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长效控释型哌甲酯治疗成人注意缺陷多动障碍的疗效和安全性:一项 13 周、随机、双盲、安慰剂对照、固定剂量研究。

Efficacy and safety of prolonged-release OROS methylphenidate in adults with attention deficit/hyperactivity disorder: a 13-week, randomized, double-blind, placebo-controlled, fixed-dose study.

机构信息

Department of Psychiatry, Hospital Universitari Vall d'Hebron and Department of Psychiatry and Legal Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.

出版信息

World J Biol Psychiatry. 2013 May;14(4):268-81. doi: 10.3109/15622975.2011.600333. Epub 2011 Nov 22.

DOI:10.3109/15622975.2011.600333
PMID:22106853
Abstract

OBJECTIVES

Methylphenidate (MPH) is effective for adults with attention-deficit/hyperactivity disorder (ADHD). This study aimed to evaluate the efficacy and safety of OROS MPH in adults with ADHD.

METHODS

Randomized, double-blind study; 279 subjects received OROS MPH 54 or 72 mg/day, or placebo, for 13 weeks. Primary endpoint was the Conners' Adult ADHD Rating Scale - Screening Version (CAARS-O:SV). Secondary outcomes included CAARS Self Report - Short Version (CAARS-S:S), Sheehan Disability Scale (SDS) and ADHD Impact Module - Adult (AIM-A).

RESULTS

Improvements in CAARS-O:SV were significantly greater with OROS MPH 72 mg vs. placebo (P = 0.0024). CAARS-S:S scores decreased significantly vs. placebo in both OROS MPH arms (P < 0.05). There was no significant change in SDS score from baseline in either treatment arm, although significant benefit vs. placebo was observed on several AIM-A subscales. Treatment was well tolerated.

CONCLUSIONS

OROS MPH provided overall benefits in the treatment of adults with ADHD.

摘要

目的

哌醋甲酯(MPH)对成人注意缺陷多动障碍(ADHD)有效。本研究旨在评估控释哌甲酯(OROS MPH)治疗成人 ADHD 的疗效和安全性。

方法

随机、双盲研究;279 名受试者接受 OROS MPH 54 或 72mg/天或安慰剂治疗 13 周。主要终点为 Conners 成人 ADHD 评定量表-筛查版(CAARS-O:SV)。次要结局包括 CAARS 自评量表-短版(CAARS-S:S)、Sheehan 残疾量表(SDS)和成人 ADHD 影响量表-模块(AIM-A)。

结果

与安慰剂相比,OROS MPH 72mg 组的 CAARS-O:SV 改善显著更大(P=0.0024)。与安慰剂相比,OROS MPH 两组的 CAARS-S:S 评分均显著降低(P<0.05)。在任何治疗组中,SDS 评分从基线开始均无显著变化,但在几个 AIM-A 子量表上观察到与安慰剂相比有显著获益。治疗耐受性良好。

结论

OROS MPH 为成人 ADHD 的治疗提供了整体获益。

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