Method, program, device and system for supporting determining at least one of usage and dosage of medicine

Abstract

To enable a medical professional to specify at least one of usage and dosage of medicine more suitable for a patient.SOLUTION: Disclosed is a method according to one embodiment of the present invention which is used for determining at least one of usage and dosage of a pharmaceutical agent capable of being administered to a patient. A processor executes the steps of: acquiring the electrocardiogram data indicative of an electrocardiogram of the patient who has been dosed with medicine based on the usage and dosage; and determining, based on the electrocardiogram data, whether or not there is a possibility that the waveform abnormality can be evaluated by the electrocardiogram, and outputting information on whether or not to change at least one of the usage and the dosage based on the determined result.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] The present invention relates to a method, a program, an apparatus and a system for assisting in determining at least one of the usage and dosage of a pharmaceutical drug. [Background technology]

[0002] For pharmaceuticals, directions for use indicating how to administer the drug to a patient and a dosage indicating the amount to be administered to the patient are specified. Patent Document 1 discloses a system that accepts input of a patient's weight, determines the dosage of the drug based on the input weight, and injects the determined dosage of the drug into the patient's body. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2016-064309 A Summary of the Invention [Problem to be solved by the invention]

[0004] Since drugs have side effects, a universal dosage and administration method is predefined to ensure safety. However, the degree of side effects that may occur due to the administration of a drug varies from person to person depending on the constitution of the patient. Therefore, there may be a dosage and administration method that is more suitable for a patient than the predefined dosage and administration method. The system described in Patent Document 1 simply administers a drug to a patient in a dose proportional to the patient's body weight, and does not take into account the constitution of the patient other than the weight. Therefore, there may be a dosage that is suitable for an individual patient that is different from the predefined dosage for the drug, or a dose that is more or less suitable for an individual patient than the predefined dosage for the drug. In addition, in clinical trials to determine the dosage and administration method for a new drug, there is a possibility that a dosage and administration method that is suitable for a patient can be found by considering the constitution of the patient as a subject.

[0005] The present invention has been made in consideration of these points, and aims to enable medical professionals to identify at least one of the usage and dosage of a pharmaceutical drug that is more suitable for a patient. [Means for solving the problem]

[0006] A method of a first aspect of the present invention is a method used for determining at least one of the usage and dosage of a pharmaceutical product that can be administered to a patient, and includes the steps of acquiring electrocardiogram data indicating the electrocardiogram of a patient who has been administered the pharmaceutical product in said usage and dosage throughout their daily life, executed by a processor, and determining, based on the electrocardiogram data, whether or not the patient is experiencing a waveform abnormality that can be evaluated by an electrocardiogram, and outputting information regarding whether or not at least one of the usage and dosage can be changed based on the determination result.

[0007] The method may further include a step of re-acquiring the electrocardiogram data of the patient who has been administered the pharmaceutical drug in the changed dosage and administration after at least one of the administration and dosage has been changed, determining whether or not the possibility exists based on the re-acquired electrocardiogram data, and re-outputting information regarding whether or not at least one of the administration and dosage can be changed based on the determination result.

[0008] The acquiring step may include successively acquiring the electrocardiogram data from an electrocardiograph worn by the patient during daily life.

[0009] The outputting step may determine whether or not there is a possibility that a waveform indicating that arrhythmia is occurring or that arrhythmia may occur is occurring as the waveform abnormality.

[0010] The output step may determine whether or not there is a possibility that a waveform indicating the occurrence of an adverse event that can be evaluated by an electrocardiogram is occurring, as the waveform abnormality.

[0011] The outputting step may determine whether or not there is a possibility that the waveform abnormality has occurred by detecting at least one of QT prolongation, atrial fibrillation, ventricular tachycardia, supraventricular extrasystoles, ventricular extrasystoles, atrial flutter, and atrial tachycardia in the electrocardiogram data.

[0012] The outputting step may determine whether or not there is a possibility that the waveform abnormality has occurred by comparing the electrocardiogram data with normal electrocardiogram data that indicates an electrocardiogram of the patient under normal circumstances.

[0013] The outputting step may include transmitting information regarding whether or not at least one of the usage method and the dosage can be changed to an information terminal associated with a medical professional examining the patient.

[0014] The re-outputting step may output information indicating the risk of increasing the dose based on the electrocardiogram data of the patient who has been administered the medicine at the dose and the electrocardiogram data of the patient who has been administered the medicine at the changed dose.

[0015] The acquiring step may acquire the electrocardiogram data of the patient who has been administered the pharmaceutical agent for therapeutic or clinical trial purposes.

[0016] A program of a second aspect of the present invention is a program used for determining at least one of the usage and dosage of a pharmaceutical product that can be administered to a patient, and causes a processor to execute the steps of acquiring electrocardiogram data showing the electrocardiogram of a patient who has been administered the pharmaceutical product according to said usage and dosage during his or her daily life, determining based on the electrocardiogram data whether or not the patient is experiencing a waveform abnormality that can be evaluated by an electrocardiogram, and outputting information regarding whether or not at least one of the usage and dosage can be changed based on the determination result.

[0017] The device of the third aspect of the present invention is a device used to determine at least one of the usage and dosage of a pharmaceutical product that can be administered to a patient, and has an acquisition unit that acquires electrocardiogram data showing the electrocardiogram of a patient who has been administered the pharmaceutical product according to said usage and dosage during their daily life, and an output unit that determines, based on the electrocardiogram data, whether or not the patient is experiencing a waveform abnormality that can be evaluated by an electrocardiogram, and outputs information regarding whether or not at least one of the usage and dosage can be changed based on the determination result.

[0018] A fourth aspect of the system of the present invention is a system used for determining at least one of the usage and dosage of a pharmaceutical product that can be administered to a patient, and comprises an information output device and an electrocardiograph, wherein the electrocardiograph has a measuring unit that measures an electrocardiogram of a patient who has been administered the pharmaceutical product according to the usage and dosage during their daily life, and a transmitting unit that transmits electrocardiogram data indicating the electrocardiogram, and the information output device has an acquiring unit that acquires the electrocardiogram data transmitted by the electrocardiograph, and an output unit that determines, based on the electrocardiogram data, whether or not the patient may have a waveform abnormality that can be evaluated by the electrocardiogram, and outputs information regarding whether or not at least one of the usage and dosage can be changed based on the determination result. Effect of the Invention

[0019] The present invention has an effect of enabling medical personnel to specify at least one of the usage and dosage of a medicine that is more suitable for a patient. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 is a diagram for explaining an overview of an information output system according to an embodiment. [Diagram 2] 1 is a block diagram of an information output system according to an embodiment. [Diagram 3] FIG. 2 is a schematic diagram of a patient's baseline electrocardiogram and initial dose electrocardiogram. [Figure 4] FIG. 13 is a front view of a doctor terminal displaying a support information screen. [Diagram 5]FIG. 2 is a schematic diagram of a patient's modified dose electrocardiogram. [Figure 6] FIG. 2 is a flowchart illustrating an information output method executed by the information output system according to the embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] [Outline of Information Output System S] FIG. 1 is a diagram for explaining an overview of an information output system S according to this embodiment. The information output system S is a system for supporting the determination of at least one of the usage and dosage of a medicine that may cause side effects detectable based on an electrocardiogram. That is, the information output system S is mainly applied to medicines whose usage and dosage are restricted by side effects detectable based on an electrocardiogram (for example, medicines whose bottleneck is arrhythmia). The information output system S includes an information output device 1, an electrocardiograph 2, and a doctor terminal 3.

[0022] The electrocardiograph 2 is an electrocardiograph worn by a patient, and is, for example, an electrocardiogram measuring device that generates electrocardiogram data showing the patient's electrocardiogram by measuring pulse and potential while worn on the patient's wrist, palm, chest, etc. In other words, the electrocardiograph 2 is a wearable electrocardiograph (continuously worn electrocardiograph). The electrocardiograph 2 transmits the generated electrocardiogram data to the information output device 1 via a network N including a wireless communication line. The electrocardiogram data generated by the electrocardiograph 2 may be delivered to the information output device 1 without going through the network N, for example, by using a storage medium.

[0023] The doctor terminal 3 is an information terminal used by a medical professional such as a doctor who examines a patient, and includes, for example, a display and a computer. The doctor terminal 3 is associated in advance with the medical professional who uses the doctor terminal 3 by an ID or the like assigned to the medical professional. The doctor terminal 3 displays the support information output by the information output device based on the electrocardiogram data generated by the electrocardiograph 2.

[0024] The information output device 1 is a device, for example a server, that generates support information for supporting the determination of at least one of the usage and dosage of a medicine based on electrocardiogram data generated by the electrocardiograph 2. The support information is information on whether or not at least one of the usage and dosage of a medicine can be changed. The support information includes, for example, electrocardiogram data and information indicating the presence or absence of a possibility of a waveform abnormality occurring in the electrocardiogram.

[0025] FIG. 2 is a block diagram of an information output system S according to this embodiment. In FIG. 2, arrows indicate main data flows, and there may be data flows not shown in FIG. 2. In FIG. 2, each block indicates a functional configuration, not a hardware (device) configuration. Therefore, the blocks shown in FIG. 2 may be implemented in a single device, or may be implemented separately in multiple devices. Data may be exchanged between blocks via any means, such as a data bus, a network, or a portable storage medium.

[0026] The information output device 1 has a control unit 11, a communication unit 12, and a storage unit 13. The control unit 11 has an acquisition unit 111, a determination unit 112, and an output unit 113. The communication unit 12 has a communication controller for transmitting and receiving data between the electrocardiograph 2 and the doctor terminal 3 via the network N. The communication unit 12 notifies the control unit 11 of data received from the electrocardiograph 2 via the network N. In addition, the communication unit 12 transmits data output from the control unit 11 to the doctor terminal 3 via the network N.

[0027] The storage unit 13 is a storage medium including a ROM (Read Only Memory), a RAM (Random Access Memory), a hard disk drive, etc. The storage unit 13 stores in advance a program to be executed by the control unit 11. The storage unit 13 may be provided outside the information output device 1, in which case data may be exchanged between the storage unit 13 and the control unit 11 via a network N.

[0028] The control unit 11 is a processor such as a CPU (Central Processing Unit), and functions as an acquisition unit 111, a determination unit 112, and an output unit 113 by executing a program stored in the storage unit 13. At least a part of the functions of the control unit 11 may be executed by an electric circuit. Also, at least a part of the functions of the control unit 11 may be realized by the control unit 11 executing a program executed via a network.

[0029] The information output system S according to the present embodiment is not limited to the specific configuration shown in Fig. 2. For example, the information output device 1 may be configured by a single computer, may be configured by a plurality of computers linked to each other, or may be configured by a cloud that is a collection of computer resources. In addition, two or more of the information output device 1, the electrocardiograph 2, and the doctor terminal 3 may be configured as one device.

[0030] [Explanation of how to output information] An information output method executed by the information output system S according to this embodiment will be described in detail below. First, the electrocardiograph 2 measures the electrocardiogram of the patient in normal conditions. The patient in normal conditions is a patient who is not administered a medicine whose usage and dosage are determined using the information output system S. The electrocardiograph 2 generates electrocardiogram data indicating the measured electrocardiogram and transmits it to the information output device 1.

[0031] In the information output device 1, the acquisition unit 111 acquires electrocardiogram data indicating the patient's electrocardiogram in normal conditions, generated by the electrocardiograph 2, via the network N. The acquisition unit 111 may acquire electrocardiogram data indicating the patient's electrocardiogram in normal conditions, which has been measured in advance in a hospital or the like.

[0032] 3(a) is a schematic diagram of a normal electrocardiogram H0 of a patient in a normal state. The determination unit 112 determines whether or not there is a possibility of occurrence of a waveform abnormality that can be evaluated by an electrocardiogram, based on the normal electrocardiogram H0 indicated by the electrocardiogram data acquired by the acquisition unit 111. A method for the determination unit 112 to determine whether or not there is a possibility of occurrence of a waveform abnormality based on an electrocardiogram will be described later.

[0033] If the judgment unit 112 judges that there is a possibility that a waveform abnormality has occurred for the patient under normal circumstances, the output unit 113 transmits information to the doctor's terminal 3 indicating that the method of use and dosage for the patient cannot be determined based on the waveform abnormality, and the processing is terminated.

[0034] When the determination unit 112 determines that there is no possibility that a waveform abnormality occurs in the patient under normal circumstances, the output unit 113 stores the electrocardiogram data of the normal electrocardiogram H0 of the patient in the storage unit 13. In addition, the output unit 113 does not need to store the electrocardiogram data of the normal electrocardiogram H0 in the storage unit 13.

[0035] Next, the electrocardiograph 2 measures the electrocardiogram of the patient who has been administered the medicine at the initial dose X1 for the purpose of treatment. That is, the electrocardiograph 2 measures the electrocardiogram of the patient who is living with the electrocardiograph 2 attached. The patient may be active at home, at work, or may be hospitalized in a hospital. The initial dose X1 is a predetermined dose (i.e., the dose before the change). The electrocardiograph 2 generates electrocardiogram data indicating the measured electrocardiogram and transmits it to the information output device 1.

[0036] In the information output device 1, the acquisition unit 111 acquires electrocardiogram data, which is generated by the electrocardiograph 2 and indicates an electrocardiogram of a patient taking medication at an initial dose X1, via the network N. The acquisition unit 111 may successively acquire electrocardiogram data from the electrocardiograph 2 worn by the patient during daily life. This enables the information output device 1 to detect electrocardiogram waveform abnormalities that may occur in a patient taking medication at an early stage, thereby improving safety. The acquisition unit 111 may also acquire electrocardiogram data for a predetermined period from the electrocardiograph 2 all at once.

[0037] 3(b) is a schematic diagram of an initial dose electrocardiogram H1 of a patient receiving medication at an initial dose X1. The determination unit 112 determines whether or not there is a possibility of occurrence of a waveform abnormality that can be evaluated by an electrocardiogram, based on the initial dose electrocardiogram H1 indicated by the electrocardiogram data acquired by the acquisition unit 111.

[0038] As the waveform abnormality, the determination unit 112 determines whether or not there is a possibility that a waveform indicating that an arrhythmia has occurred or that an arrhythmia may occur is occurring in an electrocardiogram. For example, the determination unit 112 determines whether or not there is a possibility that a waveform indicating that an arrhythmia has occurred or that an arrhythmia may occur is occurring by detecting at least one of QT prolongation, atrial fibrillation, ventricular tachycardia, supraventricular extrasystoles, ventricular extrasystoles, atrial flutter, and atrial tachycardia in an electrocardiogram. That is, when the determination unit 112 detects one or more of QT prolongation, atrial fibrillation, ventricular tachycardia, supraventricular extrasystoles, ventricular extrasystoles, atrial flutter, and atrial tachycardia according to the medicine administered to the patient, it determines that there is a possibility that a waveform indicating that an arrhythmia has occurred or that an arrhythmia may occur is occurring, and otherwise determines that there is no possibility.

[0039] Specifically, the determination unit 112 detects whether or not predefined waveforms for QT prolongation, atrial fibrillation, ventricular tachycardia, supraventricular extrasystoles, ventricular extrasystoles, atrial flutter, and atrial tachycardia appear in the electrocardiogram. The determination unit 112 detects QT prolongation when, for example, a waveform indicating that the time from the start of a QRS wave to the end of a T wave is extended to a predetermined value or more appears in the electrocardiogram. The determination unit 112 detects atrial fibrillation when, for example, a waveform indicating that irregular fine oscillations (f waves) are occurring appears in the electrocardiogram. The determination unit 112 detects ventricular tachycardia when, for example, a waveform indicating that the heart rate is a predetermined value or more and that the width of a QRS wave is a predetermined value or more appears in the electrocardiogram. Similarly, the determination unit 112 detects ventricular extrasystoles, atrial flutter, or atrial tachycardia when a predetermined waveform appears in the electrocardiogram.

[0040] As the waveform abnormality, the determination unit 112 may determine whether or not there is a possibility that a waveform indicating the occurrence of an adverse event, not limited to arrhythmia, that can be evaluated in an electrocardiogram is occurring. An adverse event is, for example, not being in sinus rhythm. In this case, when the determination unit 112 detects a waveform in an electrocardiogram that has a shape or timing different from that of a normal sinus rhythm, it determines that there is a possibility that a waveform indicating the occurrence of an adverse event is occurring, and otherwise determines that there is no such possibility.

[0041] The determination unit 112 may also determine whether or not there is a possibility that a waveform abnormality has occurred by comparing the normal electrocardiogram H0 with the initial dose electrocardiogram H1. In this case, the determination unit 112 compares the normal electrocardiogram H0 indicated by the electrocardiogram data stored in the storage unit 13 with the initial dose electrocardiogram H1 indicated by the electrocardiogram data acquired by the acquisition unit 111, and determines that there is a possibility that a waveform abnormality has occurred if the difference between them (e.g., the difference in QT time) is equal to or greater than a predetermined value, and determines that there is no possibility that a waveform abnormality has occurred if this is not the case. In this way, the determination unit 112 can determine whether or not there is a possibility that a waveform abnormality has occurred based on the difference from normal times, even if QT prolongation, atrial fibrillation, or ventricular tachycardia itself is not detected in the electrocardiogram.

[0042] The determination unit 112 may determine whether or not there is a possibility that a waveform abnormality that can be evaluated by an electrocardiogram has occurred by using another determination method, not limited to the determination method shown here. Also, the determination unit 112 may determine that there is a sinus rhythm, not limited to the determination whether or not there is a possibility that a waveform abnormality has occurred.

[0043] The determination unit 112 may determine whether or not there is a possibility that a waveform abnormality occurs in the electrocardiogram by using a machine learning model generated by learning an electrocardiogram. In this case, the storage unit 13 pre-stores a machine learning model generated by learning an electrocardiogram in a normal state and an abnormal state by a known learning method. An abnormal electrocardiogram is, for example, an electrocardiogram of a patient in which a predetermined one or more of the above-mentioned QT prolongation, atrial fibrillation, ventricular tachycardia, supraventricular extrasystole, ventricular extrasystole, atrial flutter, atrial tachycardia, and sinus rhythm abnormality occurs according to the medicine administered to the patient.

[0044] The determination unit 112 obtains a determination result indicating whether or not there is a possibility that a waveform abnormality has occurred by inputting an electrocardiogram to the machine learning model stored in the storage unit 13. This allows the determination unit 112 to determine whether or not there is a possibility that a waveform abnormality has occurred using the machine learning model, even if a specific waveform corresponding to a waveform abnormality is not defined in advance.

[0045] The output unit 113 outputs support information regarding whether or not the dosage of the medicine can be changed to the doctor terminal 3 via the network N based on the determination result by the determination unit 112. The output unit 113 outputs support information including, for example, electrocardiogram data and determination information indicating whether or not the waveform abnormality determined by the determination unit 112 may have occurred. When it is determined that the waveform abnormality determined by the determination unit 112 has occurred, the determination information may indicate the content of the waveform abnormality that may have occurred.

[0046] Furthermore, the output unit 113 may specify an increase candidate value when the determination unit 112 determines that there is no possibility of waveform abnormality occurring. The increase candidate value is a value to be added to or multiplied by the initial dose X1, which is assumed to be used for increasing the dose from the initial dose X1. The output unit 113 specifies the increase candidate value according to an increase table indicating the increase candidate value, which is stored in advance in the storage unit 13, for example. The increase table may indicate a constant increase candidate value, or may indicate an increase candidate value that differs depending on the initial dose X1. Then, the output unit 113 outputs support information including the specified increase candidate value in addition to the electrocardiogram data and the determination information.

[0047] The doctor terminal 3 displays a support information screen on a display (display unit) based on the support information output by the information output device 1. Fig. 4(a) and Fig. 4(b) are front views of the doctor terminal 3 displaying the support information screen D.

[0048] FIG. 4(a) shows the support information screen D when the determination unit 112 of the information output device 1 determines that there is no possibility of waveform abnormality occurring. In this case, the support information screen D includes an electrocardiogram D1, determination information D2, a dosage D3, and an increase candidate value D4. The electrocardiogram D1 is an electrocardiogram indicated by electrocardiogram data. The determination information D2 is information indicating that there is no possibility of waveform abnormality occurring. The dosage D3 is the amount of the medicine administered to the patient (here, the initial dosage X1). The increase candidate value D4 is an increase candidate value identified by the output unit 113 of the information output device 1.

[0049] 4(b) shows a support information screen D when the determination unit 112 of the information output device 1 has determined that there is a possibility of a waveform abnormality occurring. In this case, the support information screen D includes an electrocardiogram D1, determination information D2, and a dosage D3. The electrocardiogram D1 may represent the entire electrocardiogram shown by the electrocardiogram data, or may represent an electrocardiogram obtained by extracting a portion of the electrocardiogram data that has been determined to have a possible waveform abnormality. The determination information D2 is information that represents the content of the waveform abnormality. The dosage D3 is the amount of medicine administered to the patient.

[0050] In this way, by referring to the support information displayed on support information screen D, medical professionals can easily determine whether a patient who has been prescribed a medication is experiencing waveform abnormalities that can be evaluated on an electrocardiogram, and can identify the dosage of medication that is most appropriate for the patient.

[0051] The medical professional determines whether the dosage can be increased based on the support information, and determines the changed dosage X2 when the next medication is administered to the patient. For example, the medical professional determines the changed dosage X2 as a value obtained by adding or multiplying the dosage D3 by the increase candidate value D4. The medical professional may also determine another value as the changed dosage X2 based on the support information. The medical professional inputs the determined changed dosage X2 by operating the doctor terminal 3.

[0052] After the dosage is changed, i.e., after the changed dosage X2 is determined, the electrocardiograph 2 measures the electrocardiogram of the patient who has been administered the medicine at the changed dosage X2 during his / her daily life. The electrocardiograph 2 generates electrocardiogram data indicating the measured electrocardiogram and transmits it to the information output device 1. The acquisition unit 111 reacquires, via the network N, the electrocardiogram data generated by the electrocardiograph 2 indicating the electrocardiogram of the patient who is being administered the medicine at the changed dosage X2.

[0053] 5 is a schematic diagram of a modified dose electrocardiogram H2 of a patient being administered a modified dose X2. The determination unit 112 determines whether or not there is a possibility of occurrence of a waveform abnormality that can be evaluated by an electrocardiogram, based on the modified dose electrocardiogram H2 indicated by the electrocardiogram data reacquired by the acquisition unit 111. The method by which the determination unit 112 determines whether or not there is a possibility of occurrence of a waveform abnormality based on the modified dose electrocardiogram H2 is the same as that for the initial dose electrocardiogram H1.

[0054] The output unit 113 outputs support information regarding whether or not the dosage of the medicine can be changed to the doctor terminal 3 via the network N based on the determination result by the determination unit 112. The output unit 113 re-outputs support information including, for example, electrocardiogram data and determination information indicating whether or not the waveform abnormality determined by the determination unit 112 may have occurred. When it is determined that the waveform abnormality determined by the determination unit 112 has occurred, the determination information may indicate the content of the waveform abnormality that may have occurred.

[0055] Furthermore, the output unit 113 may specify an increase candidate value when the determination unit 112 determines that there is no possibility of waveform abnormality occurring. The increase candidate value is a value to be added to or multiplied by the changed dose X2, which is assumed to be used for increasing the dose from the changed dose X2. The method in which the output unit 113 specifies the increase candidate value is the same as that in the case of the initial dose X1. Then, the output unit 113 re-outputs support information including the specified increase candidate value in addition to the electrocardiogram data and the determination information.

[0056] Furthermore, the output unit 113 may output support information including risk information indicating the degree of risk of increasing the dose. In this case, the output unit 113 compares multiple electrocardiograms at multiple doses (for example, the initial dose X1 and the changed dose X2) and specifies the degree of risk such that the greater the difference between them (for example, the difference in QT time), the greater the degree of risk, and the smaller the difference, the smaller the degree of risk. Then, the output unit 113 outputs risk information indicating the specified degree of risk in addition to the electrocardiogram data and the determination information. This allows medical personnel to refer to the support information to grasp not only the presence or absence of waveform abnormalities but also the degree of risk of increasing the dose, making it easier to determine whether or not to increase the dose.

[0057] The doctor terminal 3 displays the support information screen shown in Fig. 4(a) and Fig. 4(b) on the display again based on the support information output by the information output device 1. The medical staff again determines whether or not to increase the dosage based on the support information, and determines the changed dosage X2 when the next medication is administered to the patient.

[0058] The information output system S repeats obtaining an electrocardiogram of a patient who has been administered the modified dose X2 and outputting support information until the modified dose X2 reaches a predetermined upper limit or the dose is increased a predetermined number of times. When the modified dose X2 reaches a predetermined upper limit or the dose is increased a predetermined number of times, the medical staff determines, for example, the maximum initial dose X1 or modified dose X2 among the initial doses X1 or modified doses X2 when the determination unit 112 determines that there is no possibility of waveform abnormality occurring, as the dose suitable for the patient. This allows the medical staff to repeatedly try to increase the dose based on the support information within a range where no waveform abnormality occurs, and efficiently find a dose of the medicine that is more suitable for the patient.

[0059] When the determining unit 112 determines that there is a possibility of waveform abnormality occurring in the changed dose electrocardiogram H2 of a patient being administered the changed dose X2, the medical staff may reduce the changed dose X2 based on the support information. For example, the medical staff determines a value obtained by subtracting or dividing a predetermined value from or by the changed dose X2 as the reduced changed dose X2.

[0060] The electrocardiograph 2 measures the electrocardiogram of the patient who is prescribed the medicine at the reduced changed dose X2 during his / her daily life. The electrocardiograph 2 generates electrocardiogram data showing the measured electrocardiogram and transmits it to the information output device 1. The information output device 1 determines whether or not there is a possibility of waveform abnormality occurring in the changed dose electrocardiogram H2 of the patient who is prescribed the reduced changed dose X2, and re-outputs the support information. The doctor terminal 3 displays the support information screen shown in Fig. 4(a) and Fig. 4(b) on the display again based on the support information output by the information output device 1.

[0061] If the determining unit 112 determines that there is no possibility of waveform abnormality occurring for the reduced changed dose X2, the medical professional determines the reduced changed dose X2 as a dose suitable for the patient. If the determining unit 112 determines that there is a possibility of waveform abnormality occurring for the reduced changed dose X2, the medical professional may further reduce the changed dose X2 or may stop changing the dose. In this way, the medical professional can efficiently find a dose of the medicine that is more suitable for the patient by not only increasing but also decreasing the dose.

[0062] The information output device 1 may be capable of identifying a more suitable drug usage for a patient by repeatedly changing not only the drug dosage but also the drug usage method and acquiring an electrocardiogram of the patient and outputting the support information. In this case, in the information output device 1, the acquisition unit 111 acquires electrocardiogram data generated by the electrocardiograph 2, which indicates an electrocardiogram of a patient taking the drug at a predetermined dosage and usage method (e.g., taking the drug three times a day), via the network N. The determination unit 112 determines the presence or absence of a possibility of waveform abnormality occurring based on the electrocardiogram at the predetermined dosage and usage method using the above-mentioned method.

[0063] The output unit 113 outputs the support information to the doctor terminal 3 via the network N based on the determination result by the determination unit 112. The medical professional determines whether or not the dosage should be changed based on the support information output by the information output device 1, and determines the dosage for the next administration to the patient. At this time, the medical professional may change only the dosage, or may change both the dosage and the dosage. For example, the medical professional changes the dosage from three times a day to four times a day. As in the case of changing only the dosage, the medical professional repeatedly tries to change at least one of the dosage and the dosage based on the support information within a range where no waveform abnormality occurs, and determines at least one of the dosage and the dosage of the medicine suitable for the patient.

[0064] In this way, by referring to the support information output by the information output device 1, medical professionals can easily determine whether or not a patient who has been prescribed a drug is experiencing waveform abnormalities that can be evaluated by an electrocardiogram, while repeatedly attempting to change at least one of the usage method and dosage to the extent that no waveform abnormalities occur, and can identify at least one of the usage method and dosage of the drug that is most appropriate for the patient.

[0065] [Variations] In the above embodiment, an example has been described in which the information output system S is used to determine at least one of the usage and dosage when administering a medicine to an actual patient, but the information output system S may also be used to determine at least one of the usage and dosage in clinical trials of a medicine. In this case, the electrocardiograph 2 is attached to a subject as a patient who is administered the medicine for the purpose of the clinical trial. The electrocardiograph 2 measures the electrocardiogram of the subject who has been administered the medicine with a predetermined usage and dosage. The information output device 1 determines whether or not there is a possibility that a waveform abnormality has occurred in the subject who has been administered the medicine, and outputs support information.

[0066] The medical professional refers to the support information output by the information output device 1 based on the subject's electrocardiogram while repeatedly trying to change at least one of the usage and dosage within a range in which no waveform abnormality occurs. Based on the support information, the medical professional determines, as the usage and dosage of the pharmaceutical product, one of the usage and dosages when it is determined that there is no possibility of waveform abnormality occurring. This allows the medical professional to efficiently search for at least one of the appropriate usage and dosage of the pharmaceutical product within a range in which no waveform abnormality occurs in the subject based on the support information.

[0067] [Flowchart of information output method] Fig. 6 is a diagram showing a flowchart of an information output method executed by the information output system S according to this embodiment. The flowchart shown in Fig. 6 illustrates a case where the dosage of a medicine is changed, but the same applies to a case where the usage method of the medicine is changed. In Fig. 6, steps that are not performed by the information output system S (specifically, steps of administering medicine to a patient) are indicated by dashed lines.

[0068] First, the electrocardiograph 2 measures the electrocardiogram of the patient in a normal state. The electrocardiograph 2 generates electrocardiogram data indicating the measured electrocardiogram and transmits it to the information output device 1. In the information output device 1, the acquisition unit 111 acquires the electrocardiogram data indicating the electrocardiogram of the patient in a normal state generated by the electrocardiograph 2 via the network N (S11).

[0069] The determination unit 112 determines whether or not there is a possibility of occurrence of a waveform abnormality that can be evaluated by an electrocardiogram, based on the normal electrocardiogram indicated by the electrocardiogram data acquired by the acquisition unit 111 (S12). When the determination unit 112 determines that there is a possibility of occurrence of a waveform abnormality for the patient under normal conditions (NO in S13), the output unit 113 transmits to the doctor terminal 3 information indicating that the method of use and dosage for the patient cannot be determined based on the waveform abnormality, and ends the process.

[0070] When the judgment unit 112 judges that there is no possibility that a waveform abnormality has occurred in the patient under normal circumstances (YES in S13), the output unit 113 stores the electrocardiogram data of the patient's normal electrocardiogram in the memory unit 13.

[0071] A medical professional or a patient administers the medicine to the patient at an initial dose X1 (S14). The electrocardiograph 2 measures the electrocardiogram of the patient who has been administered the medicine at the initial dose X1 during his or her daily life. The electrocardiograph 2 generates electrocardiogram data indicating the measured electrocardiogram and transmits it to the information output device 1. In the information output device 1, the acquisition unit 111 acquires the electrocardiogram data generated by the electrocardiograph 2 indicating the electrocardiogram of the patient who is being administered the medicine at the initial dose X1 via the network N (S15).

[0072] The determination unit 112 determines whether or not there is a possibility of occurrence of a waveform abnormality that can be evaluated by an electrocardiogram, based on the initial dose electrocardiogram indicated by the electrocardiogram data acquired by the acquisition unit 111 (S16). When the determination unit 112 determines that there is a possibility of occurrence of a waveform abnormality in the patient being administered the initial dose X1 (NO in S17), the output unit 113 transmits support information including the electrocardiogram data and the determination information to the doctor terminal 3. The doctor terminal 3 displays the support information output by the information output device 1, and ends the process.

[0073] When the determination unit 112 determines that there is no possibility that waveform abnormality has occurred in the patient receiving medication at the initial dose X1 (YES in S17), the output unit 113 transmits support information including the electrocardiogram data, the determination information, and the increase candidate value to the doctor terminal 3. The doctor terminal 3 displays the support information output by the information output device 1.

[0074] The medical professional determines whether or not to increase the dose based on the support information, and determines the changed dose X2 for the next time the medicine is administered to the patient. The medical professional or the patient administers the medicine to the patient at the increased changed dose X2 (S18).

[0075] The electrocardiograph 2 measures the electrocardiogram of the patient who has been administered the medicine at the changed dose X2 during his / her daily life. The electrocardiograph 2 generates electrocardiogram data indicating the measured electrocardiogram and transmits it to the information output device 1. The acquisition unit 111 reacquires the electrocardiogram data indicating the electrocardiogram of the patient who is being administered the medicine at the changed dose X2, generated by the electrocardiograph 2, via the network N (S19).

[0076] The determination unit 112 determines whether or not there is a possibility of occurrence of a waveform abnormality that can be evaluated by an electrocardiogram, based on the changed-dose electrocardiogram indicated by the electrocardiogram data reacquired by the acquisition unit 111 (S20). When the determination unit 112 determines that there is no possibility of occurrence of a waveform abnormality in the patient being medicated at the changed dose X2 (YES in S21) and a predetermined termination condition (e.g., the changed dose X2 has reached an upper limit value) is not satisfied (NO in S22), the output unit 113 transmits support information including the electrocardiogram data, the determination information, and the increase candidate value to the doctor terminal 3. Here, the output unit 113 may output support information including risk information indicating the degree of risk of an increase in the dose, based on the initial dose electrocardiogram indicated by the electrocardiogram data of the patient being medicated at the initial dose X1 and the changed dose electrocardiogram indicated by the electrocardiogram data of the patient being medicated at the changed dose X2.

[0077] The doctor terminal 3 displays the support information output by the information output device 1. The medical staff again determines whether the dosage should be increased based on the support information, and determines the changed dosage X2 for the next administration to the patient. Then, the information output system S repeats steps S18 to S21.

[0078] When the determination unit 112 determines that there is no possibility of waveform abnormality occurring for the patient being medicated with the changed dose X2 (YES in S21) and a predetermined termination condition is satisfied (YES in S22), the output unit 113 transmits support information including the electrocardiogram data and the determination information to the doctor terminal 3. The doctor terminal 3 displays the support information output by the information output device 1. For example, the medical professional determines the maximum initial dose X1 or changed dose X2 among the initial doses X1 or changed doses X2 when it is determined by the determination unit 112 that there is no possibility of waveform abnormality occurring as the dose suitable for the patient.

[0079] When the judgment unit 112 judges that there is a possibility that a waveform abnormality has occurred for the patient who is being administered the changed dose X2 (NO in S21), the output unit 113 transmits support information including the electrocardiogram data and the judgment information to the doctor terminal 3. The doctor terminal 3 displays the support information output by the information output device 1. The medical worker determines the reduced changed dose X2 based on the support information. The medical worker or the patient administers the medicine to the patient at the reduced changed dose X2 (S23). Then, the information output system S repeats steps S19 to S21.

[0080] The electrocardiograph 2 measures the electrocardiogram of the patient who is administered the medicine at the reduced modified dose X2 during his / her daily life. The electrocardiograph 2 generates electrocardiogram data indicating the measured electrocardiogram and transmits it to the information output device 1. The acquisition unit 111 acquires the electrocardiogram data indicating the electrocardiogram of the patient who is administered the medicine at the reduced modified dose X2, generated by the electrocardiograph 2, via the network N (S24).

[0081] The determination unit 112 determines whether or not there is a possibility of occurrence of a waveform abnormality that can be evaluated by an electrocardiogram, based on the changed-dose electrocardiogram indicated by the electrocardiogram data acquired by the acquisition unit 111 (S25). The output unit 113 transmits support information including the electrocardiogram data and the determination information to the doctor terminal 3. The doctor terminal 3 displays the support information output by the information output device 1. If the determination unit 112 determines that there is no possibility of occurrence of a waveform abnormality for the reduced changed dose X2, the medical professional determines the reduced changed dose X2 as a dose suitable for the patient. If the determination unit 112 determines that there is a possibility of occurrence of a waveform abnormality for the reduced changed dose X2, the medical professional may further reduce the changed dose X2 or may stop changing the dose.

[0082] [Effects of the embodiment] According to the information output system S of this embodiment, the information output device 1 determines whether or not there is a possibility of waveform abnormality occurring based on the electrocardiogram of the patient who has been prescribed a drug during his or her daily life, and transmits support information regarding whether or not at least one of the drug's usage and dosage should be changed to the doctor's terminal 3. By referring to the support information on the doctor's terminal 3, a medical professional can easily grasp whether or not there is a waveform abnormality that can be evaluated by an electrocardiogram occurring in the patient who has been prescribed the drug, while repeatedly trying to change at least one of the usage and dosage to the extent that no waveform abnormality occurs, and can identify at least one of the drug's usage and dosage that is more suitable for the patient.

[0083] Although the present invention has been described above using the embodiments, the technical scope of the present invention is not limited to the scope described in the above embodiments, and various modifications and changes are possible within the scope of the gist of the present invention. For example, all or part of the device can be configured by distributing or integrating functionally or physically in any unit. In addition, new embodiments resulting from any combination of multiple embodiments are also included in the embodiments of the present invention. The effect of the new embodiment resulting from the combination combines the effect of the original embodiment.

[0084] The processor of the information output device 1 is a subject of each step (process) included in the information output method shown in Fig. 6. That is, the processor of the information output device 1 reads a program for executing the information output method shown in Fig. 6 from a storage unit, executes the program, and controls each unit of the information output system S to execute the information output method shown in Fig. 6. Some of the steps included in the information output method shown in Fig. 6 may be omitted, the order of the steps may be changed, and multiple steps may be performed in parallel. [Explanation of symbols]

[0085] S Information Output System 1. Information output device 11 Control section 111 Acquisition Department 112 Judgment section 113 Output section 2 Electrocardiograph 3. Doctor's terminal

Claims

1. 1. A method for use in determining at least one of a method and a dosage of a pharmaceutical agent that can be administered to a patient, comprising: The processor executes obtaining electrocardiogram data indicative of a life-long electrocardiogram of a patient administered said pharmaceutical product at said dosage and administration; determining whether or not there is a possibility that the patient has a waveform abnormality that can be evaluated by an electrocardiogram based on the electrocardiogram data, and outputting information regarding whether or not at least one of the dosage and administration method should be changed based on the determination result; The method comprising:

2. After at least one of the dosage and administration is changed, reacquiring the electrocardiogram data of the patient who has been administered the medicine according to the changed dosage and administration; determining whether or not the possibility exists based on the reacquired electrocardiogram data, and re-outputting information regarding whether or not at least one of the dosage and administration can be changed based on the result of the determination; The method of claim 1 further comprising:

3. The acquiring step includes sequentially acquiring the electrocardiogram data from an electrocardiograph worn by the patient during daily life. The method according to claim 1 or 2.

4. The output step determines whether or not there is a possibility that a waveform indicating that arrhythmia is occurring or that arrhythmia may occur is occurring as the waveform abnormality.

4. The method according to any one of claims 1 to 3.

5. The output step includes determining whether or not there is a possibility that a waveform indicating the occurrence of an adverse event that can be evaluated by an electrocardiogram is occurring as the waveform abnormality.

5. The method according to any one of claims 1 to 4.

6. The output step determines whether or not there is a possibility that the waveform abnormality has occurred by detecting at least one of QT prolongation, atrial fibrillation, ventricular tachycardia, supraventricular extrasystole, ventricular extrasystole, atrial flutter, and atrial tachycardia in the electrocardiogram data.

6. The method according to any one of claims 1 to 5.

7. The output step includes determining whether or not there is a possibility that the waveform abnormality has occurred by comparing the electrocardiogram data with normal electrocardiogram data that indicates an electrocardiogram of the patient under normal conditions.

7. The method according to any one of claims 1 to 6.

8. The output step includes transmitting information regarding whether or not at least one of the dosage and the method of use can be changed to an information terminal associated with a medical professional who examines the patient.

8. The method according to any one of claims 1 to 7.

9. The re-outputting step outputs information representing a risk of increasing the dose based on the electrocardiogram data of the patient who has been administered the medicine at the dose and the electrocardiogram data of the patient who has been administered the medicine at the changed dose. The method of claim 2.

10. The acquiring step acquires the electrocardiogram data of the patient who has been administered the pharmaceutical product for the purpose of treatment or clinical trial.

10. The method according to any one of claims 1 to 9.

11. A program used to determine at least one of a method of use and a dosage of a pharmaceutical agent that can be administered to a patient, comprising: The processor: obtaining electrocardiogram data indicative of a life-long electrocardiogram of a patient administered said pharmaceutical product at said dosage and administration; determining whether or not there is a possibility that the patient has a waveform abnormality that can be evaluated by an electrocardiogram based on the electrocardiogram data, and outputting information regarding whether or not at least one of the dosage and administration method should be changed based on the determination result; A program to execute.

12. 1. An apparatus for use in determining at least one of a method and a dosage of a pharmaceutical agent that can be administered to a patient, comprising: An acquisition unit that acquires electrocardiogram data indicating an electrocardiogram during the life of a patient administered the medicine according to the dosage and administration method; an output unit that determines whether or not there is a possibility that a waveform abnormality that can be evaluated by an electrocardiogram is occurring in the patient based on the electrocardiogram data, and outputs information regarding whether or not at least one of the dosage and administration method should be changed based on the determination result; An apparatus having the above configuration.

13. 1. A system for use in determining at least one of a method and a dosage of a pharmaceutical agent that can be administered to a patient, comprising: An information output device; An electrocardiograph, Equipped with The electrocardiograph comprises: A measuring unit for measuring an electrocardiogram during the daily life of a patient administered the medicine according to the dosage and administration method; A transmitter for transmitting electrocardiogram data indicative of the electrocardiogram; having The information output device includes: an acquisition unit that acquires the electrocardiogram data transmitted by the electrocardiograph; an output unit that determines whether or not there is a possibility that a waveform abnormality that can be evaluated by an electrocardiogram is occurring in the patient based on the electrocardiogram data, and outputs information regarding whether or not at least one of the dosage and administration method should be changed based on the determination result; The system has:

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