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CN1379671A - 使用去甲氯雷他定治疗睡眠障碍 - Google Patents

使用去甲氯雷他定治疗睡眠障碍 Download PDF

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CN1379671A
CN1379671A CN00814382A CN00814382A CN1379671A CN 1379671 A CN1379671 A CN 1379671A CN 00814382 A CN00814382 A CN 00814382A CN 00814382 A CN00814382 A CN 00814382A CN 1379671 A CN1379671 A CN 1379671A
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desloratadine
effective dose
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A·G·哈里斯
D·G·伊佐尼
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Abstract

本发明公开了通过单独施用或与其它活性剂如减充血剂如假麻黄碱联合施用治疗有效量的去甲氯雷他定,来治疗和/或预防患有上气道过敏性炎症和/或与过敏性鼻炎有关的充血的人的睡眠障碍的方法,所述过敏性鼻炎包括季节性过敏性鼻炎或全年过敏性鼻炎。

Description

使用去甲氯雷他定治疗睡眠障碍
                        发明领域
本发明涉及通过施用治疗有效量的去甲氯雷他定(desloratadine)来治疗和/或预防患有上气道过敏性炎症和充血的人的睡眠障碍。
                        发明背景
处于″连续一整夜作生意″的快节奏社会，睡眠障碍增长得日益普遍起来。据估计，有4千万美国人遭受着各种睡眠障碍的煎熬。另有超过2千5万美国人承受着间断睡眠有关的障碍的痛苦。睡眠障碍存在多种病因，包括环境引起的紧张和生活方式因素、生理因素如疾病或肥胖，以及精神障碍如抑郁。此外，过敏性鼻炎可以引起睡眠障碍。过敏性鼻炎是由与鼻充血有关的呼吸道病症导致睡眠紊乱的常见原因。业已观察到，80％以上患有季节性过敏性鼻炎和/或全年过敏性鼻炎的患者存在上气道充血。过敏性鼻炎充血可能与后鼻滴注(postnasal drip)、鼻窦炎、鼻息肉有关，其中的每一种病症均使气流通过上气道(呼吸)更加困难。参见Young，T.等，Journal of AllergyClin.Immunol.，pp.S757-762，February 1997，and Finn，L.等，Am.J Respiratory Critical Care Medicine，Vol.157，No.3，p.A61，March 1998。睡眠障碍包括打鼾、睡眠呼吸暂停、失眠症、嗜眠症、多动腿综合征、睡眠惊悸、梦游症和睡眠进食。可能的治疗可以是简单的行为矫正，或者其可涉及机械、手术或药物干预。譬如，用称为充气夹板的机械装置或用抗过敏枕套、滴鼻类固醇或毛果芸香硷治疗睡眠呼吸暂停。用三环类抗抑郁剂、单胺氧化酶抑制剂或苯丙胺治疗嗜眠症。用Valium和其它苯二氮杂类药物或褪黑激素治疗失眠症。用Valium治疗多动腿综合征。
然而，睡眠研究中心和旨在提供缓解病情的睡眠临床诊所的扩大，以及ENT服务(″sinus clinics″)和鼻息肉手术与上气道手术的增加，均证明对患有上气道充血的病人的睡眠障碍进行改良的非侵害性治疗的需要。
                        发明概述
本发明提供去甲氯雷他定在制备治疗和/或预防患有上气道过敏性炎症和/或充血的人的睡眠障碍的药物中的应用，所述药物包含治疗有效量的去甲氯雷他定与治疗有效量的上气道减充血剂联合。
本发明还提供去甲氯雷他定在制备治疗和/或预防患有上气道过敏性炎症和/或与过敏性鼻炎有关的充血的人的睡眠障碍的药物的应用，其中所述药物包含治疗有效量的去甲氯雷他定。
本发明还提供去甲氯雷他定在制备治疗和/或预防患有上气道过敏性炎症和/或与过敏性鼻炎有关的充血的人的睡眠障碍的药物中的应用，其中所述药物包含治疗有效量的去甲氯雷他定与治疗有效量的上气道减充血剂联合。
本发明进一步提供上气道减充血剂在制备治疗和/或预防患有上气道过敏性炎症和/或与过敏性鼻炎有关的充血的人的睡眠障碍的药物中应用，其中所述药物包含治疗有效量的去甲氯雷他定与治疗有效量的上气道减充血剂联合。
                      发明详述
本发明对于治疗和/或预防患有上气道过敏性炎症和/或与过敏性鼻炎有关的充血的人的睡眠障碍和所致的紊乱性睡眠特别有效。本文所用术语″过敏性鼻炎″是指季节性过敏性鼻炎和全年过敏性鼻炎。本文所用术语″睡眠障碍″和″紊乱性睡眠″是指紊乱的、被打断的或片段性睡眠，其以下列表现为特征，包括但不限于：打鼾、睡眠呼吸暂停期、失眠症、嗜眠症、多动腿综合征、睡眠惊悸、梦游症、睡眠进食和白天瞌睡。在控制与上气道充血有关的急性或慢性睡眠障碍中，去甲氯雷他定治疗或预防的有效剂量值，将依所治疗病症的严重程度和给药途径的不同而异。治疗有效量，以及或者治疗频率，也将依年龄、体重和具体患者的反应不同而异。一般而言，对于本文所述病症的有效治疗量的每日总量为约1mg～约20mg，单次或分次剂量给药，给药途径为口服、局部、透皮或局部吸入。举例来说，优选的每日口服剂量范围应该在约5mg～约20mg。
美国专利4659716公开了作为非-镇静抗组胺药的去甲氯雷他定及其制备方法，和含有去甲氯雷他定的药物组合物，以及使用去甲氯雷他定组合物治疗哺乳动物过敏反应的方法。美国专利5595997公开了含有去甲氯雷他定的药物组合物，和使用去甲氯雷他定治疗过敏性鼻炎的方法。在此引入美国专利4659716和美国专利5595997作为参考。
去甲氯雷他定可购自Schering Corporation，Kenilworth，N.J。
去甲氯雷他定的药物组合物适应于任何给药模式，例如口服、肠胃外给药，后者如皮下(｀SC″)、肌内(″IM″)、静脉内(″IV″)和腹膜内(″IP″)给药，或者经局部、阴道或直肠给药(如栓剂)。去甲氯雷他定优选口服给药。
将去甲氯雷他定或其相当量的可药用盐与适宜的惰性可药用载体或稀释剂(可以是固体或液体)结合，可以制备该组合物。通过使去甲氯雷他定与相当量的药学上可接受的酸混合，可将去甲氯雷他定转化为可药用酸加成盐。通常，适宜的药学上可接受的酸包括无机酸，如HNO3、H2SO4、H3PO4、HCl、HBr，有机酸，包括但不限于乙酸、三氟乙酸、丙酸、乳酸、马来酸、琥珀酸、酒石酸、葡萄糖醛酸和枸橼酸以及烷基或芳基磺酸，如对-甲苯磺酸、2-萘磺酸或甲磺酸。优选的可药用盐是三氟乙酸盐、甲苯磺酸盐、甲磺酸盐和氯化物。去甲氯雷他定的游离碱较其酸加成盐更为稳定，在本发明药物组合物中优选使用去甲氯雷他定游离碱。
固体形式制剂包括粉剂、片剂、可分散颗粒、胶囊、扁囊剂和栓剂。粉剂和片剂包括约5％～约95％活性成分。适宜的固体载体为本领域所熟知的，如碳酸镁、硬脂酸镁、滑石、糖或乳糖。片剂、粉剂、扁囊剂和胶囊可用作适于口服给药的固体剂型。可药用载体的实例和制备各种组合物的方法，可以参见A.Gennaro(ed.)，Remington′sPharmaceutical Sciences，18th Ed.，Mack Publishing Co.，Easton，Pennsylvania。
液体形式制剂包括溶液、悬浮液和乳液。水或水-丙二醇溶液可以作为肠胃外注射的一个实例提及。在口服或给药之前，可即时将固体形式制剂转化为液体制剂。经静脉内、肌内或皮下注射给药的肠胃外制剂，通常是无菌溶液形式并可以含有渗透压调节剂(盐或葡萄糖)和缓冲剂。口服溶液、悬浮液和乳液中可包括遮光剂。液体形式制剂也可包括用于鼻内给药的溶液。
适于吸入的气溶胶制剂，可包括溶液和粉末形式的固体，它们可与可药用载体结合，所述载体如惰性压缩气体，例如氮气。
也包括打算在使用前即时转化为液体形式制剂的固体形式制剂，所述液体形式制剂用于口服或肠胃外给药。所述液体形式包括溶液、悬浮液和乳液。
本发明化合物也可经皮释放。经皮组合物可以呈乳膏剂、洗剂、气溶胶和/或乳剂形式并可包括在基质的透皮贴剂中，或者采用贮库形式，其均是本领域为了经皮给药目的而惯常使用的。
优选地，药物制剂呈单位剂型。以这种剂型，将制剂再分为含有适宜量活性成分的适当大小的单位剂量，如有效量，以达到预期目的。
             用于实施本发明的其它活性成分
另外，去甲氯雷他定活性组分可与治疗有效量的选自下述的一种或多种辅助活性组分联合用药：减充血剂、阿斯匹林，(乙酰水杨酸(acetysalicytic acid))、对乙酰氨基酚、非甾类抗炎药(NSAIDs)、镇咳药和祛痰药。所述辅助组分按照本领域普通技术人员已知的和在内科医师手册(Physicians’Desk Reference)中描述的给药剂量给药。代表性的NSAID包括但不限于萘普生、布洛芬、酮洛芬、苯噁洛芬、氟比洛芬、非诺洛芬、芬布芬、吲哚洛芬、吡洛芬、卡洛芬、奥沙普秦、普拉洛芬、咪洛芬、硫噁洛芬、舒洛芬、阿明洛芬、赛落芬酸、氟洛芬、布氯酸或它们的可药用盐。优选与减充血剂联合用药。
代表性的上气道减充血剂，包括但不限于去氧肾上腺素、假麻黄碱和苯丙醇胺。代表性的祛痰药，包括但不限于愈创甘油醚(guaiafenesin)、萜品醇、愈创木酚钾、愈创木酚磺酸钾。代表性镇咳剂包括但不限于右美沙芬、可待因和卡拉美芬。
去甲氯雷他定/可药用载体的联合和任选的其它活性组分可合并给药或分开给药，以治疗或预防与上气道充血特别是鼻充血有关的能导致紊乱睡眠的呼吸系统病症。本文所用术语″与…联合″，是指独立的去甲氯雷他定药物组合物和任选的其它组分如上气道减充血剂，可以同时给药或者按照适宜顺序顺次给药。优选地，去甲氯雷他定和任选的其它组分以单一剂型给药。代表性的DCL和DCL联合治疗
实施例1
按照本领域技术人员已知的方法制备含5mg去甲氯雷他定和240mg假麻黄碱的片剂，并将片剂施用于需要治疗的患者。实施例2
制备含5mg去甲氯雷他定和240mg苯丙醇胺的片剂，并施用于需要治疗的患者。
实施例3
按照本领域技术人员已知的方法制备含2.5mg去甲氯雷他定和120mg假麻黄碱的片剂，并将片剂施用于需要治疗的患者。
实施例4
按照本领域技术人员已知的方法制备含有2.5mg去甲氯雷他定和120mg苯丙醇胺的片剂，并将片剂施用于需要治疗的患者。
实施例5
按照本领域技术人员已知的方法制备含有5mg去甲氯雷他定的片剂，并将之施用于需要治疗的患者。
在控制睡眠障碍领域工作的普通临床医师懂得，应当施用去甲氯雷他定直至导致特定睡眠障碍的上气道紊乱呼吸症状病症得到改善。
按照本发明人的方法治疗的患者，将享受到因上气道充血减轻而无间断睡眠的愉快，并且将体验到不再有上气道过敏性炎症和/或与过敏性鼻炎有关的充血所致的白天瞌睡的个人状况的改善及工作生产效率的提高。

Claims (9)

1.去甲氯雷他定在制备治疗和/或预防患有上气道过敏性炎症和/或充血的人的睡眠障碍的药物中的应用，所述药物包含治疗有效量的去甲氯雷他定。
2.去甲氯雷他定在制备治疗和/或预防患有上气道过敏性炎症和/或与过敏性鼻炎有关的充血的人的睡眠障碍的药物中的应用，所述药物包含治疗有效量的去甲氯雷他定。
3.去甲氯雷他定在制备治疗和/或预防患有上气道过敏性炎症和/或充血的人的睡眠障碍的药物中的应用，所述药物包含治疗有效量的去甲氯雷他定与治疗有效量的上气道减充血剂联合。
4.上气道减充血剂在制备治疗和/或预防患有上气道过敏性炎症和/或充血的人的睡眠障碍的药物中的应用，所述药物包含治疗有效量的去甲氯雷他定与治疗有效量的上气道减充血剂联合。
5.前述任一项权利要求所述的应用，其中去甲氯雷他定的治疗有效量是约1mg/日～约20mg/日。
6.前述任一项权利要求所述的应用，其中去甲氯雷他定的治疗有效量是约2.5mg/日～约20mg/日。
7.权利要求1所述应用，其中上气道充血与过敏性鼻炎有关。
8.权利要求3或4所述应用，其中上气道减充血剂是假麻黄碱或苯丙醇胺。
9.权利要求8所述的方法，其中假麻黄碱的治疗有效量是120mg/日或240mg/日。
CN00814382A 1999-10-22 2000-10-19 使用去甲氯雷他定治疗睡眠障碍 Pending CN1379671A (zh)

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