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一项针对成人迟发性注意力缺陷多动障碍患者的奥罗速释型哌甲酯开放标签试验。

An open-label trial of OROS methylphenidate in adults with late-onset ADHD.

作者信息

Biederman Joseph, Mick Eric, Spencer Thomas, Surman Craig, Hammerness Paul, Doyle Robert, Dougherty Megan, Aleardi Megan, Schweitzer Karl

机构信息

Joint Program, Pediatric Psychopharmacology Research Office, Massachusetts General Hospital, Boston, MA 02114, USA.

出版信息

CNS Spectr. 2006 May;11(5):390-6. doi: 10.1017/s1092852900014528.

DOI:10.1017/s1092852900014528
PMID:16641844
Abstract

INTRODUCTION

Many adults with current impairing symptoms of attention-deficit/hyperactivity disorder (ADHD) do not report an age at onset before 7 years of age and cannot, therefore, be assigned the full Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), diagnosis of ADHD. We hypothesized that treatment with oral release osmotic system (OROS) methylphenidate (MPH) will be safe and efficacious for the treatment of adults with late-onset ADHD.

METHOD

This was a 6-week, open-label, prospective treatment study of OROS MPH monotherapy in 36 adult patients with late-onset ADHD (onset later than the required 7 years of age) using standardized instruments for diagnosis and a robust oral daily dose of up to 1.3 mg/kg/day. Symptom severity was assessed with the Adult ADHD Investigator Symptom Report Scale (AISRS) and the Clinical Global Impression (CGI) scale.

RESULTS

Subjects reported robust current symptoms of ADHD at pre-treatment baseline (11.1+/-2.8 DSM-IV symptoms), but had an atypical mean age at onset of 14.2+/-8.6 years. Treatment with OROS MPH at an average daily dose of 78.2+/-29.4 mg was associated with a statistically and clinically significant reduction in ADHD symptoms relative to baseline as assessed through the AISRS (-16.4+/-10.5; P<.001). Using a categorical definition of response (CGI-I much or very much improved), a majority (n = 26; 72%) of subjects were rated as improved at endpoint.

CONCLUSION

These results extend previous findings in adults with full ADHD to adults meeting criteria for late-onset ADHD and support the need for further controlled clinical trials in this population.

摘要

引言

许多患有当前注意力缺陷/多动障碍(ADHD)损害性症状的成年人并未报告7岁之前的起病年龄,因此无法被完全诊断为《精神疾病诊断与统计手册》第四版(DSM-IV)中的ADHD。我们假设口服渗透系统(OROS)哌甲酯(MPH)治疗对于晚发性ADHD成年人是安全有效的。

方法

这是一项为期6周的开放标签前瞻性治疗研究,对36例晚发性ADHD(起病晚于规定的7岁)成年患者进行OROS MPH单药治疗,使用标准化诊断工具,口服日剂量最高可达1.3mg/kg/天。使用成人ADHD研究者症状报告量表(AISRS)和临床总体印象(CGI)量表评估症状严重程度。

结果

受试者在治疗前基线时报告有明显的当前ADHD症状(11.1±2.8项DSM-IV症状),但平均起病年龄为非典型的14.2±8.6岁。通过AISRS评估,平均日剂量78.2±29.4mg的OROS MPH治疗与ADHD症状相对于基线有统计学和临床意义的减轻相关(-16.4±10.5;P<0.001)。使用反应的分类定义(CGI-I改善很多或非常多),大多数受试者(n = 26;72%)在终点时被评为改善。

结论

这些结果将先前在完全ADHD成年人中的发现扩展到符合晚发性ADHD标准的成年人,并支持在该人群中进行进一步对照临床试验的必要性。

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