托吡酯单药及托吡酯联合维生素D3预防儿童偏头痛的疗效：一项随机临床试验
Efficacy of Topiramate Alone and Topiramate Plus Vitamin D3 in the Prophylaxis of Pediatric Migraine: A Randomized Clinical Trial.
作者信息
Fallah Razieh, Sarraf Yazd Saeedreza, Sohrevardi Seid Mojtaba
机构信息
Department of Pediatrics, Growth Disorders of Children Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Department of Clinical Pharmacology, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
出版信息
Iran J Child Neurol. 2020 Fall;14(4):77-86.
OBJECTIVE
Topiramate is effective in the prevention of pediatric migraine, and studies show that vitamin D supplementation might also be useful in the treatment of adult migraineurs with a normal vitamin D level. The present study aimed at comparing the efficacy and safety of topiramate plus vitamin D and topiramate alone in the prophylaxis of pediatric migraine.
MATERIALS & METHODS: In a single-blinded, randomized, clinical trial, 5-15-year-old children with migraine headaches, referred to the Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from January 2016 to January 2017, were randomly allocated to receive 2 mg/kg/day of topiramate or 2 mg/kg/day of topiramate plus one 500,000 IU vitamin D pearl weekly for two consecutive months.Primary outcomes were the reduction of monthly frequency, severity, duration, and the disability score of migraine, and the secondary outcomes included a good response to treatment (more than 50% reduction in monthly headache frequency) and a lack of clinical adverse events.
RESULTS
Totally, 31 female and 26 male children with the mean age of 10.02±2.11 years were evaluated. Both drugs were effective in the reduction of monthly frequency, severity, duration, and disability for headaches. Nevertheless, the combination of topiramate and vitamin D was more effective than topiramate alone in reducing the monthly headaches frequency (6.12±1.26 vs. 9.87±2.44 times, P=0.01) and disability score (19.24±6.32 vs. 22.11±7.91, P=0.02). Good response to treatment was observed in 60.7% and 75.9% of the subjects in the topiramate alone and topiramate plus vitamin D groups, respectively, and topiramate plus vitaminD3 was more effective (P= 0.01). Transient mild side effects were observed in 14.3% and 17.2% of the subjects in the topiramate alone and topiramate plus vitamin D groups, respectively (P=0.8).
CONCLUSION
A combination of topiramate and vitamin D might be considered safe and more effective than topiramate alone in the prophylaxis of pediatric migraine.
目的
托吡酯对预防儿童偏头痛有效，且研究表明，补充维生素D可能对维生素D水平正常的成年偏头痛患者也有帮助。本研究旨在比较托吡酯加维生素D与单用托吡酯预防儿童偏头痛的疗效和安全性。
材料与方法
在一项单盲、随机临床试验中，2016年1月至2017年1月转诊至伊朗亚兹德沙希德萨杜基医科大学儿科神经科诊所的5至15岁偏头痛儿童被随机分配接受2mg/kg/天的托吡酯或2mg/kg/天的托吡酯加每周一颗500,000IU维生素D软胶囊，持续两个月。主要结局指标为偏头痛每月发作频率、严重程度、持续时间及残疾评分的降低，次要结局指标包括对治疗的良好反应（每月头痛频率降低超过50%）和无临床不良事件。
结果
共评估了31名女性和26名男性儿童，平均年龄为10.02±2.11岁。两种药物均能有效降低头痛的每月发作频率、严重程度、持续时间及残疾程度。然而，托吡酯与维生素D联合使用在降低每月头痛频率（6.12±1.26次对9.87±2.44次，P=0.01）和残疾评分（19.24±6.32对22.11±7.91，P=0.02）方面比单用托吡酯更有效。单用托吡酯组和托吡酯加维生素D组分别有60.7%和75.9%的受试者对治疗有良好反应，托吡酯加维生素D3更有效（P=0.01）。单用托吡酯组和托吡酯加维生素D组分别有14.3%和17.2%的受试者出现短暂轻度副作用（P=0.8）。
结论
在预防儿童偏头痛方面，托吡酯与维生素D联合使用可能比单用托吡酯更安全、更有效。
Zotero 插件