Medical information processing apparatus

Abstract

To provide a medical information processing apparatus that evaluates the tissue transferability of a drug.SOLUTION: A medical information processing apparatus comprises a first information acquisition unit, a second information acquisition unit, and an evaluation unit. The first information acquisition unit acquires first information related to the characteristics of an extracellular vesicle (EV) obtained from a subject administered with a drug, the characteristics having a correlation with a tissue derived from the EV. The second information acquisition unit acquires second information related to the presence or absence or the content of the drug included in the EV. The evaluation unit collates the first information and the second information with a database stored in advance in a storage unit to evaluate the tissue transferability of the drug.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] An embodiment of the present invention relates to a medical information processing apparatus. [Background technology]

[0002] In general, the dosage of a drug is determined based on the body weight and body surface area so that the drug concentration in the target tissue is within the expected range based on the pharmacokinetics of the drug. However, since pharmacokinetics varies due to various factors, even if the drug is taken at a prescribed dosage, the efficacy and duration of action vary from person to person. For example, it takes 2-4 weeks to confirm the efficacy of antidepressants, so if the first drug is not effective, it may be necessary to change to another drug and wait another 2-4 weeks. Alternatively, some drugs are administered as prodrugs and metabolized in the body to exert their efficacy, but if the metabolic efficiency is reduced due to a patient's decreased liver function, the effective component may be lower than expected. In the case of anticancer drugs, the amount of drug that reaches the cancer tissue is not constant depending on the characteristics of the cancer.

[0003] Currently, blood concentration of a drug is commonly used as an indicator of the pharmacokinetics of a drug. However, when the expected efficacy is not achieved, it is difficult to distinguish whether the drug is not sufficiently delivered to the target tissue or is less effective due to the patient's disease mechanism. Summary of the Invention [Problem to be solved by the invention]

[0004] An object of the present invention is to provide a medical information processing device for evaluating the tissue transferability of a drug. [Means for solving the problem]

[0005] A medical information processing device according to an embodiment includes a first information acquisition unit, a second information acquisition unit, and an evaluation unit. The first information acquisition unit acquires first information related to characteristics of extracellular bodies (EVs) obtained from a subject administered with a drug, the characteristics being correlated with the tissue of origin of the EVs. The second information acquisition unit acquires second information related to the presence or absence or content of the drug contained in the EVs. The evaluation unit evaluates the tissue migration of the drug by collating the first information and the second information with a database stored in advance. [Brief description of the drawings]

[0006] [Figure 1] FIG. 1 is a block diagram illustrating an example of a first embodiment. [Diagram 2] FIG. 11 is a block diagram illustrating an example of a second embodiment. [Diagram 3] FIG. 13 is a block diagram illustrating an example of a third embodiment. [Figure 4] FIG. 13 is a block diagram illustrating an example of a fourth embodiment. [Diagram 5] 13 is a workflow according to an example of the fifth embodiment. [Figure 6] 13A to 13C are schematic diagrams illustrating an example of a capture mechanism according to a fifth embodiment. [Figure 7] FIG. 1 is a block diagram showing an apparatus according to a first embodiment. [Figure 8] FIG. 11 is a block diagram showing an apparatus according to a second embodiment. [Figure 9] FIG. 11 is a block diagram showing an apparatus according to a third embodiment. [Figure 10] 1 shows a workflow for evaluating the tissue migration of a drug using the device of Example 4. [Figure 11] 13 shows a workflow for evaluating the tissue migration of a drug using the device of Example 5. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] (First embodiment) The medical information processing device of the first embodiment is a device for evaluating the tissue migration of a drug. An example of this medical processing device will be described with reference to Figs. 1(a) and (b). The medical information processing device 1 includes a first information acquisition unit 2, a second information acquisition unit 3, and an evaluation unit 4. The first information acquisition unit 2 acquires first information (S1). The first information is information related to characteristics of extracellular bodies (EVs) obtained from a subject administered with a drug, and is correlated with the tissue from which the EVs originate. The second information acquisition unit 3 acquires second information (S2). The second information is information related to the presence or absence or content of the drug contained in the EVs. The evaluation unit 4 evaluates the tissue migration of the drug by collating the first information and the second information with a database previously stored therein (S3).

[0008] The first information acquisition unit 2 may be configured to acquire characteristics correlated with the tissue of origin of EVs. For example, it may be configured to acquire characteristics from EVs collected in advance from a subject. For example, the first information acquisition unit 2 may include an EV identification unit. The EV identification unit may be configured to acquire information on characteristics such as the size of each EV, the amount of EVs in an input sample, the relative amount of EVs, and / or the tissue of origin from EVs collected in advance from a subject. In addition to the EV identification unit, the first information acquisition unit 2 may further include a configuration necessary for acquiring first information related to characteristics correlated with the tissue of origin of EVs or for assisting in acquiring such first information. Alternatively, the first information acquisition unit 2 may be configured to acquire the first information by electrically receiving information related to characteristics correlated with the tissue of origin of EVs, which is experimentally obtained in any external detection device.

[0009] The second information acquisition unit 3 is configured to acquire information on the presence or absence or amount of a drug contained in an EV. For example, the second information acquisition unit 3 may be configured to acquire information on a drug for the EV from which the first information was acquired. Alternatively, the second information acquisition unit 3 may acquire the second information by receiving information on the presence or absence or amount of a drug contained in an EV, which is acquired by any external detection device, as the second information.

[0010] The evaluation unit 4 is electrically connected to the first information acquisition unit 2 and the second information acquisition unit 3, and can be configured to receive information from the first information acquisition unit 2 and the second information acquisition unit 3, and evaluate the drug tissue migration based on the received information. In the example of FIG. 1(a), the first information acquisition unit 2 and the second information acquisition unit 3 are connected to the evaluation unit 4 in series in the order of the first information acquisition unit 2, the second information acquisition unit 3, and the evaluation unit 4. However, this is not limited to this, and the first information acquisition unit 2 and the second information acquisition unit 3 may be connected to the evaluation unit 4, respectively, that is, in parallel. The evaluation unit 4 may further include a display unit configured to output the evaluation result and any information.

[0011] Second embodiment A medical information processing device according to an embodiment includes an input unit that introduces extracellular vesicles (EVs) obtained from a subject to which a drug has been administered, an EV identification unit that determines the characteristics of the introduced EVs, a drug detection unit that measures the presence or content of the drug contained in the EVs, and an information processing unit that evaluates the tissue migration of the drug by comparing measurement information obtained in the EV identification unit and the drug detection unit with a pre-stored database. An example of a medical information processing device according to the second embodiment will be described with reference to Figures 2(a) and (b). The medical information processing device 10 includes an input unit 11, an optional pre-processing unit 12, an EV identification unit 13, a drug detection unit 14, an information processing unit 15, and an optional output unit 16 (Figure 2(a)).

[0012] The input unit 11 has an opening for physically inputting a sample obtained from a subject to which a drug has been administered. The sample input to the input unit 11 includes extracellular vesicles (EVs) derived from the subject. For example, such a sample may be blood, plasma, or serum, or an EV-containing liquid extracted by pretreatment. When it is necessary to pretreat blood, plasma, or serum, etc., to a state in which a signal related to EVs can be detected, a pretreatment unit 12 connected to the input unit 11 may be arranged. In this case, the pretreatment unit 12 is configured to perform processes such as isolation, extraction, and washing of EVs in a container. For example, the pretreatment unit 12 may include a liquid treatment unit and a liquid storage tank to which an extraction liquid, a washing liquid, and an EV maintenance liquid can be added and discharged. When the medical treatment device 10 does not include the pretreatment unit 12, the input unit 11 is connected to an EV identification unit. The pretreatment unit 12 receives the sample input from the input unit 11 (S11) and performs pretreatment, such as extraction, as desired (S12). The extracellular vesicles (EVs) obtained in S12 are sent to the EV identification unit 13. S13 identifies the EV sent from S12 as desired (S13).

[0013] Specifically, the EV identification unit 13 receives EVs input from the input unit 11 or EVs obtained in the pre-treatment unit 12 from the input unit 11 or the pre-treatment unit 12. The EV identification unit 13 then obtains information on characteristics such as the size of individual EVs, the amount of EVs in the input sample, the relative amount of EVs, and / or the tissue of origin from the received EVs (S13). Extracellular vesicles (EVs) include, for example, microvesicles and exosomes, which are extracellular vesicles derived from endosomes. They contain information from cell membranes and intracellular multivesicular bodies and are present in the blood of mammals including humans. EVs contain information about the organism they originate from, such as adhesion or signaling molecules such as integrins, CD9, CD63, and CD81, immune-related molecules such as MHCI and MHCII, nucleic acids such as miRNA, mRNA, and DNA, enzymes, cytoskeletal proteins such as actin, tubulin, and cofilin, MVB component molecules such as Alix, Tsg101, and clathrin, and chaperones such as HSP70, HSP90, and HSP50. By obtaining this information and signals such as optical and electrochemical information of EVs, it is possible to obtain information about the tissue or organ from which EVs originate.

[0014] For example, to estimate the tissue of origin using a surface antigen as a biomarker, for example, a corresponding antibody may be immobilized on a chip, and the antibody may be used to capture the tissue-specific antigen on the surface of the EV, and / or the biomarker on the surface of the EV may be antibody-labeled to detect the tissue of origin. Alternatively, mass spectrometry imaging may be used. That is, the EV identification unit 13 may include, for example, a detection unit based on an antigen-antibody reaction, or a mass spectrometry imaging unit.

[0015] It has also been reported that EVs are released from various tissues in the body and contain nucleic acids and proteins held by the tissue of origin, as well as substances that have been taken up. For example, it has been reported that EVs contain and release drugs taken up by cells. The drug detection unit 14 is an element that obtains information about drugs held by such EVs, i.e., information about drugs taken up by the tissue of origin of the EVs (S14). The drug detection unit 14 may be disposed in the medical information processing device 10 as the same component as the EV identification unit 13, or may be disposed in the medical information processing device 10 as a component different from the EV identification unit 13. Alternatively, the drug detection unit 14 and the EV identification unit 13 may be disposed in the medical information processing device 10 as a single component. Thus, the drug detection unit 14 may be connected to the EV identification unit 13, the pre-processing unit 12, and / or the input unit 11. The signal and / or information from the EV identification unit 13 and the signal and / or information from the drug detection unit 14 are sent to the information processing unit 15. The information processing unit 15 is electrically connected to the drug detection unit 14 and the EV identification unit 13. The information processing unit 15 may convert the signal and / or information obtained from the drug detection unit 14 and / or the EV identification unit 13 into information in a predetermined format. For example, the information processing unit 15 includes a calculation unit and a storage unit (not shown), and performs information processing such as calculation based on information such as a table, a calculation formula, and an association between a specific drug and an EV feature stored in advance in the storage unit, and further, as desired, according to a program stored in advance in the storage unit (S15). Incidentally, the above-mentioned storage unit is also called a database. For example, the database may store a group of information, a calculation formula, and a threshold value. The medical information processing device 10 may output the result formed in the information processing unit 15 from an arbitrary output unit 16. The output unit 16 may be a display unit, a sound generation unit, a recording unit, a storage unit, and / or a communication unit, and displays the information obtained in the information processing unit 15 and the raw data collected in the EV identification unit and / or the drug detection unit 14 to an operator or a preset target (S16). Examples of the output unit 16 may be a display, a speaker, a transmitter, a memory, and the like. For example, both the information processing unit 15 and the output unit 16 may be a CPU or a computer.

[0016] The medical information processing device 10 provides a medical information processing device for evaluating the tissue transferability of a minimally invasive drug.

[0017] (Third embodiment) A third embodiment will be described with reference to Fig. 3. A medical information processing device 20 shown in Fig. 3 has basically the same configuration as the medical information processing device 10. However, the medical information processing device 20 has a measurement unit 21 including an EV identification unit 13 and a drug detection unit 14, and a processing unit 22 including an information processing unit 15 and an output unit 16. Here, the medical information processing device 20 may have its operations controlled by a control unit (not shown) included in the processing unit 22 for each component and / or collectively.

[0018] Such a medical information processing device 20 provides a medical information processing device for evaluating the tissue transferability of a minimally invasive drug.

[0019] (Fourth embodiment) A fourth embodiment will be described with reference to FIG. 4. The medical information processing device 30 shown in FIG. 4 has basically the same configuration as the medical information processing devices 10 and 20. However, the components included therein are largely included in two units and provided in the medical information processing device 30. That is, the medical information processing device 30 includes a reaction unit 31 that performs a first procedure such as a material reaction or liquid transfer, and a processing unit 22 that performs a second procedure such as electrical calculation or control. The reaction unit 31 that performs the first procedure includes an input unit 11, an optional pre-processing unit 12, an EV identification unit 13, and a drug detection unit 14. The processing unit 22 includes an information processing unit 15 and an output unit 16. Here, the medical information processing device 30 may have its operations controlled by a control unit (not shown) included in the calculation unit 22 for each component and / or comprehensively.

[0020] Such a medical information processing device 30 provides a medical information processing device for evaluating the tissue transferability of a minimally invasive drug.

[0021] Fifth embodiment The fifth embodiment is a further example of a method for evaluating the tissue migration of a drug using the medical information processing device 10, 20, or 30. This method will be described with reference to FIG. 5. The medical information processing device 10, 20, or 30 used in the fifth embodiment is an example of using the medical information processing device A when it does not include the pre-processing unit 12 that is optionally included as described above. The process before inputting a sample into the medical information processing device A is as follows. That is, a patient takes a drug (S0-0). Blood is collected from the patient (S0-1). EVs are extracted from the obtained blood (S0-2). Of the procedures up to this point, (S0-0) and (S0-1) correspond to medical procedures. Except for cases where the method is used in a method including a medical procedure or when there are special circumstances in which a medical procedure is intended, such procedures and the method for evaluating the tissue migration of a drug according to the fifth embodiment are not included.

[0022] Incidentally, the fifth embodiment shows an example in which the step of extracting EVs from blood collected from a patient is not included. However, as described above, the step of extracting EVs from the obtained blood can be included in the method according to the embodiment as desired. In that case, the configuration of the medical information processing device is also as described above.

[0023] In the fifth embodiment, miRNA information (S41-1) and / or antibody information (S42-1) for identifying the tissue of origin of the EV are selected as the information obtained in the EV identification unit 13. To obtain such information, the EV identification unit 13 is provided with a capture mechanism for capturing the EV. The previously obtained EV is captured on a carrier (S41-2, S42-2). An example of the capture mechanism is shown in FIG. 6. As described above, the EV identification unit 13 is provided with a reaction field for carrying out a biochemical reaction therein. Such a reaction field is formed on a support capable of supporting a liquid in a container, a convex portion, a flow channel, a column, or on a flat plate.

[0024] As shown in FIG. 6(a), the EV capture mechanism 50a for obtaining antibody information comprises a plate-shaped support 51a and an antibody 52a immobilized on its surface. For example, one type of antibody selected based on the predicted pharmacokinetics of the drug to be evaluated may be immobilized on the support 51a, or multiple types of antibodies may be immobilized in a distinguishable manner based on any kinetics, or a single or multiple antibodies selected randomly may be immobilized in a distinguishable manner. In the reaction field, EV55a-1 is captured by an antibody 52a having the corresponding anti-EV55a-1 characteristics. On the other hand, EV55a-2 to which the antibody corresponding to the support 51a is not immobilized is not captured by the capture mechanism 50a and is discharged. Such a mechanism makes it possible to selectively capture EVs. In addition, depending on the type of antibody to be immobilized, it is also possible to comprehensively capture multiple EVs contained in a sample. The support 51a may be a part of the wall surface of a column or a flow channel, or a part of the upper surface of a flat plate.

[0025] As shown in FIG. 6(b), an EV capture mechanism 50b for obtaining antibody information may include particles 51b such as beads and antibodies 52b immobilized on the surfaces thereof.

[0026] On the other hand, as shown in Fig. 6(c), in order to obtain information on miRNA, for example, the capture mechanism 50c may be provided with any nucleic acid capture means known per se. For example, the wall surface 51c in contact with the reaction space may be coated with a coating agent, modified with a specific substituent, or may have a complementary nucleic acid immobilized thereon. Information from the miRNA captured by the capture mechanism 50c may be obtained by using a target-specific molecule that identifies the miRNA known per se.

[0027] For example, as described above, in S41-3, the EVs captured in S41-2 are identified by target-specific molecules (S41-3). For example, the information to be identified may be whether or not the EVs are miRNA, whether or not they are a specific type of miRNA, or the type of miRNA.

[0028] 5, the drug detection unit 14 quantifies the amount of the drug contained in the EV identified by the EV identification unit 13 (S41-4) (S42-3). A drug detection means that can be commonly used in the methods using both miRNA and antibody indicators is, for example, mass spectrometry imaging, which is known per se. The drug is detected and / or measured while immobilized on the capture mechanisms 50a, b, and c.

[0029] In mass spectrometry imaging, a matrix, which is an ionizing agent, is applied to the sample, set in the mass spectrometry imaging device, laser light is applied to the specified area, and mass spectrum acquisition is repeated to obtain overall information. Based on the obtained mass spectrum information, analysis is performed for each molecular ion peak to obtain the distribution of the target compound. The main subjects of analysis are animal tissues, human clinical specimens, three-dimensional model tissues (skin, tumors, etc.), plants (leaves, seeds, etc.), and food, but visualization of low molecular weight metabolites, visualization of low molecular weight drugs, quantitative analysis, imaging of special samples (e.g. hard tissues, microtissues, insects, etc.) and drugs are also possible.

[0030] When antibodies are utilized, liquid chromatography may be used to quantitate the agent.

[0031] Next, in (S41-5) and (S42-4), the data obtained by the EV identification unit and drug detection unit 44 is sent to the electrically connected information processing unit 15, where the amount of drug in the EV is quantified or converted into a relative value or standardized, and converted into comparable data. This conversion is performed by comparing or collating with a database on the correlation between tissue concentration and drug efficacy, a table or equation correlating tissue transferability and drug efficacy, or other predetermined thresholds or equations.

[0032] The results calculated by the information processing unit 15 are sent to the output unit 16 as desired and displayed (not shown in FIG. 5).

[0033] Example 1 A medical information processing device using mass spectrometry imaging of Example 1 will be described with reference to FIG. 7. As shown in FIG. 7(a), the medical information processing device 60 of Example 1 includes an input unit 11 (not shown) which is an opening for inputting input blood 71 as a sample, a pre-processing unit 12, a measurement unit 21, and a processing unit 22. The pre-processing unit 12 includes a blood cell removal unit 121 and an EV purification unit 122. The blood cell removal unit 121 removes blood cells from the input blood 71. For example, the blood cell removal unit 121 can be a centrifugal mechanism or a membrane or filter mechanism. The EV purification unit 122 can be, for example, a size exclusion column or an ion exchange column. The measurement unit 21 includes a substrate processing unit 131 and an analysis unit 141. The substrate processing unit 131 includes an EV capture unit 1311 and an EV labeling unit 1312. The EV capture unit 1311 may be configured with a mechanism similar to that of the EV capture unit described above. For example, Fig. 7(b) includes a capture mechanism 50c having a configuration similar to that of the capture mechanism 50c shown in Fig. 6(c). The EV labeling unit 1312 is configured to label the EV captured by the capture mechanism 50c with an antibody. The analysis unit 141 includes a substrate preparation unit 1412 and a mass analysis unit 1413. The analysis unit 141 is configured to perform mass spectrometry imaging, and a matrix is ​​supplied by a mass spectrometry imaging system to analyze the mass of the drug.

[0034] The information obtained in the measurement unit 21 is sent to the processing unit 22. The measurement unit 21 and the processing unit 22 are electrically connected. The processing unit 22 includes an information processing unit 15, a storage unit 151, and a display unit 16, which are electrically connected to each other. The data obtained in the measurement unit 21 is sent to the information processing unit 15. The information processing unit 15 processes and / or processes the data received from the measurement unit 21 by checking against a correspondence table between tissue concentration and drug efficacy stored in the storage unit 151, a correspondence between actual measurement data and EV quantitative values, and / or based on a predetermined arithmetic formula, etc. The final result obtained in the information processing unit 15 is sent to the display unit 16 and displayed. Examples of the final result may be a tissue concentration and / or an estimated drug efficacy value of a drug.

[0035] Such a medical information processing device 60 provides a medical information processing device for evaluating the tissue transferability of a minimally invasive drug.

[0036] Example 2 A medical information processing device 70 using mass spectrometry imaging of the second embodiment will be described with reference to FIG. 8. The medical information processing device 70 has the same configuration as the medical information processing device 60, except that the measurement unit 21 of the medical information processing device 60 of the first embodiment shown in FIG. 7(a) further includes a labeled EV detection unit 1411. The labeled EV detection unit 1411 is connected to the EV labeling unit 1312 and the substrate preparation unit 1412. The EVs captured by the EV labeling unit 1312 and labeled with antibodies are imaged by the mass spectrometry imaging system. Here, the mass spectrometry imaging system may include, for example, an optical microscope that images the two-dimensional position of the sample, an imaging device unit using a CCD imaging element or a CMOS imaging element, a stage unit that moves the sample, a sample introduction unit, an ionization unit that ionizes molecules in the sample, a mass separation unit that separates the ionized molecules by m / z, a detection unit that detects the separated ions, an imaging mass spectrometry data storage unit, and a data processing unit that performs analysis processing. For the obtained image, the substrate preparation unit 1412 performs matrix supply and the like, and the mass spectrometry unit 1413 obtains a quantitative value by correlating it with the position information corresponding to the labeled EV. The obtained actual measurement data is sent to the information processing unit 15. The subsequent processing is performed in the same manner as in the first embodiment.

[0037] Such a medical information processing device 70 provides a medical information processing device for evaluating the tissue transferability of a minimally invasive drug.

[0038] Example 3 A medical information processing device utilizing the bead capturing mechanism of Example 3 will be described with reference to Fig. 9. As shown in Fig. 9(a), a medical information processing device 80 of Example 1 includes an input unit 11 (not shown) which is an opening for inputting input blood 71 as a sample, a pre-processing unit 12, a measurement unit 21, and a processing unit 22. The pre-processing unit 12 is as described in Example 1.

[0039] The measurement section 21 includes a substrate processing section 132 and an analysis section 142. The substrate processing section 132 includes an EV capture section 1321 and an EV capture particle purification section 1322. The EV capture section 1321 may be configured with a mechanism similar to that of the EV capture section described above. For example, FIG. 9(b) includes a capture mechanism 50b using a bead capture mechanism, which has a structure similar to that of the capture mechanism (EV capture particle) 50b shown in FIG. 6(b). In this embodiment, magnetic particles are used as beads for EV capture. In the EV capture section 1321, EVs from the EV purification section 122 are adsorbed to the EV capture magnetic particles. Then, in the EV capture particle purification section 1322, the EV capture particles 50b are extracted using magnetism. The extracted EV capture particles 50b are sent to the EC processing section 1421. In the EV processing section 1421, the captured EV components are dissolved by a surfactant treatment or the like, and released from the capture particles 50b. The released EV components are sent to the analysis unit 1422, where the amount of the drug is quantified by mass spectrometry or the like. The measurement results obtained by the analysis unit 1422 are sent to the information processing unit 15. The subsequent processing is performed in the same manner as in the first embodiment.

[0040] Such a medical information processing device 80 provides a medical information processing device for evaluating the tissue transferability of a minimally invasive drug.

[0041] Example 4 The medical information processing device 60 of the first embodiment is used to evaluate the tissue transferability of an antidepressant. As shown in FIG. 10, when the test is started, first, the drug content is quantified in blood collected from the patient before administration of the antidepressant. This value is set as the baseline EV measurement value. The baseline EV measurement value may be measured in the same manner as the quantification method performed on blood samples described later.

[0042] After obtaining the baseline EV measurement value, administration of an antidepressant to the patient is started. For monitoring, blood is drawn periodically. As the antidepressant, for example, a tricyclic antidepressant may be used. The EV measurement value of a blood sample obtained by drawing blood from the patient to whom the drug has been administered is measured by the medical information processing device 60, and the tissue transferability of the drug is evaluated.

[0043] In the same procedure as in the first embodiment described above, a blood sample is input into the medical information processing device 60, and EVs are isolated in the pre-processing unit 12, and then captured on a substrate in the measuring unit 21. Next, the distribution of EVs derived from the central nervous system is identified from the miRNA contained in the EVs captured on the substrate. This identification can be performed by identifying EVs derived from the central nervous system from a group of EVs distributed using the type of miRNA as an index. Mass spectrometry imaging is performed on the identified EVs, and the drug amount per EV is calculated. The calculated drug amount is compared in the processing unit 22 with the information in the database stored in the storage unit 15, that is, the correlation information between the drug concentration in the EVs derived from the central nervous system and the drug effect. A specific judgment is made by comparing the drug amount calculated by the measuring unit 21 with a predetermined threshold value, and if it is judged that the "drug amount per EV<tissue drug concentration range", the display unit 16 displays "consider changing the type of drug" since "tissue migration is low and drug efficacy cannot be expected". If the comparison with the threshold value determines that the concentration is within the tissue drug range, the display unit 16 displays a message to the effect that the drug should be continued since the drug is properly transferred to the tissue and efficacy can be expected. If the comparison with the threshold value determines that the drug amount per EV is greater than the tissue drug concentration range, the display unit 16 displays a message to the effect that the drug should be reduced since it is desirable to maintain efficacy and reduce the risk of side effects. The display unit 16 displays the results, and thus the evaluation of the tissue transferability of the antidepressant using the medical information processing device 60 is completed.

[0044] Thus, according to Example 4, it is possible to evaluate the tissue migration of antidepressant drugs. The origin tissue can be examined by biomarkers (surface antigen markers / miRNA, etc.) held by EVs (extracellular vesicles), and when EVs are released from cells, they may encapsulate and release drugs (e.g., paclitaxel) that the cells have taken up. By utilizing such biological reactions, it is possible to evaluate the tissue migration of less invasive drugs using a medical information processing device.

[0045] Example 5 The tissue migration of an anticancer drug is evaluated using the medical information processing device 60 of the first embodiment. As shown in FIG. 11, when the test is started, first, the drug content is quantified in blood collected from a breast cancer patient before the administration of an anticancer drug. This value is set as a baseline EV measurement value. The baseline EV measurement value may be measured in the same manner as the quantification method performed on blood samples described later.

[0046] After obtaining the baseline EV measurement value, administration of the anticancer drug to the patient is started. Blood is drawn periodically for monitoring. The EV measurement value of the blood sample obtained by blood drawing from the patient who has been administered the drug is measured by the medical information processing device 60, and the tissue migration of the drug is evaluated.

[0047] A blood sample is input into the medical information processing device 60 in the same manner as in Example 1 described above, and EVs are isolated in the pre-processing unit 12. Then, the measurement unit 21 captures the EVs on a substrate coated with a breast cancer-specific marker. Next, mass spectrometry imaging is performed on the EVs captured on the substrate to calculate the drug amount per EV. The calculated drug amount is compared in the processing unit 22 with the information in the database stored in the storage unit 15, that is, the correlation information between the drug concentration in the EVs derived from breast cancer and the drug effect. A specific judgment is made by comparing the drug amount calculated by the measurement unit 21 with a predetermined threshold value, and if it is judged that "the drug amount per EV < tissue drug concentration range", the display unit 16 displays "consider changing the type of drug" since "tissue migration is low and drug efficacy cannot be expected". If it is judged that "within the tissue drug range" as a result of the comparison with the threshold value, the display unit 16 displays "continue drug administration" since "the drug is properly migrated to the tissue and drug efficacy can be expected". If it is determined that "drug amount per EV>tissue drug concentration" as a result of the comparison with the threshold, it is desirable to "maintain drug efficacy while reducing the risk of side effects," so that "reduce the drug dosage" is displayed on the display unit 16. With the display of the result on the display unit 16, the evaluation of the tissue migration of the anticancer drug using the medical information processing device 60 is completed.

[0048] Thus, according to Example 5, it is possible to evaluate the tissue migration of anticancer drugs. The origin tissue can be examined by biomarkers (surface antigen markers / miRNA, etc.) held by EVs (extracellular vesicles), and when EVs are released from cells, they may encapsulate and release drugs (e.g., anticancer drugs) that have been taken up by the cells. By utilizing such biological reactions, it is possible to evaluate the tissue migration of less invasive drugs using a medical information processing device.

[0049] For patients, simply taking a blood sample will enable evaluation of drug delivery to target and off-target tissues, making it possible to predict drug efficacy and side effects with minimal burden. This will enable adjustments to the optimal drug administration method for each patient, which is expected to improve therapeutic efficacy and reduce side effects. [Explanation of symbols]

[0050] 1, 10, 20, 30, 50, 60, 70, 80... medical information processing device, 2... first information acquisition unit, 3... second information acquisition unit, 4... evaluation unit, 11... input unit, 12... pre-processing unit, 13... EV identification unit, 14... drug detection unit, 15... information processing unit, 16... output unit, display unit, 21... measurement unit, 50a, 50b, 50c... EV capture mechanism, 51a... support, 51b... particles, 51c... wall surface, 52a, 52b... antibodies, 71... blood, 141... analysis unit, 121... blood cell removal unit, 122... EV purification unit, 151... storage unit, 1312... EV labeling unit, 1412... base preparation unit, mass analysis unit 1413.

Claims

1. A first information acquisition unit that acquires first information relating to a characteristic of an extracellular body (EV) obtained from a subject to which a drug has been administered, the characteristic being correlated with the tissue from which the EV originates; A second information acquisition unit that acquires second information related to the presence or absence or content of the drug contained in the EV; an evaluation unit that evaluates the tissue migration of the drug by collating the first information and the second information with a database that has been previously stored; A medical information processing device comprising:

2. The medical information processing apparatus according to claim 1 , further comprising a display unit that displays a result obtained by the evaluation unit.

3. The medical information processing device according to claim 1 , wherein the characteristics of the EV are information about the tissue of origin.

4. The medical information processing device according to claim 1 , wherein the characteristics of the EV are obtained from miRNA contained in the EV.

5. The medical information processing device according to claim 1 , wherein the characteristics of the EV are obtained from an antigen presented by the EV.

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