WO2017175673A1 - 歯周病ステージの判定方法 - Google Patents
歯周病ステージの判定方法 Download PDFInfo
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- WO2017175673A1 WO2017175673A1 PCT/JP2017/013551 JP2017013551W WO2017175673A1 WO 2017175673 A1 WO2017175673 A1 WO 2017175673A1 JP 2017013551 W JP2017013551 W JP 2017013551W WO 2017175673 A1 WO2017175673 A1 WO 2017175673A1
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
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- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
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- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56966—Animal cells
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
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- G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
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- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
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- G01N33/487—Physical analysis of biological material of liquid biological material
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Definitions
- the present invention relates to a method for determining a periodontal disease stage.
- the present invention also relates to an apparatus, a method, and a program for creating a determination result sheet for presenting a determination result obtained by the determination method.
- oral diseases include caries (worm teeth) and periodontal disease.
- diagnosis of the susceptibility and progression of these oral diseases uses saliva and gargle collected from the subject as samples, and individual components and properties that reflect susceptibility and progression, etc. This has been done based on the results of measuring the inspection items.
- occult blood, leukocytes, alkaline phosphatase, and the like are known as test items that reflect the ease and progression of periodontal disease. That is, when the gum tissue is destroyed due to periodontal disease, occult blood is detected in the saliva, and leukocytes collect at the affected area of periodontal disease. Alkaline phosphatase is also produced in large quantities from bacteria associated with periodontal disease. In addition, as a material for dentists and the like to determine the degree of progression of periodontal disease by observing the depth of the periodontal pocket and bleeding during probing in a probing test in which the inside of the oral cavity is examined and the probe is inserted into the periodontal pocket Yes.
- Patent Document 1 A method for determining a risk level has been proposed (Patent Document 1). According to this method, it is possible to comprehensively determine the risk level such as the susceptibility and the degree of progression of oral diseases such as periodontal disease from the measurement results of a plurality of test items.
- the conventional periodontal disease evaluation methods and systems are all determined by a dentist or the like based on the measurement values of the examination items. In other words, it cannot be established without a person with specialized knowledge and experience. However, there is a high demand for more easily and in a short time to ascertain the susceptibility and progress of an individual's periodontal disease. Therefore, there is a need for a method that can objectively, easily, and reliably determine the susceptibility and progression of periodontal disease without involving a dentist or the like.
- the present invention is based on the measurement result of the test item, and is not objectively, easily, and reliably without using a dentist or the like. It is an object to provide a method for determining the degree (hereinafter referred to as “stage”). Another object of the present invention is to provide an apparatus, a method, and a program for creating a determination result sheet for presenting a determination result obtained by such a determination method.
- the present inventors have made a specific order in determining the periodontal disease stage using occult blood volume, white blood cell count, total protein concentration, and ammonia as an index in a sample such as saliva after intensive studies. By determining whether each test item is positive or negative, it was possible to objectively determine the periodontal disease stage with few steps, and the determination result was highly reliable, and the present invention was completed. .
- the first aspect of the present invention is a method for determining the following periodontal disease stage (hereinafter, also referred to as “determination method of the present invention”).
- a method for determining a periodontal disease stage as at least two indicators selected from a occult blood amount, a white blood cell count, and a total protein concentration in a test sample obtained from the oral cavity, Determining positive or negative occult blood or total protein concentration; If the occult blood amount or the total protein concentration is positive, determining whether the white blood cell count is positive or negative; Determining the positive or negative total protein concentration if the occult blood amount is negative, or determining the positive or negative occult blood amount if the total protein concentration is negative.
- [2] determining whether the occult blood volume is positive or negative; The method according to [1], including a step of determining positive or negative white blood cell count when the occult blood amount is positive, or a step of determining positive or negative total protein concentration when the occult blood amount is negative. . [3] If the occult blood volume is positive and the white blood cell count is positive, severe periodontitis, If the occult blood volume is positive and the white blood cell count is negative, moderate periodontitis, If the occult blood volume is negative and the total protein concentration is positive, mild periodontitis, The method according to [2], wherein gingivitis is determined when the amount of occult blood is negative and the total protein concentration is negative.
- the second aspect of the present invention is the following periodontal disease stage determination result sheet creation apparatus and an inspection apparatus including the same (hereinafter, also referred to as “the production apparatus of the present invention” and “the inspection apparatus of the present invention”).
- An input unit that receives measurement values of occult blood volume, white blood cell count, total protein concentration, and ammonia concentration in a test sample obtained from the oral cavity;
- a determination unit for determining a periodontal disease stage by the method according to any one of [1] to [5];
- a display unit for displaying a determination result determined by the determination unit and a comment corresponding to the determination result;
- a storage unit for storing the measurement value, the determination result, and the comment;
- a determination result sheet creating apparatus comprising: a control unit that creates a determination result sheet including the measurement value, the determination result, and the comment.
- the determination result sheet creation device further including a communication unit that outputs the created determination result sheet to an external device.
- a test apparatus comprising: a measurement unit that measures a occult blood amount, a white blood cell count, a total protein concentration, and an ammonia concentration in a test sample obtained from the oral cavity.
- the third aspect of the present invention is the following periodontal disease stage determination result sheet creation method (hereinafter also referred to as “creation method of the present invention”).
- the computer Accepting measured values of occult blood volume, white blood cell count, total protein concentration, and ammonia concentration in a test sample obtained from the oral cavity; Determining the periodontal disease stage by the method according to any one of [1] to [5], Selecting a comment corresponding to the determined determination result; A determination result sheet creation method for executing a step of creating a determination result sheet including the measurement value, the determination result, and a selected comment.
- the computer The determination result sheet creating method according to [9], further comprising a step of outputting the created determination result sheet to an external device.
- the fourth aspect of the present invention is the following periodontal disease stage determination result sheet creation program (hereinafter also referred to as “program of the present invention”).
- program of the present invention In the computer, Accepting measured values of occult blood volume, white blood cell count, total protein concentration, and ammonia concentration in a test sample obtained from the oral cavity; Determining the periodontal disease stage by the method according to any one of [1] to [5], Selecting a comment corresponding to the determined determination result; A determination result sheet creation program for executing a step of creating a determination result sheet including the measurement value, the determination result, and a selected comment.
- the determination result sheet creation program according to [11] further executing a step of outputting the created determination result sheet to an external device.
- the determination method of the present invention based on the measurement result of the test item for the test sample obtained from the oral cavity, it is possible to objectively and easily perform a simple and quick procedure of two steps without using a dentist or the like. In addition, a highly reliable periodontal disease stage determination result can be obtained. In addition, according to the creation device, inspection device, creation method, and program of the present invention, it is possible to provide a reliable determination result of the periodontal disease stage not only in dentistry but also in a drug store or a mass screening scene. Can be useful.
- periodontal disease stage refers to the degree of progression of periodontal disease expressed in a plurality of stages. Usually represents a grade of severity according to the stage of progression, for example, gingivitis or periodontitis, and more specifically, gingivitis, mild periodontitis, moderate periodontitis, and It is preferably represented by 4 stages of severe periodontitis. In more detail, it is more preferable to express six stages of healthy, gingivitis, mild periodontitis, moderate periodontitis, severe periodontitis, and an improvement period.
- the degree of progression of general oral diseases only an independent state at the time of examination (for example, healthy to severe periodontitis) is determined, but in a preferred embodiment of the present invention, the state before the time of examination is determined. It is technological in that changes (improvement period) can be determined.
- the improvement period can be generally regarded as a healthy state as a periodontal disease stage.
- Healthy represents a healthy state in which there is no periodontal disease bacteria, no bleeding from the gums, and the depth of the gap between the teeth and gums (periodontal pocket) is about 1 to 2 mm.
- gingivitis refers to a condition in which periodontal bacteria are present and inflammation begins in the gums, but there is no bleeding from the gums and the periodontal pockets are deepened to 2 to 3 mm.
- Meld periodontitis refers to a condition in which the inflammation of the gums has deteriorated due to periodontal disease bacteria and the alveolar bone and periodontal ligament have begun to be destroyed.
- “Moderate periodontitis” refers to a state in which the inflammation of the gums is further aggravated by periodontal disease bacteria, the alveolar bone has been destroyed to nearly half, and the teeth have started to wobble. There are moderate symptoms of bleeding from the gums and deepening of the periodontal pockets to 4-6 mm.
- “Severe periodontitis” refers to a condition in which the alveolar bone is destroyed by more than half due to periodontal disease bacteria and the teeth become loose. Severe symptoms of bleeding from the gums and deepening of the periodontal pocket to 6 mm or more are observed.
- “Improvement period” represents a state in which periodontal disease bacteria have disappeared from the mouth and periodontal disease has improved in the improvement direction. Although the periodontal pocket is slightly deeper than 4 mm, there is no bleeding from the gingiva, or even if there is bleeding from the gingival, the symptom that the periodontal pocket is shallow to less than 4 mm is observed to improve.
- examples of the test sample obtained from the oral cavity include resting saliva (unstimulated saliva), stimulated saliva, and mouthwash discharge.
- Examples of stimulated saliva include saliva collected by stimulation with gum.
- mouthwash discharge liquid is preferred.
- the mouthwash discharge liquid is obtained, for example, by containing purified water in the mouth and discharging it. Specifically, for example, 3 mL of purified water may be contained in the mouth for 10 seconds and discharged into the container. The volume of purified water and the time for the mouth can be changed as needed.
- the obtained test sample can be used for subsequent operations without any special pretreatment, but additional operations such as dilution may be performed as necessary.
- Oxid blood volume refers to the blood volume in a test sample obtained from the oral cavity. It is known that occult blood is detected in saliva when gum tissue is destroyed due to periodontal disease, and the amount of occult blood is an item that reflects the degree of destruction of periodontal tissue. The greater the amount of occult blood, the higher the degree of periodontal tissue destruction and the more severe the periodontal disease stage.
- the measurement of the occult blood amount is not particularly limited and can be performed by a known method. For example, it is preferably performed by a hemoglobin contact activity method.
- the hemoglobin contact activity method is the ability of blood components hemoglobin, myoglobin, or their degradation products to catalyze the transfer of oxygen from oxygen donors such as peroxides to oxygen acceptors (peroxidase-like activity) ) Is used.
- oxygen donors such as peroxides to oxygen acceptors (peroxidase-like activity)
- the occult blood amount is measured through measurement of the concentration of hemoglobin or the like by measuring the color reaction.
- White blood cell count refers to the number of white blood cells in a test sample obtained from the oral cavity. It is known that leukocytes collect at a site affected by periodontal disease (inflammatory site), and the white blood cell count is an item reflecting the degree of inflammation of periodontal tissue. The greater the white blood cell count, the higher the degree of inflammation of the periodontal tissue, and the more severe the periodontal disease stage.
- the measurement of the white blood cell count is not particularly limited and can be performed by a known method.
- the leukocyte esterase method is preferable.
- the leukocyte esterase method makes use of the fact that leukocytes increase when tissue is inflamed, and the production of esterase by leukocytes also increases accordingly.
- An ester compound is used as a substrate, and the alcohol (phenol) component produced by hydrolysis by esterase (leukocyte esterase) produced by leukocytes is directly colored, or the alcohol (phenol) ) Is colored with a diazonium salt to measure the esterase activity.
- the white blood cell count can be calculated based on the measured value of the esterase activity.
- Total protein concentration refers to the concentration of total protein in a test sample obtained from the oral cavity. Since the total protein concentration increases as the number of periodontal disease bacteria in the oral cavity increases, the total protein concentration is an item that reflects the number of periodontal disease bacteria. The higher the total protein concentration, the more severe the periodontal disease stage.
- the measurement of the total protein concentration is not particularly limited and can be performed by a known method.
- the protein error method is preferable.
- the protein error method is a method that utilizes the fact that the pH indicator shows a pH higher than the true pH of the solution in proportion to the protein concentration, and quantifies the total protein concentration from the color of the indicator. Can do.
- Ammonia concentration refers to the concentration of ammonia in a test sample obtained from the oral cavity. Since the ammonia concentration increases as bacteria containing periodontal disease bacteria actively propagate in the oral cavity, the ammonia concentration is an item that reflects the number of oral bacteria. The higher the ammonia concentration, the more severe the periodontal disease stage. In general, the ammonia concentration is used as an index for the determination of oral cleanliness rather than the determination of periodontal disease risk in the diagnosis of the oral condition, but in a preferred embodiment of the determination method of the present invention, the ammonia concentration is used as an indicator of periodontal disease risk. By using it as an index in the determination, it is possible to perform more detailed and reliable stage determination including a healthy state and an improvement period.
- the measurement of the ammonia concentration is not particularly limited and can be performed by a known method.
- a micro-diffusion method Conway method
- the micro-diffusion method is a technique used for the determination of ammonia nitrogen, and it is possible to trap the ammonia gas volatilized from a sample made alkaline with an alkaline buffer in an absorbing solution, etc. This is a technique for quantifying by a technique such as color.
- each test item is positive or negative is determined according to the magnitude of the measurement value of each test item. That is, when the test item is measured quantitatively, it is determined as positive when the measured value is larger than a predetermined threshold value (cutoff value) set in advance, and negative when the measured value is small.
- the measurement of the test item may be qualitative, and in that case, based on a predetermined standard set in advance, it is determined as positive when the measurement result is larger than the standard and negative when the measurement result is small.
- the cut-off value and the reference are set according to the type of test sample. Table 1 shows an example of a threshold value (cut-off value) when determining positive or negative of each test item.
- the threshold value (cutoff value) for determining the positive or negative of each test item may be determined by the value of an intermediate parameter in the measurement of the test item in addition to the direct value such as the concentration as shown in Table 1. .
- the reflectance data can be, for example, a reflectance value at a specific wavelength after a predetermined time has elapsed since the test sample was brought into contact with the measurement reagent for each parameter.
- the reflectance value can be obtained by irradiating a colored portion, for example, an absorbent carrier portion spotted with a test sample, and measuring the reflected light.
- the reflectance data may be, for example, a value obtained by dividing the reflectance value obtained as described above from 100%. Note that the higher the absorbance at a specific wavelength, the lower the reflectance value at the specific wavelength, and the lower the absorbance at the specific wavelength, the higher the reflectance value at the specific wavelength.
- the fixed time may be, for example, the reaction time in each parameter measurement method as described above, and may be set as appropriate according to the type of parameter to be measured and the measurement method.
- the determination method of the present invention determines whether each test item is positive or negative in a specific order, using as an index at least two selected from the occult blood amount, the white blood cell count, and the total protein concentration in the test sample obtained from the oral cavity. It is characterized by that.
- a step of determining whether the occult blood volume is positive or negative is performed.
- a step of determining whether the white blood cell count is positive or negative is performed, and when the occult blood amount is negative, a step of determining positive or negative of the total protein concentration is performed.
- the four types classified through these steps are “when occult blood volume is positive and white blood cell count is positive”, “when occult blood volume is positive and white blood cell count is negative”, “occult blood volume is negative, and In the order of “when the total protein concentration is positive” and “when the occult blood volume is negative and the total protein concentration is negative”, the results correspond to the state where the periodontal disease stage is severe to mild, and reflect the actual medical condition. can get.
- occult blood volume is positive and white blood cell count is positive
- occult blood volume is positive and white blood cell count is negative
- moderate periodontitis is moderate periodontitis
- occult blood volume is “If negative and the total protein concentration is positive” is determined as mild periodontitis, and “If occult blood amount is negative and the total protein concentration is negative” is determined as gingivitis.
- a step of determining whether the total protein concentration is positive or negative is performed.
- a step of determining positive or negative of the white blood cell count is performed, and when the total protein concentration is negative, a step of determining positive or negative of the occult blood amount is performed.
- “when the total protein concentration is positive and the white blood cell count is positive” “when the total protein concentration is positive and the white blood cell count is negative”, “the total protein concentration is negative and the occult blood amount is positive.
- test items for determining positive or negative and the order thereof are performed as described above, and it is necessary to measure the occult blood amount or the total protein concentration in the first step.
- the amount of occult blood is measured in the first step. As shown in the examples described later, when only the occult blood amount is used as an index, it is insufficient for the determination of the periodontal disease stage (Table 4).
- the occult blood volume it is possible to significantly determine gingivitis, mild periodontitis, moderate periodontitis, and severe periodontitis without determining positive or negative for all three items of white blood cell count and total protein concentration (Table 1). 5). Further, when the total protein concentration is positive, the white blood cell count is determined to be positive or negative, and when the total protein concentration is negative, the occult blood volume is determined to be positive or negative.
- the method of the present invention it is preferable to further perform a step of determining whether the ammonia concentration is negative or positive.
- this process is not specifically limited, It is preferable to add to the aspect which performs the process which concerns on the amount of occult blood first. This step may be performed before, during, or after the step related to the occult blood amount or the total protein concentration and the step related to another item performed after the above step. That is, when the ammonia concentration is also added to the index, the determination step of positive or negative of the ammonia concentration is performed regardless of the positive or negative of the other two items.
- FIG. 3 shows an example of the determination flow of this aspect, but the step of determining whether the ammonia concentration is negative or positive is performed after the step relating to the leukocyte or total protein concentration as shown in FIG. Not limited to.
- the occult blood volume is positive, the white blood cell count is positive, and the ammonia concentration is positive
- the occult blood volume is positive, the white blood cell count is positive, and the ammonia concentration is negative
- Is periodontal disease improvement period “if occult blood volume is positive, white blood cell count is negative, and ammonia concentration is positive” is moderate periodontitis, “occult blood volume is positive, white blood cell count is negative, and ammonia If the concentration is negative, the periodontal disease is improving, and if the occult blood amount is negative, the total protein concentration is positive, and the ammonia concentration is positive, the periodontitis is mild, and the occult blood amount is negative.
- Periodontal disease stage determination result sheet preparation device is a occult blood amount, white blood cell count, total
- An input unit for receiving measured values of protein concentration and ammonia concentration, a determination unit for determining a periodontal disease stage by the method of the present invention, a determination result determined by the determination unit, and a comment corresponding to the determination result
- a display unit for displaying, a storage unit for storing the measurement value, the determination result, and the comment; and a control unit for creating a determination result sheet including the measurement value, the determination result, and the comment.
- the communication device further includes a communication unit that outputs the created determination result sheet to an external device.
- the determination result sheet creation apparatus of the present invention can also be used as an inspection apparatus in combination with a measurement unit that measures occult blood volume, white blood cell count, total protein concentration, and ammonia concentration in a test sample obtained from the oral cavity.
- the measurement unit is not particularly limited and can be performed by a known method.
- a measurement unit described in Patent Document 1 can be used.
- FIG. 4 shows a configuration example of the determination result sheet creation apparatus 10 and the inspection apparatus 30 of the present invention.
- the determination result sheet creation apparatus 10 includes a control unit 11, an input unit 12, a determination unit 13, a display unit 14, a storage unit 15, and a communication unit 16.
- the inspection device 30 includes a determination result sheet creation device 10 and a measurement unit 20.
- the measuring unit 20 measures the amount of occult blood, the number of white blood cells, the total protein concentration, and the ammonia concentration in a test sample obtained from the oral cavity of the subject.
- the determination result sheet creation apparatus 10 acquires a measurement result from the measurement unit 20, determines a periodontal disease stage based on the measurement result, and creates a determination result sheet.
- the control unit 11 controls the overall operation of the inspection result sheet creation apparatus 10.
- the control unit 11 may control the operation of the measurement unit 20 via the communication unit 16.
- the input unit 12 receives measurement values of the occult blood amount, the white blood cell count, the total protein concentration, and the ammonia concentration in the test sample obtained from the oral cavity from the measurement unit 20.
- the input unit 12 may receive the measurement value of the subject via a network or the like.
- the input unit 12 accepts input of characters, selection of buttons, etc., operation, etc. by a user (dentist, dental hygienist, health checker, drug store clerk, subject himself).
- the input unit 12 can be realized by a keyboard, a pointing device, or the like.
- the determination unit 13 determines the periodontal disease stage based on the measurement value according to the flow of the determination method of the present invention.
- the storage unit 15 includes a program storage unit 151 and a data storage unit 152.
- the program storage unit stores the determination result sheet creation program of the present invention.
- the data storage unit 152 stores data such as measurement values, determination results, comments to be described later, and subject information used by the determination unit 13.
- the display unit 14 displays subject information, measurement values, determination results, comments corresponding to the determination results, and the like.
- the display unit 14 can be realized by a display device such as a display, for example.
- the comment corresponding to the determination result is a message provided to the subject, such as an explanation of the determined periodontal disease stage, instruction of a care method, or a proposal of a care product.
- For each determined periodontal disease stage one comment corresponding to each item (explanation of periodontal disease stage, guidance on care method, proposal of care product, etc.) is prepared in advance, and based on the determination result The corresponding comment is called up and displayed.
- the communication unit 16 performs data communication with the measurement unit 20, the output device 40, and the like. Further, an external device such as an external storage device can be connected to the communication unit 16. Based on the instruction from the control unit 11, the output device 40 sends a determination result sheet including subject information, measurement values, determination results, comments corresponding to the determination results, and the like via a communication unit 16 to a sheet or the like. Print.
- the output device 40 can be realized by a printing device such as a printer.
- the inspection device 30 displays the operation method of the measuring unit 20 and uses the measuring unit 20 for a user (dentist, dental hygienist, medical checkup person, drug store clerk, subject himself). Samples such as saliva can be collected and occult blood volume, white blood cell count, total protein concentration, and ammonia concentration can be measured. When the measurement unit 20 finishes the examination of saliva, the determination result sheet creation apparatus 10 receives the measurement value transmitted from the measurement unit 20 by the input unit 12 and stores it in the storage unit 15.
- the determination result sheet creation apparatus 10 uses a dedicated or general-purpose computer (information processing apparatus) such as a PC, a workstation (WS, Work Station), a PDA (Personal Digital Assistant), or an electronic device equipped with a computer. Is feasible.
- the determination result sheet creation apparatus 10 can also be realized by using a smartphone, a mobile phone, a tablet terminal, a dedicated or general-purpose computer, or an electronic device equipped with a computer.
- FIG. 5 shows a hardware configuration example of the information processing apparatus.
- the determination result sheet creation apparatus 10 can be realized by an information processing apparatus 100 as shown in FIG.
- the information processing apparatus 100 in FIG. 5 includes a processor 102, a memory 104, a storage unit 106, an input unit 108, an output unit 110, and a communication unit 112.
- the memory 104 and the storage unit 106 are computer-readable recording media.
- the hardware configuration of the information processing apparatus is not limited to the example illustrated in FIG. 5, and components may be omitted, replaced, or added as appropriate.
- the processor 102 loads a program stored in a recording medium into the work area of the memory 104 and executes the program, and each component is controlled through the execution of the program, thereby meeting a predetermined purpose. Function can be realized.
- the processor 102 is, for example, a CPU (Central Processing Unit) or a DSP (Digital Signal Processor).
- the memory 104 includes, for example, a RAM (Random Access Memory) and a ROM (Read Only Memory).
- the memory 104 is also called a main storage device.
- the storage unit 106 is, for example, an EPROM (Erasable Programmable ROM) or a hard disk drive (HDD, Hard Disk Drive).
- the storage unit 106 may include a removable medium, that is, a portable recording medium.
- the removable media is, for example, a USB (Universal Serial Bus) memory or a disc recording medium such as a CD (Compact Disc) or a DVD (Digital Versatile Disc).
- the storage unit 106 is also called a secondary storage device.
- the storage unit 106 stores various programs, various data, and various tables in a recording medium in a readable and writable manner.
- the storage unit 106 stores an operating system (OS), various programs, various tables, and the like.
- Information stored in the storage unit 106 may be stored in the memory 104.
- Information stored in the memory 104 may be stored in the storage unit 106.
- the operating system is software that mediates between software and hardware, manages memory space, manages files, manages processes and tasks, and so on.
- the operating system includes a communication interface.
- the communication interface is a program for exchanging data with other external devices connected via the communication control unit 112. Examples of the external device include other information processing devices and external storage devices.
- the input unit 108 includes a keyboard, a pointing device, a wireless remote controller, a touch panel, and the like.
- the input unit 108 may include a video / image input device such as a camera, and an audio input device such as a microphone.
- the output unit 110 includes a display device such as a CRT (Cathode Ray Tube) display, an LCD (Liquid Crystal Display), a PDP (Plasma Display Panel), and an EL (Electroluminescence) panel, and an output device such as a printer.
- the output unit 110 may include an audio output device such as a speaker.
- the input unit 108 and the output unit 110 may be an input device and an output device, which are peripheral devices independent of the information processing apparatus 100, respectively. At this time, the input device and the output device are connected to the information processing apparatus 100 via the communication control unit 112 of the information processing apparatus 100.
- the communication control unit 112 is connected to another device and controls communication between the information processing device 100 and the other device.
- the communication control unit 112 is, for example, a USB (Universal Serial Bus) interface board, a video output circuit, a LAN (Local Area Network) interface board, a wireless communication circuit for wireless communication, or a communication circuit for telephone communication.
- the LAN interface board and the wireless communication circuit are connected to a network such as the Internet.
- a communication circuit for telephone communication is connected to a telephone communication network.
- the information processing apparatus 100 is connected to the inspection apparatus 20 via the communication control unit 112.
- the information processing apparatus that implements the determination result sheet creation apparatus 10 includes a control unit 11, an input unit 12, and a determination unit that the processor 102 loads and executes a program stored in the secondary storage device to the main storage device. 13, functions as the display unit 14 and the communication unit 16 are realized.
- the storage unit 15 is provided in a storage area of the main storage device or the secondary storage device.
- Each unit of the determination result sheet creation apparatus 10 can be realized as a hardware component, a software component, or a combination thereof.
- the hardware component is a hardware circuit, such as an FPGA (Field Programmable Gate Array), an application specific integrated circuit (ASIC), a gate array, a combination of logic gates, and an analog circuit.
- FPGA Field Programmable Gate Array
- ASIC application specific integrated circuit
- Software components are parts that realize predetermined processing as software.
- the components of software are not a concept that limits the language, development environment, etc. for realizing software.
- the step of describing the program includes processing executed in parallel or individually even if processing is not necessarily performed in time series, as well as processing performed in time series in the described order. Some of the steps describing the program may be omitted.
- step S ⁇ b> 1 the control unit 11 of the determination result sheet creation apparatus 10 displays a patient information input screen for inputting subject information on the display unit 14.
- the control unit 11 waits for the user to input subject information.
- the subject information include, but are not limited to, patient name, date of birth, sex, medical chart number, and the like.
- the medical record table is a table for storing information on the subject.
- One chart table is created for one subject, and each chart table is identified by a chart number.
- the medical record table of each subject may include past examination results (measurement values, determination results, comments, etc.) in addition to the subject information.
- the control unit 11 acquires a medical record table corresponding to the input medical record number from the data storage unit 152, and from the medical record table, the name of the subject, the year of birth The date, sex, etc. are extracted and set as the subject information items displayed on the display unit 14.
- the user inputs subject information such as the subject's name, date of birth, and sex.
- the input unit 12 receives the subject information, and the control unit newly creates a chart table, registers the input subject information in the chart table, and stores it in the storage data storage unit 152.
- step S ⁇ b> 2 the control unit 11 of the determination result sheet creation apparatus 10 displays an examination procedure ad on the display unit 14, and in the test sample obtained from the subject's oral cavity on the measurement unit 20 via the communication unit 16. , Occult blood volume, white blood cell count, total protein concentration, and ammonia concentration.
- the determination result sheet creation apparatus 10 displays the inspection procedure on the display unit 14.
- the user transmits a signal indicating the start of measurement from the measurement unit 20 to the determination sheet creating apparatus 10 after collecting the test sample from the oral cavity of the subject based on the examination procedure displayed on the display unit 14.
- the determination result sheet creation apparatus 10 displays the measurement procedure and the like on the display unit 14.
- the user Based on the measurement procedure displayed on the display unit 14, the user sets the test sample on the measurement unit 20 in an appropriate manner, for example, a test paper spotted with the test sample. Further, the determination result sheet creation apparatus 10 causes the measurement unit 20 to measure the occult blood amount, the white blood cell count, the total protein concentration, and the ammonia concentration for the set test sample. The measurement is performed, for example, by the measurement method described in Patent Document 1, and the measurement result is acquired as reflectance data correlated with the progress of the color reaction, for example. When the measurement ends, a signal indicating the end of the measurement is transmitted from the measurement unit 20 to the determination result sheet creating apparatus 10.
- step S ⁇ b> 3 when the control unit 11 of the determination result sheet creation apparatus 10 receives a signal indicating the end of measurement from the measurement unit 20 via the communication unit 16, the control unit 11 transmits the inspection date and measurement result to the measurement unit 20. Instruct to do.
- the measurement unit 20 transmits the inspection date and measurement result to the determination result sheet creation apparatus 10.
- the measurement unit 20 may transmit the inspection date and measurement result and the measurement result to the determination result sheet creation apparatus 10 together with a signal indicating the end of measurement.
- the determination result sheet creation apparatus 10 receives the examination date and measurement results acquired from the measurement unit 20 at the input unit and stores them in the patient's chart table stored in the data storage unit 152.
- step S4 the control unit 11 of the determination result sheet creation apparatus 10 causes the determination unit 13 to determine the periodontal disease stage based on the measurement result according to the determination method of the present invention.
- the determination result is stored in the chart of the subject stored in the data storage unit 152.
- step S ⁇ b> 5 the control unit 11 of the determination result sheet creation apparatus 10 selects and calls a comment corresponding to the determination result from the data storage unit 152, and the subject stored in the data storage unit 152 as the current result is displayed.
- the comment corresponding to the determination result is prepared in advance for each determined periodontal disease stage, one for each item such as explanation of the determined periodontal disease stage, instruction of care method, or suggestion of care product It is. For example, if the periodontal disease stage judgment result is “mild periodontitis”, the description of the periodontal disease stage such as “It is the initial stage of periodontal disease.
- step S6 the control unit 11 of the determination result sheet creation apparatus 10 displays on the display unit 14 the measurement result of the current examination performed in step S2, the determination result of the periodontal disease stage determined in step S4, and the step The comment displayed in S5 is displayed on the screen.
- the display at this time may be only numbers and letters, or may be a graphic (such as a radar chart).
- step S7 the control unit 11 of the determination result sheet creating apparatus 10 calls the test result of this time from the patient's chart table stored in the data storage unit 152, and includes the subject information and the step S2.
- a determination result sheet including the measurement result of the current examination performed, the determination result of the periodontal disease stage determined in step S4, and the comment called in step S5 is created, and printed on paper on the output device 40 Let The printed inspection result sheet is provided to the subject. The subject receives an explanation about the test result and future care from the user. Further, the output of step S7 may not be performed, and the user may explain to the subject while viewing the determination result displayed on the display unit 14 in step S6.
- Periodontal disease stage based on the oral examination by the dentist was determined by the following procedure. That is, 231 probing subjects who cooperated in the test were subjected to a probing inspection by a dentist, and probing pocket depth (PD) and bleeding during probing (BOP) were evaluated. For both PD and BOP, 6 points were measured per tooth, and the maximum PD of all teeth was calculated. In addition, BOP (+) was used when there was bleeding even at one location, and BOP (-) was used when there was no bleeding in all teeth. Using these two clinical parameters, the periodontal disease stage was determined according to Table 2.
- ⁇ 2> Measurement and type classification by saliva test system Each test item was measured by the saliva test system according to the following procedure for 231 subjects who were the same as the above-mentioned subjects. That is, a test sample was prepared by a test subject containing 3 mL of distilled water in his mouth and then gently rinsing for 10 seconds before discharging (a mouth rinse discharge liquid). In accordance with the method described in Patent Document 1, 10 ⁇ L of the test sample is spotted on each absorbent carrier provided in the test piece, and using a pocket chem UA PU-4010 (manufactured by ARKRAY, Inc.), saliva components Was measured. The measurement was performed under the conditions shown in Table 3 at room temperature. The color change after 5 minutes from the spotting of the test sample was measured for the reflectance (%) at a predetermined wavelength, and used as a measurement value for each inspection item.
- the type classification When the occult blood volume is positive, the type is classified as positive or negative of the total protein concentration, when the occult blood volume is negative, the type is classified as positive or negative of the white blood cell count (Table 6), or when the total protein concentration is positive If the total protein concentration is negative, type classification with white blood cell count positive or negative (Table 8), or type classification with white blood cell count positive or negative, In the case of another type of positive or negative type classification (Tables 9 and 10), the type classification consistent with the periodontal disease stage was insufficient. In the type classification in three stages of the four inspection items including the ammonia concentration, the eight type classifications were matched to the more detailed stages including the healthy and improvement stages (Tables 11 and 12). From these results, it can be seen that the determination method of the present invention can provide a highly reliable determination result.
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Abstract
Description
また、歯科医師等は、口腔内を診察してプローブを歯周ポケットに差し込むプロービング検査において歯周ポケットの深さ及びプロービング時の出血を観察して、歯周病の進行度を判定する材料としている。
また他に、唾液中の潜血を検出することで歯周病への罹患の有無を判定できるシステムも実用化されている。このシステムによれば5分という短時間での検査が可能であるが、潜血以外の項目を検査することはできず、歯周病の進行度についても評価されない。
しかしながら、より手軽に、短時間で、個人の歯周病の罹患しやすさや進行度を把握したいという需要は高い。そのため、歯科医師等を介さずとも、客観的に、簡便に、かつ信頼性高く、歯周病の罹患しやすさや進行度を判定できる方法が求められている。
本発明の第一の態様は、以下の歯周病ステージを判定する方法である(以降、「本発明の判定方法」ともいう)。
[1]口腔から得られる被検試料における、潜血量、白血球数及び総タンパク質濃度から選択される少なくとも2つ指標として歯周病ステージを判定する方法であって、
潜血量又は総タンパク質量濃度の陽性又は陰性を決定する工程と、
潜血量又は総タンパク質濃度が陽性の場合は、白血球数の陽性又は陰性を決定する工程、
潜血量が陰性の場合は、総タンパク質濃度の陽性又は陰性を決定する工程、又は
総タンパク質濃度が陰性の場合は、潜血量の陽性又は陰性を決定する工程とを含む、方法。
[2]潜血量の陽性又は陰性を決定する工程と、
潜血量が陽性の場合は、白血球数の陽性又は陰性を決定する工程、又は
潜血量が陰性の場合は、総タンパク質濃度の陽性又は陰性を決定する工程とを含む、[1]に記載の方法。
[3]潜血量が陽性、かつ白血球数が陽性の場合は、重度歯周炎と、
潜血量が陽性、かつ白血球数が陰性の場合は、中度歯周炎と、
潜血量が陰性、かつ総タンパク質濃度が陽性の場合は、軽度歯周炎と、
潜血量が陰性、かつ総タンパク質濃度が陰性の場合は、歯肉炎と判定される、[2]に記載の方法。
[4]さらに、アンモニア濃度を指標とし、アンモニア濃度の陽性又は陰性を決定する工程を含む、[1]又は[2]に記載の方法。
[5]潜血量が陽性、かつ白血球数が陽性、かつアンモニア濃度が陽性の場合は、重度歯周炎と、
潜血量が陽性、かつ白血球数が陽性、かつアンモニア濃度が陰性の場合は、歯周病改善期と、
潜血量が陽性、かつ白血球数が陰性、かつアンモニア濃度が陽性の場合は、中度歯周炎と、
潜血量が陽性、かつ白血球数が陰性、かつアンモニア濃度が陰性の場合は、歯周病改善期と、
潜血量が陰性、かつ総タンパク質濃度が陽性、かつアンモニア濃度が陽性の場合は、軽度歯周炎と、
潜血量が陰性、かつ総タンパク質濃度が陽性、かつアンモニア濃度が陰性の場合は、歯周病改善期と、
潜血量が陰性、かつ総タンパク質濃度が陰性、かつアンモニア濃度が陽性の場合は、歯肉炎と、
潜血量が陰性、かつ総タンパク質濃度が陰性、かつアンモニア濃度が陰性の場合は、健全と判定される、[4]に記載の方法。
[6]口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度の測定値を受け付ける入力部と、
[1]~[5]の何れかに記載の方法により歯周病ステージを判定する判定部と、
判定部で判定された判定結果と、前記判定結果に対応するコメントとを表示する表示部と、
前記測定値と前記判定結果と前記コメントとを記憶する記憶部と、
前記測定値と前記判定結果と前記コメントとを含む判定結果シートを作成する制御部とを備える、判定結果シート作成装置。
[7]さらに、作成された判定結果シートを外部装置に出力する通信部を含む、[6]に記載の判定結果シート作成装置。
[8][6]又は[7]に記載の判定結果シート作成装置と、
口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度を測定する測定部とを備える、検査装置。
[9]コンピュータが、
口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度の測定値を受け付ける工程、
[1]~[5]の何れかに記載の方法により歯周病ステージを判定する工程、
判定された判定結果に対応するコメントを選択する工程、
前記測定値と、前記判定結果と、選択されたコメントとを含む判定結果シートを作成する工程を実行する、判定結果シート作成方法。
[10]前記コンピュータが、
さらに、作成された判定結果シートを外部装置に出力する工程を実行する、[9]に記載の判定結果シート作成方法。
[11]コンピュータに、
口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度の測定値を受け付ける工程、
[1]~[5]の何れかに記載の方法により歯周病ステージを判定する工程、
判定された判定結果に対応するコメントを選択する工程、
前記測定値と、前記判定結果と、選択されたコメントとを含む判定結果シートを作成する工程を実行させる、判定結果シート作成プログラム。
[12]前記コンピュータに、
さらに、作成された判定結果シートを外部装置に出力する工程を実行させる、[11]に記載の判定結果シート作成プログラム。
本発明において、歯周病ステージとは、歯周病の進行度を複数の段階で表したものをいう。通常は進行時期に応じた重症の程度を段階的に表し、例えば、歯肉炎又は歯周炎の別で表され、より詳細には、歯肉炎、軽度歯周炎、中度歯周炎、及び重度歯周炎の4ステージで表すことが好ましい。また、さらに詳細に、健全、歯肉炎、軽度歯周炎、中度歯周炎、重度歯周炎、及び改善期の6ステージで表すこともより好ましい。一般的な口腔疾患の進行度の判定においては、検査時の独立した状態(例えば、健全~重度歯周炎)のみが判定されるが、本発明の好ましい一態様では、検査時以前の状態からの変化(改善期)をも判定することができる点で、画期的である。改善期は、歯周病ステージとしては、一般には健全な状態とみなすこともできる。
「健全」とは、歯周病菌がおらず、歯肉からの出血もなく、歯と歯茎の境目の隙間(歯周ポケット)の深さは1~2mm程度である、健康な状態を表す。
「歯肉炎」とは、歯周病菌が存在し、歯茎に炎症が起き始めるが、歯肉からの出血はなく、歯周ポケットが2~3mmに深くなった状態を表す。
「軽度歯周炎」とは、歯周病菌により歯茎の炎症が悪化して、歯槽骨や歯根膜が破壊され始めた状態を表す。歯肉から出血する、又は歯周ポケットが4~6mmに深くなる軽度の症状がみられる。
「中度歯周炎」とは、歯周病菌により歯茎の炎症がさらに悪化して、歯槽骨が半分近くまで破壊が進み、歯がぐらつき始めた状態を表す。歯肉から出血し、歯周ポケットが4~6mmに深くなった中度の症状がみられる。
「重度歯周炎」とは、歯周病菌により歯槽骨が半分以上破壊され、歯がぐらぐらになった状態を表す。歯肉から出血し、歯周ポケットが6mm以上に深くなった重度の症状がみられる。
「改善期」とは、歯周病菌が口内からいなくなり、歯周病が改善方向へ好転した状態を表す。歯周ポケットは4mm以上とやや深いものの歯肉からの出血はない、又は歯肉からの出血があっても歯周ポケットが4mm未満に浅い、という症状が快方へ向かうのが認められる。
「潜血量」は、口腔から得られる被検試料中の血液量をいう。歯周病に伴って歯茎の組織が破壊されると唾液中に潜血が検出されることが知られており、潜血量は歯周組織の破壊度を反映する項目である。潜血量が多いほど、歯周組織の破壊度が高く、歯周病ステージが重い傾向にある。
潜血量の測定は、特に制限されず公知の方法で行うことができる。例えば、ヘモグロビン接触活性法により行うのが好ましい。ヘモグロビン接触活性法とは、血液成分であるヘモグロビン、ミオグロビン、又はそれらの分解産物が、過酸化物(ペルオキシド)等の酸素供与体から、酸素受容体に酸素の移動を触媒する能力(ペルオキシダーゼ様活性)を有することを利用するものである。酸素受容体として、酸化により色調の変化する指示薬を用いることで、その呈色反応を測定することによりヘモグロビン等の濃度の測定を介して潜血量が測定される。
白血球数の測定は、特に制限されず公知の方法で行うことができる。例えば、白血球エステラーゼ法により行うのが好ましい。白血球エステラーゼ法とは、組織が炎症を起こした際には、白血球が増加するが、それに伴い白血球によるエステラーゼ産生もまた増大することを利用するものである。エステル化合物を基質として用い、これが白血球により産生されたエステラ-ゼ(白血球エステラーゼ)により加水分解されることで生じたアルコ-ル(フェノ-ル)成分を直接呈色させる、あるいは、前記アルコール(フェノール)をジアゾニウム塩とカップリングして呈色させることにより、エステラーゼ活性を測定する手法である。エステラーゼ活性の測定値に基づいて白血球数を算出できる。
総タンパク質濃度の測定は、特に制限されず公知の方法で行うことができる。例えば、タンパク誤差法により行うのが好ましい。タンパク誤差法とは、pH指示薬が、タンパク質の濃度に比例して、溶液の真のpHよりも高いpHを示すことを利用する方法であり、指示薬の呈色から、総タンパク質濃度を定量することができる。
一般に、アンモニア濃度は、口腔状態の診断において歯周病リスクの判定よりは、口腔清潔度の判定の指標として用いられるが、本発明の判定方法の好ましい態様では、アンモニア濃度を歯周病リスクの判定における指標に用いることで、健全状態及び改善期も含む、より詳細かつ信頼性の高いステージ判定を行うことができる。
アンモニア濃度の測定は、特に制限されず公知の方法で行うことができる。例えば、微量拡散法(コンウェイ法)により行うのが好ましい。微量拡散法とは、アンモニア態窒素の定量に用いられる手法であり、アルカリ緩衝剤によりアルカリ性にした試料から揮発するアンモニアガスを吸収用溶液等にトラップし、それにより指示薬が呈色するのを比色等の手法により定量する手法である。
各検査項目の陽性又は陰性を決定する際の閾値(カットオフ値)の一例を表1に示す。
反射率データは、例えば、被検試料を各パラメータの測定用試薬と接触させてから一定時間経過後の、特定の波長における反射率の値とすることができる。反射率の値は、具体的には、特定の波長の光を呈色部位、例えば被検試料を点着した吸収性担体部分に照射し、その反射光を測定することにより取得できる。また、反射率データは、例えば、上記のようにして得られる反射率の値を100%から除算した値であってもよい。なお、特定の波長における吸光度が高いほど当該特定の波長における反射率の値は低く、特定の波長における吸光度が低いほど当該特定の波長における反射率の値は高いといえる。一定時間とは、例えば、上述したような各パラメータ測定法における反応時間であってよく、測定するパラメータの種類や測定方法に応じて適宜設定すればよい。
好ましくは、「潜血量が陽性、かつ白血球数が陽性の場合」は重度歯周炎と、「潜血量が陽性、かつ白血球数が陰性の場合」は中度歯周炎と、「潜血量が陰性、かつ総タンパク質濃度が陽性の場合」は軽度歯周炎と、及び「潜血量が陰性、かつ総タンパク質濃度が陰性の場合」は歯肉炎と、それぞれ判定される。
好ましくは、「総タンパク質濃度が陽性、かつ白血球数が陽性の場合」は重度歯周炎と、「総タンパク質濃度が陽性、かつ白血球数が陰性の場合」は軽度又は中度歯周炎と、「総タンパク質濃度が陰性、かつ潜血量が陽性の場合」は軽度歯周炎と、及び「総タンパク質濃度が陰性、かつ潜血量が陰性の場合」は歯肉炎と判定される。
後述の実施例で示されるように、潜血量のみを指標とする場合は、歯周病ステージの判定としては不十分(表4)である。それに対して、潜血量が陽性の場合に白血球数の陽性又は陰性を決定し、潜血量が陰性の場合に総タンパク質濃度の陽性又は陰性を決定した本発明の判定方法を行う場合は、潜血量、白血球数、及び総タンパク質濃度の3項目すべてについてその陽性又は陰性を決定しなくても、歯肉炎、軽度歯周炎、中度歯周炎、及び重度歯周炎を有意に判定できる(表5)。また、総タンパク質濃度が陽性の場合に白血球数の陽性又は陰性を決定し、総タンパク質濃度が陰性の場合に潜血量の陽性又は陰性を決定した本発明の判定方法を行う場合は、潜血量、白血球数、及び総タンパク質濃度の3項目すべてについてその陽性又は陰性を決定しなくても、歯肉炎と歯周炎の区別を有意に判定でき、さらには歯肉炎、軽度又は中度歯周炎、中度歯周炎、及び重度歯周炎を判定できる(表7)。
一般に、判定に際してパラメータの個数を増やせば判定結果の信頼性が向上すると考えられるが、本発明によれば判定に用いるパラメータである検査項目(指標)を適切に選択して組み合わせた2つとすることで、2つのパラメータに基づく判定であっても信頼性の確保を達成している。また、2工程で判定を行えることは、迅速化・簡素化に寄与する。
なお、同じく2工程であっても、潜血量が陽性の場合に総タンパク質濃度の陽性又は陰性を決定し、潜血量が陰性の場合に白血球数の陽性又は陰性を決定した場合(表6)や、総タンパク質濃度が陽性の場合に潜血量の陽性又は陰性を決定し、総タンパク質濃度が陰性の場合に白血球数の陽性又は陰性を決定した場合(表8)、初めに白血球数の陽性又は陰性を決定する工程を行い、その後にもう1項目の陽性又は陰性を決定した場合(表9、10)では、歯周病ステージを正しく判定することができない。
好ましくは、「潜血量が陽性、かつ白血球数が陽性、かつアンモニア濃度が陽性の場合」は重度歯周炎と、「潜血量が陽性、かつ白血球数が陽性、かつアンモニア濃度が陰性の場合」は歯周病改善期と、「潜血量が陽性、かつ白血球数が陰性、かつアンモニア濃度が陽性の場合」は中度歯周炎と、「潜血量が陽性、かつ白血球数が陰性、かつアンモニア濃度が陰性の場合」は歯周病改善期と、「潜血量が陰性、かつ総タンパク質濃度が陽性、かつアンモニア濃度が陽性の場合」は軽度歯周炎と、「潜血量が陰性、かつ総タンパク質濃度が陽性、かつアンモニア濃度が陰性の場合」は歯周病改善期と、「潜血量が陰性、かつ総タンパク質濃度が陰性、かつアンモニア濃度が陽性の場合」は歯肉炎と、「潜血量が陰性、かつ総タンパク質濃度が陰性、かつアンモニア濃度が陰性の場合」は健全と、それぞれ判定される。
アンモニア濃度も指標に加えることにより、「健全」及び「改善期」のステージをも判定することができ、歯科医師等を介さずとも、客観的でより詳細なかつ信頼性の高い判定が行える(後述の実施例を参照)。特に、従来の一般的な判定方法では考慮されなかった検査時以前の状態からの変化である「改善期」をも判定することができる点は、画期的である。
本発明の歯周病ステージの判定結果シート作成装置は、口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度の測定値を受け付ける入力部と、本発明の方法により歯周病ステージを判定する判定部と、判定部で判定された判定結果と、前記判定結果に対応するコメントとを表示する表示部と、前記測定値と前記判定結果と前記コメントとを記憶する記憶部と、前記測定値と前記判定結果と前記コメントとを含む判定結果シートを作成する制御部とを備える。好ましくは、さらに、作成された判定結果シートを外部装置に出力する通信部を備える。
本発明の判定結果シート作成装置は、口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度を測定する測定部と組み合わせて、検査装置の態様とすることもできる。
測定部としては、特に制限されず公知の方法で行うことができ、例えば特許文献1に記載の測定手段を有するものを適用できる。
図4は、本発明の判定結果シート作成装置10及び検査装置30の構成例を示す。判定結果シート作成装置10は、制御部11、入力部12、判定部13、表示部14、記憶部15、及び通信部16を備える。検査装置30は、判定結果シート作成装置10と測定部20とを備える。
測定部20は、被検者の口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度を測定する。判定結果シート作成装置10は、測定部20から測定結果を取得し、これに基づいて歯周病ステージを判定し、判定結果シートを作成する。
入力部12は、測定部20から、口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度の測定値を受け付ける。入力部12は、ネットワークなどを経由して、被検者の前記測定値を受け付けてもよい。また、入力部12は、利用者(歯科医師、歯科衛生士、健診担当者、ドラッグストア店員、被検者自身等)による文字等の入力、ボタン等の選択、操作などを受け付ける。入力部12は、キーボード、ポインティングデバイスなどによって実現されうる。
判定部13は、前記測定値に基づいて、本発明の判定方法のフローに従って、歯周病ステージを判定する。
記憶部15は、プログラム記憶部151とデータ記憶部152とを備える。プログラム記憶部は、本発明の判定結果シート作成プログラムを格納する。データ記憶部152は、判定部13で使用される測定値、判定結果、後述するコメント、被検者情報等のデータを格納する。
判定結果に対応するコメントは、判定された歯周病ステージの説明、ケア方法の指導、又はケア製品の提案等の、被検者に提供されるメッセージである。判定された歯周病ステージ毎に、各項目(歯周病ステージの説明、ケア方法の指導、又はケア製品の提案等)について対応するコメントが1つずつ予め用意されており、判定結果に基づいて対応するコメントが呼び出されて表示される。
出力装置40は、制御部11からの指示に基づいて、通信部16を経由して、被検者情報、測定値、判定結果、判定結果に対応するコメント等を含む判定結果シートを用紙等に印刷する。出力装置40は、プリンタなどの印刷装置によって実現されうる。
プロセッサ102は、例えば、CPU(Central Processing Unit)やDSP(Digital Signal Processor)である。
メモリ104は、例えば、RAM(Random Access Memory)やROM(Read Only Memory)を含む。メモリ104は、主記憶装置とも呼ばれる。
記憶部106は、各種のプログラム、各種のデータ及び各種のテーブルを読み書き自在に記録媒体に格納する。記憶部106には、オペレーティングシステム(Operating System :OS)、各種プログラム、各種テーブル等が格納される。記憶部106に格納される情報は、メモリ104に格納されてもよい。また、メモリ104に格納される情報は、記憶部106に格納されてもよい。
出力部110は、CRT(Cathode Ray Tube)ディスプレイ、LCD(Liquid Crystal Display)、PDP(Plasma Display Panel)、EL(Electroluminescence)パネル等の表示装置、プリンタ等の出力装置を含む。また、出力部110は、スピーカのような音声の出力装置を含むことができる。
入力部108及び出力部110は、それぞれ、情報処理装置100と独立した周辺装置である、入力装置及び出力装置であってもよい。このとき、入力装置及び出力装置は、情報処理装置100と、情報処理装置100の通信制御部112を介して接続される。
判定結果シート作成装置10の各ユニットは、ハードウェアの構成要素、ソフトウェアの構成要素、又は、これらの組み合わせとして、それぞれ実現されうる。
被検者情報としては、例えば、患者氏名、生年月日、性別、カルテ番号等が挙げられるが、これらに限定されない。
利用者により当該被検者のカルテ番号が入力されると、制御部11は、入力されたカルテ番号に対応するカルテテーブルをデータ記憶部152から取得し、当該カルテテーブルから被検者氏名、生年月日、性別等を抽出し、表示部14に表示する被検者情報項目とする。
判定結果シート作成装置10は、表示部14に検査手順を表示する。利用者は、表示部14に表示される検査手順等に基づいて、被検者の口腔から被検試料採取後、測定部20から判定シート作成装置10に測定開始を示す信号を送信する。さらに、判定結果シート作成装置10は、表示部14に、測定手順等を表示する。利用者は、表示部14に表示される測定手順等に基づいて、測定部20に被検試料を適当な態様で、例えば被検試料を点着した試験紙をセットする。また、判定結果シート作成装置10は、セットされた被検試料について、測定部20に潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度の測定をさせる。測定は、例えば特許文献1に記載の測定方法で行われ、測定結果は例えば呈色反応の進行と相関する反射率データとして取得される。に測定が終了すると、測定部20から判定結果シート作成装置10に測定終了を示す信号が送信される。
判定結果シート作成装置10は、測定部20から取得した検査日時及び測定結果を、入力部で受け付け、データ記憶部152に格納されている被検者のカルテテーブルに記憶する。
判定結果に対応するコメントは、判定された歯周病ステージ毎に、判定された歯周病ステージの説明、ケア方法の指導、又はケア製品の提案等の項目について1つずつ予め用意されたものである。例えば、歯周病ステージの判定結果が「軽度歯周炎」の場合は、「歯周病の初期段階です。歯茎に炎症があり、出血があります。」といった歯周病ステージの説明、「歯ブラシの毛先を歯と歯肉の境目に45度の角度に当てて磨きましょう。」といったケア方法の指導、「殺菌成分が配合された歯磨剤を使いましょう。」といったケア製品の提案等のコメントが用意されており、ステップS5で呼び出される。これらのコメントは、歯科医師等を介さずとも、歯周病ステージの判定結果に対応する適切な説明や指導等を客観的かつ自動で提供することを実現するものであり、被検者のセルフメディケーションの手助けとなり得る。
この際の表示は、数字と文字のみでもよいし、図形(レーダーチャート等)を用いたものであってもよい。
また、ステップS7の出力は行われなくてもよく、ステップS6で表示部14に表示された判定結果等を見ながら、利用者から被検者への説明がなされてもよい。
以下の手順で、歯科医師による口腔内検査に基づく歯周病ステージの判定を行った。すなわち、試験に協力いただいた被検者231名に対して歯科医師によるプロービング検査を行い、プロービングポケット深さ(PD)及びプロービング時の出血(BOP)を評価した。PD及びBOPともに1歯につき6点を測定し、全歯の最大PDを算出した。また、1箇所でも出血があった場合にBOP(+)とし、全歯で出血がなかった場合にBOP(-)とした。これら2つの臨床パラメータを用いて、表2に従って歯周病ステージを判定した。
前述の被検者と同一の被検者231名に対して、以下の手順で唾液検査システムによる各検査項目の測定を行った。すなわち、被検者が蒸留水3mLを口に含み、10秒間軽く洗口した後に吐出したもの(洗口吐出液)を被検試料とした。特許文献1に記載の方法に準じて、試験片に備えられた各吸収性担体に被検試料を10μLずつ点着し、ポケットケムUA PU-4010(アークレイ株式会社製)を用いて、唾液成分を測定した。測定は、室温下、表3の条件で行った。被検試料を点着してから5分間経過後の呈色変化を、所定の波長における反射率(%)を測定して、各検査項目の測定値とした。
各検査項目の陽性又は陰性に基づいて、各被検者を表4に示す2つのタイプ、表5~10にそれぞれ示す4つのタイプ又は表11に示す8つのタイプに分類した。各タイプと歯周病ステージとの判定一致率をそれぞれの表に示す。
3つの検査項目の2段階でのタイプ分類では、潜血量が陽性の場合に白血球数の陽性又は陰性でタイプ分類し、潜血量が陰性の場合に総タンパク質濃度の陽性又は陰性でタイプ分類した場合は、歯肉炎、軽度歯周炎、中度歯周炎、及び重度歯周炎のステージに1つずつのタイプ分類が一致した(表5)。総タンパク質濃度が陽性の場合に白血球数の陽性又は陰性でタイプ分類し、総タンパク質濃度が陰性の場合に潜血量の陽性又は陰性でタイプ分類した場合は、歯肉炎と歯周炎とで歯科医による判定が一致したことから両者は明確に区別ができ、さらに、総タンパク質濃度が陽性かつ白血球数が陰性の場合は軽度又は中度歯周炎に一致してその判別は決定的ではないものの、他の場合は歯肉炎、中度歯周炎、及び重度歯周炎のステージにタイプ分類が一致した(表7)。潜血量が陽性の場合に総タンパク質濃度の陽性又は陰性でタイプ分類し、潜血量が陰性の場合に白血球数の陽性又は陰性でタイプ分類した場合(表6)や、総タンパク質濃度が陽性の場合に潜血量の陽性又は陰性でタイプ分類し、総タンパク質濃度が陰性の場合に白血球数の陽性又は陰性でタイプ分類した場合(表8)や、白血球数の陽性又は陰性でタイプ分類してから、もう1項目の陽性又は陰性でタイプ分類した場合(表9、10)では、歯周病ステージに一致するタイプ分類が不十分だった。
アンモニア濃度も加えた4つの検査項目の3段階でのタイプ分類では、健全及び改善期のステージも加えたより詳細なステージに8つのタイプ分類が重複も含めて一致した(表11、12)。
これらの結果から、本発明の判定方法が、信頼性の高い判定結果を提供できることが分かる。
11 制御部
12 入力部
14 表示部
15 記憶部
151 プログラム記憶部
152 データ記憶部
16 通信部
20 測定部
30 検査装置
100 情報処理装置
102 プロセッサ
104 メモリ
106 記憶部
108 入力部
110 出力部
112 通信制御部
Claims (12)
- 口腔から得られる被検試料における、潜血量、白血球数及び総タンパク質濃度から選択される少なくとも2つを指標として歯周病ステージを判定する方法であって、
潜血量又は総タンパク質量濃度の陽性又は陰性を決定する工程と、
潜血量又は総タンパク質濃度が陽性の場合は、白血球数の陽性又は陰性を決定する工程、
潜血量が陰性の場合は、総タンパク質濃度の陽性又は陰性を決定する工程、又は
総タンパク質濃度が陰性の場合は、潜血量の陽性又は陰性を決定する工程とを含む、方法。 - 潜血量の陽性又は陰性を決定する工程と、
潜血量が陽性の場合は、白血球数の陽性又は陰性を決定する工程、又は
潜血量が陰性の場合は、総タンパク質濃度の陽性又は陰性を決定する工程とを含む、請求項1に記載の方法。 - 潜血量が陽性、かつ白血球数が陽性の場合は、重度歯周炎と、
潜血量が陽性、かつ白血球数が陰性の場合は、中度歯周炎と、
潜血量が陰性、かつ総タンパク質濃度が陽性の場合は、軽度歯周炎と、
潜血量が陰性、かつ総タンパク質濃度が陰性の場合は、歯肉炎と判定される、請求項2に記載の方法。 - さらに、アンモニア濃度を指標とし、アンモニア濃度の陽性又は陰性を決定する工程を含む、請求項1又は2に記載の方法。
- 潜血量が陽性、かつ白血球数が陽性、かつアンモニア濃度が陽性の場合は、重度歯周炎と、
潜血量が陽性、かつ白血球数が陽性、かつアンモニア濃度が陰性の場合は、歯周病改善期と、
潜血量が陽性、かつ白血球数が陰性、かつアンモニア濃度が陽性の場合は、中度歯周炎と、
潜血量が陽性、かつ白血球数が陰性、かつアンモニア濃度が陰性の場合は、歯周病改善期と、
潜血量が陰性、かつ総タンパク質濃度が陽性、かつアンモニア濃度が陽性の場合は、軽度歯周炎と、
潜血量が陰性、かつ総タンパク質濃度が陽性、かつアンモニア濃度が陰性の場合は、歯周病改善期と、
潜血量が陰性、かつ総タンパク質濃度が陰性、かつアンモニア濃度が陽性の場合は、歯肉炎と、
潜血量が陰性、かつ総タンパク質濃度が陰性、かつアンモニア濃度が陰性の場合は、健全と判定される、請求項4に記載の方法。 - 口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度の測定値を受け付ける入力部と、
請求項1~5の何れか一項に記載の方法により歯周病ステージを判定する判定部と、
判定部で判定された判定結果と、前記判定結果に対応するコメントとを表示する表示部と、
前記測定値と前記判定結果と前記コメントとを記憶する記憶部と、
前記測定値と前記判定結果と前記コメントとを含む判定結果シートを作成する制御部とを備える、判定結果シート作成装置。 - さらに、作成された判定結果シートを外部装置に出力する通信部を備える、請求項6に記載の判定結果シート作成装置。
- 請求項6又は7記載の判定結果シート作成装置と、
口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度を測定する測定部とを備える、検査装置。 - コンピュータが、
口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度の測定値を受け付ける工程、
請求項1~5何れか一項に記載の方法により歯周病ステージを判定する工程、
判定された判定結果に対応するコメントを選択する工程、
前記測定値と、前記判定結果と、選択されたコメントとを含む判定結果シートを作成する工程を実行する、判定結果シート作成方法。 - 前記コンピュータが、
さらに、作成された判定結果シートを外部装置に出力する工程を実行する、請求項9に記載の判定結果シート作成方法。 - コンピュータに、
口腔から得られる被検試料における、潜血量、白血球数、総タンパク質濃度、及びアンモニア濃度の測定値を受け付ける工程、
請求項1~5の何れか一項に記載の方法により歯周病ステージを判定する工程、
判定された判定結果に対応するコメントを選択する工程、
前記測定値と、前記判定結果と、選択されたコメントとを含む判定結果シートを作成する工程を実行させる、判定結果シート作成プログラム。 - 前記コンピュータに、
さらに、作成された判定結果シートを外部装置に出力する工程を実行させる、請求項11に記載の判定結果シート作成プログラム。
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JP7479447B2 (ja) | 2019-08-15 | 2024-05-08 | コーニンクレッカ フィリップス エヌ ヴェ | 人の歯茎の健康状態のインジケーションの提供 |
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