Departments of Psychiatry and Child and Adolescent Psychiatry, NYU School of Medicine, 403 E. 34th St, 4th Floor, New York, NY 10016, USA.
J Clin Psychopharmacol. 2011 Feb;31(1):108-14. doi: 10.1097/JCP.0b013e318203ea0a.
To evaluate the long-term safety of OROS methylphenidate in the management of attention-deficit/hyperactivity disorder (ADHD) in adults.
This multicenter, open-label, dose-titration, flexible dose study enrolled adults with ADHD for 6 or 12 months of treatment with OROS methylphenidate. Dosing began at 36 mg/d, with titration in 18-mg increments every 7 days until a predefined outcome (efficacy threshold, maximum dosage of 108 mg/d, or limiting adverse event). Dose reduction occurred for prespecified reasons, and the subjects discontinued if unable to tolerate 36 mg/d. Assessments included ADHD symptoms, adverse events, vital signs, and laboratory results.
A total of 550 subjects received treatment (52% were men; mean age, 39 years; range, 18-65 years), and 57% (146/258) and 44% (129/292) completed their 6 or 12 months of treatment with mean durations of 128 and 213 days, respectively. The final prescribed dosages were 36 mg/d (22.4%), 54 mg/d (25.1%), 72 mg/d (22.0%), 90 mg/d (17.1%), and 108 mg/d (13.5%). Modest increases from baseline to final visit were observed in mean systolic (2.6 mm Hg) and diastolic (1.9 mm Hg) blood pressure and pulse (4.1 beats per minute). The mean weight decreased by 2.3 kg. No clinically meaningful changes in laboratory values or electrocardiogram parameters were observed other than increased heart rate. Most common adverse events included decreased appetite (26.7%), headache (24.0%), and insomnia (20.7%). No serious adverse event was considered related to study medication. Several measures of efficacy indicated improvement during the study.
OROS methylphenidate, in the flexible dosage range from 36 to 108 mg/d, was well tolerated for up to 1 year in adults with ADHD.
评估控释型哌甲酯治疗成人注意缺陷多动障碍（ADHD）的长期安全性。
这项多中心、开放性、剂量滴定、灵活剂量研究共纳入 6 或 12 个月接受控释型哌甲酯治疗的 ADHD 成年患者。起始剂量为 36mg/d，每 7 天增加 18mg，直至达到预先设定的结局（疗效阈值、最大剂量 108mg/d 或出现限制用药的不良事件）。由于预先规定的原因进行剂量减少，如果患者不能耐受 36mg/d，则停止治疗。评估包括 ADHD 症状、不良事件、生命体征和实验室结果。
共有 550 例患者接受了治疗（52%为男性；平均年龄为 39 岁；范围，18-65 岁），57%（146/258）和 44%（129/292）完成了 6 或 12 个月的治疗，平均持续时间分别为 128 天和 213 天。最终的处方剂量为 36mg/d（22.4%）、54mg/d（25.1%）、72mg/d（22.0%）、90mg/d（17.1%）和 108mg/d（13.5%）。与基线相比，最终访视时的平均收缩压（2.6mmHg）、舒张压（1.9mmHg）和脉搏（4.1 次/分钟）略有增加。平均体重下降 2.3kg。除心率增加外，实验室值或心电图参数无其他有临床意义的变化。最常见的不良事件包括食欲下降（26.7%）、头痛（24.0%）和失眠（20.7%）。无严重不良事件被认为与研究药物有关。几项疗效指标表明，在研究期间有所改善。
在 ADHD 成年患者中，控释型哌甲酯的灵活剂量范围为 36-108mg/d，可耐受长达 1 年。
