注意缺陷多动障碍共病物质使用障碍青少年中渗透压释放型哌甲酯与认知行为疗法的随机对照试验。
Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders.
机构信息
University of Colorado-Denver, Aurora, CO 80045, USA.
出版信息
J Am Acad Child Adolesc Psychiatry. 2011 Sep;50(9):903-14. doi: 10.1016/j.jaac.2011.06.010. Epub 2011 Aug 4.
OBJECTIVE
To evaluate the efficacy and safety of osmotic-release methylphenidate (OROS-MPH) compared with placebo for attention-deficit/hyperactivity disorder (ADHD), and the impact on substance treatment outcomes in adolescents concurrently receiving cognitive-behavioral therapy (CBT) for substance use disorders (SUD).
METHOD
This was a 16-week, randomized, controlled, multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents (aged 13 through 18 years) meeting DSM-IV diagnostic criteria for ADHD and SUD. Primary outcome measures included the following: for ADHD, clinician-administered ADHD Rating Scale (ADHD-RS), adolescent informant; for substance use, adolescent-reported days of use in the past 28 days. Secondary outcome measures included parent ADHD-RS and weekly urine drug screens (UDS).
RESULTS
There were no group differences on reduction in ADHD-RS scores (OROS-MPH: -19.2, 95% confidence interval [CI], -17.1 to -21.2; placebo, -21.2, 95% CI, -19.1 to -23.2) or reduction in days of substance use (OROS-MPH: -5.7 days, 95% CI, 4.0-7.4; placebo: -5.2 days, 95% CI, 3.5-7.0). Some secondary outcomes favored OROS-MPH, including lower parent ADHD-RS scores at 8 (mean difference = 4.4, 95% CI, 0.8-7.9) and 16 weeks (mean difference =6.9; 95% CI, 2.9-10.9) and more negative UDS in OROS-MPH (mean = 3.8) compared with placebo (mean = 2.8; p = .04).
CONCLUSIONS
OROS-MPH did not show greater efficacy than placebo for ADHD or on reduction in substance use in adolescents concurrently receiving individual CBT for co-occurring SUD. However, OROS-MPH was relatively well tolerated and was associated with modestly greater clinical improvement on some secondary ADHD and substance outcome measures. Clinical Trial Registration Information-Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents with Substance Use Disorders (SUD); http://www.clinicaltrials.gov; NCT00264797.
目的
评估渗透释放型哌甲酯（OROS-MPH）治疗注意缺陷多动障碍（ADHD）的疗效和安全性，并评估其对同时接受认知行为治疗（CBT）治疗物质使用障碍（SUD）的青少年物质治疗结局的影响。
方法
这是一项为期 16 周、随机、对照、多地点的 OROS-MPH+CBT 与安慰剂+CBT 治疗 303 名符合 DSM-IV 诊断标准的 ADHD 和 SUD 青少年（年龄 13 至 18 岁）的试验。主要结局测量指标包括：ADHD，临床医生管理的 ADHD 评定量表（ADHD-RS），青少年报告；物质使用，青少年报告过去 28 天内的使用天数。次要结局测量指标包括父母 ADHD-RS 和每周尿液药物筛查（UDS）。
结果
在 ADHD-RS 评分降低（OROS-MPH：-19.2，95%置信区间[CI]，-17.1 至-21.2；安慰剂：-21.2，95%CI，-19.1 至-23.2）或物质使用天数减少方面（OROS-MPH：-5.7 天，95%CI，4.0-7.4；安慰剂：-5.2 天，95%CI，3.5-7.0），两组之间无差异。一些次要结局有利于 OROS-MPH，包括在 8 周（平均差异=4.4，95%CI，0.8-7.9）和 16 周（平均差异=6.9；95%CI，2.9-10.9）时父母 ADHD-RS 评分较低，以及 OROS-MPH 组（均值=3.8）较安慰剂组（均值=2.8；p=0.04）的 UDS 更呈阴性。
结论
与安慰剂相比，OROS-MPH 并未显示出对 ADHD 或同时接受针对共病 SUD 的个体 CBT 的青少年物质使用减少的更大疗效。然而，OROS-MPH 耐受性相对较好，与一些次要 ADHD 和物质结局测量指标上的适度更大临床改善相关。
临床试验注册信息-注意力缺陷多动障碍（ADHD）在患有物质使用障碍（SUD）的青少年中；http://www.clinicaltrials.gov；NCT00264797。
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