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Title:  Method of treatment of human immunodeficiency diseases
United States Patent: 
7,090,839
Issued: 
August 15, 2006

Inventors: 
Khatchatrian; Ashot P. (Glendale, CA), Khatchatrian; Robert G. (Glendale, CA)
Assignee: 
Hidden Valley, N.V. (Curacao, AN)
Appl. No.:  10/348,341
Filed: 
January 21, 2003


 

Pharm Bus Intell & Healthcare Studies


Abstract

The present invention relates to a method of treating human immunodeficiency diseases with electroactivated aqueous salt solutions followed by reconstitution of a healthy microflora.

Description of the Invention

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a method of treating human immunodeficiency diseases with electroactivated aqueous salt solutions followed by reconstitution of a healthy microflora.

2. Description of the Related Art

Acquired immune deficiency syndrome is a disease of the human immune system. The immunodeficient state is reflected in an inability of the immune system to respond to various antigens. The immunodeficient state may allow for the growth of tumors, due to a defect in the normal antitumor activity of the immune system. The immunodeficient state may also lead to allergic or autoimmune problems. The development of an immunodeficient state is often caused by metabolic disorders. These metabolic disorders may result from diabetes, obesity, artherosclerosis, uremia and attrition.

Irritable colon syndrome is a common aspect of many diseases and is often connected with problems in the immune system. Many diseases that appear unrelated, such as AIDS, chronic renal failure, bacterial endocarditis, and bronchial asthma are related by a unified feature: irritable colon syndrome, a common disruption of the balance of microflora in the intestine and growth of pathogenic bacteria. The disruption of the balance of microflora, followed by disruption of the immune system, determines the onset and course of many diseases.

Thus, novel methods of treatment of immunodeficient states can be achieved through the development of new methods of purifying an organism from pathogenic accumulations, normalizing metabolism, and restoring the healthy intestinal microflora. Such methods would make it possible for a person to control the illness by a natural means.

A number of methods of treating immunodeficient states are known. In one, a hexapeptide drug is administered through hypodermic injections. (Patent of Russian Federation No. 2062096). This drug has shown good results in the treatment of immunodeficient patients with chronic and active persistent hepatitis B, brucellosis and chronic bronchitis.

In another method, patients suffering from AIDS or AIDS-related syndromes are treated by the injection of a pharmaceutical composition containing zidovudin (31-azid-31-deoxythymidine) and inosyplex (paracyd-benzoic acid), possibly in combination with inosinum. (European Patent No. 0362162).

Unfortunately, the positive results obtained through these two methods are accompanied by side effects that can lead to damage of the liver, kidney and heart, resulting in severe complications. In addition, these methods do not restore the healthy microflora of the intestine, which has been disrupted by the disease being treated.

Another method of treating immunodeficient patients uses a solution of water mixed with either sodium hydrocarbonate, alcohol solution of iodine, potassium permanganate or sulficil-sodium. In the course of treatment, the patient takes the mixture orally and by means of rectal or vaginal lavage. (Patent of Russian Federation No. 2077886). This method is based on the removal of pathogenic accumulations and the normalization of the metabolism in a natural way that can be regulated by the patient. However, like the methods described above, this method does not restore the healthy microflora of the intestine.

A method of treating irritable colon syndrome that may also be used to treat immunodeficiencies involves purification of the intestine with enemas. This is followed by the implantation of microflora in the intestine with the help of colonoscopy. Lactobacteria are implanted in the ascending section of the intestine, Bifidobacteria are implanted in the transversal section and colibacteria are implanted in the descending section. (Patent of Russian Federation No. 2092167). Unfortunately, aside from the cleansing enemas, this method does not contemplate removing pathogenic agents from the intestine and thus, is not as effective as it might be.

Another method of treating autoimmune diseases, as well as AIDS, consists of inhibiting, removing or neutralizing a variety of growth factors, antigens or receptors. This treatment comprises either administering the active molecules directly to the patient's blood or removing the patient's blood, treating it, and returning it to the patient. (U.S. Pat. No. 5,888,511).

It is also possible to treat immunological disorders, inflammatory diseases and infections with magnesium gluconate. The magnesium gluconate may be administered alone or in combination with antioxidants or anti-inflammatory agents. (U.S. Pat. No. 5,853,738). Additional methods use pharmacologically accepted salts, such as NaPa alone or in combination with suraminum, interferon or Pag. These agents act directly to suppress the growth of tumor cells and to prevent the onset of problems associated with viral infections. (U.S. Pat. No. 5,877,213).

The inadequacy of the treatment described above is insufficient stimulation of the immune system and a failure to normalize metabolism. Additionally, they do not regenerate the healthy microflora.

Finally, a generalized method of treating viral infections, such as AIDS, herpes and hepatitis, and the accompanying immunodeficiencies has been described. The method is based on a course of therapy consisting of the introduction into the patient of an electroactivated aqueous NaCl solution in an amount that does not exceed the daily requirements for electrolytes and water. Simultaneously, the patient is exposed to dry radon with a frequency of radiation of 17 gHz for 1.5 to 2 minutes. (Patent of Russian Federation No. 2089194). As with the other described methods, this method is problematic because it does not provide sufficient immunostimulation, does not normalize metabolic processes and does not regenerate the healthy microflora.

SUMMARY OF THE INVENTION

The present invention relates to a method of treating humans suffering from a disease. The method comprises rectally administering to said human an electroactivated aqueous salt solution with negative redox potential. This is followed by implantation of bacteria in the intestine to restore a healthy microflora. The method may additionally comprise administering an electroactivated aqueous salt solution with negative redox potential orally or by injection. The method of the present invention may also comprise rinsing the oral cavity, nasopharynx and vaginal cavity with an electroactivated aqueous salt solution with positive redox potential.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The method of the present invention is a preventative and treatment for immunodeficiencies. The aim of the present invention is to provide a more effective method to prevent and treat immune diseases through intensive decontamination and the restoration of the microflora found in the healthy individual (healthy microflora).

The method of the present invention comprises a course of treatment. The first step comprises the administration of electroactivated aqueous salt solutions to the patient. Preferably the volume of electroactivated aqueous salt solution administered does not exceed the daily requirements for electrolytes and water.

Aqueous solutions of salts with negative or positive redox potential are activated by any method known in the art. Preferably they are activated on a membranous electrolyzer. Any membranous electrolyzer known in the art may be used. For example, a membranous electrolyzer of the Espero type may be used. For aqueous salt solutions with negative redox potential, the measured values are preferably -300 to -1200 mV and pH 8.0 to 12.0. More preferably, the measured values are -500 to -900 mV and pH 9.0 to 11.0. For aqueous salt solutions with positive redox potential, the measured values are preferably +500 to +1200 mV and pH 0.05 to 5.0. More preferably the measured values are +900 to +1200 and pH 1.0 to 2.0.

For the aqueous salt solutions, the salt may be any salt know in the art. However, the salt is preferably either AgNO.sub.3, in a density of no more than 14 grams/liter or a mixture of the salts NaCl, KCl, CaCl.sub.2 and MgCl.sub.2, in any ratio and at a density of no more than 15 grams/liter. More preferably the salt is either AgNO.sub.3 in a density of no more than 7 grams/liter or the salts NaCl, KCl, CaCl.sub.2 and MgCl.sub.2 in the same ratio as they are found in the plasma (80:2:2:1) and at a density of no more than 10 grams/liter.

The electroactivated aqueous solution of salts with negative redox potential is administered to the patient through three separate routes. First, it is administered to the patient by way of intravenous injection of preferably no more than 400 ml per day. More preferably no more than 200 ml/day is administered.

Second, it is administered orally, in an amount of no more than 600 ml per day, for 40 days. More preferably it is administered orally before a meal in an amount of no more than 300 ml per day for 15 to 20 days.

Finally, it is administered by way of cleansing enemas, preferably in an amount of 3 liters, twice a day. More preferably it is administered by enema in an amount of 0.5 to 1.5 liters, once per day.

The electroactivated aqueous solution of salts with positive redox potential is also administered to the patient in a number of ways. First, it is administered as an aerosol with a particle size of no more than 10 microns. More preferably, it is administered as an aerosol with a particle size of no more than 3.5 microns. The aerosol is inhaled through the nose or mouth. Preferably, 1 to 10 ml are inhaled four times per day. More preferably, 1 to 3 ml are inhaled twice a day, once in the morning and once in the evening.

Second, in female patients it is administered by way of rinsing vaginal cavity with an amount of 10 to 800 ml four times per day. More preferably, it is administered by this route twice a day in an amount of 200 to 400 ml.

Finally, it is administered by way of rinsing the oral cavity and nasopharynx with an amount of 10 to 800 ml four times per day. More preferably it is administered by this route twice a day in an amount of 200 to 400 ml.

After preliminary cleansing of the intestine through the enemas described above, the healthy microflora is restored. To restore the healthy microflora, bacteria are implanted in the intestine with the aid of a colonoscopy. Any bacteria known in the art may be implanted following any procedure known in the art. Preferably, lactobacteria, bifidobacteria and colibacteria are implanted in the following manner. First, a culture of lactobacteria is implanted in the ascending section of the intestine through a biopsy canal. Second, a culture of bifidobacteria is implanted in the transverse section of colon. Third, a culture of colibacteria is implanted in the descending section of colon. In each section not less than 100 ml of liquid culture is administered. More preferably, not less than 20 ml is administered. The implanted bacteria may be in any phase of growth and the titer is not less than 10.sup.4 units/ml. More preferably, the bacteria is in the log phase of growth and the titer is not less than 10.sup.8 units/ml.

In female patients, healthy microflora is also restored in the urogenital tract. After rinsing the vaginal cavity as described above, liquid lactobacteria is are implanted in the vagina. Preferably not more than 20 ml is implanted. More preferably 5 to 10 ml is implanted. The implanted bacteria may be in any phase of growth and the titer is not less than 10.sup.4 units/ml. More preferably, the bacteria is in the log phase of growth and the titer is not less than 10.sup.8 units/ml.

Healthy microflora is also restored in the oral cavity and nasopharynx. Following rinsing of the oral cavity and nasopharynx, liquid lactobacteria culture is applied. The applied bacteria may be in any phase of growth and the titer is not less than 10.sup.4 units/ml. More preferably the bacteria are in the log phase of growth and the titer is not less than 10.sup.8 units/ml. From 1 to 10 ml are applied through the oral cavity and from 0.1 to 4 ml through the nose. More preferably, from 3 to 5 ml are applied through the oral cavity and from 1 to 2 ml through the nose.

Experimental research has shown that when an electric current is passed through the aqueous salt solution in the membranous electrolyzer, the molecules, atoms and ions are electroactivated and the ions are redistributed in the electric field. As a result, a portion of the aqueous solution in the cathode zone (catolite) acquires restorative properties and maintains a potential energy. A high biological activity is observed with electroactivated aqueous salt solution in a range of from -400 to -900 mV and pH 7.5 to 11. Application of the activated solution increases the electrochemical processes in living cells. It accelerates all natural biological processes, including regeneration of cells and tissues and immune processes. The catolite has an immunostimulating, detoxifying ability, which acts to normalize the metabolic process in an organism. In addition, the catolite has some bacteriostatic properties.

Electrolyzing aqueous salt solution also produces solution with a positive redox potential. The aqueous solution with a positive redox potential of +900 to +1200 mV and pH 1.0 to 2.0 (anolite), has antiseptic, antiflammatory and antiproliferative properties.

For the correction of the healthy microflora, any bacterial strains known in the art may be used. The following strains are preferable: Bifidobacterium bifidum 1 or 791; Bifidobacterium longum 397; Bifidobacterium adolescentis MC-42; and Lactobacillus acidophilus 317/402. The Bifidobacteria and Lactobacteria are the main components of the microflora of the intestine and urogenital tract of humans. These bacteria are antagonistic to many agents that cause intestinal and urogenital infection, stimulate self-protective mechanisms and increase resistance to many diseases.

One example of a strain of Lactobacillus acidophilus that may be used in the present invention is Strain 317/402, known as "Narine." This strain synthesizes vitamins such as folic acid, thiamin and riboflavin. It also induces the production of interferon, which increases the strain's beneficial properties.

Combining drug therapy with regeneration of healthy microflora increases the effectiveness of treatment. Oral, vaginal and rectal administration of bacteria combined with the use of pharmacologically active solutions improves the ability to destroy pathogenic microflora in the intestine and urogenital tract and restore a healthy microflora. The implanted bacteria compete with the pathogenic microflora for binding sites on the epithelial cells of the intestine and urogenital tract, thus, displacing the pathogenic microflora and allowing for the development of a healthy microflora.
 


Claim 1 of 10 Claims

1. A method of treating chronic fatigue syndrome or disbacteriosis in a human, said method comprising: electroactivating an aqueous solution of an inorganic salt selected from the group consisting of AgNO3, NaCl, KCl, CaCl.sub.2 and MgCl.sub.2 to create an electroactivated aqueous inorganic salt solution having a redox potential in the range from -300 mV to -1200 mV and a pH from 8 to 12; administering to said human said electroactivated aqueous inorganic salt solution; and implanting bacteria in the intestine of said human, wherein said bacteria are selected from the group consisting of lactic acid bacteria, bifidobacteria and Escherichia coli bacteria.

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