Effectiveness of methylphenidate in the 10-month continuation phase of the Preschoolers with Attention-Deficit/Hyperactivity Disorder Treatment Study (PATS).

Effectiveness of methylphenidate in the 10-month continuation phase of the Preschoolers with Attention-Deficit/Hyperactivity Disorder Treatment Study (PATS).
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哌醋甲酯在学龄前儿童注意力缺陷/多动障碍治疗研究 (PATS) 10 个月持续阶段的有效性。

DOI:
10.1089/cap.2007.0058
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发表时间:
2007
影响因子:
1.9
通讯作者:
Cunningha
Cunningha
中科院分区:
医学3区
文献类型:
--
作者:
Vitiello,Benedetto;Abikoff,HowardB;Chuang,ShirleyZ;Kollins,ScottH;McCracken,JamesT;Riddle,MarkA;Swanson,JamesM;Wigal,Tim;McGough,JamesJ;Ghuman,JaswinderK;Wigal,SharonB;Skrobala,AnneM;Davies,Mark;Posner,Kelly;Cunningha

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目的:本研究的目的是检查立即释放哌甲酯的有效性在10个月的开放标签持续阶段的学龄前儿童注意缺陷多动障碍(ADHD)治疗研究(PATS)。方法:140名学龄前儿童ADHD,谁改善了急性立即释放哌甲酯(IR-MPH)治疗,进入了10个月,开放标签药物维持在6个网站。评估包括临床总体印象-严重程度(CGI-S)、CGI-改善(CGI-I)、儿童总体评估量表(C-GAS)、Swanson、Nolan和Pelham问卷(SNAP)、ADHD-症状和正常行为的量表优势和劣势(SWAN)、社交能力量表、社交技能评定系统(SSRS)和育儿压力指数-简表(PSI-SF)。对于完成10个月治疗的95名儿童,CGI-S(p= 0.02)、CGI-I(p< 0.01)、C-GAS(p= 0.001)和SSRS(p= 0.01)均有所改善。SNAP和SWAN评分保持稳定。45名儿童停药:7例为不良反应,7例为行为恶化,7例为改用长效兴奋剂,3例为获益不足,21例为其他原因。平均MPH剂量从第1个月的14.04 mg/d ± SD 7.57(0.71 ± 0.38 mg/kg/d)增加到第10个月的19.98 mg/d ± 9.56(0.92 ± 0.40 mg/kg/d)。结论:在严密监测和逐渐增加药物剂量的情况下,大多数学龄前ADHD儿童在长期IR-MPH治疗期间保持了改善。有效和耐受剂量存在显著差异。
Objective:The aim of this study was to examine immediate-release methylphenidate effectiveness during the 10-month open-label continuation phase of the Preschoolers with attention-deficit/hyperactivity disorder (ADHD) Treatment Study (PATS).Methods:One hundred and forty preschoolers with ADHD, who had improved with acute immediate-release methylphenidate (IR-MPH) treatment, entered a 10-month, open-label medication maintenance at six sites. Assessments included the Clinical Global Impression-Severity (CGI-S), CGI-Improvement (CGI-I), Children's Global Assessment Scale (C-GAS), Swanson, Nolan, and Pelham Questionnaire (SNAP), Scale Strengths and Weaknesses of ADHD-Symptoms and Normal Behaviors (SWAN), Social Competence Scale, Social Skills Rating System (SSRS), and Parenting Stress Index–Short Form (PSI-SF).Results:For the 95 children who completed the 10-month treatment, improvement occurred on the CGI-S (p= 0.02), CGI-I (p< 0.01), C-GAS (p= 0.001), and SSRS (p= 0.01). SNAP and SWAN scores remained stable. Forty five children discontinued: 7 for adverse effects, 7 for behavior worsening, 7 for switching to long-acting stimulants, 3 for inadequate benefit, and 21 for other reasons. The mean MPH dose increased from 14.04 mg/day ± SD 7.57 (0.71 ± 0.38 mg/kg per day) at month 1 to 19.98 mg/day ± 9.56 (0.92 ± 0.40 mg/kg per day) at month 10.Conclusions:With careful monitoring and gradual medication dose increase, most preschoolers with ADHD maintained improvement during long-term IR-MPH treatment. There was substantial variability in effective and tolerated dosing.