AU2071395A - The use of dimeticone for the local antibacterial therapy and/or the prevention and therapy of helicobacter pylori (hp) associated syndromes and infectious diseases - Google Patents
The use of dimeticone for the local antibacterial therapy and/or the prevention and therapy of helicobacter pylori (hp) associated syndromes and infectious diseasesInfo
- Publication number
- AU2071395A AU2071395A AU20713/95A AU2071395A AU2071395A AU 2071395 A AU2071395 A AU 2071395A AU 20713/95 A AU20713/95 A AU 20713/95A AU 2071395 A AU2071395 A AU 2071395A AU 2071395 A AU2071395 A AU 2071395A
- Authority
- AU
- Australia
- Prior art keywords
- therapy
- dimeticone
- helicobacter pylori
- prevention
- infectious diseases
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 title claims description 14
- 229960001275 dimeticone Drugs 0.000 title claims description 12
- CXQXSVUQTKDNFP-UHFFFAOYSA-N octamethyltrisiloxane Chemical compound C[Si](C)(C)O[Si](C)(C)O[Si](C)(C)C CXQXSVUQTKDNFP-UHFFFAOYSA-N 0.000 title claims description 12
- 238000002560 therapeutic procedure Methods 0.000 title claims description 9
- 230000000844 anti-bacterial effect Effects 0.000 title claims description 8
- 241000590002 Helicobacter pylori Species 0.000 title claims description 5
- 229940037467 helicobacter pylori Drugs 0.000 title claims description 5
- 230000002265 prevention Effects 0.000 title description 6
- 208000011580 syndromic disease Diseases 0.000 title description 3
- 208000035473 Communicable disease Diseases 0.000 title description 2
- 208000007882 Gastritis Diseases 0.000 claims description 8
- 201000005917 gastric ulcer Diseases 0.000 claims description 5
- 201000010099 disease Diseases 0.000 claims description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 4
- 208000023652 chronic gastritis Diseases 0.000 claims description 3
- 206010017758 gastric cancer Diseases 0.000 claims description 3
- 208000010749 gastric carcinoma Diseases 0.000 claims description 3
- 201000000498 stomach carcinoma Diseases 0.000 claims description 3
- 206010019375 Helicobacter infections Diseases 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 description 12
- 210000004877 mucosa Anatomy 0.000 description 7
- 230000001717 pathogenic effect Effects 0.000 description 7
- 244000052769 pathogen Species 0.000 description 5
- 210000002784 stomach Anatomy 0.000 description 5
- 230000002496 gastric effect Effects 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 239000004205 dimethyl polysiloxane Substances 0.000 description 2
- 235000013870 dimethyl polysiloxane Nutrition 0.000 description 2
- 210000001198 duodenum Anatomy 0.000 description 2
- -1 e.g. a oxicillin Substances 0.000 description 2
- 210000000981 epithelium Anatomy 0.000 description 2
- 210000003238 esophagus Anatomy 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- VMXUWOKSQNHOCA-LCYFTJDESA-N ranitidine Chemical compound [O-][N+](=O)/C=C(/NC)NCCSCC1=CC=C(CN(C)C)O1 VMXUWOKSQNHOCA-LCYFTJDESA-N 0.000 description 2
- 229960000620 ranitidine Drugs 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 241000589989 Helicobacter Species 0.000 description 1
- 206010054949 Metaplasia Diseases 0.000 description 1
- 206010030216 Oesophagitis Diseases 0.000 description 1
- 235000012364 Peperomia pellucida Nutrition 0.000 description 1
- 240000007711 Peperomia pellucida Species 0.000 description 1
- 208000008469 Peptic Ulcer Diseases 0.000 description 1
- 208000035415 Reinfection Diseases 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 239000004098 Tetracycline Substances 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 229940069428 antacid Drugs 0.000 description 1
- 239000003159 antacid agent Substances 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 244000052616 bacterial pathogen Species 0.000 description 1
- 238000001574 biopsy Methods 0.000 description 1
- 229960002626 clarithromycin Drugs 0.000 description 1
- AGOYDEPGAOXOCK-KCBOHYOISA-N clarithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@](C)([C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)OC)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 AGOYDEPGAOXOCK-KCBOHYOISA-N 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000002183 duodenal effect Effects 0.000 description 1
- 208000006881 esophagitis Diseases 0.000 description 1
- 206010016766 flatulence Diseases 0.000 description 1
- 244000000058 gram-negative pathogen Species 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229960000282 metronidazole Drugs 0.000 description 1
- VAOCPAMSLUNLGC-UHFFFAOYSA-N metronidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1CCO VAOCPAMSLUNLGC-UHFFFAOYSA-N 0.000 description 1
- 230000001175 peptic effect Effects 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 229940126409 proton pump inhibitor Drugs 0.000 description 1
- 239000000612 proton pump inhibitor Substances 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 229960002180 tetracycline Drugs 0.000 description 1
- 229930101283 tetracycline Natural products 0.000 description 1
- 235000019364 tetracycline Nutrition 0.000 description 1
- 150000003522 tetracyclines Chemical class 0.000 description 1
- 210000002438 upper gastrointestinal tract Anatomy 0.000 description 1
Classifications
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/80—Polymers containing hetero atoms not provided for in groups A61K31/755 - A61K31/795
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Communicable Diseases (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Description
The Use of Di eticone for the Local Antibacterial Therapy and/or the Prevention and Therapy of Helicobacter Pylori
(Hp) Associated Syndromes and Infectious Diseases
TECHNICAL FIELD OF THE INVENTION
The invention relates to the use of dimethylpolysiloxane (dimeticone) for the local antibacterial therapy and the prevention and treatment of syndromes and infections associated with Helicobacter pylori (Hp) .
BACKGROUND OF THE INVENTION
Commercial dimeticone-containing products such as for instance sab simplex **R* and LefaxftΛ (see the Rote Liste 1993) are used to treat flatulence and to prepare patients for sonography.
WO 90/07930 discloses the use of dimethylpolysiloxane, in particular in conjunction with silica gel in the treatment of diseases of the esophagus, the stomach and the duodenum, such as esophagitis, ulcera (ventriculi and duodeni) and gaεtrites. Said document describes the capability of dimeticone to form and maintain a protective film in the
esophagus, the stomach and the duodenum after oral administration.
In recent years, it has become known that in some forms of chronic gastritis and in the development of ulcera (ulcus ventriculi and duodeni) , the infection of the gastro¬ intestinal (GI) tract with the gram negative pathogen Hp is a pathogenetic factor, and its relationship to the genesis of gastric carcinoma is being increasingly discussed.
Although it has been known among pathologists since the close of the 19th century that spiral bacteria are present in the stomach mucosa, it was not until 1983 that Hp was cultured from bioptic material of the antrum mucosa of patients afflicted with peptic ulcera and gastritis. (Marshall, B.J.: Unidentified curved bacilli on gastric epithelium in active chronic gastritis. Lancet I (1983), 1273-1275) .
Hp is acid-instable and sensitive to competition from other bacteria. Hence, the pathogen can only grow in a particular ecological niche. It finds this niche directly underneath the protective mucosa layer on the epithelium of the antrum and the body mucosa, but also on gastric metaplasies of the duodenal mucosa.
The route of Hp infection has not, so far, been elucidated. The infection was thought likely to be passed on orally from man to man, especially since it has not yet been possible to establish a pathogen reservoir of animal origin. The rate of infection depends on sanitation standards. In Western industrialized countries, the infection rate is about 1% per year. Hence, Hp infections are found in 60% of the persons aged 60.
The association of the Hp pathogen with different symptoms of the upper GI tract was systematically investigated in the past few years. The high prevalence of Hp infection in a population not afflicted with ulcus initially led to the assumption that Hp is a harmless saprophyte. Nowadays it is considered an established fact that the pathogen causes the B-type gastritis in the mucosa of the stomach. (Dixon, M.F.: Helicobacter pylori and peptic ulceration: Histopathological aspects. J. Gastroenterol. Hepatol. 6 (1991), 125-130).
The B-type gastritis is closely related to Hp infection which is detected in almost 100% of these patients.
The B-type gastritis is almost always present in patients suffering from ulcus duodeni, although the pathogenetic relationship is still unclear.
Experiences made in many years with acid blockers not possessing an antibacterial effect against Hp, have shown that ulcera can be cured even in cases of persistent Hp growth. About 10% of the patients cured from Hp by an antibacterial therapy, show an ulcus relapse within a year. Admittedly, these patients, as a rule, also suffer from an Hp re-infection. It must remain an open question why the relapse of the Hp infection in these patients is sufficient to cause an ulcus relapse within a year, when 40% of the population not afflicted with ulcera are Hp positive.
Ulcus ventriculi is also considered to be associated with Hp. In this case, the correlation with the Hp infection is not as close, as only 70-80% of the patients with gastric ulcera are Hp positive (Marshall, B.J. , loc. cit.).
SUMMARY OF THE INVENTION
Surprisingly, dimeticone has been found to be effective in the local antibacterial therapy of Hp infections and the prevention and treatment of Hp associated diseases, as it reduces Hp growth.
Therefore, the invention relates to the use of dimeticone for the local antibacterial therapy and the prevention and treatment of Hp associated diseases, in particular the prevention and treatment of gastritis, ulcus ventriculi, ulcus duodeni and gastric carcinoma.
In a randomized clinical comparative test, dimeticone was found to significantly reduce the growth of Hp in test persons with diagnosed ulcus ventriculi, when it was administered in a dose of 80 mg four times a day over 4 weeks. A similar result was not achieved with ranitidine administered in a dose of 300 mg for 4 weeks in the evening.
In a gastroscopic investigation of the stomach, the Hp growth was examined by an additional biopsy of the antrum mucosa. The results of this study are summarized in the following table.
T A B L E
Helicobacter Dimeticone (N = 27) Ranitidine (N = 30) pylori τo Tl τo Tl not present 2/ 9.5% 11/52.4% 2/13.6% 4/18.2% little 9/42.9% 5/23.8% 9/40.9% 13/59.1% medium 8/38.1% 5/23.8% 6/27.3% 4/18.2% much 2/ 9.5% 0/ 0.0% 4/18.2% 1/ 4.5%
T0 = without treatment
Tη_ = after a 4-week treatment
The foregoing data clearly show that the administration of dimeticone leads to a significant reduction of the Hp growth. In 52.4% of the patients treated with dimeticone, the pathogen could no longer be detected after a 4 week treatment.
According to the invention, dimeticone may be used either alone or in combination with other active ingredients, such as antibiotics, e.g. a oxicillin, tetracycline, clathromycin or metronidazole and/or proton-pump-inhibitors, H2-blockers, antacids or antitumor agents.
While we have described an embodiment of this invention, it is apparent that our embodiment may be altered to provide other embodiments which utilize the method of this invention. Therefore, it will be appreciated that the scope of this invention is to be defined by the appended claims, rather than by the specific embodiment which has been presented by way of example.
Claims (6)
1. The use of dimeticone for preparing a pharmaceutical composition for the local antibacterial therapy of Helicobacter pylori infections.
2. The use according to claim 1 for preventing and treating diseases associated with Helicobacter pylori.
3. The use according to claim 1 for preventing and treating chronic gastritis.
4. The use according to claim 1 for preventing and treating ulcus ventriculi.
5. The use according to claim 1 for preventing and treating ulcus duodeni.
6. The use according to claim 1 for preventing gastric carcinoma.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DEP4409357 | 1994-03-18 | ||
| DE4409357A DE4409357C2 (en) | 1994-03-18 | 1994-03-18 | Use of Dimeticon to eradicate Heliobacter pylori |
| PCT/EP1995/000972 WO1995025525A1 (en) | 1994-03-18 | 1995-03-15 | The use of dimeticone for the local antibacterial therapy and/or the prevention and therapy of helicobacter pylori (hp) associated syndromes and infectious diseases |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2071395A true AU2071395A (en) | 1995-10-09 |
| AU699199B2 AU699199B2 (en) | 1998-11-26 |
Family
ID=6513210
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU20713/95A Ceased AU699199B2 (en) | 1994-03-18 | 1995-03-15 | The use of dimeticone for the local antibacterial therapy and/or the prevention and therapy of helicobacter pylori (HP) associated syndromes and infectious diseases |
Country Status (14)
| Country | Link |
|---|---|
| EP (1) | EP0804242A1 (en) |
| JP (1) | JPH09510466A (en) |
| CN (1) | CN1244129A (en) |
| AU (1) | AU699199B2 (en) |
| CA (1) | CA2185882A1 (en) |
| CZ (1) | CZ300796A3 (en) |
| DE (1) | DE4409357C2 (en) |
| FI (1) | FI963682A (en) |
| HU (1) | HU215595B (en) |
| NO (1) | NO963893L (en) |
| NZ (1) | NZ282805A (en) |
| PL (1) | PL316307A1 (en) |
| SK (1) | SK132496A3 (en) |
| WO (1) | WO1995025545A1 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6100245A (en) * | 1999-09-07 | 2000-08-08 | Mcneil-Ppc, Inc. | Use of simethicone to treat ulcerative colitis |
| BR0318319A (en) * | 2003-05-25 | 2006-07-18 | Yuwan Wang | preparation methods and formulations / compositions sustained by the use of dimethicone as a vehicle |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR3848M (en) * | 1964-05-04 | 1966-01-17 | Robert Schapiro | Therapeutic associations for the treatment of numerous organic or functional digestive disorders. |
| GB1357737A (en) * | 1970-10-09 | 1974-06-26 | Arpic Sa | Sustained release pharmaceutical compositions |
| NZ217844A (en) * | 1985-10-11 | 1989-10-27 | Sumitomo Pharma | A sustained release pharmaceutical composition containing silicone elastomer and an albumin |
| US4837029A (en) * | 1987-04-06 | 1989-06-06 | Carolina Medical Products, Inc. | Low foaming, aqueously homogenizable rifampin composition |
| US5446070A (en) * | 1991-02-27 | 1995-08-29 | Nover Pharmaceuticals, Inc. | Compositions and methods for topical administration of pharmaceutically active agents |
| WO1990007930A1 (en) * | 1989-01-19 | 1990-07-26 | Steigerwald Arzneimittelwerk Gmbh | Use of dimethylpolysiloxane for treating disorders of the gastrointestinal tract |
| IE903302A1 (en) * | 1989-09-15 | 1991-04-10 | Pehrom Pharmaceutical Corp | Topical preparation for treatment of aphthous ulcers and¹other lesions |
| NZ235876A (en) * | 1989-11-01 | 1992-06-25 | Mcneil Ppc Inc | Pharmaceutical compositions containing effective amount of antidiarrheal composition and antiflatulent effective amount of simethicone |
| US5229137A (en) * | 1992-05-06 | 1993-07-20 | Brigham And Women's Hospital, Inc. | Methods and pharmaceutical compositions for treating episodic heartburn |
| WO1994003209A1 (en) * | 1992-07-29 | 1994-02-17 | Merck & Co., Inc. | Dexibuprofen/antacid/simethicone combinations |
-
1994
- 1994-03-18 DE DE4409357A patent/DE4409357C2/en not_active Expired - Fee Related
-
1995
- 1995-03-15 CN CN95192553A patent/CN1244129A/en active Pending
- 1995-03-15 HU HU9602839A patent/HU215595B/en not_active IP Right Cessation
- 1995-03-15 JP JP7524363A patent/JPH09510466A/en not_active Withdrawn
- 1995-03-15 CZ CZ963007A patent/CZ300796A3/en unknown
- 1995-03-15 PL PL95316307A patent/PL316307A1/en unknown
- 1995-03-15 CA CA002185882A patent/CA2185882A1/en not_active Abandoned
- 1995-03-15 EP EP95913130A patent/EP0804242A1/en not_active Withdrawn
- 1995-03-15 NZ NZ282805A patent/NZ282805A/en not_active IP Right Cessation
- 1995-03-15 WO PCT/EP1995/000973 patent/WO1995025545A1/en not_active Application Discontinuation
- 1995-03-15 AU AU20713/95A patent/AU699199B2/en not_active Ceased
- 1995-03-15 SK SK1324-96A patent/SK132496A3/en unknown
-
1996
- 1996-09-17 NO NO963893A patent/NO963893L/en not_active Application Discontinuation
- 1996-09-17 FI FI963682A patent/FI963682A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PL316307A1 (en) | 1997-01-06 |
| HUT75711A (en) | 1997-05-28 |
| NZ282805A (en) | 1998-02-26 |
| CN1244129A (en) | 2000-02-09 |
| EP0804242A1 (en) | 1997-11-05 |
| NO963893D0 (en) | 1996-09-17 |
| SK132496A3 (en) | 1997-06-04 |
| NO963893L (en) | 1996-11-04 |
| HU9602839D0 (en) | 1996-12-30 |
| CZ300796A3 (en) | 1997-09-17 |
| DE4409357C2 (en) | 1996-10-17 |
| JPH09510466A (en) | 1997-10-21 |
| HU215595B (en) | 1999-01-28 |
| FI963682A0 (en) | 1996-09-17 |
| CA2185882A1 (en) | 1995-09-28 |
| DE4409357A1 (en) | 1995-09-21 |
| WO1995025545A1 (en) | 1995-09-28 |
| AU699199B2 (en) | 1998-11-26 |
| FI963682A (en) | 1996-11-13 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MK14 | Patent ceased section 143(a) (annual fees not paid) or expired |