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首页> 外文期刊>The journal of clinical psychiatry >Efficacy of a novel biphasic controlled-release methylphenidate formula in adults with attention-deficit/hyperactivity disorder: results of a double-blind, placebo-controlled crossover study.
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Efficacy of a novel biphasic controlled-release methylphenidate formula in adults with attention-deficit/hyperactivity disorder: results of a double-blind, placebo-controlled crossover study.

机译：新型双相控释哌醋甲酯配方对患有注意力缺陷/多动症的成年人的疗效：一项双盲，安慰剂对照交叉研究的结果。

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OBJECTIVE: To evaluate the efficacy and safety of a new biphasic multilayer-release (MLR) methylphenidate formulation in a double-blind, placebo-controlled crossover study of adults with attention-deficit/hyperactivity disorder (ADHD). METHOD: Adults 18 to 60 years of age with a DSM-IV diagnosis of ADHD entered a no-medication baseline week and were then randomly assigned to once-daily MLR methylphenidate or matching placebo. Patients were titrated to optimal effect over 1 to 3 weeks followed by 2 weeks of treatment on a stable dose. The same titration protocol was repeated with the alternate treatment. Clinical Global Impressions scale (CGI) and Conners' Adult ADHD Rating Scales (Self-rated, CAARS-S, and Observer-rated, CAARS-O) were collected at weekly clinic visits. The study was conducted between October 2003 and April 2004. RESULTS: Fifty patients were randomly assigned to treatment, and 39 were analyzed in a per-protocol population (23 men, 16 women; mean age = 37.9 years). CGI-Improvement scoresof subjects taking MLR methylphenidate were significantly improved compared with placebo (Global Improvement: 2.6 vs. 3.7; p = .0015). MLR methylphenidate produced improvements over placebo on the ADHD Index T scores of the CAARS-S (12.2 vs. 5.4 [change from baseline score]; p = .0083) and the CAARS-O (10.9 vs. 6.6 [change from baseline score]; p = .1404). The most frequent adverse events for MLR methylphenidate and placebo were headache (26% and 24%, respectively), anorexia (22% and 6%), insomnia (22% and 8%), nervousness (20% and 4%), and nausea (16% and 8%). There were no serious adverse events. CONCLUSIONS: Once-daily MLR methylphenidate produces significant improvements in ADHD symptoms and situational behavior in adult patients with ADHD, with a prolonged duration of effect and minimal side effects, thus having the potential to improve compliance and, therefore, treatment outcomes in routine clinical use.
机译：目的：评估一种新的双相多层释放（MLR）哌醋甲酯制剂在双盲，安慰剂对照的交叉研究中对成人注意力不足/多动障碍（ADHD）的疗效和安全性。方法：18至60岁的DSM-IV诊断为ADHD的成年人进入非药物治疗基准周，然后随机分配至每天一次的MLR哌醋甲酯或匹配的安慰剂。在1至3周内将患者滴定至最佳效果，然后以稳定剂量治疗2周。替代处理重复相同的滴定方案。在每周的临床访视中收集了《临床总体印象量表》（CGI）和《康纳斯成人ADHD评定量表》（自评定为CAARS-S，观察者评定为CAARS-O）。该研究在2003年10月至2004年4月之间进行。结果：50名患者被随机分配接受治疗，按协议人群中的39名进行了分析（23名男性，16名女性;平均年龄= 37.9岁）。与安慰剂相比，服用MLR哌醋甲酯的受试者的CGI改善评分显着改善（总体改善：2.6 vs. 3.7; p = .0015）。 MLR哌醋甲酯对CAARS-S的ADHD指数T评分（12.2 vs. 5.4 [较基线评分变化; p = .0083）和CAARS-O（10.9 vs. 6.6 [较基线评分变化]）产生了优于安慰剂的改善。 ; p = .1404）。 MLR哌醋甲酯和安慰剂最常见的不良事件是头痛（分别为26％和24％），厌食（22％和6％），失眠（22％和8％），神经质（20％和4％）和恶心（16％和8％）。没有严重的不良事件。结论：每天一次的MLR哌醋甲酯对成人多动症患者的多动症症状和处境行为有显着改善，作用时间延长且副作用最小，因此具有改善依从性的潜力，因此可提高常规临床使用中的治疗结果。

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