Specimen examination and health support system

Abstract

To provide a system for specimen examination and health support for the purpose of maintaining and improving the health condition of the oral cavity and the whole body.SOLUTION: To provide a health support service capable of maintaining / improving the health condition of a subject by analyzing a specimen inspection result including a specimen inspection including an antibody inspection related to oral bacteria or Candida and a blood inspection related to sugar metabolism in inspection items and various information of the subject.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] This relates to a test that can provide useful information not only for treating systemic diseases but also for prognostic care, and for maintaining and improving the overall health of elderly and weak people in particular, by combining oral cavity-related information such as oral hygiene and health conditions, which are becoming increasingly apparent as factors contributing to systemic diseases and disorders, with specimen test information related to the above-mentioned systemic diseases and disorders, and a system that utilizes this test to support the health of subjects. [Background technology]

[0002] In recent years, it has become clear that oral hygiene and health conditions may be a factor in systemic disease and problems, and this information is becoming important to refer to not only in the treatment of systemic diseases but also in prognostic care and in maintaining and improving the overall health of the elderly and infirm. However, oral information is collected for a short period of time, and even when it is collected, it remains within the institution that collected it, such as a dental clinic, and is not used by other institutions. In particular, it is extremely rare for information to be shared with medical institutions, and even in general hospitals that have oral surgery departments, medical and dental information is often not shared with each other. Summary of the Invention [Problem to be solved by the invention]

[0003] We provide tests that can grasp information about the state of the oral cavity, which is closely related to the maintenance and improvement of a person's quality of life, along with information about the whole body that is thought to be related to the state of the oral cavity.Furthermore, we also provide a health support system that uses knowledge about the relationship between oral function and oral hygiene and whole body health to prevent and treat diseases and disorders of the whole body of the subject, provide prognostic care, and support the maintenance and promotion of health. [Means for solving the problem]

[0004] The present inventors have made extensive studies in light of the above-mentioned circumstances and have attempted to solve the problem by providing a test that combines information on the state of microorganisms present in the oral cavity, which may affect the entire body, the state of oral hygiene, the presence or absence of infection, and other specimen test items that are thought to be related to the oral cavity, such as blood glucose levels.Furthermore, by utilizing the test, a health support system is provided that enables subjects to maintain and improve their health and receive effective disease prevention and medical treatment compared to a general blood test alone. [Effects of the Invention]

[0005] The present invention enables subjects to achieve and maintain a high quality of life by understanding the condition of the subject's oral cavity and throat as well as the subject's overall health without imposing a heavy burden of effort or expense on the subject or test administrator, and by providing useful information for maintaining the subject's health, it also constructs a health support system that can contribute to improving the subject's daily life and hygiene, providing effective medical treatment and prognosis measures, and maintaining and improving the health of healthy people. [Brief explanation of the drawings]

[0006]

Figure 1

Figure 2

Figure 3

[0007] That is, the present invention includes the following inventions. Item 1: Specimen testing that includes the following items i to iii. i) Antibody test for one or more microorganisms selected from the group consisting of oral bacteria and Candida ii) Blood glucose and / or hemoglobin A1c testing iii) LDL and HDL level testing Item 2: A specimen test according to Item 1, wherein the oral bacteria include one or more bacteria selected from the genus Porphyromonas. Item 3: At least one of the oral bacteria Porphyromonas gingivalis The specimen test according to item 2, comprising: Item 4: At least two or three different types of oral bacteria Porphyromonas gingivalis The specimen test according to item 3, wherein the strain is Item 5: At least one of the oral bacteria Streptococcus mutans Item 5. The specimen test according to any one of items 1 to 4, comprising: Item 6: At least one of the oral bacteria Streptococcus intermedius Item 6. The specimen test according to any one of items 1 to 5, comprising: Item 7: A specimen test according to any one of Items 1 to 6, wherein the oral bacteria include one or more bacteria selected from the genus Fusobacterium. Item 8: The specimen test according to any one of Items 1 to 7, wherein the oral bacteria include one or more bacteria selected from the genus Prevotella. Item 9: Specimen testing that includes an antibody test related to oral bacteria and one or more tests selected from the group consisting of a C-reactive protein test, a procalcitonin test, and an erythrocyte sedimentation rate test. Item 10: A specimen test according to Item 9, wherein the oral bacteria include one or more species of bacteria belonging to the genus Staphylococcus and one or more species of bacteria belonging to the genus Streptococcus. Item 11: A specimen test according to any one of Items 1 to 10, which includes an antigen test and / or a nucleic acid test related to one or more microorganisms selected from the group consisting of oral bacteria and Candida. Item 12: The specimen test according to any one of claims 1 to 11, wherein the test items include providing information about the subject's oral cavity. Item 13: A specimen test according to Item 12, wherein the information relating to the subject's oral cavity includes information contained in any of the following: recommended information for dental examinations, recommended information for dental health guidance, information on oral health status, information on risk factors for oral health, information on oral hygiene, and information on recommended oral care products. Item 14: A health support system that uses the results of antibody tests related to oral bacteria and / or Candida bacteria, and the information in (i) or (ii) below, to create information useful for preventing and treating disease in subjects and maintaining and improving oral and overall health, and provides this information to subjects, medical institutions, medical professionals, etc. (i) Information on the results of specimen tests including one or more test items selected from the group consisting of blood glucose level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate level. (ii) Subject information including at least one or more of the following: dental examination recommendation information, dental health guidance recommendation information, general attribute information such as the subject's own sex, age, height, weight, waist circumference, BMI, waist-to-hip ratio, medical history information of blood relatives, self-awareness information about oral and general health conditions, treatment history information, information about oral function and oral condition, oral hygiene habits, actual information about dietary, lifestyle, exercise, drinking, and smoking habits, bedtime behavior information, and psychological state information. Item 15: A health support system that uses three pieces of information, namely, information on the results of antibody tests related to oral bacteria and / or Candida, and information (i) and (ii) below, to create information useful for preventing and treating disease in subjects and maintaining and improving oral and overall health, and provides this information to subjects, medical institutions, medical professionals, etc. (i) Information on the results of specimen tests including one or more test items selected from the group consisting of blood glucose level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate level. (ii) Subject information including at least one or more of the following: dental examination recommendation information, dental health guidance recommendation information, general attribute information such as the subject's own sex, age, height, weight, waist circumference, BMI, waist-to-hip ratio, medical history information of blood relatives, self-awareness information about oral and general health conditions, treatment history information, information about oral function and oral condition, oral hygiene habits, actual information about dietary, lifestyle, exercise, drinking, and smoking habits, bedtime behavior information, and psychological state information. Item 16: A health support system according to Item 14 or 15, wherein the oral bacteria include one or more bacteria selected from the genus Porphyromonas. Item 17: At least one of the oral bacteria Porphyromonas gingivalis Item 17. The health support system according to item 16, comprising: Item 18: At least two or three different types of oral bacteria Porphyromonas gingivalis Item 18. The health support system according to Item 17, comprising a strain of the bacteria. Item 19: At least one of the oral bacteria Streptococcus mutans 19. The health support system according to any one of items 14 to 18, comprising: Item 20: At least one of the oral bacteria Streptococcus intermedius 19. The health support system according to any one of items 14 to 18, comprising: Item 21: A health support system according to any one of Items 14 to 20, wherein the oral bacteria include one or more bacteria selected from the genus Fusobacterium. Item 22: A health support system according to any one of Items 14 to 21, wherein the oral bacteria include one or more bacteria selected from the group consisting of bacteria belonging to the genus Prevotella. Item 23: A health support system according to any one of items 14 to 18, in which some or all of the test results of the specimen test and information useful for the subject's disease prevention and treatment and maintenance and promotion of health created from the test results of the specimen test are stored in an electronic medical record or a database used for the subject's health management, and used for the subject's disease prevention and treatment and maintenance and promotion of health. Item 24: A health support system according to any one of items 14 to 23, wherein the test items include an antigen test and / or a nucleic acid test related to one or more microorganisms selected from the group consisting of oral bacteria and Candida.

[0008] The oral bacteria that are the subject of testing in the present invention refer to bacteria present in the oral cavity and throat, which are said to number more than 400 to 800 species. The types of bacteria that constitute the normal oral flora vary from subject to subject, and even within a given subject, they are known to fluctuate depending on age, oral hygiene status, systemic diseases, metabolism, and other factors. While the presence or absence of periodontal disease, caries, and other conditions is determined during dental checkups and dental treatments, the technology of the present invention not only provides a simple method for predicting these conditions, but also provides information that can be used to estimate oral infection risks, such as the risk of oral infection contraction and recurrence, and the likelihood of oral infection becoming severe, as well as the presence and extent of constitutions that make standard oral infection treatments and preventative measures less effective. Therefore, the oral bacteria that are the subject of specimen testing in the present invention are preferably bacteria known to affect oral health, and it is even more preferable to target bacteria that may affect the onset and progression of disease. In addition to bacteria, fungi such as Candida albicans ( Candida albicans ) is also known to be a causative bacterium of oral infections, so it is preferable to subject it to specimen testing. Examples of bacteria that can negatively affect oral health include the bacteria known as the red complex, which is associated with periodontal disease. Porphyromonas gingivalis (Porphyromonas gingivalis), Treponema denticola (Treponema denticola), Tannerella forsythia In addition to three types of bacteria from Tannerella forsythia, Aggregatibacter actinomycetemcomitans (Aggregatibacter actinomycetemcomitans: former scientific name is Actinobacillus actinomycetemcomitans ), known as the orange complex, Prevotella intermedia (Prevotella intermedia), Eubacterium nodatum (Eubacterium nodatum), Fusobacterium nucleatum (Fusobacterium nucleatum), Fusobacterium polymorphum (Fusobacterium polymorphum), Prevotella nigrescens(Prevotella nigrescens), Peptostreptococcus micros (Peptostreptococcus micros), Campylobactor rectus (Campylobacter rectus), Campylobacter showae , Campylobacter gracilis (Campylobacter gracilis), Streptococcus constellatus (Streptococcus constellatus), etc. Other bacteria known to have a direct or indirect relationship with dental caries include: Streptococcus mutans (Streptococcus mutans), Streptococcus sobrinus (Streptococcus sobrinus), Actinomyces naeslundii (Actinomyces naeslundii), Actinomyces viscosus (Actinomyces viscosus), Actinomyces odontolyticus (Actinomyces odontolyticus), Actinomyces oris (Actinomyces oris), and others known to be associated with dental plaque formation. Corynebacterium matruchotii (Corynebacterium mattorkoti), known to be associated with jaw actinomycosis Actinomyces israelli (Actinomyces israelii), known to be associated with invasive infections in the elderly Streptococcus agalactiae (Streptococcus agalactiae), etc.

[0009] "Related to one or more microorganisms selected from the group consisting of oral bacteria and Candida" means that the test subject is nucleic acid, antigen, and antibody derived from one or more microorganisms selected from the group consisting of oral bacteria and Candida, or nucleic acid, antigen, and antibody that show reactivity equivalent to the genes, antigens, and antibodies derived from the above. Specifically, in the case of nucleic acid testing, the test subject is nucleic acid corresponding to each of the oral bacteria and Candida that are the subject of the test subject; in the case of antigen testing, the test subject is antigen corresponding to each of the oral bacteria and Candida that are the subject of the test subject; and in the case of antibody testing, the test subject is antibody corresponding to each of the oral bacteria and Candida that are the subject of the test subject, or a substance that shows reactivity equivalent to these.

[0010] The antibodies tested in antibody tests refer to proteins that specifically bind to antigens produced by antigenic stimulation with the bacterial cells themselves, parts of the bacterial cells, and compounds derived from the bacteria. Test antigens that react with antibodies include the bacterial cells themselves, parts of the bacterial cells, and compounds derived from the bacteria, as well as antigen peptides and combinations thereof that have similar reactivity. When testing for antibodies associated with two or more bacteria, an antigen-antibody reaction is used, utilizing antigens with distinct antigenic structures corresponding to each antibody. In this case, it is desirable to have no substantial cross-reactivity between the individual antigen-antibody reactions or with antibodies against other bacteria contained in the sample. Here, "no substantial cross-reactivity" means that, as long as the presence of antibodies to each of the tested bacteria can be distinguished, even if some cross-reactivity occurs, it is considered to be no cross-reaction. Furthermore, while antibody tests can be qualitative tests that determine the presence or absence of antibodies, tests that can measure antibody titers are preferred, as this provides information that can be used to infer the degree and timing of infection.

[0011] It has been found that oral hygiene and periodontal disease are closely related to diabetes and arteriosclerosis. There is also a correlation between oral hygiene and blood glucose fluctuations, and it has been reported that managing oral hygiene can control blood glucose levels, which is extremely important in managing diabetes. However, there is little collaboration between the medical and dental fields, and medical information is not shared between the two fields, not only at private practices but also at general hospitals with oral surgery departments, and medical procedures are also performed independently. Oral bacterial antibody testing can determine the presence or absence of antibodies produced when oral bacteria invade the body, as well as information on the microorganisms from which those antibodies originate. This allows for understanding the condition of the oral cavity and the extent of infection caused by oral microorganisms that have invaded the body. By conducting this specimen test in conjunction with conventional tests such as blood glucose levels, which are indicators of glucose metabolism, and hemoglobin A1c levels, and LDL and HDL levels, which are indicators of lipid metabolism and are a major factor in the development of arteriosclerosis, it becomes possible to treat oral diseases such as periodontal disease and provide dental health guidance to people with poor oral hygiene, thereby improving the effectiveness of treatment for diseases such as diabetes, and effectively managing disease conditions such as blood glucose levels.The specimen test of the present invention, which can provide all of this information at once, is extremely effective.

[0012] The test samples used for blood glucose, hemoglobin A1c, LDL, and HDL tests and antibody tests can be the same or different, but they must be collected at the same time. While sampling on the same day or even several days apart is considered "same-time," sampling on the same day is preferable. Different sampling times are undesirable because they may alter the subject's condition and make it difficult to accurately grasp the subject's information. Test samples for antibody tests can be blood (including blood components) obtained by collection from the mouth, throat, or oral tissues, gingival crevicular fluid, dental plaque, tongue coating, or saliva. However, blood collected during health checkups or blood tests at medical institutions is preferable. When different test samples are used for blood glucose, hemoglobin A1c, LDL, HDL, and antibody tests, the samples must be collected at the same time. While sampling on the same day or even several days apart is considered "same-time," sampling on the same day is preferable. If the sampling times differ, the condition of the subject may change, which is undesirable because it creates the risk that it may become difficult to accurately grasp the subject's information.

[0013] As mentioned above, it is becoming clear that bacteria related to periodontal disease are associated with systemic diseases. Medical professionals are also increasingly aware that poor oral hygiene can lead to complications such as infections after surgical procedures. Cases have been reported in which oral hygiene is improved as a pre-operative measure, or measures to alleviate periodontal disease symptoms are taken. Periodontal disease, in particular, is a disease in which oral bacteria proliferate and invade periodontal tissues, causing inflammation and damaging periodontal tissues such as the gums and alveolar bone. However, because periodontal tissues contain numerous capillaries, oral bacteria can enter the bloodstream and potentially affect tissues throughout the body. Research to date has revealed a deep connection with several systemic diseases, and understanding the state of bioinfection of oral bacteria related to periodontal disease is crucial for managing overall health. Bacteria known as the Red Complex play a central role in explaining the pathogenesis of periodontal disease. Among these, Porphyromonas gingivalis plays the most important role. On the other hand, it has been pointed out that Porphyromonas bacteria present in the oral cavity are associated with systemic diseases. For example, systemic diseases that are thought to be associated with Porphyromonas bacteria include arteriosclerosis, which has been reported to be associated based on research into bacteria detected from lesions and animal test results, and rheumatoid arthritis, diabetes, and non-alcoholic fatty liver disease, which have been reported to be associated based on the production of an enzyme (peptidylarginine deminase) that generates anti-citrullinated proteins used as a marker, as well as observational information on the effects of periodontal disease treatment and changes in symptoms. Among these, Porphyromonas gingivalis is known to be particularly relevant, and not only has an impact on infectious diseases, Porphyromonas gingivalis It has been reported that gingipains and liposaccharides (LPS) produced by the bacteria have been detected in the brain tissue of dementia patients, and that they are related to the onset and progression of dementia symptoms. Porphyromonas gingivalis It is becoming increasingly known that even if the bacteria belong to the same group, the effects on the oral cavity and the overall health status vary greatly depending on the strain. Porphyromonas gingivalisIt is preferable that the test contains information on the bacterial species as well as the bacterial strain, and it is even more preferable that the test content can grasp information on the bacterial species as well as the bacterial strain. In addition, it has been reported that the ratio of the total number of bacteria belonging to the Red Complex to the total number of all bacteria in the oral cavity is significantly correlated with the amount of adiponectin secreted, which works to improve insulin resistance, and therefore may be related to diabetes. Furthermore, it has been confirmed that the above ratio is also correlated with the levels of IL-1β and TNF-α, which are inflammatory cytokines in the blood, and therefore it has been reported that there is some connection with inflammatory diseases such as arteriosclerosis and diabetes. Furthermore, high levels in the serum of pregnant women in premature births and low birth weight babies have been reported. Porphyromonas gingivalis IgG antibody titers of 1000 or more were detected in the oral cavity of these pregnant women. Porphyromonas gingivalis , Tannerella forsythia , Aggregatibacter actinomycetemcomitans It has been reported that oral bacteria have some effect on the fetus and placenta, as significantly higher numbers of bacteria such as , etc. have been detected. Although it is a special disease, arteriosclerosis obliterans and thromboangiitis obliterans (Buerger's disease) are caused by three types of bacteria in the Red Complex and Campylobactor rectus It has been reported that there is a relationship with the following. Porphyromonas gingivalis (Porphyromonas gingivalis) as well as those belonging to the Red Complex Treponema denticola , Tannerella forsythia These bacteria are also important subjects for specimen testing, and it is preferable to use a combination of nucleic acid tests, antigen tests, and antibody tests on specimens collected from blood or the oral cavity depending on the purpose. Therefore, it is preferable to test these bacteria.

[0014] Dental caries is a typical oral disease along with periodontal disease. The causative bacteria of dental caries are Streptococcus mutans is widely known, but like Porphyromonas bacteria, its association with systemic diseases has been pointed out. Streptococcus mutans Infective endocarditis, valvular heart disease, cerebral hemorrhage, and aspiration pneumonia have been reported to be associated with serotype κ. Streptococcus mutans It has been pointed out that Streptococcus spp. is associated with cerebral microbleeds and dementia. Streptococcus constellatusIt has been reported that these bacteria are associated with the formation of liver abscesses. Therefore, it is preferable to target these bacteria for testing.

[0015] Streptococcus intermedius is a bacterium that is closely related to the formation of dental plaque in the oral cavity. Many Streptococcus species have been identified as oral bacteria, Streptococcus intermedius are known to form abscesses in the brain and liver. Streptococcus and Staphylococcus, which are also normal oral bacteria, account for 80-90% of the bacteria detected in blood cultures from patients with infective endocarditis. Genetic identification has also been reported to confirm the identity of the bacteria in the cultures with the bacteria in the oral cavity of the subjects. Staphylococcus epidermidis or Streptococcus milius Therefore, it is very useful to perform an antibody test to check for one or more species of bacteria belonging to the genus Staphylococcus and one or more species of bacteria belonging to the genus Streptococcus in the oral bacteria in combination with a C-reactive protein test, a procalcitonin test, and an erythrocyte sedimentation rate test. Streptococcus blood It has been reported that these bacteria are associated with infectious heart disease. Therefore, it is preferable to test for these bacteria.

[0016] Fusobacterium is a gram-negative, non-sporeforming bacillus that is normally present in the human oral cavity, pharynx, and intestinal tract, but its association with systemic diseases is also becoming known. Fusobacterium necrophorum and Fusobacterium nucleatum It has been reported that these two bacteria are associated with liver abscess and aspiration pneumonia, and these two types of bacteria have been detected in both the oral cavity and placenta of normal pregnant women, suggesting that they may have some effect on the fetus. There have also been reports of a relationship with digestive cancers such as esophageal cancer and colon cancer. Therefore, it is preferable to test for these bacteria.

[0017] Prevotella is found primarily in the intestines, but is also found as a normal inhabitant of the oral cavity. Prevotella pallens In the case of premature birth or low birth weight Prevotella intermedii , in Buerger's disease Prevotella intermedia or Prevotella nigrescens It has been reported that there is some correlation between these bacteria and the flu. Therefore, it is preferable to test for these bacteria.

[0018] In addition, elderly people, people with dry mouth, people taking steroid medication or chemotherapy, and people who wear dentures may have test samples taken from their mouths. Candida albicans If Candida albicans is detected, it can be inferred that the patient is suffering from oral candidiasis or that they may be suffering from it. In addition, nucleic acid tests, antigen tests, and antibody tests on test samples taken from periodontal tissues can Streptococcus constellatus (Streptococcus constellatus) and Prevotella intermedius If test results suggest a mixed infection with Prevotella intermedias, it is possible that a closed abscess may have developed in the oral cavity. Therefore, it is preferable to test for these microorganisms.

[0019] C-reactive protein tests, procalcitonin tests, and erythrocyte sedimentation rate tests are all specimen tests that provide information that can infer the possibility of an inflammatory reaction occurring somewhere in the body and the degree of inflammation. The results of antibody tests for oral bacteria, etc., can indicate the possibility of an inflammatory disease in the oral region, and if the results suggest a strong inflammatory reaction, it can also indicate the possibility of an inflammatory disease occurring in a region other than the oral region in which oral bacteria are somehow involved. Therefore, by conducting these tests in addition to antibody tests related to oral microorganisms and tests such as blood glucose levels, it can provide important information for analyzing test results and estimating the subject's physical condition.

[0020] The antigens tested in antigen tests refer to the bacterial body itself, parts of the bacterial body, and compounds derived from bacteria that have an antigenic structure. When simultaneously testing for antigens related to two or more bacteria, antigen tests are performed using a combination of antibodies corresponding to each bacterium. In this case, it is desirable that the antibodies used for each antigen test do not substantially cross-react with other bacteria contained in the sample. Here, "does not substantially cross-react" means that, as long as it is possible to distinguish the presence of antigens of each of the bacteria being tested, even if some cross-reaction occurs, it is considered to be no cross-reaction.

[0021] The testing methods that can be used for nucleic acid testing are not particularly limited as long as they utilize nucleic acids, and the optimal method can be adopted depending on the purpose of the test. Examples include conventional PCR, real-time PCR, reverse transcription PCR, nested PCR, hot start PCR, multiplex PCR, quantitative PCR, quantitative real-time PCR, touchdown PCR, inverse PCR, GC-rich PCR, 2-step PCR, loop-mediated isothermal amplification, digital PCR, multiple displacement amplification such as whole genome amplification, strand displacement amplification, nicking enzyme amplification reaction, helicase-dependent amplification, recombinase polymerase amplification, strand-invasion based amplification, nucleic acid sequence based amplification, transcription mediated amplification, etc.

[0022] It is preferable to select either nucleic acid testing or antigen testing, or both, depending on the purpose of the test. Both nucleic acid testing and antigen testing can detect the presence of oral bacteria, Candida, or their fragments in the test sample at the time of testing. Because the former detects the presence of nucleic acids, while the latter detects the presence of antigens, the results of the two tests cannot be said to be completely consistent. Therefore, analysis of test results must take into account the principles of the test being performed and the specific test conditions. Nucleic acid testing and antigen testing also differ in terms of detection accuracy and test time. In nucleic acid testing, methods using EMA (ethidium bromide monoazide) or PMA (propidium monoazide) can identify the possible presence of live bacteria. Therefore, when conducting testing, the optimal method or methods should be selected based on a comprehensive consideration of the test purpose, cost, and testing environment.

[0023] The test results of nucleic acid tests and antigen tests include the species and number of bacteria detected, their proportion of the total (ratio to total bacterial count), and the species detected in specific strains, and can be selected appropriately from these to provide the test results, taking into account the purpose of the test, etc. The test results of antibody tests include the presence or absence of antibodies derived from specific species or strains and their antibody titers (neutralizing antibody titer, agglutinating antibody titer, etc.), and can be selected appropriately from these to provide the test results, taking into account the purpose of the test, etc. Furthermore, by comprehensively examining the test results (combinations of bacterial species and their proportions, detected test items and test samples, etc.), inferences can be made regarding the health status of the oral cavity and can be included in the test results. Examples of patent publications that describe technologies related to these include JP 2009-52945 (method for testing or diagnosing periodontal disease using immunochromatography), JP 2022-96817, JP 2022-96815, JP 2022-96814, JP 2022-96812, and JP 2017-111095 (all of which are technical information related to measuring antibody titers against periodontal pathogens), but are not limited to these descriptions.

[0024] Including information about the subject's oral cavity in the test items is useful because it allows the subject to recognize the state of their own oral cavity, improves their awareness of oral hygiene, and leads to specific oral hygiene practices and the implementation of dental medical treatment and dental health guidance that the subject needs. Information about the subject's oral cavity can include, for example, information on the condition of tongue coating that can cause periodontal disease, caries, dental plaque, halitosis, glossitis, and taste abnormalities, recommendations for dental examinations if oral disease is suspected, recommendations for dental health guidance if oral hygiene is presumed to be poor, other information about oral health conditions, information on risk factors for oral health in the oral cavity and in other body parts, information on the importance of oral hygiene and specific oral hygiene methods, and information on the provision of oral care products and services that can be recommended to the subject.

[0025] The present invention also provides a health support system that provides subjects, medical institutions, medical professionals, etc. with information useful for preventing and treating disease and maintaining and improving the subjects' health. This allows subjects to increase their awareness of oral care, acquire knowledge and skills related to oral care, and improve their daily oral care behaviors, thereby maintaining and improving their oral and overall health. At medical institutions, etc., the system not only helps to avoid and reduce risks in medical procedures for subjects, but also improves the efficiency and effectiveness of procedures such as treatment.

[0026] The health support system of the present invention requires information on the results of antibody tests related to one or more microorganisms selected from the group consisting of oral bacteria and Candida fungi, and by conducting analysis and other studies in combination with information belonging to either one of the following (i) and (ii), preferably both, it creates "information useful for the prevention and treatment of disease in subjects and for the maintenance and improvement of oral and general health" and provides this information to subjects, medical institutions, medical professionals, etc. Here, (i) refers to "information on the results of specimen tests, including one or more test items selected from the group consisting of blood glucose, hemoglobin A1c, oxidized HDL, C-reactive protein, procalcitonin, and erythrocyte sedimentation rate," and (ii) refers to "one or more of the following information: recommendations for dental examinations, recommendations for dental health guidance, general attribute information such as the subject's gender, age, height, weight, waist circumference, BMI, waist-to-hip ratio, and medical history of blood relatives, subjective information on oral and general health status, treatment history, oral hygiene habits, actual information on dietary, lifestyle, exercise, drinking, and smoking habits, bedtime behavior, and psychological state information." The former is an indicator closely related to diabetes, arteriosclerosis, and inflammatory diseases, while the latter is information that subjects can understand themselves, such as genetic information closely related to lifestyle-related diseases, daily lifestyle factors, and information useful for understanding and predicting oral health.

[0027] The subject information (ii) can be obtained from the subject's self-reporting, monitoring using a terminal device, electronic medical records, etc. Self-reporting methods include, for example, subject information from specific health checkups. In specific health checkups, subject information regarding medical history and subjective symptoms is obtained. Part of the medical history information and subjective symptoms in specific health checkups are obtained through questionnaires or other questionnaires. For example, in addition to medical history, smoking habits, exercise habits, dietary habits, drinking habits, and sleep habits are typically included, and this information can be utilized. Specific examples of subject information include general attribute information such as the subject's own gender, age, height, weight, waist circumference, BMI, waist-to-hip ratio, and medical history information of blood relatives; subjective information regarding oral and overall health status; treatment history information; information on oral function; oral hygiene habits; dietary habits and food preferences; actual information regarding lifestyle (life cycle), exercise habits, drinking habits, and smoking habits; bedtime behavior information; and psychological state information. In addition to this, if necessary, recommended information for dental examinations and recommended information for dental health guidance will also be provided as useful information.

[0028] In this invention, "maintaining and improving oral and systemic health" also includes the meaning of "maintaining and improving healthy oral function." It is said that oral function is related to systemic function. A decline in oral function can lead to declines in motor skills, such as grip strength and walking ability, and a decline in masticatory function is associated with the progression of dementia symptoms. A significant decline in masticatory and swallowing ability can lead to malnutrition, adversely affecting overall health. Therefore, maintaining and improving oral function is essential for maintaining and improving overall health. Therefore, "information necessary for maintaining and improving the subject's oral health" includes "information necessary for maintaining and improving the subject's oral function." Oral function is related to feeding (taking food into the mouth), mastication, bolus formation and transport, swallowing, articulation, taste, touch, and saliva secretion, and is a fundamental function necessary for people to lead healthy lives in society. For these reasons, understanding information on these conditions is extremely useful.

[0029] Information necessary to maintain and improve oral function in a healthy state can be obtained, for example, by using sensors to measure the state of oral function, taking images and videos of the oral cavity and oral-related movements such as chewing, and recording sounds such as movements. Furthermore, information necessary to maintain and improve oral function in a healthy state includes not only the above-mentioned acquired information, but also secondary information obtained by analyzing and evaluating that information. Examples of the "state of oral function" that is of interest include mastication, swallowing, and other functions related to mastication (occlusion, bite force, tongue motor function during mastication, and functional evaluation when wearing dentures), saliva secretion, mouth opening, and movements when taking food into the mouth (especially the movement of the mandible).

[0030] The "information useful for the prevention and treatment of disease and the maintenance and improvement of oral and general health of subjects" provided to subjects, medical institutions, medical professionals, and subjects' employers includes information useful for the treatment and prognosis management of subjects' diseases, and information for raising awareness about the relationship between disease prevention, the maintenance and improvement of general health, and the state of the oral cavity; information useful for understanding, maintaining, and improving oral function; information on the treatment of oral-related diseases and the prevention of recurrence necessary to maintain and improve oral function; problems that arise when using improper toothpaste, toothbrush, and other products, as well as criteria and methods for selecting appropriate products, and information on various oral care products (including information on ingredients, incorrect use, etc.). This information may include oral care information such as: problems that may arise when using dentures and the correct way to use them, specific optimal oral care methods for a set period of time (for example, one week), oral problems that arise due to differences in age and gender, and those requiring care, and how to prevent and deal with them, an introduction to the latest oral-related research, basic knowledge about dentures and implants, common problems that may occur with dentures and how to prevent them; information about oral care services and offers for oral care products and services; and information introducing message boards and communities that serve as a place to exchange information and exercise with the aim of maintaining and improving oral and overall health.

[0031] As shown in Fig. 1, the health support system according to this embodiment includes a support server 1, a terminal 2 for inputting test results, and a terminal 5 for outputting information for communicating test results, etc. to subjects, medical professionals, etc., all connected via a network N such as the Internet to transmit and receive various information, and the support server 1 is also connected for communication via the network N to transmit and receive various information, etc. A computing device 3 is connected via the network N to estimate the subject's oral and systemic health conditions and their correlations based on the test results and other necessary information, as needed, and to create and select appropriate information to be provided to individual subjects, medical professionals, etc. regarding the maintenance and improvement of oral health conditions and the maintenance, improvement, and treatment of systemic health, other than the support server, as needed, and an external server 4 is connected via the network N such as the Internet to obtain various information, other than the test results, that is necessary to estimate the subject's oral and systemic health conditions, and various information not stored in the support server 1 that is necessary for selecting and creating useful information regarding the maintenance and improvement of oral and systemic health conditions to be provided to subjects. The external system server may include a database utilizing the My Number system, an electronic health insurance card, or an electronic medical record managed by a medical institution or data management institution. Information on subjects, etc., may be acquired from the external system server and utilized. Information acquired or created by the health support system of the present invention may also be transferred to the external system server and utilized within the system.

[0032] In the health support system according to the above embodiment, the support server 1 may be divided into two or more servers. In this case, the divided servers may be able to exchange various information with each other via a connection method that does not involve the Internet, such as a local network, or may be connected via a network N such as the Internet to exchange various information. If multiple support servers are present, each support server can be assigned to perform tasks such as recording and data processing (calculation), and data and system backup in an optimal manner for operating the system. If multiple support servers are present, at least one support server 1 must have the function of selecting test results and information useful for improving or maintaining oral and general health, and transmitting the information to a designated terminal. Since test results and subject attribute information are personal information, it is preferable to transmit and receive such information less frequently from the perspective of confidentiality. If the location of the information data input terminal 2 is geographically distant from the support server 1, a separate support server 1 can be set up in the same location as the information data input terminal 2, and the two can be connected without using a network such as the Internet, and the acquired or input information can be recorded in the support server 1. This significantly reduces the number of times personal information is sent and received over the Internet, thereby reducing the risk of leaking confidential information such as personal information. Also, if the useful information generation unit of the processing device of the support server 1 cannot process or cannot handle all the information due to reasons such as information processing capacity, a calculation device outside the system can be used.

[0033] As shown in Figure 2, the support server 1 is composed of one or more computers each having a processing device 10 with a communication control unit 12 and a storage means 11. Specifically, a conventional, widely used computer device can be used, which is centered around the processing device 10 and includes the storage means 11, the communication control unit 12, and a pointing device, keyboard, display, etc. as input operation means (not shown).

[0034] The processing device 10 is mainly composed of a CPU such as a microprocessor, and has a memory unit consisting of RAM and ROM (not shown) in which programs defining the procedures of various processing operations and processing data are stored. The storage means 11 can be selected from memory inside or outside the support server 1, a hard disk drive (HDD), a solid state drive (SSD), a removable disk exchange system (RDX), a redundant array of independent disks (RAID), etc. Part or all of the contents of the storage unit may be stored in the memory or hard disk of another computer communicatively connected to the support server 1.

[0035] The processing device 10 is broadly divided into two functionalities: an "information collection and recording function" that acquires information necessary for system operation and stores it in the storage means of a designated support server; and an "information generation and transmission function" that acquires information necessary for generating test result information to be provided to each subject and information useful for improving or maintaining the subject's oral and general health from the recording means, creates useful information, and transmits the information to the terminal 5, which outputs it. Specifically, each piece of information to be recorded is input from the terminal 2 sequentially as the information to be input is obtained and recorded in the recording means. In this case, for example, if there are multiple support servers, it is possible to specify a recording means for recording information for each information item to be input, or to specify a recording means for recording information on a subject-by-subject basis. It is desirable to adopt the optimal method from the perspective of convenience and prevention of information leaks for the "information generation and transmission function" that utilizes the recorded information. When providing information to a subject, the test results to be provided and, if necessary, information useful for improving or maintaining the subject's oral and general health are generated, and this information is then compiled and transmitted to the terminal 5. The terminal 5 not only displays or prints information on a display or the like, but also transfers the information to computers, smartphones, recording media, etc. owned by the subject, medical institution, or medical professional via the terminal 5. In this case, the terminal 5 of the support system is a computer owned by the subject, and the support server 1 can send information directly to the terminal 5, i.e., a computer owned by the subject.

[0036] When there is only one support server 1, the support server 1 includes at least a subject attribute information storage unit that stores subject attribute information acquired by the subject general attribute information acquisition unit, a test information storage unit that stores test result information acquired by the test result information acquisition unit, a subject information storage unit that stores subject information acquired by the subject information acquisition unit, and a useful information storage unit that stores information useful for improving or maintaining the subject's oral cavity in a healthy state, generated by the useful information generation unit. On the other hand, when there are multiple support servers 1, the subject attribute information storage unit, test information storage unit, subject information storage unit, and useful information storage unit must be present in at least one support server 1. However, for example, multiple support servers 1 may be provided with all of the storage units, and each storage unit may be present in multiple support servers 1. These features can be freely designed in accordance with the actual operation of the system.

[0037] For subject information, such as behavioral movements, behavioral habits, and dietary content, which are prone to insufficient objectivity and accuracy when measured using questionnaires, it is desirable to collect information using image and video data or devices utilizing various sensors. While these devices are preferably dedicated measurement devices (terminals), they can also be substituted by connecting the necessary accessories to a device, such as a smartphone, or installing a measurement application. Information acquired by these devices is ultimately stored in the support server 1 as primary information or as processed secondary information. Regarding the method of transmitting information from the terminal to the system, if the terminal has a communication unit that can be directly connected to a network, such as a smartphone, the information is transmitted to the support server 1 via a network such as the Internet. If the terminal does not have such a communication unit, the information acquired is transferred from the wireless or wired communication unit of the device that acquired the information to a computer or smartphone using short-range wireless communication (e.g., ANT+, Bluetooth (registered trademark), ZigBee, IrDA, etc.) and then transmitted to the support server 1 via a network such as the Internet for storage. The following are specific examples of information acquisition, but the invention is not limited to these.

[0038] Methods for obtaining information on the function and state of chewing and swallowing include capturing video information of the subject's actual chewing movements and analyzing the captured video information to understand the details of the chewing movements; capturing video information of the throat movements when swallowing saliva and analyzing the captured video information to understand the details of the throat movements during swallowing; analyzing information obtained from electromyography sensors and photoelectric sensors to obtain the movements of the throat during swallowing to understand swallowing function; and analyzing audio information obtained during "oral diadochokinesis," in which specific sounds "pa," "ta," and "ka" are repeatedly pronounced within a set period of time, to evaluate the speed and dexterity of the movements of the tongue, lips, soft palate, etc. to understand oral function. These include a method of grasping pressure changes and maximum bite force during occlusion by biting a piezoelectric sensor; a method of tracing occlusal function from myoelectric potential information obtained by attaching an electromyographic sensor to the jaw or temples during chewing; a method of capturing the state of occlusion as image information and analyzing it with AI to evaluate the occlusion; a method of grasping jaw movement and number of chews using images and videos during chewing, phase difference information from distance sensors, and myoelectric potential and acceleration information from masticatory muscles; a method of grasping tongue pressure ability by analyzing stress information when a probe equipped with a piezoelectric or pressure sensor is held between the tongue and jaw; and a method of measuring blood flow in the tongue by pressing a probe equipped with an SpO2 photoelectric sensor against the tongue.

[0039] Information on oral functions and conditions other than mastication and swallowing can be obtained using the following methods: For example, a sensor device equipped with a probe with a pH sensor can be used by a user holding the probe in the oral cavity to obtain information such as the pH and buffering capacity of saliva (ability to maintain pH in a normal range), the amount of saliva secreted, the dryness of the oral cavity and throat, serum antibody titers of oral bacteria, various salivary analyses (calcium ion concentration, type and content of immunoglobulins, amount of reactive oxygen, ammonia quantification, heparanase quantification, DNA / RNA analysis, quantification of female hormones, quantification of white blood cells, and type and quantification of oxidative stress markers), oral stickiness, the type and concentration of major gases indicating bad breath, which can be obtained by a user blowing breath into a sensor device equipped with a gas / breath sensor nozzle, the size (opening area) of the embrasure space between the teeth, the color of the tooth surface, the number of remaining teeth, etc., as the condition of the gums, the color, blood flow rate, and the presence or absence of occult blood (for example, tests that utilize the catalytic action of hemoglobin or immune reactions), and the state of the user's oral flora.

[0040] Information on oral hygiene habits includes, for example, the type of toothbrush and toothpaste used, brushing frequency and time, brushing technique and skill level, and other brushing behavior information, including whether and how often interdental cleaning tools are used, the type of interdental cleaning tool used, whether and how often mouthwash is used, and the type and frequency of use of mouthwash, and whether other oral hygiene tools (e.g., single-tuft brushes, Waterpik, etc.) are used. This information can be obtained not only through subject questionnaires but also using devices equipped with various sensors. For example, detailed information on toothbrushing behavior can be obtained by attaching a device equipped with a gyro sensor or accelerometer to the toothbrush, video information on oral hygiene behaviors such as toothbrushing, or interactive lifestyle support systems such as wearable devices and smart bathroom vanities.

[0041] In addition to the information declared by the subject, information on the treatment history can be obtained from external servers 4 used by medical institutions, health insurance agencies, labor unions, and organizations that manage electronic medical record systems. Examples of information that can be obtained include past health checkup and dental checkup history information, treatment information for systemic and dental diseases, history information on fluoride application, scaling, and root planing, whether or not an implant has been used and treatment history information, and medical history such as dietary guidance, health guidance, and dental health guidance.

[0042] Dietary information includes, for example, the number of usual meals, the start time and time taken for usual meals, the contents of the meal, whether or not assistance is provided, whether or not snacks are consumed, and the type and amount of food consumed. It is preferable that this information be collected automatically without the subject's input using a dedicated device. For example, for information on meal contents that is difficult to provide, it is preferable to use methods such as capturing and sending photos of the meal, which are then analyzed by AI and converted into meal content information. It is also preferable to collect as much information as possible about the subject's eating and drinking habits, such as the number of times they eat out, the contents of meals when they do eat out, whether or not they snack and the contents of snacks, and the contents and time of ingestion of beverages. Other preferable examples include recently developed methods using taste sensors attached to spoons or chopsticks to directly measure salt and sugar concentrations during eating, and methods using mass sensors attached to dish trays to measure the actual amount of food consumed before and after eating.

[0043] Although the embodiments of the present invention have been described above, the present invention is not limited to these examples, and it goes without saying that the present invention can be embodied in various forms without departing from the spirit of the present invention. [Explanation of symbols]

[0044] 1 Support Server 2. Devices 3. External computing device 4. External Server 5. Terminal 10 Processing equipment 11 Memory means 12 Communication control section

Claims

1. Specimen testing that includes the following items i, ii, and / or iii. i) Nucleic acid testing related to one or more microorganisms selected from the group consisting of bacteria and Candida present in the oral cavity and throat ii) Blood glucose and / or hemoglobin A1c testing iii) LDL and / or HDL level testing

2. 2. The specimen test according to claim 1, wherein the bacteria present in the oral cavity or throat include at least one or more bacteria selected from the group consisting of Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Aggregatibacter actinomycetemcomitans, Fusobacterium (such as Fusobacterium nucleatum), Streptococcus mutans, Streptococcus sobrinus, Actinomyces naeslundii, Actinomyces viscosus, Actinomyces odontolyticus, Actinomyces oris, Streptococcus mitis, Prevotella nigrescens, Aggregatibacter actinomycetemcomitans, Corynebacterium matruchotii, and Streptococcus constellatus.

3. 2. The specimen test according to claim 1, wherein the bacteria present in the oral cavity or throat include one or more bacteria selected from bacteria belonging to at least the genus Porphyromonas.

4. 2. The specimen test according to claim 1, wherein the bacteria present in the oral cavity or throat include one or more bacteria selected from bacteria belonging to at least the genus Fusobacterium.

5. 2. The specimen test according to claim 1, wherein the bacteria present in the oral cavity or throat include one or more bacteria selected from bacteria belonging to at least the genus Prevotella.

6. The specimen test according to claim 1, wherein the bacteria present in the oral cavity or throat include at least Streptococcus mutans.

7. The specimen test according to claim 1, wherein the bacteria present in the oral cavity or throat include at least Streptococcus intermedius.

8. A specimen test that includes one or more tests selected from a nucleic acid test related to bacteria present in the oral cavity and throat, a C-reactive protein test, a procalcitonin test, and an erythrocyte sedimentation rate test.

9. The sample test of claim 1, which provides information about the subject's oral cavity in addition to the results of the sample test.

10. The specimen test of claim 9, wherein the information regarding the subject's oral cavity includes at least information corresponding to any of recommended dental treatment information, recommended dental health guidance information, information regarding oral health status, information regarding risk factors in oral health, information regarding oral hygiene, and information regarding recommended oral care products.

11. The specimen test according to claim 9 , wherein the information relating to the subject's oral cavity includes recommended information for dental health guidance.

12. A health support system that uses nucleic acid test results related to bacteria and / or Candida present in the oral cavity and throat, and information (i) or (ii) below, to create information useful for preventing and treating disease and maintaining and improving oral and overall health of subjects, and provides the nucleic acid test results and the created useful information to subjects, medical institutions, and medical professionals. (i) Information on the results of specimen tests including one or more test items selected from the group consisting of blood glucose level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate level. (ii) Subject information including at least one or more pieces of information included in any of the following: dental examination recommendation information, dental health guidance recommendation information, the subject's own gender, age, height, weight, waist circumference, BMI, waist-to-hip ratio, medical history information of blood relatives, subjective information on oral and general health status, treatment history information, information on oral function and oral status, oral hygiene habits, dietary habits, lifestyle habits, exercise habits, drinking habits, smoking habits, bedtime behavior information, and psychological state information.

13. A health support system that uses nucleic acid test results related to bacteria and / or Candida present in the oral cavity and throat, as well as the information in (i) and (ii) below, to create useful information related to the prevention and treatment of disease and the maintenance and promotion of oral and general health of subjects, and provides the nucleic acid test results and the created useful information to subjects, medical institutions, and medical professionals. (i) Information on the results of specimen tests including one or more test items selected from the group consisting of blood glucose level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate level. (ii) Subject information including at least one or more of the following information: dental examination recommendation information, dental health guidance recommendation information, the subject's own sex, age, height, weight, waist circumference, BMI, waist-to-hip ratio, medical history information of blood relatives, subjective information on oral and general health status, treatment history information, information on oral function and oral status, oral hygiene habits, dietary habits, lifestyle habits, exercise habits, drinking habits, smoking habits, bedtime behavior information, and psychological state information.

14. 14. The health support system of claim 12 or 13, wherein the bacteria present in the oral cavity or throat include at least one or more bacteria selected from the group consisting of Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Aggregatibacter actinomycetemcomitans, Fusobacterium (such as Fusobacterium nucleatum), Streptococcus mutans, Streptococcus sobrinus, Actinomyces naeslundii, Actinomyces viscosus, Actinomyces odontolyticus, Actinomyces oris, Streptococcus mitis, Prevotella nigrescens, Aggregatibacter actinomycetemcomitans, Corynebacterium matruchotii, and Streptococcus constellatus.

15. 14. The health support system according to claim 12 or 13, wherein the bacteria present in the oral cavity or throat include at least one or more bacteria selected from bacteria belonging to the genus Porphyromonas.

16. 14. The health support system according to claim 12 or 13, wherein the bacteria present in the oral cavity or throat include at least one or more bacteria selected from bacteria belonging to the genus Fusobacterium.

17. 14. The health support system according to claim 12 or 13, wherein the bacteria present in the oral cavity or throat include at least one or more bacteria selected from bacteria belonging to the genus Prevotella.

18. 14. The health support system according to claim 12 or 13, wherein the bacteria present in the oral cavity or throat include at least Streptococcus mutans.

19. 14. The health support system according to claim 12 or 13, wherein the bacteria present in the oral cavity or throat include at least Streptococcus intermedius.

20. The health support system according to claim 12 or 13, further comprising one or more evaluations selected from the group consisting of: understanding and evaluation of oral function and oral condition using images or videos of the oral cavity; evaluation of oral function using videos including the head during chewing and / or vocalization and chewing sounds; and evaluation of oral function using oral diadochokinesis.

21. The health support system according to claim 12 or 13, wherein the test items further include one or more pieces of information relating to the oral cavity and dietary information acquired using a sensor device.

22. A method for transferring the test results of the specimen test described in claim 1 and the useful information created regarding the maintenance and improvement of oral and general health to an external server such as a database utilizing the My Number system, an electronic health insurance card, or an electronic medical record managed by a medical institution or data management institution, and utilizing the results within the external server.

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