Fallah Razieh, Shoroki Fatemeh F, Ferdosian Farzad
Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Curr Drug Saf. 2015;10(2):132-5. doi: 10.2174/1574886309666140605114614.
Preventive therapy in migraine must be started with frequent or disabling headaches in children, while, no drugs have been approved for migraine preventive therapy of them up to now. The aim of the present research was to investigate safety and efficacy of melatonin in pediatric migraine prophylaxis.
In a quasi- experimental study, monthly frequency, severity and duration of headache, migraine disability and clinical side effects in sixty migraineur referred children to Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from January to June 2013 whom were treated with single dose of 0.3 mg/kg melatonin for three months, were evaluated.
Thirty two (53.3%) girls and 28(46.7%) boys with mean age of 10.31 ± 2.39 years were evaluated, 38 of whom (63.3%) had migraine without aura. Clinical adverse events were seen in 23.3% (N=14) of children including sleepiness in seven, vomiting in four, mild hypotension in two and constipation in one child. Excessive daytime sleepiness as a serious side effect was seen in three children which caused the drug use to be stopped. Monthly frequency, severity and duration of headache reduced from 15.63 ± 7.64 to 7.07 ± 4.42 attacks, from 6.20 ± 1.67 to 3.55 ± 2.11 scores, and from 2.26 ± 1.34 to 1.11 ± 0.55 hours, respectively. Pediatric Migraine Disability Assessment score decreased from 31.72 ± 8.82 to 17.78 ± 10.64. (All p < 0.05).
Melatonin might be considered as an effective and without life-threatening side effects drug in prophylaxis of migraine in children.
儿童偏头痛的预防性治疗必须在头痛频繁发作或严重影响日常生活时开始，然而目前尚无药物被批准用于儿童偏头痛的预防性治疗。本研究的目的是探讨褪黑素在儿童偏头痛预防中的安全性和有效性。
在一项准实验研究中，对2013年1月至6月转诊至伊朗亚兹德沙希德萨杜基医科大学儿科神经科门诊的60例偏头痛儿童进行了评估，这些儿童接受单剂量0.3mg/kg褪黑素治疗3个月，评估其头痛的每月发作频率、严重程度和持续时间、偏头痛残疾程度及临床副作用。
共评估了32名（53.3%）女孩和28名（46.7%）男孩，平均年龄为10.31±2.39岁，其中38名（63.3%）为无先兆偏头痛。23.3%（N=14）的儿童出现临床不良事件，包括7名儿童嗜睡、4名儿童呕吐、2名儿童轻度低血压和1名儿童便秘。3名儿童出现严重副作用白天过度嗜睡，导致停药。头痛的每月发作频率、严重程度和持续时间分别从15.63±7.64次发作减少到7.07±4.42次发作，从6.20±1.67分减少到3.55±2.11分，从2.26±1.34小时减少到1.11±0.55小时。儿童偏头痛残疾评估评分从31.72±8.82降至17.78±10.64。（所有p<0.05）。
褪黑素可被视为一种有效且无危及生命副作用的儿童偏头痛预防药物。
