CN1115146C - 利福昔明在治疗由隐孢子虫病引起的腹泻中的用途 - Google Patents
利福昔明在治疗由隐孢子虫病引起的腹泻中的用途 Download PDFInfo
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Abstract
本发明的目的是治疗有效量的利福昔明和含有它的药物组合物在患有严重形式的免疫抑制病人中因隐孢子虫病而引起腹泻症状的治疗中的用途，患有严重形式的免疫抑制的病人是例如患有艾滋病或恶性肿瘤，或进行了移植或用化疗或免疫抑制剂治疗的病人。
Description
本发明的目的是治疗有效量的利福昔明和含有它的药物组合物在患有严重形式的免疫抑制病人中因隐孢子虫病而引起腹泻症状的治疗中的用途，患有严重形式的免疫抑制的病人是例如患有艾滋病或恶性肿瘤，或进行了移植或用化疗或免疫抑制剂治疗的病人。
Cryptosporidium parvum是一种直到约20年前还属于唯兽医关注的口-粪便传播的动物传染病的原生物。
正如Meisel J.L.等在《胃肠病学》(Gastroenterology)
70，1156-1160，(1976)中以及Current W.L.和Carcia L.S.在《临床微生物学回顾》(Clin.Microbiol.Rev.)
4，325-358，(1991)中所报道的，在近来免疫缺陷综合征的发生(主要由于HIV感染)和对导致患有恶性肿瘤或进行器官移植病人免疫抑制的治疗增加后，长时间显著扩散的腹泻情况(有时许多周)和危重加剧已经发生。由Laughon B.E.等在《胃肠病学》(Gastroenterol.)
94，984-993，(1988)和Colbunders R.等在《美国胃肠病学杂志》(Am.J.Gastroenterol.)
82，859-864，(1987)中对患有获得性免疫缺陷综合征(AIDS)的病人进行的流行病学研究表明：由隐孢子虫病引起的腹泻率可达到美国患有AIDS病人的10-15％，并进而上升到发展中国家中相同病人的30-50％。
导致腹泻感染的机理尚不明确；Bonnin A.和Camerlynck P.在《医学大全手册》(Encycl.Med.Chir.)(巴黎-法国)中的《传染病》
8，501-10，(1992)中认为：直接对肠上皮的腺苷酸环化酶系统或一种绒毛的继发性改变(导致通过具有继发性渗透腹泻的大肠而排泄未消化的二糖)起作用的霍乱样毒素可导致患有AIDS的病人中发生严重的腹泻症状。
患有AIDS的病人中由于Cryptosporidium parvum(培养约一周后)引起的感染可出现大量水样腹泻的症状，并伴有剧烈的腹痛，呕吐，发热，头痛和无力。这种严重的腹泻形式可持续几周并导致已经非常衰弱的生物体内严重的水电解质不平衡，脱水，营养不良，肾功能不全和(有时)支气管肺并发症。
Petersen C.在《临床传染性疾病》(Clin.Infect.Dis.)
15，903-909，(1992)和Goodgame R.W.等在《传染病杂志》(J.Infect.Dis.)，
167，704-709，(1993)中证明了这种腹泻形式的严重和持久程度与免疫抑制程度之间的一种密切关系：在患有AIDS的病人中从开始的一个月内可观察到腹泻情况的自发缓解，在这些病人中CD4值还高于200mm3，此时在更严重的免疫抑制病例中腹泻病转变成慢性，同时伴随着常见的并发症，具有的CD4值低于100mm3。
尽管有些作者报道了使用某些类药物的部分结果，但是目前还没有与获得性免疫缺陷综合征(AIDS)相关的隐孢子虫病引起的腹泻的非常明确的疗法。
Portnoy D.等在《国际医学年鉴》(Ann.Intern.Med.)，
101，202-204，(1984)和Connolly G.M.等在《内脏》(Gut)，29，593-597没有，(1988)中报道了使用螺旋霉素的初期阳性结果，但随后Wittenberg D.F.等在《传染病杂志》(J.Infect.Dis.)，159，131-132，(1989)中没有证明这些结果。
White A.C.Jr等在《传染病杂志》(J.Infect.Dis.)，
170，419-424，(1994)和Walmsley S.等在《大纲和摘要》(AIDS/IV STD世界委员会(柏林)第九次国际会议，伦敦：可喜的基本原则，(1993))中报道了使用以每天给予2g paramomicin持续两周或多周为主治疗的显著临床和寄生虫学进展，但正如在58％的复发病例中所证明的，没有任何寄生虫被杀灭。
最后Vargas S.L.等在《儿科学杂志》(J.Pediatr.Dis.)，123，154-156，(1993)和Dunne M.W.在《大纲和摘要》(AIDS/IV STD世界委员会(柏林)第九次国际会议，伦敦：可喜的基本原则，(1993))中展示了通过使用高剂量阿齐红霉素(azitromycin)的初期效果证明。
本发明的目的是治疗有效量的利福昔明和含有它的药物组合物(口服给药)在患有严重形式的免疫抑制病人中因隐孢子虫病而引起腹泻的治疗中的用途，所述的病人主要是患有艾滋病或恶性肿瘤，或进行了移植或用化疗或免疫抑制剂治疗的病人。
利福昔明是1980年发现的一种抗菌素，并在意大利取得专利权。1987年1月21日授予它的专利号为1154655，在许多其它国家中，它对许多类的细菌包括革兰氏阳性菌和革兰氏阴性菌具有活性。自从1985年以来，它在意大利以NORMIX商标销售，用于治疗由革兰氏阳性菌和革兰氏阴性菌引起的急性和慢性肠感染，并作为高血氨治疗中的佐剂。
目前NORMIX以制成片剂或颗粒剂的药物组合物(口服给药)的形式销售，所述的片剂或颗粒剂含有合适的药物上可接受的赋形剂以及利福昔明，而其它口服给药的药物形式如胶囊，包糖衣片和糖浆也可以有利地用于实施本发明。
目前已经研究和销售的利福昔明仅用于某些种类细菌感染的治疗，且任何可能的抗原生物活性或任何可能的作为抗原生物药的用途还从未研究。
我们的研究人员目前已经发现这种抗菌素还具有对原生物Cryptosporidium parvum的抗原生物活性，并且它按1200-2400mg的日剂量给药1-4周的时间期限可导致杀灭寄生虫，并引起免疫抑制病人中隐孢子虫病感染相关的腹泻现象消失。
隐孢子虫病的诊断已经基于通过使用光学显微镜和免疫酶测定(ELISA)的检测来对粪便中Cryptosporidium parvum的鉴定而作出。
一天使用1200-2400mg包含在200mg药物NORMIX片剂内的利福昔明对患有艾滋病且受隐孢子虫病引起的腹泻症状侵害的病人治疗1-4周，已经取得了阳性结果，导致在治疗结束时约80％受治疗的病人中临床照片有了显著的改善，并且约60％的病例中的粪便内缺乏Cryptosporidium parvum的卵囊。
在证明利福昔明用途效果的治疗结束时，所有临床参数发生了明显的改善。
与下面报道的临床试验相关的实施例用作进一步解释本发明而不用来限定它。
实施例1
12名病人，8名男性和4名女性，年龄在29至51岁之间，他们均患有艾滋病并受由Cryptosporidium parvum感染导致的继发性腹泻的侵害，已经将他们在由Turin大学传染病研究所协助的PiedmontRegion传染病学的某些部门进行了登记。所有登记的病人均表现出很强的免疫抑制，具有的CD4值低于50mm3，并且在治疗开始前腹泻症状平均存在13天以上。
通过使用电子显微镜检测粪便，并通过免疫酶测定(ELISA)已经证明了因Cryptosporidium parvum而感染的临床诊断。
将三种NORMIX片剂(每种均含有200mg的利福昔明)每天对病人进行口服给药三次，每天总计为1800mg，时间平均持续14天，从最少10天至最多21天。
在治疗结束时，粪便的寄生虫检测表明12名病人中的7名中Cryptosporidium parvum的卵囊消失。4名病人的全部腹泻症状消失，而6名病人的临床照片有了明显改善，肠排泄物明显减少并且粪便类型有了从软或水样到良好形状的改变；只有2名病人对治疗没有良好的反应。
没有病人表现出国利福昔明而引起的副反应，且剂量从未减小，治疗也从未中断。
Claims (2)
1)利福昔明的用途，用于制备治疗因隐孢子虫病引起的腹泻的可口服给药的药物组合物。
2)根据权利要求1的用途，其特征在于药物组合物为片剂，胶囊剂，包糖衣片，颗粒剂或糖浆剂。
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT97BO000064A IT1290679B1 (it) | 1997-02-14 | 1997-02-14 | Uso della rifaximina e delle composizioni farmaceutiche che la contengono nel trattamento della diarrea da criptosporidiosi. |
| IT000064A/1997 | 1997-02-14 | ||
| IT000064A/97 | 1997-02-14 |
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| CN1214244A CN1214244A (zh) | 1999-04-21 |
| CN1115146C true CN1115146C (zh) | 2003-07-23 |
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| CN98106920A Expired - Lifetime CN1115146C (zh) | 1997-02-14 | 1998-02-13 | 利福昔明在治疗由隐孢子虫病引起的腹泻中的用途 |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US5886002A (zh) |
| EP (1) | EP0858804B1 (zh) |
| JP (1) | JP4848083B2 (zh) |
| KR (1) | KR100436243B1 (zh) |
| CN (1) | CN1115146C (zh) |
| AT (1) | ATE218342T1 (zh) |
| DE (1) | DE69805672T2 (zh) |
| DK (1) | DK0858804T3 (zh) |
| ES (1) | ES2178048T3 (zh) |
| HU (1) | HU224592B1 (zh) |
| IT (1) | IT1290679B1 (zh) |
| PT (1) | PT858804E (zh) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6861053B1 (en) * | 1999-08-11 | 2005-03-01 | Cedars-Sinai Medical Center | Methods of diagnosing or treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth |
| US7048906B2 (en) | 1995-05-17 | 2006-05-23 | Cedars-Sinai Medical Center | Methods of diagnosing and treating small intestinal bacterial overgrowth (SIBO) and SIBO-related conditions |
| KR20060006953A (ko) * | 2003-04-30 | 2006-01-20 | 디 인스티튜트스 포 파마슈티컬 디스커버리, 엘엘씨 | 치환된 카르복실산 |
| US8003118B2 (en) * | 2005-03-02 | 2011-08-23 | Kodsi Robert E | Use of rifaximin for the prevention of aspiration pneumonia and/or sepsis |
| US20060210483A1 (en) * | 2005-03-02 | 2006-09-21 | Kodsi Robert E | Non-systemic antibiotic formulations and related method of use and treatment of upper respiratory infections |
| US20060210492A1 (en) * | 2005-03-02 | 2006-09-21 | Kodsi Robert E | Use of rifaximin for treatment and prevention of periodontal conditions |
| SI1698630T1 (sl) | 2005-03-03 | 2015-01-30 | Alfa Wassermann S.P.A. | Nove polimorfne oblike rifaksimina, postopki za njihovo pripravo in njihova uporaba v medicinskih pripravkih |
| ITBO20050123A1 (it) | 2005-03-07 | 2005-06-06 | Alfa Wassermann Spa | Formulazioni farmaceutiche gastroresistenti contenenti rifaximina |
| JP5844961B2 (ja) * | 2006-08-02 | 2016-01-20 | サリックス ファーマシューティカルズ， インコーポレイテッド | 放射線直腸ｓ状結腸炎を処置するための組成物および方法 |
| US20080161337A1 (en) * | 2007-01-03 | 2008-07-03 | Leonard Weinstock | Use of Rifaximin for the Treatment of Chronic Prostatitis |
| US20080159987A1 (en) * | 2007-01-03 | 2008-07-03 | Leonard Weinstock | Use of Rifaximin for the Treatment of Restless Legs Syndrome |
| US8980872B2 (en) * | 2008-09-26 | 2015-03-17 | Aska Pharmaceutical Co., Ltd. | Agent for preventing and/or treating functional gastrointestinal disorder |
| US20110035232A1 (en) | 2008-10-02 | 2011-02-10 | Salix Pharmaceuticals, Ltd. | Methods of treating hepatic encephalopathy |
| HUE065491T2 (hu) | 2008-10-02 | 2024-05-28 | Salix Pharmaceuticals Ltd | A hepatikus enkefalopátia kezelése rifaximin alkalmazásával |
| CA2781580A1 (en) | 2009-11-23 | 2011-05-26 | Cipla Limited | Topical foam composition |
| IT1398550B1 (it) | 2010-03-05 | 2013-03-01 | Alfa Wassermann Spa | Formulazioni comprendenti rifaximina utili per ottenere un effetto prolungato nel tempo |
| CA2800235C (en) * | 2010-03-10 | 2018-10-16 | Lupin Limited | Rifaximin ready-to-use suspension |
| EP2616044A1 (en) | 2010-09-13 | 2013-07-24 | Cilpa Limited | Pharmaceutical composition |
| WO2012076832A1 (en) | 2010-12-09 | 2012-06-14 | Cipla Limited | Suppositories comprising rifaximin |
| ITBO20110461A1 (it) | 2011-07-29 | 2013-01-30 | Alfa Wassermann Spa | Composizioni farmaceutiche comprendenti rifaximina, processi per la loro preparazione e loro uso nel trattamento di infezioni vaginali. |
| EP2927235B1 (en) | 2014-03-31 | 2017-02-08 | Euticals S.P.A. | Polymorphic mixture of rifaximin and its use for the preparation of solid formulations |
| WO2015173697A1 (en) | 2014-05-12 | 2015-11-19 | Alfa Wassermann S.P.A. | New solvated crystal form of rifaximin, production, compositions and uses thereof |
| WO2016003536A1 (en) * | 2014-06-30 | 2016-01-07 | Salix Pharmaceuticals, Inc. | Methods for retreating irritable bowel syndrome (ibs) |
| US20180021297A1 (en) * | 2015-02-26 | 2018-01-25 | Jaguar Health, Inc. | Use Of Croton- Or Calophyllum-Derived Proanthocyanidin Polymers Or Botanical Extracts In Combination With Rifaximin For The Treatment Of Diarrhea In Non-Human Animals |
| EP3307879A2 (en) * | 2015-06-10 | 2018-04-18 | Synlogic, Inc. | Bacteria engineered to treat diseases associated with hyperammonemia |
| AU2017343886B2 (en) | 2016-10-14 | 2023-07-06 | Cipla Limited | Pharmaceutical compositions comprising rifaximin |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1264494B1 (it) * | 1993-03-23 | 1996-09-24 | Alfa Wassermann Spa | Uso di rifaximin e di formulazioni che la contengono nel trattamento delle dispepsie gastriche originate da helicobacter |
-
1997
- 1997-02-14 IT IT97BO000064A patent/IT1290679B1/it active IP Right Grant
-
1998
- 1998-01-22 DE DE69805672T patent/DE69805672T2/de not_active Expired - Lifetime
- 1998-01-22 PT PT98101081T patent/PT858804E/pt unknown
- 1998-01-22 ES ES98101081T patent/ES2178048T3/es not_active Expired - Lifetime
- 1998-01-22 HU HU9800115A patent/HU224592B1/hu active IP Right Grant
- 1998-01-22 DK DK98101081T patent/DK0858804T3/da active
- 1998-01-22 EP EP98101081A patent/EP0858804B1/en not_active Expired - Lifetime
- 1998-01-22 AT AT98101081T patent/ATE218342T1/de active
- 1998-01-26 US US09/013,655 patent/US5886002A/en not_active Expired - Lifetime
- 1998-02-12 JP JP02981398A patent/JP4848083B2/ja not_active Expired - Lifetime
- 1998-02-13 CN CN98106920A patent/CN1115146C/zh not_active Expired - Lifetime
- 1998-02-13 KR KR10-1998-0004389A patent/KR100436243B1/ko not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| ATE218342T1 (de) | 2002-06-15 |
| HU9800115D0 (en) | 1998-03-30 |
| ITBO970064A0 (it) | 1997-02-14 |
| ITBO970064A1 (it) | 1998-08-14 |
| US5886002A (en) | 1999-03-23 |
| DE69805672T2 (de) | 2003-01-23 |
| PT858804E (pt) | 2002-10-31 |
| CN1214244A (zh) | 1999-04-21 |
| KR19980071348A (ko) | 1998-10-26 |
| JPH10226645A (ja) | 1998-08-25 |
| DK0858804T3 (da) | 2002-07-08 |
| HUP9800115A1 (hu) | 1999-06-28 |
| JP4848083B2 (ja) | 2011-12-28 |
| EP0858804B1 (en) | 2002-06-05 |
| DE69805672D1 (de) | 2002-07-11 |
| KR100436243B1 (ko) | 2004-08-25 |
| ES2178048T3 (es) | 2002-12-16 |
| HU224592B1 (hu) | 2005-11-28 |
| IT1290679B1 (it) | 1998-12-10 |
| HUP9800115A3 (en) | 2000-04-28 |
| EP0858804A1 (en) | 1998-08-19 |
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