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在长期使用哌甲酯后嵌入临床实践的N = 1项随机、双盲、安慰剂对照、交叉停药试验的结果:一项试点研究。

Results of N = 1 randomized, double-blind, placebo-controlled, cross-over discontinuation trials embedded in clinical practice after longer term methylphenidate use: a pilot study.

作者信息

Rosenau Paul T, Dietrich Andrea, van den Hoofdakker Barbara J, Hoekstra Pieter J

机构信息

Department of Child and Adolescent Psychiatry, University of Groningen, University Medical Center Groningen, Lübeckweg 2, Groningen, 9723 HE, The Netherlands.

Accare Child Study Center, Groningen, The Netherlands.

出版信息

Eur Child Adolesc Psychiatry. 2024 Nov 27. doi: 10.1007/s00787-024-02609-1.

DOI:10.1007/s00787-024-02609-1
PMID:39601808
Abstract

Attention-deficit/hyperactivity (ADHD) guidelines recommend that the need for continued stimulant medication treatment of children and adolescents needs to be reviewed at least annually. We aimed to assess the outcomes in clinical practice of placebo-controlled discontinuation trials after long-term methylphenidate treatment. We asked clinicians to implement N = 1 randomized, double-blind, placebo-controlled, cross-over discontinuation trials after at least one year of methylphenidate treatment of children and adolescents (n = 26, 6-15 years of age). We analyzed the effectiveness of ongoing methylphenidate treatment compared to placebo on symptoms of ADHD, oppositional defiant disorder, and conduct disorder according to both parents and teachers, and the global improvement or deterioration according to the clinicians. We also assessed the proportion of individuals who continued using methylphenidate after the discontinuation trial. Teacher-rated hyperactivity and impulsivity symptoms were significantly lower during methylphenidate treatment compared to placebo (β = 3.80, SD = 1.69, t = 2.25, p =.04). No other significant differences were found between methylphenidate and placebo. Almost two-thirds (n = 16, 61.5%) of individuals continued using methylphenidate after the discontinuation trials, of which seven did not deteriorate during placebo according to their clinician. Our findings support the need for regular evaluations of methylphenidate treatment effectiveness and emphasize the importance of including the school setting when evaluating treatments. Better guidance for clinicians when to continue or cease methylphenidate treatment is urgently needed.

摘要

注意缺陷多动障碍(ADHD)指南建议,儿童和青少年持续使用兴奋剂药物治疗的必要性至少每年审查一次。我们旨在评估长期使用哌醋甲酯治疗后安慰剂对照停药试验在临床实践中的结果。我们要求临床医生在对儿童和青少年(n = 26,6 - 15岁)进行至少一年的哌醋甲酯治疗后,实施N = 1的随机、双盲、安慰剂对照、交叉停药试验。我们根据家长和教师的评价,分析了持续使用哌醋甲酯治疗与安慰剂相比对ADHD、对立违抗障碍和品行障碍症状的有效性,以及根据临床医生的评价分析了整体改善或恶化情况。我们还评估了停药试验后继续使用哌醋甲酯的个体比例。与安慰剂相比,哌醋甲酯治疗期间教师评定的多动和冲动症状显著更低(β = 3.80,标准差 = 1.69,t = 2.25,p = 0.04)。哌醋甲酯和安慰剂之间未发现其他显著差异。几乎三分之二(n = 16,61.5%)的个体在停药试验后继续使用哌醋甲酯,其中7人根据其临床医生的评价在服用安慰剂期间症状未恶化。我们的研究结果支持定期评估哌醋甲酯治疗效果的必要性,并强调在评估治疗时纳入学校环境的重要性。迫切需要为临床医生提供关于何时继续或停止哌醋甲酯治疗的更好指导。

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Continued Benefits of Methylphenidate in ADHD After 2 Years in Clinical Practice: A Randomized Placebo-Controlled Discontinuation Study.在临床实践 2 年后,哌醋甲酯治疗 ADHD 的持续获益:一项随机安慰剂对照停药研究。
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Dutch version of the Strengths and Difficulties Questionnaire (SDQ).《优势与困难问卷》(SDQ)荷兰语版本。
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