JP7366331B2 - Compositions and methods for preventing and/or ameliorating organ-specific autoimmune diseases - Google Patents

Description

The present invention relates to a composition for preventing and/or ameliorating organ-specific autoimmune diseases.
The present invention also relates to methods for preventing and/or ameliorating organ-specific autoimmune diseases.

Organ-specific autoimmune diseases are autoimmune diseases whose pathology is localized to specific organs, and include autoimmune hemolytic anemia, thrombocytopenic purpura, Hashimoto's disease, Guillain-Barre syndrome, Graves' disease, I Type diabetes, myasthenia gravis, autoimmune gastritis, pemphigus, etc.
In recent years, it has been proposed that hydrogen molecules suppress chronic inflammation by scavenging hydroxyl radicals generated within cells and mitochondria, and may be effective against many diseases caused by chronic inflammation. (Non-patent Document 1). However, it has not been reported that organ-specific autoimmune diseases are prevented and/or improved when patients with organ-specific autoimmune diseases inhale, aspirate, or drink hydrogen gas-containing gases.

Shin-ichi Hirano, Yusuke Ichikawa, Bunpei Sato, Haru Yamamoto, Yoshiyasu Takefuji, Fumitake Satoh ″Potential Therapeutic App lications of Hydrogen in Chronic Infrastructure Diseases: Possible Inhibiting Role on Mitochondrial Stress” International Jour nal of Molecular Science, 2021, 22, 2549

An object of the present invention is to provide a new composition for preventing and/or ameliorating organ-specific autoimmune diseases that has few side effects and can be easily produced.

As a result of intensive research, the present inventors unexpectedly discovered that hydrogen gas-containing gas prevents and/or improves organ-specific autoimmune diseases.
Accordingly, the invention includes the following features.
(1) A composition containing hydrogen as an active ingredient for improving symptoms caused by an organ-specific autoimmune disease and/or suppressing worsening of symptoms in a subject.
(2) The organ-specific autoimmune disease is myasthenia gravis, Hashimoto's disease, Graves' disease, ulcerative colitis, autoimmune hemolytic anemia, thrombocytopenic purpura, Guillain-Barre syndrome, type I diabetes, autoimmune disease, The composition according to (1), characterized in that the composition is selected from one or more diseases consisting of immune gastritis and pemphigus.
(3) Symptoms caused by the organ-specific autoimmune disease are
Myasthenia gravis causes general muscle weakness, limb muscle weakness, easy fatigability, ptosis, eye symptoms such as double vision, dysphagia, breathing difficulties, and quality of life associated with these symptoms. ), as well as side effects of myasthenia gravis treatment drugs,
Hashimoto's disease causes fatigue, coldness, swelling of the body, weight gain, drowsiness, memory loss, shortness of breath, decreased pulse rate, muscle weakness, slow movement, anovulation, amenorrhea, constipation, thyroid swelling, eyelid swelling, depression, Constipation, hypercholesterolemia, and decreased quality of life associated with these symptoms, as well as side effects of Hashimoto's treatment drugs,
Graves' disease causes fatigue, profuse sweating, hot flashes, weight loss, arrhythmia, hand tremors, irritability, anxiety, irritability, sleep disturbance, increased number of excuses, decreased cholinesterase, oligomenorrhea, amenorrhea, and loose stools. , swelling of the thyroid gland, bulging eyes, and decreased quality of life associated with these symptoms, as well as side effects of Graves' disease treatment drugs,
Ulcerative colitis causes bloody diarrhea, bloody diarrhea, abdominal pain, fever, loss of appetite, weight loss, anemia, arthritis, iritis, pancreatitis, erythema nodosum, pyoderma gangrenosum, and these symptoms. Decline in quality of life associated with this, as well as side effects of ulcerative colitis treatment drugs,
Autoimmune hemolytic anemia causes malaise due to anemia, palpitations due to anemia, shortness of breath due to anemia, dizziness due to anemia, headache due to anemia, jaundice, swelling of the spleen, and quality of life associated with these symptoms. reduction, as well as side effects of autoimmune hemolytic anemia treatment drugs,
Thrombocytopenic purpura causes gingival bleeding, epistaxis, subcutaneous bleeding, genital bleeding, bloody stool, decreased quality of life associated with these symptoms, and side effects of thrombocytopenic purpura treatment drugs. ,
Guillain-Barre syndrome causes muscle weakness, abnormal sensation, sensory loss, pain, ataxia, autonomic neuropathy, and decreased quality of life accompanying these symptoms. side effects,
Symptoms associated with organ-specific autoimmune diseases include thirst, frequent urination, rapid weight loss, fatigue, and poor quality of life associated with these symptoms in type I diabetes. reduction, as well as side effects of type I diabetes treatment drugs,
Autoimmune gastritis is characterized by gastric atrophy, pernicious anemia, numbness of the fingertips, gait disturbance, decreased quality of life accompanying these symptoms, and side effects of autoimmune gastritis treatment drugs.
Pemphigus causes erosion of the oral mucosa, ulceration of the oral mucosa, pemphigus foliaceus on the skin, a decrease in quality of life associated with these symptoms, and side effects of pemphigus treatment drugs.
The composition according to (1) or (2), characterized in that:
(4) The composition according to any one of (1) to (3), wherein the hydrogen concentration is greater than 0 and 18.5% by volume or less.
(5) The composition according to any one of (1) to (4), wherein the composition is administered to the subject by inhalation.
(6) The composition according to any one of (1) to (5), wherein the subject is a mammal including a human.
(7) A method for producing the composition according to any one of (1) to (6) above, characterized in that the composition is produced using a hydrogen gas generator. be.

According to the present invention, organ-specific autoimmune diseases can be prevented and/or improved by hydrogen gas.

The present invention will be explained in further detail.
1. Organ-specific autoimmune diseases Organ-specific autoimmune diseases in the present invention include myasthenia gravis, Hashimoto's disease, Graves' disease, ulcerative colitis, autoimmune hemolytic anemia, thrombocytopenic purpura, and Guillain-Barre syndrome. , type I diabetes, autoimmune gastritis, and pemphigus.

2. Composition for preventing and/or ameliorating organ-specific autoimmune diseases containing hydrogen gas-containing gas The present invention improves symptoms caused by organ-specific autoimmune diseases containing hydrogen gas-containing gas as an active ingredient. and/or provide a composition for suppressing worsening of symptoms.

Symptoms related to organ-specific autoimmune diseases include, in myasthenia gravis, general muscle weakness, limb muscle weakness, easy fatigability, ptosis, ocular symptoms such as double vision, dysphagia, breathing difficulties, These include a decrease in quality of life associated with these symptoms, and side effects of myasthenia gravis therapeutics.

In recent years, the incidence of myasthenia gravis has been increasing, especially in the elderly. Unlike young people, most elderly people do not have thymoma and therefore have weaker immune systems, so steroids are used for treatment. However, treatment with steroids is a heavy burden for elderly people. Additionally, side effects of steroids include cataracts and osteoporosis. Therefore, immunosuppressants are used, but they come with the risk of infection and cancer. The prognosis for elderly patients with myasthenia gravis is that most patients will die within 10 years due to cancer. Therefore, hydrogen-based drugs for myasthenia gravis are expected to be effective in preventing the onset of cancer.

Symptoms associated with organ-specific autoimmune diseases include fatigue, coldness, body swelling, weight gain, drowsiness, memory loss, shortness of breath, decreased pulse, muscle weakness, bradykinesia, anovulation, and amenorrhea in Hashimoto's disease. , constipation, thyroid swelling, eyelid swelling, depression, constipation, hypercholesterolemia, decreased quality of life associated with these symptoms, and side effects of Hashimoto's treatment drugs. .

Symptoms associated with organ-specific autoimmune diseases include fatigue, profuse sweating, hot flashes, weight loss, arrhythmia, hand tremors, nervousness, anxiety, irritability, sleep disturbance, and frequent diatribes in Graves' disease. increased cholinesterase, oligomenorrhoea, amenorrhea, loose stools, swelling of the thyroid gland, exophthalmia, decreased quality of life associated with these symptoms, and side effects of Graves' disease treatment drugs. It will be done.

Symptoms associated with organ-specific autoimmune diseases include ulcerative colitis: bloody stools, mucus-bloody stools, diarrhea, bloody diarrhea, abdominal pain, fever, anorexia, weight loss, anemia, arthritis, iritis, pancreatitis, and nodules. These include erythema erythema gangrenosum, pyoderma gangrenosum, decreased quality of life accompanying these symptoms, and side effects of drugs for treating ulcerative colitis.

Symptoms associated with organ-specific autoimmune diseases include, in autoimmune hemolytic anemia, malaise due to anemia, palpitations due to anemia, shortness of breath due to anemia, dizziness due to anemia, headache due to anemia, jaundice, swelling of the spleen, and , a decrease in quality of life accompanying these symptoms, and side effects of autoimmune hemolytic anemia therapeutics.

Symptoms related to organ-specific autoimmune diseases include gingival bleeding, epistaxis, subcutaneous bleeding, genital bleeding, bloody stool, and quality of life associated with these symptoms in thrombocytopenic purpura. and side effects of thrombocytopenic purpura treatment drugs.

Symptoms associated with organ-specific autoimmune diseases include muscle weakness, abnormal sensation, sensory loss, pain, ataxia, autonomic neuropathy, and poor quality of life associated with these symptoms. of life) and side effects of Guillain-Barre syndrome treatment drugs.

Symptoms associated with organ-specific autoimmune diseases include thirst, frequent urination, rapid weight loss, fatigue, and poor quality of life associated with these symptoms in type I diabetes. reduction, as well as side effects of type I diabetes medications.

Symptoms related to organ-specific autoimmune diseases include gastric atrophy, pernicious anemia, numbness of the fingertips, gait disturbance, and poor quality of life associated with these symptoms in autoimmune gastritis. and side effects of autoimmune gastritis treatment drugs.

Symptoms associated with organ-specific autoimmune diseases include erosion of the oral mucosa, ulceration of the oral mucosa, pemphigus foliaceus on the skin, and poor quality of life associated with these symptoms. reduction, as well as side effects of pemphigus treatment drugs.

In this specification, "hydrogen" which is an active ingredient of the composition of the present invention is molecular hydrogen (ie, gaseous hydrogen), and unless otherwise specified, it is simply referred to as "hydrogen" or "hydrogen gas." Moreover, the term "hydrogen" used in this specification refers to H ₂ , D ₂ (deuterium), HD (hydrogen deuteride), or a mixed gas thereof in molecular formula. Although _D2 is expensive, it is known to have a stronger superoxide scavenging effect than _H2 . Hydrogen that can be used in the present invention is H ₂ , D ₂ (deuterium), HD (hydrogen deuteride), or a mixed gas thereof, preferably H ₂ or in place of H ₂ , or D ₂ and/or HD may be used in combination with H ₂ .

The hydrogen gas-containing gas is preferably air containing hydrogen gas or a mixed gas containing hydrogen gas and oxygen gas. The concentration of hydrogen gas in the hydrogen gas-containing gas is greater than zero (0) and less than or equal to 18.5 volume %, and more preferably greater than zero (0) and less than or equal to 10.0 volume %. In the present invention, the higher the hydrogen gas concentration is below the explosive limit, the greater the effect of improving symptoms of organ-specific autoimmune diseases and/or the effect of suppressing worsening of symptoms tends to be greater.
Hydrogen is a flammable and explosive gas, so in order to improve the symptoms of organ-specific autoimmune diseases and/or suppress the worsening of symptoms, it is necessary to include hydrogen in the composition of the present invention under safe conditions. Preferably, it is administered to people with autoimmune diseases.

When the gas other than hydrogen gas is air, the concentration of air is, for example, in the range of 81.5 to 99.5% by volume. When the gas other than hydrogen gas is a gas containing oxygen gas, the concentration of oxygen gas is, for example, in the range of 21 to 99.5% by volume.
Nitrogen gas can be contained as another main gas. A gas such as carbon dioxide, which is a gas contained in the air, may be contained in an amount comparable to the amount present in the air.
In the present invention, a hydrogen-dissolved liquid can be administered or ingested by a patient with an organ-specific autoimmune disease in combination with the administration of a hydrogen gas-containing gas, if necessary.

When co-administered with a hydrogen-dissolved liquid, the compositions of the present invention may be administered before, simultaneously with, or after administration of the hydrogen-dissolved liquid.
The hydrogen-dissolved liquid is specifically an aqueous liquid in which hydrogen gas is dissolved, and the aqueous liquid includes, but is not limited to, water (e.g., sterile water, purified water), physiological saline, buffer solution, etc. (for example, a buffer solution with a pH of 4 to 7.4), ethanol-containing water (for example, an ethanol content of 0.1 to 2% by volume), a drip solution, an infusion, an injection solution, a drink, and the like. The hydrogen concentration of the hydrogen-dissolved liquid is, for example, 1 to 10 ppm, such as 2 to 8% by volume, 3 to 7% by volume, 3 to 6% by volume, 4 to 6% by volume, 4 to 5% by volume, 5 to 10% by volume, 5 to 8% by volume, 6 to 8% by volume, 6 to 7% by volume, etc., more preferably 5 to 8% by volume, for example 6 to 8% by volume, 6 to 7% by volume, etc. In the present invention, the higher the hydrogen gas concentration below the explosive limit, the greater the effect of improving the symptoms of organ-specific autoimmune diseases and/or suppressing the worsening of symptoms tends to be.

Pharmaceuticals for treating organ-specific autoimmune diseases may be added to the hydrogen-dissolved liquid. Alternatively, the drug may be administered separately from the administration of the hydrogen-dissolved liquid or hydrogen gas-containing gas.
After the hydrogen gas-containing gas or hydrogen-dissolved liquid is blended to a predetermined hydrogen gas concentration, it is stored in a pressure-resistant container (e.g., a stainless steel cylinder, an aluminum can, preferably a pressure-resistant container whose inside is laminated with aluminum film). It is filled into plastic bottles (e.g. pressure-resistant PET bottles) and plastic bags, aluminum bags, etc.). Aluminum has the property of being difficult for hydrogen molecules to pass through. Alternatively, the hydrogen gas-containing gas or hydrogen-dissolved liquid may be used, at the time of administration, in a hydrogen gas generation device, hydrogen water generation device, or hydrogen gas addition device, such as a known or commercially available hydrogen gas supply device (for generation of hydrogen gas-containing gas). (device), hydrogenation equipment (device for generating hydrogen water), non-destructive hydrogen containing device (device for non-destructively adding hydrogen gas into the inside of a bag of biologically applicable fluids such as intravenous fluids), etc. It may also be made on the spot.

The hydrogen gas supply device mixes hydrogen gas generated by the reaction between a hydrogen generating agent (e.g. metal aluminum, magnesium hydride, etc.) and water with a dilution gas (e.g. air, oxygen, etc.) at a predetermined ratio. (Japanese Patent No. 5228142, etc.). Alternatively, hydrogen gas generated by electrolysis of water is mixed with a diluting gas such as oxygen or air (Japanese Patent No. 5502973, Japanese Patent No. 5900688, etc.). This makes it possible to prepare a hydrogen gas-containing gas having a hydrogen concentration within the range of 0.5 to 18.5% by volume.

A hydrogenation device is a device that generates hydrogen using a hydrogen generating agent and a pH adjusting agent and dissolves it in a biologically applicable liquid such as water (Japanese Patent No. 4756102, Japanese Patent No. 4652479, Japan Japanese Patent No. 4950352, Japanese Patent No. 6159462, Japanese Patent No. 6170605, Japanese Patent Publication No. 2017-104842, Japanese Patent No. 6159462, etc.). Combinations of the hydrogen generating agent and the pH adjuster include, for example, metallic magnesium and a strongly acidic ion exchange resin or organic acid (eg, malic acid, citric acid, etc.), metallic aluminum powder and calcium hydroxide powder, and the like. As a result, a hydrogen-dissolved liquid having a dissolved hydrogen concentration of about 1 to 10 ppm can be prepared (for example, the product name "Seven Water" (MiZ Corporation), etc.).

A non-destructive hydrogen containing device is a device or device that adds hydrogen molecules to a commercially available biologically applicable liquid such as an intravenous solution (for example, sealed in a hydrogen-permeable plastic bag such as a polyethylene bag) from outside the package. For example, it is commercially available from MiZ Corporation (http://www.e-miz.co.jp/technology.html). This device is capable of permeating hydrogen into the bag by immersing a bag containing a biologically applicable liquid in saturated hydrogen water, and aseptically dissolving hydrogen in the biologically applicable liquid until a concentration equilibrium is reached. The device includes, for example, an electrolytic cell and a water tank, and water in the water tank circulates between the electrolytic cell and the water tank to generate hydrogen through electrolysis. Alternatively, a simple disposable device can be used for the same purpose (Japanese Patent Application Publication No. 2016-112562, etc.). This device has a plastic bag (hydrogen permeable bag, e.g. polyethylene bag) containing a biologically applicable liquid and a hydrogen generating agent (e.g. metallic calcium, metallic magnesium/cation exchange resin, etc.) built into an aluminum bag. The hydrogen generating agent is wrapped in, for example, a nonwoven fabric (eg, a water vapor permeable nonwoven fabric). Hydrogen generated by wetting a hydrogen generating agent wrapped in a non-woven fabric with a small amount of water such as steam permeates through the plastic bag and is dissolved in a biologically applicable solution non-destructively and aseptically.

Hydrogen gas-containing gas and hydrogen-saturated biologically applicable liquids (e.g., sterile water, physiological saline, intravenous fluids, etc.) prepared using the above devices or equipment can be administered orally or to patients with organ-specific autoimmune diseases. Can be administered parenterally.
Another form of the composition of the present invention includes a composition containing a hydrogen generating agent that enables the generation of hydrogen in the gastrointestinal tract, which is prepared for oral administration (or ingestion) to patients with organ-specific autoimmune diseases. Forms (eg, tablets, capsules, etc.) are included. Preferably, the hydrogen generator is constituted by, for example, an ingredient approved as a food or food additive.

3. Improvement of symptoms and/or suppression of worsening of symptoms of organ-specific autoimmune disease The present invention, according to a second aspect, comprises administering the composition of the present invention to a patient with an organ-specific autoimmune disease. Provided is a method for improving symptoms, including a decrease in activity level, associated with symptoms caused by organ-specific autoimmune diseases and/or suppressing aggravation of symptoms in a patient.

The composition of the invention allows for improvement of the patient's QOL (quality of life).
As a method for administering the composition of the present invention to patients with organ-specific autoimmune diseases, when hydrogen gas is used as an active ingredient, pulmonary administration by, for example, inhalation or suction is preferred. When inhaling gas, the gas can be inhaled through the mouth or nose through a nasal cannula or a mask-type device that covers the mouth and nose, into the lungs, and then delivered through the blood to the rest of the body.

Furthermore, when administering a hydrogen-dissolved liquid to a patient, oral administration, intravenous administration, or intraarterial administration (including infusion) is preferable. Hydrogen-dissolved liquids to be administered orally are preferably stored at low temperatures, and chilled liquids or liquids stored at room temperature may be administered to patients with organ-specific autoimmune diseases. It is known that hydrogen dissolves in water at a concentration of about 1.6 ppm (1.6 mg/L) at room temperature and pressure, and the difference in solubility depending on temperature is relatively small. Alternatively, when the hydrogen-dissolved liquid is in the form of an intravenous drip or injection solution containing hydrogen gas prepared using the above-mentioned non-destructive hydrogen containing device, it may be administered parenterally, such as intravenously or intraarterially. It may be administered to patients with organ-specific autoimmune diseases depending on the route of administration.
A hydrogen gas-containing gas having the above hydrogen concentration or a hydrogen-dissolved liquid having the above dissolved hydrogen concentration is applied once or multiple times (for example, 2 to 3 times) per day for a period of 1 week to 3 months or more, for example 1 week to It can be administered to patients with organ-specific autoimmune diseases for six months or more. When the hydrogen gas-containing gas is administered, it can be administered over a period of, for example, 10 minutes to 2 hours or more, preferably 20 minutes to 40 minutes or more, and more preferably 30 minutes to 2 hours. In addition, when administering a hydrogen gas-containing gas through the lungs by inhalation, suction, etc., it should be done in an atmospheric pressure environment, or in a range of, for example, above standard atmospheric pressure (approximately 1.013 atm) and below 7.0 atm. For example, in the range of 1.02 to 7.0 atm, preferably 1.02 to 5.0 atm, more preferably 1.02 to 4.0 atm, still more preferably 1.02 to 1.35 atm. The gas can be administered to patients with organ-specific autoimmune diseases in a hyperbaric environment within the body. Administration under hyperbaric environment may enhance the absorption of hydrogen in the body in patients with organ-specific autoimmune diseases.

The above-mentioned high-pressure environment can be formed by, for example, injecting the above-mentioned hydrogen gas-containing gas (for example, hydrogen-containing oxygen or air) into the interior to form a high pressure above standard atmospheric pressure and below 7.0 atmospheres. , can be made by the use of a hyperbaric enclosure (eg, a capsule-like enclosure) designed to have sufficient strength. The shape of the high-pressure housing is preferably rounded with no corners, since it is pressure resistant. Further, the material of the high-pressure housing is preferably lightweight and high strength, and examples thereof include reinforced plastic, carbon fiber composite material, titanium alloy, and aluminum alloy. Patients with organ-specific autoimmune diseases are administered a composition for improving symptoms and/or suppressing worsening of symptoms of organ-specific autoimmune diseases, which contains hydrogen gas together with oxygen gas or air in the above-mentioned hyperbaric housing. can receive.

When treating organ-specific autoimmune diseases with the composition of the present invention, hydrogen gas generators, hydrogen water generators, or hydrogen gas addition devices that have been confirmed to have sufficient therapeutic effects and safety (for example, the above-mentioned Hydrogen gas supply device (or gaseous hydrogen inhalation device), hydrogen addition device (or hydrogen water generation device), non-destructive hydrogen containing device (non-destructive for biologically applicable fluids such as intravenous fluids sealed in hydrogen-permeable bags) It is desirable to use a device (such as a device that dissolves hydrogen gas).

The present invention will be explained in more detail with reference to the following examples, but the technical scope of the present invention is not limited to these examples.

Improvement of symptoms of myasthenia gravis and/or suppression of worsening of symptoms by hydrogen gas inhalation (progress before hydrogen gas inhalation)
Patient: Japanese female, 64 years old at the time of onset. The following is the progress from onset.
August 22, 2021: Symptoms of double vision suddenly appeared.
August 24, 2021: Symptoms of ptosis appeared.
August 26, 2021: Upper lip paralysis appeared. Visited the Department of Neurology, Juntendo University Hospital. The ice pack test and Tensilon test were positive, and he was diagnosed with myasthenia gravis. CT scan showed no abnormalities. Blood sampling results were falsely positive for anti-acetylcholine antibodies. An immunosuppressant (tacrolimus 3 mg/day) was prescribed and the patient started taking it, but his symptoms progressed. He was unable to read newspapers, lift a frying pan, write, and his chewing ability decreased.
September 9, 2021: Visited the hospital due to worsening symptoms. An anticholinesterase drug (Mestinon 60 mg x 3/day) is prescribed. Symptoms worsened. After 3 p.m., the weight of my arm becomes unbearable and I can't remove it, so I rest my arm on the table.
September 25, 2021: Since the symptoms have not improved and are only getting worse, the attending physician has been changed to a neuroimmunology specialist. We also considered hospitalization.
September 29, 2021: The dose of the immunosuppressant was increased by 1 mg as prescribed by a neuroimmunologist. Immunosuppressants (tacrolimus 3 mg/day, Prograf 1 mg/day) were prescribed. The patient was not hospitalized, but was followed up by visiting the hospital. A blood test later revealed that he was positive for anti-mask antibodies. This confirmed that the patient had anti-Musk antibody positive type myasthenia gravis.
November 10, 2022: The patient was originally able to drink alcohol, but perhaps due to the side effects of the medication, his face turned bright red after drinking just a little beer.
January 5, 2022: Although the symptoms stopped progressing with medication, the symptoms of muscle weakness did not improve at all and remained. Blood test results on November 10 showed that his red blood cell count and hematocrit had fallen below standard values due to side effects of the medication he was taking. Changes in red blood cell count and hematocrit from September 29th to November 10th are as follows. Red blood cell count: 4.64 (10 ¹² /L) → 3.75 (10 ¹² /L), hematocrit: 44.0 (%) → 35.3 (%). Normal values for red blood cell count and hematocrit are 3.8 to 5.04 (10 ¹² /L) and 35.6 to 45.4 (%), respectively.

(Progress after hydrogen gas inhalation)
January 23, 2022: The use of drugs for myasthenia gravis carries the risk of side effects such as cancer and osteoporosis, so the patient begins inhaling hydrogen gas in an attempt to improve symptoms and reduce the dose. did. The hydrogen gas inhaler used is MiZ Co., Ltd. (Kamakura City, Kanagawa Prefecture, Japan) under the trade name Jobs-α (trademarked as Jobs), and the hydrogen concentration of Jobs-α is approximately 4% to 5%, 100% hydrogen. The amount of hydrogen generated is 200 ml/min.
January 28, 2022: On the 5th day of starting inhalation, the malaise in my arms completely disappeared.
February 1, 2022: My constipation, which was a side effect of immunosuppressants, has resolved and I feel good. I am scheduled to go to the hospital on March 9th, and I have started to think that I would like to have my medication reduced. After inhaling hydrogen, my face no longer turns red even when I drink alcohol. The patient was convinced that the side effects of the drug were suppressed.
February 16, 2022: I noticed that the age spots on my face were fading. I felt that my physical condition was clearly improving after inhaling hydrogen.
March 9, 2022: Blood test results showed that the red blood cell count and hematocrit values were 4.22 (10 ¹² /L) and 40.7 (%), respectively. The side effects of myasthenia gravis medication due to hydrogen inhalation were alleviated, so I decided to stop using the immunosuppressant while monitoring the situation.
March 20, 2022: Symptoms of myasthenia gravis disappeared after inhaling hydrogen gas.
March 22, 2022: After inhaling hydrogen gas, my body became lighter and I was able to enjoy walking.
March 30, 2022: Although there is usually a high probability of relapse when immunosuppressive drugs are discontinued, patients who are convinced that inhalation of hydrogen gas is more effective than anti-inflammatory drugs should not use immunosuppressive drugs. The patient stopped using the gas and continued to only inhale hydrogen gas.
June 30, 2022: Doctors are surprised that there has been no recurrence since the immunosuppressants were discontinued. Patients are convinced of the effectiveness of hydrogen in preventing and improving myasthenia gravis. Supplementally, drink hydrogen water once every 2 to 4 days (Seven Water, manufactured by MiZ Co., Ltd.: hydrogen concentration 7 ppm, 500 ml).
August 24, 2022: Tests were conducted at the Department of Neurology, Juntendo University Hospital. Anti-mask antibodies remain negative and there has been no recurrence.
October 19, 2022: A doctor in the neurology department at Juntendo University Hospital told me that my severe asthenia was cured, not in remission. Since then, there has been no need for hospital visits.

Improvement of symptoms of Hashimoto's disease and/or suppression of worsening of symptoms by hydrogen gas inhalation A 50-year-old Japanese male. After being diagnosed with Graves' disease by a doctor, he took antithyroid drugs, but the side effects of the drugs caused a decrease in thyroid hormone secretion, which led to Hashimoto's disease. Symptoms of Hashimoto's disease include fatigue and blurred vision. Start inhaling hydrogen gas using MiZ Co., Ltd. (Kamakura City, Kanagawa Prefecture, Japan) product name MHG-2000α (hydrogen concentration is approximately 5% to 7%, hydrogen amount is 120 ml/min as 100% hydrogen generation amount) As a result, the patient felt less fatigued and his dark vision recovered and became brighter.

The present invention improves and/or alleviates symptoms of organ-specific autoimmune diseases and/or symptoms such as decreased activity level accompanying these symptoms by simply administering hydrogen to organ-specific autoimmune diseases. This makes it possible to suppress the deterioration of Since hydrogen itself has no known side effects, it can improve the patient's QOL.

Claims (5)

Prevention, amelioration, and/or suppression of worsening of symptoms caused by organ-specific autoimmune diseases, and side effects of therapeutic agents for organ-specific autoimmune diseases in subjects containing hydrogen as an active ingredient. A composition for preventing or improving
The symptoms caused by the organ-specific autoimmune disease are symptoms of myasthenia gravis or Hashimoto's disease,
Symptoms caused by the organ-specific autoimmune disease are
Myasthenia gravis causes general muscle weakness, limb muscle weakness, easy fatigability, ptosis, eye symptoms such as double vision, dysphagia, breathing difficulties, and poor quality of life associated with these symptoms. This is a decrease in
The symptoms of Hashimoto's disease include fatigue, coldness, swelling of the body, weight gain, sleepiness, memory loss, shortness of breath, decreased pulse rate, muscle weakness, bradykinesia, anovulation, amenorrhea, constipation, swollen thyroid gland, swollen eyelids, and depression. , constipation, hypercholesterolemia, and decreased quality of life associated with these symptoms.
A composition characterized in that the organ-specific autoimmune disease therapeutic agent is a therapeutic agent for myasthenia gravis or Graves' disease . 2. The composition of claim 1, wherein the composition is administered to the subject by inhalation . The composition according to claim 1 or 2 , wherein the concentration of hydrogen is greater than 0 and less than or equal to 18.5% by volume . 3. The composition of claim 2 , wherein the subject is a mammal, including a human. A method for producing the composition according to claim 2 , characterized in that the composition is produced using a hydrogen gas generator.