Adler Lenard A, Zimmerman Brenda, Starr H Lynn, Silber Steve, Palumbo Joseph, Orman Camille, Spencer Thomas
NYU School of Medicine, New York VA Harbor Healthcare System, New York, NY 10016, USA.
J Clin Psychopharmacol. 2009 Jun;29(3):239-47. doi: 10.1097/JCP.0b013e3181a390ce.
To assess the efficacy and safety of OROS methylphenidate (Concerta; McNeil Pediatrics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, Titusville, NJ) in the management of attention-deficit/hyperactivity disorder (ADHD) in adults.
A randomized, 7-week, double-blind, placebo-controlled, dose-escalation, parallel-group study of OROS methylphenidate 36, 54, 72, 90, or 108 mg/d versus placebo was conducted in adults with ADHD. The primary end point was the Adult ADHD Investigator Symptom Report Scale. Other assessments included the Clinical Global Impressions-Improvement scale, a post hoc responder analysis, adverse events, and vital signs.
Two hundred twenty-six subjects (56.2% male; mean age, 39.0 years; range, 18-65 years) were included in the intention-to-treat population (110 subjects on OROS methylphenidate; 116 subjects on placebo). OROS methylphenidate resulted in greater ADHD symptom improvement than placebo as demonstrated by a statistically significantly lower least squares mean change from baseline in Adult ADHD Investigator Symptom Report Scale total score at the final visit (last observation carried forward [LOCF]; P = 0.012). Subjects on OROS methylphenidate also had a significantly lower least squares mean Clinical Global Impressions-Improvement score at the final visit (LOCF; P = 0.008). A significantly greater proportion of subjects on OROS methylphenidate (36.9%, 38/103 subjects) were responders at the final visit (LOCF) compared with placebo (20.9%, 24/115 subjects; P = 0.009). OROS methylphenidate was well tolerated. Adverse events were reported by 93 (84.5%) of the 110 OROS methylphenidate-treated subjects versus 74 (63.8%) of the 116 placebo-treated subjects. No serious treatment-emergent adverse events and no deaths were reported. Similar mean changes from baseline to final visit (LOCF) for systolic and diastolic blood pressures for the OROS methylphenidate and placebo groups were observed.
In a dose escalation ranging from 36 to 108 mg/d, OROS methylphenidate is effective and well tolerated in the management of ADHD in adults.
评估缓释型哌醋甲酯（专注达；麦克尼尔儿科部，奥索-麦克尼尔-杨森制药公司，新泽西州蒂特斯维尔）治疗成人注意力缺陷/多动障碍（ADHD）的疗效和安全性。
对患有ADHD的成人进行一项随机、为期7周、双盲、安慰剂对照、剂量递增、平行组研究，比较36、54、72、90或108mg/d的缓释型哌醋甲酯与安慰剂。主要终点是成人ADHD研究者症状报告量表。其他评估包括临床总体印象改善量表、事后应答者分析、不良事件和生命体征。
意向性治疗人群纳入了226名受试者（56.2%为男性；平均年龄39.0岁；范围18 - 65岁）（110名受试者接受缓释型哌醋甲酯治疗；116名受试者接受安慰剂治疗）。缓释型哌醋甲酯比安慰剂更能改善ADHD症状，最终访视时（末次观察结转[LOCF]）成人ADHD研究者症状报告量表总分从基线的最小二乘均值变化在统计学上显著更低（P = 0.012）。接受缓释型哌醋甲酯治疗的受试者在最终访视时（LOCF）的最小二乘均值临床总体印象改善评分也显著更低（P = 0.008）。与安慰剂组（20.9%，24/115名受试者）相比，接受缓释型哌醋甲酯治疗的受试者在最终访视时（LOCF）应答者比例显著更高（36.9%，38/103名受试者；P = 0.009）。缓释型哌醋甲酯耐受性良好。110名接受缓释型哌醋甲酯治疗的受试者中有93名（84.5%）报告了不良事件，而116名接受安慰剂治疗的受试者中有74名（63.8%）报告了不良事件。未报告严重的治疗中出现的不良事件和死亡病例。观察到缓释型哌醋甲酯组和安慰剂组从基线到最终访视（LOCF）收缩压和舒张压的平均变化相似。
在36至108mg/d的剂量递增范围内，缓释型哌醋甲酯治疗成人ADHD有效且耐受性良好。
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