Silva Raul R, Muniz Rafael, Pestreich Linda, Brams Matthew, Mao Alice R, Childress Ann, Wang James
Dr. Silva is with the New York University Child Study Center; Drs. Muniz and Wang and Ms. Pestreich are with Novartis Pharmaceuticals; Dr. Brams is with Bayou City Research and with Baylor College of Medicine; Dr. Mao is with the Mental Health and Mental Retardation Authority of Harris County (Texas) and with the Baylor College of Medicine; Dr. Childress is with the Center for Psychiatry and Behavioral Medicine, Inc..
Dr. Silva is with the New York University Child Study Center; Drs. Muniz and Wang and Ms. Pestreich are with Novartis Pharmaceuticals; Dr. Brams is with Bayou City Research and with Baylor College of Medicine; Dr. Mao is with the Mental Health and Mental Retardation Authority of Harris County (Texas) and with the Baylor College of Medicine; Dr. Childress is with the Center for Psychiatry and Behavioral Medicine, Inc.
J Am Acad Child Adolesc Psychiatry. 2008 Feb;47(2):199-208. doi: 10.1097/chi.0b013e31815cd9a4.
This study compared once-daily dexmethylphenidate extended release (D-MPH-ER) 20 mg/day and placebo over 12 hours in children ages 6 to 12 with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting.
All of the children were stabilized for > or =2 weeks on a total dose (nearest equivalent) MPH 40 mg/day or immediate-release D-MPH 20 mg/day before screening. After a practice day, they received 6 days of D-MPH-ER 20 mg/day or placebo at home, returning on day 7 for one dose. Subjects were evaluated at predose and postdose hours 0.5, 1, 3, 4, 5, 7, 9, 10, 11, and 12 and then crossed over to the other treatment arm using the identical protocol. The primary efficacy variable was the change from predose in Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP) combined score from 1 to 12 hours. Secondary efficacy variables included SKAMP combined score at 0.5 hours, SKAMP subscale scores, and math test results over 12 hours.
Sixty-eight children were randomized, with 67 completing the study. Onset of action was indicated by a significant difference between D-MPH-ER and placebo at 0.5 hour on the SKAMP combined score (p = .001). For efficacy measures, differences from placebo were significant at all points between 0.5 and 12 hours (p < .001 top = .013).
D-MPH-ER provided sustained improvement in attention, deportment, and academic productivity throughout the 12-hour laboratory day.
本研究在实验室课堂环境中，对6至12岁患有注意力缺陷多动障碍（ADHD）的儿童，比较了每日一次20毫克缓释右苯丙胺（D-MPH-ER）与安慰剂在12小时内的效果。
所有儿童在筛选前，均以总剂量（最接近等效剂量）40毫克/天的MPH或20毫克/天的速释D-MPH稳定治疗≥2周。在一个练习日后，他们在家中接受6天的20毫克/天D-MPH-ER或安慰剂治疗，第7天返回服用一剂。在给药前以及给药后0.5、1、3、4、5、7、9、10、11和12小时对受试者进行评估，然后使用相同方案交叉至另一个治疗组。主要疗效变量是1至12小时内，斯旺森、科特金、阿格勒、M-弗林和佩勒姆评定量表（SKAMP）综合评分相对于给药前的变化。次要疗效变量包括0.5小时时的SKAMP综合评分、SKAMP子量表评分以及12小时内的数学测试结果。
68名儿童被随机分组，67名完成研究。在0.5小时时，D-MPH-ER与安慰剂在SKAMP综合评分上存在显著差异，表明起效（p = .001）。对于疗效指标，在0.5至12小时的所有时间点，与安慰剂的差异均显著（p < .001至p = .013）。
在长达12小时的实验室日中，D-MPH-ER在注意力、行为举止和学习效率方面提供了持续改善。
