CN101917983A - 用于治疗无菌性炎症的组合物 - Google Patents
用于治疗无菌性炎症的组合物 Download PDFInfo
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Abstract
本发明公开了用于治疗无菌性炎症疾病的生物学医疗方法。本发明涉及L-精氨酸-盐酸盐(Arg)或赖氨酸(Lys)和L-亮氨酸(Leu)在制备用于治疗或预防无菌性炎症的药物组合物中的用途。所述药物组合物还包含微量元素铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)、钨(W)和叶酸。所述药物组合物还可以包含锌(Zn)和/或锰(Mn)及中枢神经系统(CNS)脂质。无菌性炎症是与例如纤维肌痛、克罗恩病、银屑病和风湿病的病症相关的。
Description
技术领域
本发明涉及天然生物学组分在制备用于治疗或预防无菌性(sterile)炎症的药物组合物中的用途。更具体地讲，本发明涉及L-氨基酸精氨酸(Arg)或赖氨酸(Lys)和亮氨酸(Leu)、微量元素(Cr、Sn、Se、Sr、V和W)以及叶酸用于治疗或预防无菌性炎症的用途。
背景技术
正常淋巴细胞生成的紊乱引起数种无菌性炎症疾病。这些经常显现的疾病以各种形式出现，其特征为经常表现为慢性疾病的影响内脏器官的严重病理组织反应。根据其各种诊断，将这些形式的有害炎症反应(其中一些发病率渐增)列为：1]纤维肌痛(fibromyalgia)，M79.0/M79.9(根据WHO的分类，ICD-10)。在芬兰2006的年发病率为2273例。2]克罗恩(Crohn’s)病，K50.1/K50.9.，年发病率为2110例。3]风湿病(rheuma)M06.0/M06.9/M05.9/M07.0.，发病率为1454例/年。4]银屑病L40/L40.5L40.9.，发病率为930例/年。这些疾病似乎与某种遗传易感性和应激相关。尽管经常达不到治疗效果，但是这些患者的治疗通常是复杂和昂贵的。在例如与肠道有关的克罗恩病中，且当影响结肠时，其表现为溃疡性结肠炎。当所述疾病的某些进一步发展时，它们还可能影响关节并引起严重疼痛，限制患者的灵活性。标准治疗最近仍没有可察觉到的改进，惯常治疗方法仍然是光疗法、某些软膏、可的松、各种抗炎药物，并且最后甚至是细胞抑制剂。还未设计出真正有效的天然药物。亟需用有效、简单、便宜且无有害副作用的方法治疗所述素质(diatheses)的改进方法。
这些慢性炎症时常需要巨大资源，并且还已经花费大量资源来寻找用于该类疾病的治疗方法。通常，通过手术、应用抗炎物质或细胞抑制剂来治疗这些疾病，以预防恶性转化。备选治疗方法包括(例如)称作生物-免疫疗法的生物学和免疫联合治疗方法(Tallberg，Thomas。生物学和免疫联合的癌症治疗方法的进展(Development of a Combined Biological andImmunological Cancer Therapy Modality)，生物-免疫疗法的综述，J.Austr.Coll.Nutr.& Env.Med.2003：22，第3-21页；通过与器官特异性线粒体有关的治疗性的接种疫苗和饮食生物调控来调节癌症(Regulation ofcancer by therapeutic vaccination and dietary bio-modulation involvingorgan specific mitochondria)，Int.J.Biotechnology Vol.9，Nos.3/4，391-409，2007)。在生物-免疫疗法中，将天然生物学组分(其由氨基酸和微量元素的混合物组成)以及任选的神经源性脂质和/或维生素提供给患者。对于不同形式的所述素质(diatheses)，已测试了这些成分的各种混合物。优选将混合物以功能性食品补充剂提供。
发明简述
本发明涉及用于治疗和/或预防无菌性炎症的药物组合物，其包含作为仅有药物活性成分的L-氨基酸精氨酸(Arg)或赖氨酸(Lys)和亮氨酸(Leu)，及微量元素铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)和钨(W)，以及叶酸。
本发明还涉及药物组合物，其包含作为仅有药物活性成分的：
a)L-氨基酸精氨酸(Arg)或赖氨酸(Lys)和亮氨酸(Leu)，
b)微量元素铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)、钨(W)和锰(Mn)，
c)叶酸，
d)CNS-脂质。
在随附的权利要求书中给出了本发明的一些优选实施方案。
本发明提供了便宜和安全的药物组合物。本发明提供了：通过将天然生物学组分施用至有其需要的个体，来治疗或补偿形成无菌性炎症的病因的起因性代谢缺乏。
发明详述
本发明基于如下意想不到的发现：在用生物-免疫疗法治疗癌症患者期间，在多个患者中明显观察到他们的不同的炎症症状被稍微减轻了。该积极效果看起来与恶性病无关。
本发明提供了天然生物学组分在制备用于治疗或预防无菌性炎症的药物组合物中的用途。该药物组合物尤其用于治疗和/或预防与疾病例如纤维肌痛、克罗恩病、风湿病和银屑病相关的无菌性炎症。
本发明涉及药物组合物，其包含作为仅有药物活性成分的天然生物学组分、任选的中枢神经系统(CNS)脂质因子，其与修正正常淋巴细胞生成相关，并因此负责调控各种组织中的炎症反应。该组合物对这些原因不明的炎症疾病具有治疗和预防作用。其目标在于矫正引起这种免疫系统失常的复杂的代谢缺乏。
因此，本发明涉及
a)L-氨基酸精氨酸(Arg)或赖氨酸(Lys)和亮氨酸(Leu)，
b)微量元素铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)和钨(W)，
c)叶酸
在制备用于治疗或预防无菌性炎症的药物组合物中的用途。该药物组合物可以优选还包含锌(Zn)、锰(Mn)和/或神经源性CNS脂质。
当分析患有所述疾病的患者和患者摄取的所述方法的生物学组分时，很明显，他们所接受的生物-免疫疗法中所用的某些氨基酸及特定必需微量元素金属离子致使对他们的疾病产生积极临床效果(即减轻的症状)。在这些癌症患者的亲近的家族成员(所述成员在其他方面是健康的但是也已遭受纤维肌痛、类风湿性关节炎(rheumatoid arthritis)或克罗恩病发作的痛苦)中，所摄取的相同天然饮食组分能够引起有利的临床效果。
因此，对未患有癌症的患者进行研究。在多数受试病例中，活性饮食组分已得到描绘。将口服摄入物以食品补充剂的形式提供给所述患者，且所述它基于如下制剂，其包含氨基酸亮氨酸(Leu)和精氨酸(Arg)或赖氨酸(Lys)的组合。所述两种氨基酸以L-氨基酸的形式施用。
除了Leu和Arg(作为盐酸盐，由于味道的缘故)外，组合物还优选包含至少一种选自铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)、钨(W)的必需微量元素。任选地，微量元素还包括例如锰(Mn)和锌(Zn)。为了是生物学活性的，微量元素应当是离子形式的，因此实际上它们作为盐施用。具有中性(neutral)味道的盐是优选的，并且应当避免具有强烈或不良味道的盐。
优选地，用于治疗或预防所述炎症综合征的制剂还包含生理量的叶酸。
根据本发明成功应用的治疗基于口服施用作为活性成分的L-精氨酸-盐酸盐和L-亮氨酸以及任选的必需微量元素和叶酸。根据本发明的一个优选实施方案，所述组合物基本上由四类组分即氨基酸、微量元素、维生素和中枢神经系统(CNS)脂质组成。所有这些组分是天然存在的并且是生物学活性的，这意味着它们参与生物学事件例如代谢过程。利用含有作为仅有药物活性成分的L-精氨酸，L-亮氨酸，Cr、Se、Sn、Sr、V、W、Mn的盐和叶酸，获得非常好的临床效果。
为了得到更好的结果，在某些情况中，氨基酸精氨酸用另一种必需氨基酸即赖氨酸替换。
所用的组合物包含生物学和药学活性量的组分，所述生物学和药学活性量是足够获得期望的健康促进效果的量。正如医生容易理解的，所述量将根据个体和他或她的健康状态以及其它因素例如重量、年龄、营养、应激、环境因素等而变化。适当量的示例包括但不限于L-精氨酸-盐酸盐和L-亮氨酸各自大约2-10g/天，通常2-5g/天。微量元素通常以Cr、Se、Sn、Sr、V和W的每种微量元素离子0.5-9mg/天、优选1-3mg/天的量使用。锰(Mn)可以以大约50mg/天的剂量施用。叶酸以低的、已确定的生理量例如1-2mg/天使用。
精神抑郁的症状常见于患有无菌性炎症并且尤其是上面所列的炎症病症的患者中。已表明CNS-脂质减轻精神抑郁的症状。还可以将无朊病毒(Prion)的神经源性CNS-脂质施用至所有患有上面列出的炎症病症的患者，用于预防和治疗精神抑郁。还可以用上面公开的组合物治疗患有精神抑郁的患者。这些极其重要的脂质获自从未患“疯牛病”的动物。因此，例如从健康的幼猪的脑获得CNS-脂质。将脑组织烹煮(boil)、冷冻并冻干，然后按照以前所述用醚-乙醇(ether-ethyl alcohol)提取脂质，以得到无朊病毒的脂质部分(Tallberg T.等人。癌症免疫(Cancer Immunity)。聚合自体肿瘤组织在癌症免疫疗法中的作用和支持措施(The Effect in Cancer-Immuno-therapy of Polymerised Autologous Tumour Tissue and SupportiveMeasures).Scand.J.Lab.Invets.1979：39；3-33)。神经源性脂质由Neurofood Ltd(芬兰)购买并罐装。推荐的CNS-脂质的日摄入量相当于大约50-100g脑，直到炎症症状消退。
所述包含氨基酸、微量元素、维生素和CNS-脂质的功能性食品组合物中的成分可以单独施用或者以不同的组合产品进行施用。它们可以例如以粉末形式单独购买，或者作为含有所有成分的预先制备的粉末而被购买。所述粉末混合物可以是预先装好的并且就这样使用，或者作为常规食物例如患者早晨酸乳酪的补充剂使用。对于消费者来说，与早餐一起或者作为两餐之间的点心来食用是容易的。所述补充性饮食治疗是比较便宜的，因为其仅由形成活性食品添加剂的天然组分组成。当然，还可以将所述药物组合物加工成可以包含药学上可接受载体的颗粒剂、胶囊剂或片剂。神经源性脂质产品可以与其它成分同时施用，或者在不同时间单独施用。优选的方式是将神经源性脂质产品与什锦水果(assorted fruits)混合，并将其冷冻或者作为冰淇淋来食用。
本发明的另一方面是提供药物组合物，其包含作为仅有的药物活性成分的：
a)L-氨基酸精氨酸(Arg)或赖氨酸(Lys)和亮氨酸(Leu)，
b)微量元素铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)和钨(W)和锰(Mn)，
c)叶酸，
d)神经源性CNS脂质。
所述药物组合物还可以包含氨基酸丝氨酸(Ser)和异亮氨酸(Ile)。
还公开了通过将药学活性量的下列物质施用至有其需要的患者来治疗或预防无菌性炎症的方法，所述物质是：
a)L-氨基酸精氨酸(Arg)或赖氨酸(Lys)和亮氨酸(Leu)，
b)微量元素铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)、钨(W)和任选的锌(Zn)和/或锰(Mn)，和
c)叶酸，和任选的
d)CNS-脂质。
通过下列实施例来阐明本发明，无论如何不应将其理解为限制本发明的范围。本领域技术人员能够对其进行具有与文中所述的相同有益作用的变通和修改。
实施例
向患有上面所列的无菌性炎症疾病的患者以食物补充剂(foodsupplementation)的形式口服给予亮氨酸和精氨酸，以及毫克量的某些生物学活性的微量元素的盐，其中金属离子以生物学活性形式存在，并包括50-100g/d(天)的无朊病毒的CNS脂质。组合物中还包含若干毫克的叶酸。将该天然食品补充剂每天提供给患者。用于治疗患有所述无菌性炎症或精神抑郁的患者的饮食生物-调控方案如下：
组合的支持性饮食措施：
1.与膳食一起，口服施用L-氨基酸精氨酸(Arg)和亮氨酸(Leu)中的每一种(2-5g/天)。
2.以若干毫克的剂量水平(1-3mg/天)口服作为生物学活性离子的必需微量元素；铬(CrCl3·6H2O)6mg(＝1.17mg Cr)；锡(SnCl4·5H2O)4mg(＝1.35mg Sn)；硒Na2SeO4·10H2O，6mg(＝1.28mg Se)；钒(Na2VO4·4H2O)，6mg(＝2.5mg V)；钨(Na2WO4·2H2O)，4mg(＝2.3mg W)；锶(SrCl2)(＝2mg Sr)。一些患者还接受140mg/天的日剂量的硫酸锰，相当于(＝51.0mg Mn)。
3.低的生理量的叶酸(1-2mg/天)。
4.患者接受另外含有为了味道的缘故而与水果混合或者做为冰淇淋的相当于大约50g脑的无朊病毒CNS神经源性脂质(由芬兰的NeurofoodLtd购买并罐装)的饮食。
5.患者接受含有成分1-3的混合物的预先装好的粉末，并且推荐患者将所述粉末混合进他们早晨的酸乳酪中，以实现他们的每日定量。可以加入或单独摄入冻干形式的CNS-脂质。
6.根据观察到的临床反应来调整剂量水平，并将剂量水平与患者的体重相关联。
在大多数受试患者中，在连续或间歇施用所述生物调控组合物的情况下，在大多数受试患者中的治疗积极临床作用持续超过25年。将所述作用以数月的时间进行记录。疼痛和出血能够减退，且检验室值正常化。关节疼痛减退。所述积极临床结果显示出轻微的个体差异，与所述生物学成分的量和相对含量及患者体重有关。在某些情况中，仅与CNS-脂质组合的Leu和Arg就能产生一定的积极作用，但是在其他患者中微量元素离子看起来是必需的辅助因素。
该变化可能是与患有所述炎症素质的患者中的某些基因特质相关。该饮食治疗旨在补偿所述疾病中的代谢缺乏，所述饮食治疗与任何受试志愿者经受的任何副作用都不相关。所述食品添加剂能对患有所述疾病的患者施加持久的缓和作用。
Claims (11)
1.如下a)、b)和c)在制备用于治疗或预防无菌性炎症的药物组合物中的用途：
a)L-氨基酸精氨酸(Arg)或赖氨酸(Lys)和亮氨酸(Leu)，
b)微量元素铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)和钨(W)
c)叶酸。
2.根据权利要求1所述的用途，特征在于所述药物组合物还包含锌(Zn)。
3.根据权利要求1或2所述的用途，特征在于所述药物组合物还包含锰(Mn)。
4.根据权利要求1-3中任何一项所述的用途，特征在于所述药物组合物还包含神经源性CNS脂质。
5.根据权利要求1-4中任何一项所述的用途，特征在于所述药物组合物包含：
a)L-精氨酸-盐酸盐和L-亮氨酸，每一种2-5g，
b)铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)和钨(W)盐，每种0.5-9mg，和
c)1-2mg叶酸。
6.根据权利要求1-5中任何一项所述的用途，特征在于所述药物组合物是粉末形式的。
7.根据权利要求1-6中任何一项所述的用途，特征在于所述药物组合物是功能性饮食补充组合物形式的。
8.根据权利要求1-6中的任何一项所述的用途，特征在于所述无菌性炎症与选自纤维肌痛、克罗恩病、银屑病和风湿病的疾病相关。
9.药物组合物，特征在于其包含作为仅有的药物活性成分的：
a)L-氨基酸精氨酸(Arg)或赖氨酸(Lys)和亮氨酸(Leu)，
b)微量元素铬(Cr)、锡(Sn)、硒(Se)、锶(S r)、钒(V)和钨(W)、锌(Zn)和锰(Mn)，
c)叶酸，和
d)神经源性CNS-脂质。
10.根据权利要求9所述的药物组合物，特征在于其还包含作为仅有的药物活性成分的丝氨酸(Ser)和异亮氨酸(Ile)。
11.治疗或预防无菌性炎症的方法，其中将药学活性量的：
a)L-氨基酸精氨酸(Arg)或赖氨酸(Lys)和亮氨酸(Leu)，
b)微量元素铬(Cr)、锡(Sn)、硒(Se)、锶(Sr)、钒(V)、钨(W)和任选的锌(Zn)和/或锰(Mn)，和
c)叶酸，和任选的
d)神经源性CNS-脂质
施用至有其需要的个体。
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2010359375B2 (en) * | 2010-08-18 | 2014-01-30 | Colgate-Palmolive Company | Oral care product and methods of use and manufacture thereof |
| FI123756B (fi) * | 2010-09-21 | 2013-10-31 | Neurofood Ab Oy | Parannettu lisäravinne syövän hoitamiseksi tai ennaltaehkäisemiseksi |
| JP5837315B2 (ja) * | 2011-03-25 | 2015-12-24 | イーエヌ大塚製薬株式会社 | 炎症性疾患用栄養組成物 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0737471A3 (fr) * | 1995-04-10 | 2000-12-06 | L'oreal | Utilisation d'un sel d'une métal alcalino-terreux comme inhibiteur de TNF-alpha dans une composition unique et composition obtenue |
| RU2156087C1 (ru) * | 1999-11-25 | 2000-09-20 | Товарищество с ограниченной ответственностью Фирма "Электронная медицина" | Биологически активная добавка |
| US20040241256A1 (en) * | 2002-12-05 | 2004-12-02 | Seymour Ehrenpreis | Medicinal compositions & therapeutic methods |
| ATE460168T1 (de) * | 2003-10-17 | 2010-03-15 | Neurofood Ab Oy | Nicht-radioaktives strontiummittel zur behandlung von krebs |
| FI121915B (fi) * | 2004-02-06 | 2011-06-15 | Neurofood Ab Oy | Koostumus psoriasiksen hoitoon |
| US20060062859A1 (en) * | 2004-08-05 | 2006-03-23 | Kenneth Blum | Composition and method to optimize and customize nutritional supplement formulations by measuring genetic and metabolomic contributing factors to disease diagnosis, stratification, prognosis, metabolism, and therapeutic outcomes |
| US20060241040A1 (en) * | 2005-04-06 | 2006-10-26 | Alberto Visintin | Methods of treating disorders associated with toll-like receptor 4 (TLR4) signalling |
| RU2308199C2 (ru) * | 2005-05-13 | 2007-10-20 | Закрытое акционерное общество "Компания "Нутритек" (ЗАО "Компания "Нутритек") | Продукт энтерального питания "нутриэн гепа" |
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2007
- 2007-12-28 FI FI20075971A patent/FI122450B/fi not_active IP Right Cessation
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2008
- 2008-12-17 EP EP08868549A patent/EP2234611B1/en not_active Not-in-force
- 2008-12-17 JP JP2010540153A patent/JP5378406B2/ja not_active Expired - Fee Related
- 2008-12-17 PL PL08868549T patent/PL2234611T3/pl unknown
- 2008-12-17 NZ NZ597976A patent/NZ597976A/xx not_active IP Right Cessation
- 2008-12-17 BR BRPI0821919-2A patent/BRPI0821919A2/pt not_active IP Right Cessation
- 2008-12-17 KR KR1020107016810A patent/KR20100103856A/ko not_active Application Discontinuation
- 2008-12-17 RU RU2010130889/15A patent/RU2462244C2/ru not_active IP Right Cessation
- 2008-12-17 DE DE08868549T patent/DE08868549T1/de active Pending
- 2008-12-17 CN CN2008801231858A patent/CN101917983B/zh not_active Expired - Fee Related
- 2008-12-17 US US12/810,150 patent/US20100291235A1/en not_active Abandoned
- 2008-12-17 NZ NZ586496A patent/NZ586496A/en not_active IP Right Cessation
- 2008-12-17 AT AT08868549T patent/ATE544450T1/de active
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- 2008-12-17 AU AU2008345508A patent/AU2008345508B2/en not_active Ceased
- 2008-12-17 DK DK08868549.0T patent/DK2234611T3/da active
- 2008-12-17 ES ES08868549T patent/ES2381690T3/es active Active
- 2008-12-17 WO PCT/FI2008/050750 patent/WO2009083643A2/en active Application Filing
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Also Published As
| Publication number | Publication date |
|---|---|
| AU2008345508A1 (en) | 2009-07-09 |
| ATE544450T1 (de) | 2012-02-15 |
| RU2010130889A (ru) | 2012-02-10 |
| DK2234611T3 (da) | 2012-05-07 |
| EP2234611B1 (en) | 2012-02-08 |
| PL2234611T3 (pl) | 2012-07-31 |
| IL206596A0 (en) | 2010-12-30 |
| NZ586496A (en) | 2012-03-30 |
| AU2008345508B2 (en) | 2013-11-14 |
| RU2462244C2 (ru) | 2012-09-27 |
| EP2234611A2 (en) | 2010-10-06 |
| FI20075971A0 (fi) | 2007-12-28 |
| FI20075971A (fi) | 2009-06-29 |
| JP5378406B2 (ja) | 2013-12-25 |
| WO2009083643A3 (en) | 2009-10-29 |
| KR20100103856A (ko) | 2010-09-28 |
| WO2009083643A2 (en) | 2009-07-09 |
| NZ597976A (en) | 2012-08-31 |
| DE08868549T1 (de) | 2011-03-17 |
| ES2381690T3 (es) | 2012-05-30 |
| BRPI0821919A2 (pt) | 2015-06-16 |
| JP2011507937A (ja) | 2011-03-10 |
| HK1143539A1 (en) | 2011-01-07 |
| NZ597977A (en) | 2012-08-31 |
| CN101917983B (zh) | 2013-08-21 |
| US20100291235A1 (en) | 2010-11-18 |
| FI122450B (fi) | 2012-01-31 |
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