JP7534666B2 - Sample testing and health support system - Google Patents

Description

The present invention 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 the elderly and infirm, by combining oral cavity-related information such as oral hygiene and health conditions, which are becoming increasingly apparent as a cause of systemic diseases and disorders, with specimen test information related to the above-mentioned systemic diseases and disorders, and a system that utilizes the test to support the health of subjects.

In recent years, it has become clear that oral hygiene and health conditions may be a factor in diseases and problems throughout the body, 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 only 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 other medical institutions in the medical field, and even in general hospitals that have oral surgery, medical and dental information is often not shared with each other.

We provide tests that can obtain 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 may 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 in the subject's whole body, provide prognostic care, and support the maintenance and promotion of health.

In light of the above situation, the inventor has made extensive research and is trying to solve the problem by providing a test that combines information such as the state of microorganisms present in the oral cavity that can affect the entire body, the oral hygiene state, and the presence or absence of infection, with sample test items such as blood glucose levels that are considered to be related to the oral cavity. Furthermore, by utilizing the above test, a health support system is provided that allows subjects to maintain and improve their health and receive effective disease prevention and medical treatment compared to a general blood test alone.

The present invention makes it possible to realize and maintain a high quality of life for subjects by understanding the condition of the subject's oral cavity and throat as well as the subject's overall health without imposing a large burden in terms of labor or expense on the subject or test administrator, providing useful information for maintaining the subject's health and building a health support system that can contribute to improving the subject's daily life and hygienic conditions, providing effective medical treatment and prognostic measures, and maintaining and improving the health of healthy individuals.

FIG. 1 is an explanatory diagram showing the configuration of a support system according to a representative embodiment of the present invention. FIG. 2 is a block diagram showing the configuration of a support server in the support system. FIG. 13 is a block diagram showing another configuration of the support server in the support system.

That is, the present invention includes the following inventions.
Item 1: Sample testing that includes the following i to iii in the test items.
i) An antibody test relating to one or more microorganisms selected from the group consisting of oral bacteria and Candida fungi; ii) A test of blood glucose level and/or hemoglobin A1c level; and iii) A test of LDL level and HDL level. Item 2: The specimen test according to Item 1, wherein the oral bacteria includes one or more bacteria selected from the genus Porphyromonas.
Item 3: The specimen test according to Item 2, wherein the oral bacteria include at least Porphyromonas gingivalis .
Item 4: The specimen test according to Item 3, wherein the oral bacteria include at least two or more different strains of Porphyromonas gingivalis .
Item 5: The specimen test according to any one of Items 1 to 4, wherein the oral bacteria include at least Streptococcus mutans .
Item 6: The specimen test according to any one of Items 1 to 5, wherein the oral bacteria include at least Streptococcus intermedius .
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: Sample testing that includes one or more tests selected from an antibody test related to oral bacteria, a C-reactive protein test, a procalcitonin test, and an erythrocyte sedimentation rate test.
Item 10: The 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: The 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 fungi.
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: The 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 examination, 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 fungi and the information (i) or (ii) below to create information useful for preventing and treating diseases in subjects and for maintaining and improving oral and general health, and provides the 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) at least information on recommendations for dental examinations, recommendations for dental health guidance, general attribute information such as the subject's own sex, age, height, weight, waist circumference, BMI, waist-to-hip ratio, and medical history information of close relatives, self-awareness of oral and general health conditions, treatment history information, and information on oral function and oral condition. and (ii) information on the results of an antibody test related to oral bacteria and/or Candida fungus, which includes one or more pieces of information on the actual state of oral hygiene habits, dietary habits, lifestyle habits, exercise habits, drinking habits, and smoking habits, information on behavior at bedtime, and information on psychological state.
(i) information on the results of a specimen test 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) information on one or more of the following: recommendation information for dental examination, recommendation information for dental health guidance, general attribute information such as the subject's own sex, age, height, weight, waist circumference, BMI, waist length/hip length ratio, and medical history information of blood relatives, subjective information on oral and general health status, treatment history information, information on oral function and oral condition, oral hygiene habits, actual information on diet, lifestyle, exercise, drinking, and smoking habits, bedtime behavior information, and psychological state information. The health support system described in item 14 or 15, wherein the oral bacteria include one or more bacteria selected from the genus Porphyromonas.
Item 17: The health support system according to Item 16, wherein the oral bacteria include at least Porphyromonas gingivalis .
Item 18: The health support system according to Item 17, wherein the oral bacteria include at least two or more different strains of Porphyromonas gingivalis .
Item 19: A health support system according to any one of Items 14 to 18, wherein the oral bacteria include at least Streptococcus mutans .
Item 20: A health support system according to any one of Items 14 to 18, wherein the oral bacteria include at least Streptococcus intermedius .
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 testing and information useful for the subject's disease prevention/treatment and maintenance/improvement of health created from the test results of the specimen testing are stored in an electronic medical record or a database used for managing the subject's health, and are utilized for the subject's disease prevention/treatment and maintenance/improvement of health.
Item 24: A health support system according to any one of Items 14 to 23, comprising 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 fungi.

The oral bacteria to be tested in the present invention refer to bacteria present in the oral cavity and throat, which are said to be of 400 to 800 types or more. The types of bacteria that constitute the oral flora vary from subject to subject, and it is known that even in a particular subject, the types vary depending on changes in age, oral hygiene, systemic disease, metabolism, and the like. The presence or absence of periodontal disease, dental caries, and the like is judged in dental examinations and dental treatments, but the technology of the present invention not only makes it possible to estimate them in a simple manner, but also provides information that can estimate the risk of oral infection, such as the risk of oral infection or recurrence, the likelihood of oral infection becoming severe, and the presence or absence and degree of a constitution that makes it difficult to obtain the effects of standard treatments and preventive measures for oral infection. Therefore, the oral bacteria to be tested in the present invention are preferably bacteria that are known to affect oral health, and it is even more preferable to target bacteria that may affect the onset and progression of diseases. In addition to bacteria, the fungus Candida albicans is also known as a causative bacterium of oral infections, and is therefore preferably used as a subject of the test. Examples of bacteria that can adversely affect oral health include the three types of bacteria Porphyromonas gingivalis , Treponema denticola , and Tannerella forsythia , which are known as the red complex associated with periodontal disease; Aggregatibacter actinomycetemcomitans (formerly known as Actinobacillus actinomycetemcomitans ); and the orange complex, Prevotella intermedia , Eubacterium nodatum , Fusobacterium nucleatum , Fusobacterium polymorphum, and Prevotella nigrescens . (Prevotella nigrescens), Peptostreptococcus micros , Campylobacter rectus , Campylobacter showae , Campylobacter gracilis, Streptococcus constellatus, etc. Other bacteria that are known to have a direct or indirect relationship with dental caries include Streptococcus mutans , Streptococcus sobrinus , Actinomyces naeslundii , Actinomyces viscosus , Actinomyces odontolyticus , and Actinomyces oris , as well as Corynebacterium matruchotii, which is known to be related to plaque formation , Actinomyces israelli , which is known to be associated with jaw actinomycosis, and Streptococcus agalactiae , which is known to be associated with invasive infections in the elderly.

"Related to one or more microorganisms selected from the group consisting of oral bacteria and Candida fungi" means that the subject of the specimen test is a nucleic acid, antigen, and antibody derived from one or more microorganisms selected from the group consisting of oral bacteria and Candida fungi, or a nucleic acid, antigen, and antibody that exhibits a reactivity equivalent to the genes, antigens, and antibodies derived from the above. Specifically, in the case of a nucleic acid test, it means that the subject of the specimen test is a nucleic acid corresponding to each of the oral bacteria and Candida fungi that are the subject of the specimen test, in the case of an antigen test, it means that the subject of the specimen test is an antigen corresponding to each of the oral bacteria and Candida fungi that are the subject of the specimen test, and in the case of an antibody test, it means that the subject of the specimen test is an antibody corresponding to each of the oral bacteria and Candida fungi that are the subject of the specimen test, and a substance that exhibits a reactivity equivalent to those.

The antibody to be tested in the antibody test means a protein having an activity of specifically binding to an antigen , which is produced by antigenic stimulation with the bacteria itself, a part of the bacteria, and a compound derived from the bacteria. Test antigens that react with antibodies include antigen peptides having similar reactivity and combinations thereof, in addition to the bacteria themselves, a part of the bacteria, and a compound derived from the bacteria. When testing antibodies related to two or more bacteria, an antigen-antibody reaction is used that utilizes antigens having separate antigenic structures corresponding to each antibody. In this case, it is desirable that there is substantially no cross-reaction between each antigen-antibody reaction or with antibodies against other bacteria contained in the sample. Here, "substantially no cross-reaction" means that, as long as it is possible to distinguish the presence of antibodies of each of the bacteria to be tested, even if some cross-reaction occurs, it is considered that there is no cross-reaction. In addition, the antibody test may be a qualitative test to determine the presence or absence of antibodies, but it is preferable that the antibody titer can be measured, since this provides information that can be used to infer the degree and timing of infection.

It has been found that oral hygiene and periodontal disease are closely related to diabetes and arteriosclerosis. There is also a relationship between oral hygiene and blood sugar fluctuations, and it has been reported that managing oral hygiene can control blood sugar levels, which is very important in managing the pathology of diabetes. However, there is almost no cooperation between the medical and dental fields, and medical information is not shared between the two fields, not only among private practice doctors but also among general hospitals that have oral surgery, and medical procedures are also independent of each other. Oral bacterial antibody tests can be used to determine the presence or absence of antibodies produced when oral bacteria invade the body and information on the microorganisms from which the antibodies are derived, allowing the state of the oral cavity and the degree of infection of oral microorganisms that have invaded the body to be understood. By conducting this specimen test in conjunction with conventional tests such as blood glucose level and hemoglobin A1c level, which are indicators of glucose metabolism, and LDL and HDL levels, which are indicators of lipid metabolism and are the main cause of the onset 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 level control, so the specimen test of the present invention, which can provide all of this information, is extremely useful.

The test samples used for the blood glucose, hemoglobin A1c, LDL and HDL tests and the antibody test may be the same or different, but the samples must be taken at the same time. The samples can be taken not only on the same day but also a few days apart to be considered "at the same time", but it is more preferable to take the samples on the same day. If the sampling times differ, the subject's condition may change, which is not preferable because it creates the risk that it will be difficult to accurately grasp the subject's information. The test samples for the antibody test can be blood (including blood components), gingival crevice fluid, dental plaque, tongue coating, or saliva, which can be obtained by taking samples from the mouth, throat, or oral tissue, but it is preferable to use blood taken during a health checkup or blood test at a medical institution. When using different test samples for the blood glucose, hemoglobin A1c, LDL, HDL and antibody tests, the samples must be taken at the same time. The samples can be taken not only on the same day but also a few days apart to be considered "at the same time", but it is more preferable to take the samples on the same day. If sampling times differ, the subject's condition may change, which is undesirable as it creates the risk that it will be difficult to accurately grasp the subject's information.

As mentioned above, it is becoming clear that bacteria related to periodontal disease are related to systemic diseases, and it is becoming recognized in the medical field that poor oral hygiene can lead to problems such as infections in the prognosis of surgical procedures. Cases have been reported in which oral hygiene is improved or measures to improve symptoms of periodontal disease are taken as pre-operative measures. Periodontal disease is a disease in which bacteria in the oral cavity grow and invade periodontal tissues, causing inflammation and damaging periodontal tissues such as the gums and alveolar bone. However, since there are many capillaries in periodontal tissues, bacteria in the oral cavity can enter the bloodstream and affect tissues throughout the body. Research has revealed a deep relationship with several systemic diseases, and understanding the state of bioinfection of oral bacteria related to periodontal disease can be said to be an important issue in managing the health of the entire body. In explaining the pathology of periodontal disease, bacteria called the Red Complex play a central role. Of these, Porphyromonas gingivalis plays the most important role. On the other hand, it has been pointed out that bacteria of the genus Porphyromonas present in the oral cavity are related to systemic diseases. For example, systemic diseases that are thought to be related to bacteria of the genus Porphyromonas include arteriosclerosis, which has been reported to be related based on research on bacteria detected from lesions and results of animal tests, and rheumatoid arthritis, diabetes, and non-alcoholic fatty liver disease, which have been reported to be related based on the production of an enzyme (peptidylarginine deminase) that produces anti-citrullinated proteins used as a marker, and observational information on the effects of periodontal disease treatment and changes in symptoms. Among them, Porphyromonas gingivalis is known to be particularly related, and it has been reported that gingipains and liposaccharides (LPS) produced by Porphyromonas gingivalis are not only related to infectious diseases, but also to the onset and progression of dementia, as they have been detected in the brain tissue of dementia patients. It is also becoming known that even if they belong to the same Porphyromonas gingivalis , the effects on the oral cavity and the health of the whole body vary greatly depending on the strain. Therefore, it is preferable that the oral bacteria test subject in the present invention includes at least Porphyromonas gingivalis , and it is more preferable that the test content can grasp not only the bacterial species but also the information of 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 secretion amount of adiponectin, which works to improve insulin resistance, and therefore is thought to be related to diabetes. Furthermore, it has been confirmed that the above ratio is correlated with the values of IL-1β and TNF-α, which are inflammatory cytokines in the blood, and therefore it has been reported that there is some relationship with inflammatory diseases such as arteriosclerosis and diabetes. Furthermore, it has been reported that the serum of pregnant women who gave birth prematurely or gave birth to a low-weight baby shows a high IgG antibody titer against Porphyromonas gingivalis , and that Porphyromonas gingivalis , Tannerella forsythia , Aggregatibacter actinomycetemcomitans , etc. are significantly detected in the oral cavity of these pregnant women, so that oral bacteria have some effect on the fetus, placenta, etc. Although it is a special disease, it has been reported that arteriosclerosis obliterans and thromboangiitis obliterans (Buerger's disease) are associated with three types of bacteria in the Red Complex and Campylobacter rectus . Therefore, not only Porphyromonas gingivalis but also Treponema denticola and Tannerella forsythia , which belong to the Red Complex, are important subjects for specimen testing, and it is preferable to perform nucleic acid testing, antigen testing, and antibody testing on specimens collected from blood or the oral cavity in an appropriate combination according to the purpose. Therefore, it is preferable to test these bacteria.

Dental caries is a typical oral disease along with periodontal disease. Streptococcus mutans is widely known as the causative bacterium of dental caries, but like Porphyromonas bacteria, it has been pointed out that it is related to systemic diseases. For example, there are infective endocarditis, valvular heart disease, cerebral hemorrhage, and aspiration pneumonia, which have been reported to be related to Streptococcus mutans , especially serotype κ. In particular, Cnm-positive Streptococcus mutans , which expresses a special protein called Cnm on the surface of the bacterial body, has been pointed out to be related to brain microbleeds and dementia. In addition, Streptococcus constellatus , which is also a member of the Streptococcus genus, has been reported to be related to the formation of abscesses in the liver. Therefore, it is preferable to use these bacteria as the test object.

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, and Streptococcus intermedius is known to form abscesses in the brain and liver. In addition, Streptococcus and Staphylococcus, which are also oral indigenous bacteria, account for 80-90% of the bacteria detected in blood cultures of patients with infective endocarditis, and there are reports that the bacteria in the culture were identified by genetic search and found to be identical to the bacteria in the oral cavity of the subject, and Staphylococcus epidermidis and Streptococcus mitis have been detected. Therefore, it is very useful to perform antibody tests for oral bacteria that include one or more bacteria belonging to the genus Staphylococcus and one or more bacteria belonging to the genus Streptococcus, in addition to C-reactive protein tests, procalcitonin tests, and erythrocyte sedimentation rate tests. In addition, Streptococcus sanguis has been reported to be associated with infectious heart disease, so it is preferable to test for these bacteria.

Fusobacterium is an obligate anaerobic nonsporulating gram-negative 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 have been reported to be 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 associations with digestive cancers such as esophageal cancer and colon cancer. Therefore, it is preferable to test for these bacteria.

The Prevotella genus is found primarily in the intestines, but is also found as a normal inhabitant of the oral cavity. It has been reported that Prevotella pallens is associated with chronic respiratory disease, Prevotella intermedi with premature birth and low birth weight, and Prevotella intermedia and Prevotella nigrescens with Buerger's disease. Therefore, it is preferable to test for these bacteria.

In addition, when Candida albicans is detected in a test sample taken from the oral cavity of elderly people, people with dry mouth, people taking steroid medication or chemotherapy, or people wearing dentures, it can be inferred that the person is suffering from oral candidiasis or may be suffering from oral candidiasis. In addition, when a nucleic acid test, antigen test, or antibody test is performed on a test sample taken from periodontal tissue, and the test result suggests a mixed infection of Streptococcus constellatus and Prevotella intermedius , it can be inferred that an obliterative abscess may have occurred in the oral cavity. Therefore, it is preferable to test for these microorganisms.

C-reactive protein, procalcitonin, 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 level 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 blood glucose level tests, etc., it is possible to provide important information for analyzing test results and estimating the subject's physical condition.

The antigens that are the subject of antigen testing refer to the bacteria themselves, parts of the bacteria, and compounds derived from bacteria that have an antigen structure. When testing for antigens related to two or more bacteria simultaneously, antigen tests using separate antibodies corresponding to each bacteria are performed in combination. In this case, it is desirable that the antibodies used for each antigen test do not substantially cross-react with at least other bacteria contained in the sample. In this case, "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 that no cross-reaction is observed.

There are no particular limitations on the testing method that can be used as a nucleic acid test, as long as it is a test that utilizes nucleic acids, and the optimal method can be adopted depending on the purpose of the test. Examples include testing methods that utilize multiple displacement amplification such as 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, whole genome amplification, and other strand displacement amplification, nicking enzyme amplification reaction, helicase-dependent amplification, recombinase polymerase amplification, strand-invasion based amplification, nucleic acid sequences based amplification, and transcription mediated amplification.

It is preferable to select either the nucleic acid test or the antigen test or both appropriately depending on the purpose of the test. Both nucleic acid tests and antigen tests can detect the presence of oral bacteria or Candida fungi, or fragments thereof, in the test sample at the time of the test. Since the former detects the presence of nucleic acid while the latter detects the presence of antigens, it cannot be said that the results of the two tests are completely consistent, so the test results must be analyzed taking into account the principle of the test to be performed and the specific test conditions. Nucleic acid tests and antigen tests also differ in detection accuracy and the time required for testing. In nucleic acid tests, the use of methods that utilize EMA (Ethidium bromide monoazide) or PMA (Propidium monoazide) can identify the possibility of the presence of live bacteria. Therefore, when conducting the test, the test purpose, test costs, test environment, etc. are comprehensively considered, and the optimal method or methods are adopted.

The test results of nucleic acid tests and antigen tests include the species and number of bacteria detected, their overall occupancy rate (ratio to total number of bacteria), and the species detected in a specific strain, and can be selected appropriately from these while taking into account the purpose of the test. The test results of antibody tests include the presence or absence of antibodies derived from a specific species or strain and their antibody titers (neutralizing antibody titer, agglutinating antibody titer, etc.), and can be selected appropriately from these while taking into account the purpose of the test. Furthermore, the test results (combinations of bacterial species and their presence rate, detected test items and test samples, etc.) can be comprehensively examined to make inferences about the health status of the oral cavity and include them in the test results. Examples of patent publications that describe related technologies include JP 2009-52945 A (method of testing or diagnosing periodontal disease using immunochromatography), JP 2022-96817 A, JP 2022-96815 A, JP 2022-96814 A, JP 2022-96812 A, and JP 2017-111095 A (all technical information related to measuring antibody titers against periodontal pathogens), but are not limited to these descriptions.

By including information on the subject's oral cavity in the test items, it is useful because it allows the subject to recognize the state of his or her own oral cavity, improves awareness of oral hygiene, and leads to specific oral hygiene practices and the implementation of dental medical treatments and dental health guidance that the subject requires. Examples of information on the subject's oral cavity include information on the condition of tongue coating that can cause periodontal disease, dental caries, dental plaque, halitosis, glossitis, taste disorders, etc., recommendations for dental examinations when oral diseases are suspected, recommendations for dental health guidance when oral hygiene is presumed to be poor, other information on the oral health condition, information on risk factors for oral health in the oral cavity and 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.

The present invention also provides a health support system that provides subjects, medical institutions, medical professionals, and the like with information useful for preventing and treating disease and maintaining and improving the health of subjects. This enables 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, while medical institutions and the like can not only avoid and reduce risks in medical procedures for subjects, but also improve the efficiency and effectiveness of procedures such as treatment.

The health support system of the present invention requires the results of an antibody test related to one or more microorganisms selected from the group consisting of oral bacteria and Candida fungi, and by analyzing and examining the results in combination with information belonging to either one of (i) and (ii) below, or preferably both, creates "information useful for preventing and treating disease in subjects and for maintaining and improving the health of the oral cavity and the entire body" 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 level, hemoglobin A1c level, oxidized HDL level, C-reactive protein level, procalcitonin level, and erythrocyte sedimentation rate level," and (ii) refers to "one or more pieces of information included in at least 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 length/hip length ratio, medical history information of blood relatives, self-awareness information on oral and general health conditions, treatment history information, oral hygiene habits, actual information on dietary habits, lifestyle habits, exercise habits, drinking habits, and smoking habits, bedtime behavior information, and psychological state information." The former is an indicator closely related to diabetes, arteriosclerosis, and inflammatory diseases, and the latter is information that the subject can grasp by himself, such as genetic information closely related to lifestyle-related diseases, and information useful for grasping and predicting matters related to daily lifestyle habits and the state of the oral cavity.

The subject information in (ii) above can be obtained from the subject's self-report, monitoring using a terminal device, electronic medical records, etc. As a method of self-report, for example, subject information in a specific health checkup can be used. In a specific health checkup, subject information on medical history and subjective symptoms is obtained. In a specific health checkup, part of the medical history information and part of the subjective symptoms are obtained in the form of questions to the subject, such as a questionnaire. For example, in addition to medical history, there are generally items such as smoking habits, exercise habits, dietary habits, drinking habits, and sleep habits, and these pieces of information can be used. Specific examples of subject information include general attribute information such as the subject's own sex, age, height, weight, abdominal circumference, BMI, waist length/hip length ratio, and medical history information of close relatives, subjective information on the oral cavity and overall health condition, treatment history information, information on oral function, oral hygiene habits, dietary habits and food preferences, actual information on lifestyle habits (life cycle), exercise habits, drinking habits, and smoking habits, bedtime behavior information, and psychological state information. In addition to this, if necessary, useful information such as recommended dental examinations and dental health guidance will also be provided.

In the present invention, "maintaining and improving the health of the oral cavity and the whole body" also includes the meaning of "maintaining and improving healthy oral function." It is said that there is a relationship between oral function and the function of the whole body. When oral function deteriorates, motor abilities such as grip strength and walking ability decline, a decline in masticatory function is related to the progression of dementia symptoms, and a significant decline in masticatory and swallowing abilities leads to malnutrition that adversely affects the health of the whole body. Therefore, maintaining and improving oral function is an essential element for maintaining and improving the health of the whole body. Therefore, "information necessary to maintain and improve the oral cavity of the subject in a healthy state" includes "information necessary to maintain and improve the oral function of the subject in a healthy state." Oral function is related to feeding (taking food into the mouth), mastication, formation and transport of a food bolus, swallowing, articulation, taste, touch, and saliva secretion, and is a basic function necessary for people to live a healthy life in society. For the above reasons, it is very useful to understand information on these conditions.

Information necessary to maintain and improve oral function in a healthy state is obtained, for example, by using sensors to measure the state of oral function, taking pictures or videos of the inside of the mouth and movements related to the oral cavity 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 targeted include chewing, swallowing, and other functions related to chewing (occlusion, bite force, tongue motor function during chewing, functional evaluation when wearing dentures), saliva secretion, mouth opening, and movements when taking food into the mouth (especially the movement of the lower jaw).

"Information useful for the prevention and treatment of the subject's disease and for the maintenance and improvement of oral and general health" provided to the subject, medical institutions, medical professionals, the subject's employer, etc., includes information useful for the treatment and prognosis management of the subject's disease, 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 that is necessary to maintain and improve oral function; problems that arise when using inappropriate toothpaste, toothbrushes, and other products, as well as criteria and methods for selecting appropriate products, and information on various oral care products (information on ingredients, incorrect use, etc.) This information may include oral care information such as: problems that may arise when using the product and the correct way to use it; specific optimal oral care methods for a set period of time (for example, one week); oral problems that may arise due to differences in age and gender, or due to pregnant women, infants, and those requiring care, and how to prevent or deal with them; an introduction to the latest oral-related research; basic knowledge about dentures and implants; problems that may occur with dentures and how to prevent them; information about oral care services and offers to provide oral care products and services; introductions to bulletin boards and communities as a place to exchange information and exercise with the aim of maintaining and improving oral and whole-body health.

As shown in FIG. 1, the health support system according to this embodiment is connected to a support server 1, a terminal 2 for inputting test results, and a terminal 5 for outputting information for transmitting test results, etc. to subjects and medical professionals, etc., through a network N such as the Internet, and various information is transmitted and received, and the support server 1 is connected for communication through the network N, and various information is transmitted and received. If necessary, a calculation device 3 for inferring the subject's oral and general health conditions and their correlations based on the test results and necessary information, and for creating and selecting appropriate information to be provided to individual subjects and medical professionals, etc. regarding the maintenance and improvement of oral health conditions and the maintenance, improvement, and treatment of general health, other than the support server, as necessary, and an external server 4 for obtaining various information not stored in the support server 1, which is necessary for selecting and creating various information other than the test results necessary to infer the subject's oral and general health conditions and useful information regarding the maintenance and improvement of oral and general health conditions to be provided to subjects, are connected through a network N such as the Internet. The external system server includes databases that utilize the My Number system, electronic health insurance cards, and electronic medical records managed by medical institutions and data management institutions. Information on subjects can be obtained from the external system server and used, and information obtained or created by the health support system of the present invention can be transferred to the external system server and used within the system.

In the health support system according to the embodiment, the support server 1 may be divided into two or more. In this case, the divided servers may be capable of transmitting and receiving various information through a connection means not via the Internet, such as a local network, or may be connected through a network N, such as the Internet, to transmit and receive various information, or may have both. When there are multiple support servers, each support server can be made to perform recording, data processing (calculation), and backup of data and the system in an optimal manner when operating the system. When there are multiple support servers, at least one of the support servers 1 must have a function to select test results and information useful for improving or maintaining oral and general health, and transmit the useful information to a specified terminal. Since test results and subject attribute information are personal information, it is preferable to transmit and receive information about them less frequently from the viewpoint of confidentiality. When the location of the data input terminal 2 for information is geographically distant from the support server 1, another support server 1 is set up in the same location as the data input terminal 2 for information, and the two are connected without using a network such as the Internet, and the information acquired or input is 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. In addition, if the useful information generation unit of the processing device of the support server 1 is unable to process or is unable to process all the information due to reasons such as information processing capacity, a calculation device outside the system can be used.

As shown in FIG. 2, the support server 1 is composed of one or more computers including 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 a storage means 11, a communication control unit 12, and an input operation means (not shown) such as a pointing device, keyboard, or display.

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 and processing data that define the procedures for various processing operations 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 indefinite disks (RAID), etc. The contents of some or all of the storage unit may be stored in the memory or hard disk of another computer that is communicatively connected to the support server 1.

The processing device 10 is broadly divided into two functional parts: an "information collection and recording function" that acquires information necessary for the operation of the system 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 oral and general health of the subject from the recording means, creates useful information, and transmits the information to the terminal 5 that outputs it. Specifically, each piece of information to be recorded is input from the terminal 2 in sequence at the stage when the information to be input is obtained and recorded in the recording means. In this case, for example, when 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 an optimal method from the viewpoint of convenience of the "information generation and transmission function" that utilizes the recorded information and prevention of information leakage. When providing information to a subject, the test results to be provided and, if necessary, information useful for improving or maintaining the oral and general health of the subject are generated, and the information is compiled and transmitted to the terminal 5. Terminal 5 not only displays or prints information on a display, but also transfers information to computers owned by subjects, medical institutions, or medical staff, smartphones, or recording media through terminal 5. In this case, terminal 5 of the support system is a computer owned by the subject, and information can be sent directly from support server 1 to terminal 5, i.e., a computer owned by the subject.

In the case where there is only one support server 1, the support server 1 is provided with at least a subject attribute information storage unit that stores the subject attribute information acquired by the subject general attribute information acquisition unit, a test information storage unit that stores the test result information acquired by the test result information acquisition unit, a subject information storage unit that stores the 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 one of the support servers 1, but for example, multiple support servers 1 may have all of the storage units, and each storage unit may be present in multiple support servers 1. These can be freely designed in accordance with the actual operation of the system.

Among the subject information, for matters such as the behavior during the activity, behavioral habits, and dietary contents, which are likely to be insufficiently objective and accurate using a questionnaire method, it is desirable to obtain the information using image and video information and terminals that utilize various sensors. It is desirable to use dedicated measuring equipment (terminals) for these terminals, but they can be substituted by connecting the necessary accessories for obtaining the information to a terminal such as a smartphone owned by the subject, or by installing a measurement application. The information obtained by these terminals is ultimately stored in the support server 1 as primary information as it is, or as secondary information obtained by processing the information. As a 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 obtained using short-range wireless communication (ANT+, Bluetooth (registered trademark), ZigBee, IrDA, etc.) from the wireless/wired communication unit of the terminal that obtained the information is transferred to a computer or smartphone, and then the information is 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 information acquisition is not limited to these.

Methods for obtaining information on the function and condition of chewing and swallowing include capturing video information of the subject's actual chewing movements and analyzing the captured video information to grasp the details of the chewing movements; capturing video information of the throat movements when swallowing saliva, etc. and analyzing the captured video information to grasp the details of the throat movements when swallowing; analyzing information obtained by using electromyography sensors or photoelectric sensors to capture the movements of the throat when swallowing to grasp swallowing functions; analyzing audio information obtained during "oral diadochokinesis," in which the specific sounds "pa," "ta," and "ka" are repeatedly pronounced within a certain period of time, to evaluate the speed and dexterity of the movements of the tongue, lips, soft palate, etc., to grasp oral functions; These include a method of grasping pressure changes and maximum bite force during biting by biting an electromyographic sensor; a method of tracing biting function from myoelectric potential information acquired by attaching an electromyographic sensor to the jaw or temples during chewing; a method of acquiring the state of biting as image information and evaluating the bite through AI analysis; 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 sensor or pressure sensor is held between the tongue and jaw; a method of measuring blood flow to the tongue by pressing a probe equipped with an SpO2 photoelectric sensor against the tongue.

Information on oral functions and conditions other than chewing and swallowing can be obtained using the following methods. For example, the following information can be obtained by a user holding a sensor device equipped with a probe equipped with a pH sensor in the oral cavity to obtain the pH of saliva, the degree of buffering capacity (ability to maintain pH in the normal range), the amount of saliva secreted, the dryness of the oral cavity and throat area, the serum antibody titer of oral bacteria, various analyses in saliva (calcium ion concentration, type and content of immunoglobulin, amount of active oxygen, ammonia quantification, heparanase quantification, DNA/RNA analysis, female hormone quantification, white blood cell quantification, type and quantification of oxidative stress markers), stickiness of the oral cavity, the type and concentration of main gases as the state of bad breath obtained by a user blowing breath into a sensor device equipped with a gas/breath sensor nozzle, the size (opening area) of the interdental embrasure, the color of the tooth surface, the number of remaining teeth, etc. as the state of the gums, the color and blood flow rate as the state of occult blood (for example, tests that apply the catalytic action of hemoglobin or immune reaction), and the state of the user's oral flora.

Examples of information on oral hygiene habits include the type of toothbrush and toothpaste used, frequency and time of brushing, brushing method and skill level, and other information on brushing behavior, whether or not interdental cleaning tools are used and how often, the type of interdental cleaning tool used, whether or not mouthwash is used and the type and frequency of use of mouthwash used, and whether or not other oral cleaning tools (one-tuft brush, Waterpik, etc.) are used. This information can be obtained not only by questionnaires of subjects, but also by using devices with various sensors. For example, detailed information on toothbrushing behavior can be obtained by attaching a device with a gyro sensor or acceleration sensor to the toothbrush, by using video information of oral hygiene behavior such as toothbrushing, or by using an interactive life support system such as a wearable device or a smart vanity.

In addition to information declared by the subject, treatment history information can be obtained from an external system server 4 used by medical institutions, health insurance and labor unions, and organizations that manage electronic medical record systems. Examples of information that can be obtained include past health and dental checkup history information, treatment information for systemic and dental diseases, history information on fluoride application, scaling and root planning, the presence or absence of implants and treatment history information, and consultation history for dietary guidance, health guidance, dental health guidance, etc.

Examples of dietary information include the number of usual meals, the start time and time taken to eat a usual meal, the contents of the meal, whether or not assistance was given for eating, whether or not snacks were given, and the type and amount of food consumed. It is preferable that this information can be obtained automatically without the subject's declaration using a dedicated device, etc. For example, it is preferable to use a method such as taking and sending photos of the meal, which is difficult to provide, and then having AI analyze and convert the information into information on the meal contents. It is also more preferable to obtain as much information as possible about the subject's eating and drinking, such as the number of times eating out, the contents of meals when eating out, whether or not snacks were given and their contents, and the contents and time of ingestion of beverages consumed. Other preferable examples include a method recently developed in which taste sensors are attached to spoons or chopsticks to directly measure salt and sugar concentrations during eating behavior, and a method in which a mass sensor is attached to a dish tray and the actual amount of food consumed is determined by measuring before and after eating.

The above describes the embodiments of the present invention, but the present invention is not limited to these examples, and can of course be embodied in various forms without departing from the spirit of the present invention.

Reference Signs List 1 Support server 2 Terminal 3 System external computing device 4 System external server 5 Terminal 10 Processing device 11 Storage means 12 Communication control unit

Claims (22)

Sample testing that provides useful information for maintaining and improving overall health, including the test items i to iii below.
i) Antibody test related to one or more microorganisms selected from the group consisting of oral bacteria and Candida fungi ii) Blood glucose and/or hemoglobin A1c level test iii) LDL and HDL level test The specimen test according to claim 1, wherein the oral bacteria include one or more bacteria selected from the genus Porphyromonas. The specimen test according to claim 2, wherein the oral bacteria include at least Porphyromonas gingivalis. The specimen test according to claim 3, wherein the oral bacteria include at least two or more different strains of Porphyromonas gingivalis. The specimen test according to claim 1 , wherein the oral bacteria include at least Streptococcus mutans . The specimen test according to claim 1 , wherein the oral bacteria include at least Streptococcus intermedius . The specimen test according to claim 1, wherein the oral bacteria include one or more bacteria selected from at least those belonging to the genus Fusobacterium. The specimen test according to claim 1, in which the oral bacteria include one or more bacteria selected from at least the Prevotella genus. The specimen test according to claim 1, the test items of which 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 fungi. The specimen test according to claim 1, in which the test items include providing information about the subject's oral cavity. The specimen test of claim 10, wherein the information regarding the subject's oral cavity includes information contained in any of the following: recommended information for a dental examination, recommended information for dental health guidance, information regarding oral health status, information regarding risk factors in oral health, information regarding oral hygiene, and information regarding recommended oral care products. A health support system that uses the results of antibody tests related to oral bacteria and/or Candida fungi, as well as 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 this 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) information on subjects including at least one or more of the following: recommendation information for dental examination, recommendation information for dental health guidance, general attribute information on the subject's own sex, age, height, weight, waist circumference, BMI, waist length/hip length ratio, medical history information of blood relatives, subjective awareness of oral and general health conditions, treatment history information, information on oral function, oral hygiene habits, actual information on dietary habits, lifestyle habits, exercise habits, drinking habits, and smoking habits, bedtime behavior information, and psychological state information.
A health support system that uses three pieces of information, namely, the results of antibody tests related to oral bacteria and/or Candida fungi, and the information in (i) and (ii) below, to create information useful for preventing and treating disease in subjects and for maintaining and improving oral and overall health, and provides this 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) information on subjects including at least one or more of the following: recommendation information for dental examination, recommendation information for dental health guidance, general attribute information on the subject's own sex, age, height, weight, waist circumference, BMI, waist length/hip length ratio, medical history information of blood relatives, subjective awareness of oral and general health conditions, treatment history information, information on oral function, oral hygiene habits, actual information on dietary habits, lifestyle habits, exercise habits, drinking habits, and smoking habits, bedtime behavior information, and psychological state information. 13. The health support system according to claim 12 , wherein the oral bacteria include one or more bacteria selected from the group consisting of bacteria belonging to the genus Porphyromonas. The health support system according to claim 14 , wherein the oral bacteria include at least Porphyromonas gingivalis . The health support system according to claim 15 , wherein the oral bacteria include at least two or more different strains of Porphyromonas gingivalis . The health support system according to claim 12 , wherein the oral bacteria include at least Streptococcus mutans . The health support system according to claim 12 , wherein the oral bacteria include at least Streptococcus intermedius . The health support system according to claim 12 , wherein the oral bacteria include one or more bacteria selected from the group consisting of bacteria belonging to the genus Fusobacterium. The health support system according to claim 12 , wherein the oral bacteria include one or more bacteria selected from the group consisting of bacteria belonging to the genus Prevotella. The health support system of claim 12, wherein some or all of the test results of the specimen test and information useful for preventing and treating disease and maintaining and improving the health of the subject, created from the test results of the specimen test, are stored in an electronic medical record or a database used for managing the subject's health, and are utilized for preventing and treating disease and maintaining and improving the health of the subject. The health support system according to claim 12 , 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 fungi.

Images