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聚焦成人注意力缺陷多动障碍患者使用托莫西汀的情况。

Spotlight on atomoxetine in adults with attention-deficit hyperactivity disorder.

作者信息

Simpson Dene, Plosker Greg L

机构信息

Adis International Limited, Auckland, New Zealand.

出版信息

CNS Drugs. 2004;18(6):397-401. doi: 10.2165/00023210-200418060-00011.

DOI:10.2165/00023210-200418060-00011
PMID:15089111
Abstract

UNLABELLED

Atomoxetine (Strattera) is a selective noradrenaline (norepinephrine) reuptake inhibitor and nonstimulant that has shown greater efficacy than placebo in attention-deficit hyperactivity disorder (ADHD) in adults. In two large, well controlled, 10-week trials in adults with ADHD, improvements in ADHD symptoms, as assessed by investigator- and patient-rated scores, were greater with oral atomoxetine (60, 90 or 120 mg/day) than with placebo. Mean reductions in the total ADHD symptom score on the investigator-rated Conners' Adult ADHD Rating Scale (CAARS) in atomoxetine versus placebo recipients were 28.3% versus 18.1% and 30.1% versus 19.6%, respectively. Mean reductions in the scores on the Clinician Global Impression of Severity Scale, patient-rated CAARS and Wender-Reimherr Adult Attention Deficit Disorder Scale were also significantly greater with atomoxetine than with placebo. Continued efficacy was demonstrated in a noncomparative, 34-week extension phase. Atomoxetine was generally well tolerated in clinical trials; withdrawal rates due to adverse events in atomoxetine- versus placebo-treated patients participating in the two major trials were 7.8% versus 4.3% and 9.3% versus 2.4% (p < 0.05 for the latter trial). Adverse events reported significantly more frequently with atomoxetine than placebo included dry mouth, insomnia, nausea, decreased appetite, constipation, dizziness, sweating, dysuria, sexual problems and palpitations. Modest increases in heart rate and blood pressure were well tolerated and gradually decreased on cessation of treatment. Atomoxetine was not associated with QT interval prolongation. Atomoxetine can be administered once or twice daily. Its subjective-effects profile is different to that of methylphenidate and atomoxetine is not associated with abuse or diversion; it is therefore not a controlled substance in the US. This also means repeat prescriptions during long-term treatment can be more conveniently processed.

CONCLUSION

Atomoxetine is an effective and generally well tolerated treatment for adults with ADHD. It is a nonstimulant and is the first ADHD treatment to be approved specifically for adult use based on its efficacy in well controlled adult trials. It can be administered as a single daily dose or split into two evenly divided doses. It carries negligible risk of abuse or diversion and is not a controlled substance. Atomoxetine is a valuable new treatment option for adults with ADHD and is particularly useful in patients who are at risk for substance abuse or who do not wish to take a controlled substance.

摘要

未标注

托莫西汀(择思达)是一种选择性去甲肾上腺素再摄取抑制剂,属于非兴奋剂,在成人注意力缺陷多动障碍(ADHD)治疗中显示出比安慰剂更高的疗效。在两项针对成人ADHD患者的大型、严格对照的10周试验中,通过研究者和患者评分评估,口服托莫西汀(60、90或120毫克/天)组的ADHD症状改善程度大于安慰剂组。在研究者评定的康纳斯成人ADHD评定量表(CAARS)上,托莫西汀组与安慰剂组相比,ADHD症状总分的平均降低幅度分别为28.3%对18.1%以及30.1%对19.6%。在临床医师整体严重程度印象量表、患者评定的CAARS和温德 - 赖姆赫尔成人注意缺陷障碍量表上,托莫西汀组的评分降低幅度也显著大于安慰剂组。在一个非对照的34周延长期试验中证实了其持续疗效。在临床试验中,托莫西汀总体耐受性良好;在两项主要试验中,接受托莫西汀治疗与接受安慰剂治疗的患者因不良事件导致的停药率分别为7.8%对4.3%以及9.3%对2.4%(后一项试验p<0.05)。与安慰剂相比,托莫西汀报告的不良事件显著更频繁的包括口干、失眠、恶心、食欲减退、便秘、头晕、出汗、排尿困难、性问题和心悸。心率和血压适度升高耐受性良好,且在停药后逐渐下降。托莫西汀与QT间期延长无关。托莫西汀可以每日服用一次或两次。其主观效应特征与哌甲酯不同,且托莫西汀与滥用或转移用途无关;因此在美国它不是受控物质。这也意味着长期治疗期间的重复处方处理会更方便。

结论

托莫西汀是治疗成人ADHD的一种有效且总体耐受性良好的药物。它是非兴奋剂,是首个基于在严格对照的成人试验中的疗效而专门获批用于成人的ADHD治疗药物。它可以作为每日单剂量给药或分成两个均分剂量。它存在滥用或转移用途的风险可忽略不计,且不是受控物质。托莫西汀对于成人ADHD患者是一种有价值的新治疗选择,对于有药物滥用风险或不希望服用受控物质的患者尤其有用。

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