CN1146154A - 二甲硅油在局部抗菌治疗和/或预防及治疗与幽门螺旋杆菌(Hp)有关的综合症和感染性疾病中的用途 - Google Patents

二甲硅油在局部抗菌治疗和/或预防及治疗与幽门螺旋杆菌(Hp)有关的综合症和感染性疾病中的用途 Download PDF

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CN1146154A
CN1146154A CN95192556A CN95192556A CN1146154A CN 1146154 A CN1146154 A CN 1146154A CN 95192556 A CN95192556 A CN 95192556A CN 95192556 A CN95192556 A CN 95192556A CN 1146154 A CN1146154 A CN 1146154A
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prevention
therapy
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dimeticone
helicobacter
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A·施米德特
H·犹比梅茵
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A—HUMAN NECESSITIES
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Abstract

本发明涉及二甲基聚硅烷(二甲硅油)在局部抗菌治疗和预防及治疗与幽门螺旋杆菌(Hp)有关的综合症和感染中的用途。

Description

二甲硅油在局部抗菌治疗和/或预防及治疗 与幽门螺旋杆菌(Hp)有关的综合症和感染性疾病中的用途
发明领域
本发明涉及二甲基聚硅烷(二甲硅油)在局部抗菌治疗和预防及治疗与幽门螺旋杆菌(Hp)有关的综合症和感染中的用途。
发明背景诸如simplexLefax(参见Rote Liste 1993)等市售的含二甲硅油产品是用来治疗肠胃气胀及用来为患者准备声像图检查。
WO90/07930公开了二甲基硅烷，特别是其与硅胶联合治疗食道、溃疡(胃及十二指肠)和胃炎的用途。所述文献描述了口服二甲硅油后其在食道、胃和十二指肠中形成及维持保护性膜的能力。
近年来，逐渐了解到在一些慢性胃炎和溃疡(胃及十二指肠溃疡)中，革兰氏阴性致病菌Hp对胃肠道(GI)的感染是一种致病元素，其与胃癌发生的关系正被越来越多地讨论。
尽管自从19世纪末病理学家就了解到，胃粘膜中存在螺旋杆菌，但是直至1983年Hp才从患有胃溃疡和胃炎患者的窦粘膜活检物中培养出。(Marshall，B.J.：Unidentified curved bacilli on gastric epithelium inactive chronic gastritis.LancetI(1983)，1273-1275)。
Hp是酸不稳定的，对与其它细菌的竞争敏感。因此，致病菌只能生长在特殊的生态小境中。它直接在窦表皮的保护粘膜层下及体粘膜下生长，而且也在十二指肠粘膜的胃化生处生长。
Hp感染的途径尚未阐明。认为这种感染可能是通过口对口传播，特别是因为它还不可能建立动物源的致病菌储库。感染率取决于卫生标准。在西方工业化国家中，感染率为每年1％。在年龄为60岁的人中有60％Hp感染。
近几年全面研究了Hp致病菌与上胃肠道不同症状的关系。在未患有溃疡人群中Hp感染的高流行率最初使人们联想Hp是无害的死物寄生菌。现在都认为是致病菌导致胃粘膜中B-型胃炎。(Dixon，M.F.：Helicobacterpylori and peptic ulceration：Histopathological aspects.J.Gastroenterol.Hepatol.6(1991)，125-130)。
B-型胃炎与Hp感染密切相关，在几乎100％的患者中发现了这种感染。
尽管其中的发病机理并不清楚，B-型胃炎几乎总是存在于十二指肠溃疡的患者中。
多年来对不具备抗Hp的抗菌活性的酸阻断剂的经验表明，即使在Hp持续增长的情况下，溃疡也可以治愈。通过Hp抗菌治疗治愈的患者中，约有10％的患者在一年内溃疡复发。通常这些患者也都有Hp再感染。为什么Hp感染在这些患者中再次复发足以引起一年内溃疡的复发，而其中40％的非溃疡患者是Hp阳性仍是一个待解决的问题。
胃溃疡也被认为与Hp有关。在这种情况下，其与Hp感染的关系并不紧密，这因为只有70-80％的胃溃疡患者为Hp阳性(Marshall，B.J.，loc.cit.)。
                    发明概述
意外地，发现二甲硅油在对Hp感染的局部抗菌治疗和预防及治疗Hp相关性疾病方面有效，因为它可降低Hp增长。
因此，本发明涉及二甲硅油在局部抗菌治疗及预防和治疗Hp相关性疾病方面的用途，特别是预防和治疗胃炎、胃溃疡、十二指肠溃疡和胃癌方面的用途。
在随机的临床对照实验中，发现二甲硅油可显著降低被诊断为胃溃疡的受试者中Hp的增长，将二甲硅油每日四次以80毫克剂量给予所述受试者共4周。在每晚以300毫克剂量给予雷尼替丁4周后未得到类似的结果。在胃镜调查中，通过另外的窦粘膜活检可检测Hp生长。这项研究的结果总结在下表中。
                  表幽门螺旋    二甲硅油    (N＝27)    雷尼替丁    (N＝30)
杆菌        T0       T1        T0         T1
没有    2/9.5％     11/52.4％   2/13.6％    4/18.2％几乎没有    9/42.9％    5/23.8％    9/40.9％    13/59.1％
中度    8/38.1％    5/23.8％    6/27.3％    4/18.2％
很多    2/9.5％     0/0.0％     4/18.2％    1/4.5％T0＝未经治疗T1＝4周治疗后
上述数据清楚地表明，给予二甲硅油后可显著降低Hp生长。在用二甲硅油治疗的52.4％患者中，治疗4周后不会检测到致病菌。
根据本发明，可以单独使用二甲硅油或者与其它活性成分如抗生素(例如阿莫西林、四环素、clathromycin或甲硝唑)和/或质子泵抑制剂、H2阻断剂、抗酸剂或抗肿瘤剂一起联合用药。
发明者已描述了本发明的实质内容，很明显可使用本发明的方法将本文公开的内容转化。因此，应理解本发明的范围应由后面的权利要求书所定义，而不是由实施例所代表的具体内容所限定。

Claims (6)

1.二甲硅油在制备用于幽门螺旋杆菌局部抗菌治疗的药物组合物中的用途。
2.根据权利要求1的用途，用于预防和治疗幽门螺旋杆菌相关的疾病。
3.根据权利要求1的用途，用于预防和治疗慢性胃炎。
4.根据权利要求1的用途，用于预防和治疗胃溃疡。
5.根据权利要求1的用途，用于预防和治疗十二指肠溃疡。
6.根据权利要求1的用途，用于预防和治疗胃癌。
CN95192556A 1994-03-18 1995-03-15 二甲硅油在局部抗菌治疗和/或预防及治疗与幽门螺旋杆菌(Hp)有关的综合症和感染性疾病中的用途 Pending CN1146154A (zh)

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CA (1) CA2185883C (zh)
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HU (1) HUT75710A (zh)
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NZ (1) NZ282804A (zh)
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CA2185883A1 (en) 1995-09-28
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CA2185883C (en) 2005-08-23
AU2071495A (en) 1995-10-09
AU706351B2 (en) 1999-06-17
HUT75710A (en) 1997-05-28
WO1995025525A1 (en) 1995-09-28
CZ300696A3 (en) 1997-09-17
JPH09510465A (ja) 1997-10-21
HU9602841D0 (en) 1996-12-30
NZ282804A (en) 2000-12-22
NO963892D0 (no) 1996-09-17
NO963892L (no) 1996-11-04
EP0759761A1 (en) 1997-03-05
US5834004A (en) 1998-11-10
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