference in responder rate or adverse event rate between the two groups (p > 0.05). By the end of the 4-month treatment period, there were no significant differences in the final average severity and monthly frequency of headaches between treatment groups.

CONCLUSION

these results suggest that the efficacy and tolerability of topiramate is equivalent to that of amitriptyline for reducing the frequency of headache in pediatric CHD patients.

摘要

目的

本前瞻性、双盲研究旨在比较阿米替林和托吡酯预防儿童慢性每日头痛(CDH)的疗效。

研究设计和方法

57 名被诊断为 CDH 的儿童(9-16 岁)被随机分配到两组:A 组(n = 29 例)接受阿米替林 0.5mg/kg/d,B 组(n = 28 例)接受托吡酯 25mg/d,根据患者反应增加至 100mg/d。至少监测 4 个月的治疗反应。

结果

A 组 55%的患者对阿米替林有反应,B 组 61%的患者对托吡酯有反应,定义为每月头痛频率降低 50%以上。两组的应答率或不良反应率无显著差异(p>0.05)。在 4 个月的治疗期末,治疗组之间头痛的最终平均严重程度和每月频率均无显著差异。

结论

这些结果表明,托吡酯的疗效和耐受性与阿米替林相当,可降低儿童 CHD 患者头痛的频率。

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