CN1168095A - 注意缺陷/活动过强障碍的治疗 - Google Patents

注意缺陷/活动过强障碍的治疗 Download PDF

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CN1168095A
CN1168095A CN96191412A CN96191412A CN1168095A CN 1168095 A CN1168095 A CN 1168095A CN 96191412 A CN96191412 A CN 96191412A CN 96191412 A CN96191412 A CN 96191412A CN 1168095 A CN1168095 A CN 1168095A
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attention
deficit
treatment
hyperactivity disorder
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J·H·黑利詹斯泰因
G·D·托勒弗森
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Abstract

用去甲肾上腺素摄取抑制剂托莫西汀治疗注意缺陷/活动过强障碍。

Description

注意缺陷/活动过强障碍的治疗
本发明属于药物化学和精神病药物领域，提供一种治疗被称为注意缺陷(attention deficit)/活动过强障碍的精神病的方法。
                    发明背景
几十年来，人们注意到相当数量的儿童持续出现活动过强障碍并且注意时间非常短暂，以致于不能适应学校生活并且处理不好个人关系。在以前，这些儿童毫无疑问地会被认为是积习难改而被开除，并在学校中受到处罚甚至禁闭。然而，人们在很早以前就发现这些儿童无法控制他们的活动过强障碍和注意力不集中，并且医学界也开始试图帮助他们。有一段时间曾用哌醋甲酯(RitalinTM)对这些儿童进行治疗，该药物能够显著地改善他们的行为能力以及在学校和家中与他人共处的能力。然而，该药物的缺点在于每日需给药多次，并且当每一剂药物的效果消退时会产生反跳作用。此外，该药物会导致部分患者失眠和缺乏食欲。哌醋甲酯同时具有去甲肾上腺素能和多巴胺能的活性。
丙咪嗪、地昔帕明、去甲替林、阿米替林和氯米帕明也用于注意缺陷/活动过强障碍(ADHD)的一些病例。然而这些三环药物有许多生理机制，作为一类药物，它们易于产生多种副反应，从而需要仔细的监控和剂量检测。
最近十年，精神病学家认识到ADHD不仅仅是儿童期的疾病，而是通常持续到成人。很明显，活动过强障碍和注意时间短会导致成人生活的极大混乱，然而只是最近这些患者才有可能得到治疗。
寻求一种适用于儿童及成人并且没有哌醋甲酯所具有的缺点的、安全方便地治疗ADHD的方法仍是精神病学界一直关心的问题。
本发明提供一种治疗注意缺陷/活动过强障碍的方法，该方法包括向需要治疗的患者给予有效量的托莫西汀。
本发明还提供托莫西汀在生产用于治疗注意缺陷/活动过强障碍的药物中的用途；以及托莫西汀用于治疗注意缺陷/活动过强障碍的用途。
托莫西汀是一种公知的药物，其化学名称为(R)-(-)-N-甲基-3-(2-甲基苯氧基)-3-苯基丙胺。它通常以盐的形式使用，并且本文所用的术语托莫西汀中包括盐。参见，例如Gehlert等，神经科学通讯(Neuroscience Letters)157，203-06(1993)关于托莫西汀作为去甲肾上腺素再摄取抑制剂的作用机制的讨论。托莫西汀的这种功能非常强，并且在其有效地抑制去甲肾上腺素再摄取的浓度或剂量下基本没有其它的中枢神经系统活性。因此，它完全没有副作用并且可以适当地认为是选择性药物。
托莫西汀是一种非常安全的药物，由于它提高了的安全性，其用于ADHD(包括成人和儿童)的用途是对该疾病较好的一种治疗。此外，如下所讨论的，托莫西汀在相对低的剂量下有效，从而可安全而有效地每日给药一次。因此，完全避免了对患者、尤其是儿童和精神紊乱的成人进行多剂量给药所造成的困难。
托莫西汀治疗ADHD的有效剂量范围从大约5mg/天至大约100mg/天。优选的成人剂量范围从大约10至大约80mg/天，更优选的成人剂量从大约20至大约60mg/天。儿童的剂量自然要小一些，在大约5至大约70mg/天的范围内，更优选从大约10至大约60mg/天并最优选从大约10至大约50mg/天。通常，对于每位患者的最佳剂量必需由负责病例的医师确定，需要考虑患者的个头大小、患者所需的其它药物、疾病的严重程度以及患者的所有其它情况。
由于托莫西汀口服很易吸收并且每日仅需给药一次，因此理应通过口服进行给药。它可以形成透明、稳定的结晶，从而易于配制成常规的口服药物剂型，例如片剂、胶囊、悬浮液等。可以使用药物学家的常规方法。在特殊情况下，也可随需要使用其它的药物剂型进行给药，例如注射液、储库注射剂、栓剂等为药物学家所公知并易于理解的剂型。然而，通常优选以片剂或胶囊的形式进行托莫西汀的给药，并且这些药物剂型是推荐剂型。
ADHD患者很容易被识别，如果未接触过成人患者的话，大多数人都接触过表现该疾病的某些或全部症状的儿童。对该疾病的最佳描述的ADHD的诊断标准，由美国精神病学会发表于精神病的诊断和统计手册，第四版(1994)，内容如下：
注意缺陷/活动过强障碍的诊断标准
A.(1)或(2)之一：
(1)持续具有以下注意缺陷症状中的六个(或更多)至少六个月，病情程度和发育水平不相适应或不协调：
注意缺陷
(a)经常对细节不能给予密切注意或在学业、工作或其它活动中犯粗心大意的错误
(b)经常在工作或娱乐中有维持注意力的困难
(c)直接面对讲话时经常不象是在听讲
(d)经常不能完成指令并且不能完成学业、杂务、或工作中的职责(不是因为对立行为或不理解指令)
(e)经常有组织工作和活动的困难
(f)经常躲避、不喜欢或不愿意从事需要持续用脑的工作(例如学业或家庭作业)
(g)经常丢失工作或活动中所需的东西(例如玩具、学校布置的作业、铅笔、书或工具)
(h)经常易受外界刺激而分心
(i)在日常活动中经常忘事
(2)持续具有以下活动过强-冲动症状中的六个(或更多)至少六个月，其程度和发育水平不相适应或不协调：
活动过强
(a)经常手足不安或在座位上扭动不安
(b)经常在教室中或其它需要保持就座的场所中离开座位
(c)经常在不恰当的场所中过度地乱跑或攀登(对于青春期或成年，可限于主观上不安静的感觉)
(d)经常有安静地参与或从事业余活动的困难
(e)经常“忙来忙去”或经常象“被马达驱动”一样地活动
(f)经常过度讲话
冲动
(g)经常在提问尚未结束前就冲口说出答案
(h)经常有排队等候的困难
(i)经常打断或干扰他人(例如插入谈话或游戏中)
B.在7岁以前出现过一些造成了损伤的活动过强-冲动症状或注意缺陷症状。
C.由该症状引起的一些损伤发生在两个或更多的场所〔例如，在学校(或工作中)和家中〕。
D.必需有关于在社会、学校、或职业行为中的有临床意义的损伤的明确证据。
E.症状不是单独发生在弥散发育障碍、精神分裂症或其它精神病的过程中并且用其它的精神病(例如情绪障碍、焦虑症、分裂症或人格失常)不能很好地进行解释。
可以发现，ADHD是一种由两部分组成的疾病，注意缺陷部分和活动过强障碍部分，二者均有独立的程度。利用托莫西汀的治疗对于主要患有其中的一组症状或同时患有两组症状的患者是有效的。
虽然ADHD仍被主要认为是一种儿童疾病，但现在发现许多患者(有50％之多)在从青春期步入成年时一直患有此症。Biederman及其助手们广泛地研究了成人ADHD患者并发现了很多病例。参见，例如Biederman等，美国精神病学杂志(Am.J.Psychiatry)150，1792-98(1993)。他们发现，成人ADHD的病例经常在儿童期ADHD患者的父母以及成人兄弟姐妹中发现。因此，似乎该疾病不仅可延续至成年，而且还可以遗传。
前面刚刚引用过的Biederman等文章以及同一作者的另一篇文章，美国精神病学杂志148，564-77(1991)报道了关于同时患有一种或多种其它精神疾病的ADHD患者的研究。作者指出，这种精神病的共同发病在ADHD患者中经常出现，从而必然会影响这些患者的诊断和治疗。托莫西汀可有效地治疗ADHD，尽管接受治疗的患者的情况可能会由于一种或多种其它疾病的同时存在而变得复杂。
以上列举出的部分诊断标准说明了ADHD的严重性及其对患者的损害。一个人患有中等严重程度的ADHD就基本上完全不能集中精力，从而不能作有意义的工作或学习；由于疾病所致的无用的冲动行为使其一直是他或她周围的人所讨厌的人；并且使他或她的家人花费钱和精力去清洗或修复他或她造成的破坏或混乱。患此症的学龄患者可能完全破坏教师完成课堂任务，因为ADHD儿童会持续地中断课堂、分散其他儿童的注意力并耗费教师的努力。因此，很明显需要改善的对于ADHD的治疗，从而本发明对于许多人是非常重要的。
本发明的方法对于儿童、青春期或成人患者的治疗是有效的，并且在不同年龄的患者中，在症状或治疗方式的细节上无显著性差异。总的来说，本发明目的中的儿童指青春期年龄以下的患者，青春期患者指从青春期年龄至大约18岁的患者，成人指18岁或年龄更大的患者。

Claims (16)

1.治疗注意缺陷(attention-deficit)/活动过强障碍的方法，包括向需要治疗的患者给予有效量的托莫西汀。
2.权利要求1的方法，其中治疗的是以注意缺陷类型为主的注意缺陷/活动过强障碍。
3.权利要求1的方法，其中治疗的是以活动过强-冲动类型为主的注意缺陷/活动过强障碍。
4.权利要求1的方法，其中治疗的是合并类型的注意缺陷/活动过强障碍。
5.权利要求1的方法，其中患者是成人。
6.权利要求5的方法，其中治疗的是以注意缺陷类型为主的注意缺陷/活动过强障碍。
7.权利要求5的方法，其中治疗的是以活动过强-冲动类型为主的注意缺陷/活动过强障碍。
8.权利要求5的方法，其中治疗的是合并类型的注意缺陷/活动过强障碍。
9.权利要求1的方法，其中的患者是青春期患者。
10.权利要求9的方法，其中治疗的是以注意缺陷类型为主的注意缺陷/活动过强障碍。
11.权利要求9的方法，其中治疗的是以活动过强-冲动类型为主的注意缺陷/活动过强障碍。
12.权利要求9的方法，其中治疗的是合并类型的注意缺陷/活动过强障碍。
13.权利要求1的方法，其中的患者是儿童。
14.权利要求13的方法，其中治疗的是以注意缺陷类型为主的注意缺陷/活动过强障碍。
15.权利要求13的方法，其中治疗的是以活动过强-冲动类型为主的注意缺陷/活动过强障碍。
16.权利要求13的方法，其中治疗的是合并类型的注意缺陷/活动过强障碍。
CN96191412A 1995-01-11 1996-01-04 注意缺陷/活动过强障碍的治疗 Pending CN1168095A (zh)

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US08/371,341 US5658590A (en) 1995-01-11 1995-01-11 Treatment of attention-deficit/hyperactivity disorder
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