Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant... – Coated – impregnated – or colloidal particulate
Patent
1997-05-29
2000-09-05
Dees, Jose' G.
Drug, bio-affecting and body treating compositions
Radionuclide or intended radionuclide containing; adjuvant...
Coated, impregnated, or colloidal particulate
424 133, 424 125, 424 181, 424 91, A61K 5100, A61K 4900
Patent
active
061138754
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/SE95/01212, filed Oct. 17, 1995.
Diseases relating to gastric ulcers, are a serious public health problem and cost the community large sums of money in the form of medical costs and lost working ability. It has been fully established that the presence of Helicobacter pylori in the stomach is a necessary prerequisite for the development of stomach ulcers and/or duodenal ulcers. If the bacterium is not present in the stomach, no ulcer will develop. It has also been established that when a Helicobacter pylori infection is cured with the aid of antibiotics, there will be no relapse in stomach ulcer diseases. Stomach ulcer diseases are therefore considered to be bacterium-caused diseases which can and shall be cured.
There is a great need for a reliable and simple diagnosis in this regard, as large patient populations inflicted with gastrointestinal problems will need to be examined with regard to the presence of a Helicobacter pylori infection.
The present invention is based on the observation that the bacterium Helicobacter pylori produces the enzyme urease in very large quantities. The enzyme urease is normally not found in human beings, and its presence in the stomach indicates that Helicobacter pylori is present. Helicobacter pylori has established an ecological niche in the human stomach. The bacterium thrives in a neutral pH, which is found beneath the mucus layer in the stomach. The bacterium produces large quantities of the enzyme urease, which in turn catalyzes the degradation of urea to ammonia and bicarbonate. The bicarbonate is then converted in the acid environment of the stomach to carbon dioxide and water.
In Sweden, about 470,000 patients seek medical care for stomach ulcer-like problems each year. The possibility of being able to diagnose and to treat Helicobacter pylori infections in a reliable and simple manner is therefore of great interest to the patient and also from the aspect of health economy.
The present invention pertains to a solid preparation for simple and reliable diagnosis of ongoing urease activity in the stomach in conjunction with Helicobacter pylori infection.
Biopsy Methods
A common feature of these methods (cultivation of the bacterium, histological examination, quick urease test) is that they are carried out on biopsy material. This means that the patient must undergo a gastroscopic examination of the stomach with the use of fibre optics, during which tissue samples are taken from the stomach epithelium. This examination is both expensive and unpleasant to the patient.
Serological Methods
A common feature of these methods consists of determining the presence of specific antibodies against Helicobacter pylori in the blood or in stomach secretion. One drawback with these methods is that it is necessary to take blood samples or secretion from the stomach. Neither are serological methods able to show the presence of bacteria on the occasion of making the examination.
It takes about twenty days from the time of being infected with Helicobacter pylori to the time that antibodies against the bacterium manifest themselves.
After successful treatment of the bacterial infection, elevated contents of antibodies remain in the blood for a very long time, thereby greatly limiting the possibility of accurately checking the condition of treated patients.
Urea-Breath Tests
The method is based on the production of the enzyme urease by the bacterium Helicobacter pylori. Urease catalyzes the degradation of urea to ammonia and bicarbonate. The bicarbonate is then converted to carbon dioxide and water in the acid environment of the stomach.
At present, the urea-breath test is performed in the following manner: The patient swallows an aqueous solution containing isotope-labelled (.sup.11 C, .sup.13 C, .sup.14 C) urea. In the presence of urease-producing Helicobacter pylori and acid in the stomach, urea is broken down so that the isotope-labelled carbon atoms convert to carbon dioxide and are secreted via the exhaled air. The amount of isotope-labelled carbon dio
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Lundqvist Thomas
Nystrom Christer
Pettersson Anders
Dees Jos,e G.
Diabact AB
Hartley Michael G.
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