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哌甲酯对患有注意力缺陷多动障碍和发育性协调障碍儿童运动表现的影响:一项随机双盲交叉临床试验

The Impact of Methylphenidate on Motor Performance in Children with both Attention Deficit Hyperactivity Disorder and Developmental Coordination Disorder: A Randomized Double-Blind Crossover Clinical Trial.

作者信息

Soleimani Robabeh, Kousha Maryam, Zarrabi Homa, Tavafzadeh-Haghi Seyede Mahnaz, Jalali Mir Mohammad

机构信息

Department of Psychiatry, Cognitive and Addiction Research Center, Shafa Hospital, Guilan University of Medical Sciences, Guilan, Iran.

Department of Child Psychiatry, Shafa Hospital, Guilan University of Medical Sciences, Guilan, Iran.

出版信息

Iran J Med Sci. 2017 Jul;42(4):354-361.

Abstract

BACKGROUND

Children with attention deficit hyperactivity disorder/developmental coordination disorder (ADHD/DCD) suffer from problems associated with gross and fine motor skills. There is no effective pharmacological therapy for such patients. We aimed to assess the impact of methylphenidate (MPH) on motor performance of children with ADHD/DCD.

METHODS

In this double-blind placebo-controlled, 17 children (12 boys) with ADHD/DCD with a mean age of 7 years 6 months were recruited in Shafa Hospital, Rasht, Iran. The response was defined as ≥25% reduction in the total score of ADHD rating scale-IV from the baseline. Sixteen boys entered phase 2 of the study in which the impact of MPH on motor function was determined through a crossover randomized clinical trial. Eligible individuals were scheduled for baseline and two assessment visits after a one-week period of intervention. We used the short form of Bruininks-Oseretsky test (BOT-2) to identify the disability of motor function. Children were randomly assigned to receive MPH or inert ingredients (placebo). In the second period, medication (MPH/placebo) was crossed over. The effects of MPH were analyzed using χ test for related samples to compare the performance during baseline, placebo, and MPH trials. The results were analyzed using the SPSS software version 16.0.

RESULTS

The mean minimal effective dose of MPH per day was 17.3 mg (0.85 mg/kg). Children with higher ADHD rating scale had a significantly lower standard score in BOT-2 (P=0.03). Following MPH intake, 26.6% of the children showed clinically significant improvement in motor function. However, the improvement was not statistically different between the MPH and placebo.

CONCLUSION

Although MPH improved ADHD symptoms, problems with motor performance still remained. Further work is required to determine the probable effects of MPH in a higher dosage or in different subtypes of ADHD.

TRIAL REGISTRATION NUMBER

IRCT201107071483N2.

摘要

背景

患有注意力缺陷多动障碍/发育性协调障碍(ADHD/DCD)的儿童存在与粗大和精细运动技能相关的问题。此类患者尚无有效的药物治疗方法。我们旨在评估哌甲酯(MPH)对ADHD/DCD儿童运动表现的影响。

方法

在伊朗拉什特的沙法医院招募了17名(12名男孩)患有ADHD/DCD的儿童,平均年龄为7岁6个月。以ADHD评定量表-IV总分较基线降低≥25%作为反应标准。16名男孩进入研究的第二阶段,通过交叉随机临床试验确定MPH对运动功能的影响。符合条件的个体在一周的干预期后安排进行基线和两次评估访视。我们使用布吕尼inks-奥塞雷茨基测试简表(BOT-2)来识别运动功能障碍。儿童被随机分配接受MPH或惰性成分(安慰剂)。在第二阶段,药物(MPH/安慰剂)进行交叉。使用相关样本的χ检验分析MPH的效果,以比较基线、安慰剂和MPH试验期间的表现。结果使用SPSS 16.0软件进行分析。

结果

MPH的平均每日最小有效剂量为17.3毫克(0.85毫克/千克)。ADHD评定量表得分较高的儿童在BOT-2中的标准得分显著较低(P=0.03)。摄入MPH后,26.6%的儿童运动功能有临床显著改善。然而,MPH组和安慰剂组之间的改善在统计学上无差异。

结论

虽然MPH改善了ADHD症状,但运动表现问题仍然存在。需要进一步研究以确定更高剂量的MPH或ADHD不同亚型中MPH的可能效果。

试验注册号

IRCT201107071483N2。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe73/5523042/1843855a38fc/IJMS-42-354-g001.jpg

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