DEVICE, METHOD AND PROGRAM FOR EVALUATING THE SENSITIVITY OF BLOOD PRESSURE TO Na / K RATIO
The device and method analyze the Na/K ratio sensitivity of blood pressure to identify individual sensitivity types, enhancing the accuracy of hypertension management by providing personalized dietary guidance.
Patent Information
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- OMRON HEALTHCARE CO LTD
- Filing Date
- 2018-05-31
- Publication Date
- 2026-05-07
AI Technical Summary
Existing methods for managing hypertension through dietary sodium-potassium (Na/K) ratio guidance are inaccurate as they assume a linear correlation between systolic blood pressure and urine Na/K ratio, failing to account for individual variations in sensitivity types.
A device and method that evaluates the Na/K ratio sensitivity of blood pressure by creating a scatter plot of blood pressure and urine Na/K ratio data, identifying one of four predefined sensitivity types, and providing personalized guidance based on the determined type.
Enhances the accuracy of hypertension management by providing personalized dietary advice tailored to an individual's specific sensitivity type, improving the effectiveness of Na/K ratio-based dietary interventions.
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Abstract
Description
TECHNICAL AREA
[0001] The present invention relates to a device and a method for evaluating the Na / K ratio sensitivity of a blood pressure, namely the sensitivity of a blood pressure to a ratio of a sodium concentration to a potassium concentration in urine or in food intake. The present invention also relates to a program for instructing a computer to carry out the method. BACKGROUND TO THE STATE OF THE TECHNOLOGY
[0002] It is known that there is a significant positive correlation between blood pressure and the urinary sodium / potassium ratio (e.g., see non-patent literature 1 below). The ratios of sodium and potassium ingested with food and excreted in urine by humans are 86% and 77%, respectively (see non-patent literature 2 below). Based on this knowledge, a dietary regimen is implemented for a hypertensive patient to limit the sodium-potassium ratio (Na / K ratio) in their food intake. QUOTE LIST NON-PATENT LITERATURE
[0003] Non-patent literature 1: Naosuke Sasaki “Relationship of urinary findings, especially the sodium-potassium ratio, to blood pressure values in northeastern Japan”, “Medicine and Biology” or “Medizin und Biologie”, 39 (6), pp. 182-187, June 1956
[0004] Non-patent literature 2: “Nutritional Epidemiology”, written by Walter Willet, translated by Heizo Tanaka; 2nd edition; DAI-ICHI SHUPPAN Col, Ltd.; May 2003
[0005] DE 11 2012 003 248 T5 describes a device and a method for analyzing urine components, in particular for determining the concentration ratio between two specific components, such as sodium and potassium, in a daily urine sample. The device includes, among other things, a correlation memory, data input, calculation, display and storage sections, and a sensor. The determination is performed by correlating individual urine samples with daily urine samples, without volume measurement. Variants for handheld use, toilet mounting, and server operation are described. Recommendations based on the Na / K ratio are displayed.
[0006] MENTE, Andrew, et al. Association of urinary sodium and potassium excretion with blood pressure. New England Journal of Medicine, 2014, Vol. 371, No. 7, pp. 601-611, describes an international study of 102,216 adults from 18 countries in which the 24-hour excretion of sodium and potassium from a morning urine sample was estimated. A non-linear relationship between sodium and potassium excretion and blood pressure is shown, with high sodium intake, hypertension, and older age causing greater increases in blood pressure; potassium has a blood pressure-lowering effect. SUMMARY OF INVENTIONAL PROBLEMS
[0007] Up to now, in medical practice, the correlation between blood pressure (specifically systolic blood pressure (SBP)) and a urine Na / K ratio is approximated by a straight line L0, as shown in Fig. 9 is shown (in Fig.9. A data point, determined by the systolic blood pressure data and the corresponding urine Na / K ratio, is indicated by a symbol “◯”. The same applies to Fig. 7A to 7D (to be described later). For example, guidance is provided for restricting the Na / K ratio in the diet so that the systolic blood pressure falls below a hypertension reference value UL (= 135 mmHg) of a home blood pressure, which is required in guidelines for the management of hypertension (Japanese Society of Hypertension). In one example of the Fig. 9. Instructions are carried out so that the urine Na / K ratio is less than or equal to 3.5, and therefore the Na / K ratio in food intake is less than or equal to approximately 3.1 by change.
[0008] The present invention recorded systolic blood pressure data and urine Na / K ratio data multiple times over a specific time period for a large number of people, while the systolic blood pressure data and the urine Na / K ratio data were assigned to each other for each person, and performed an analysis by producing a scatter plot on a plane 99, which is formed by a horizontal axis (x-axis) representing the urine Na / K ratio and a vertical axis (y-axis) representing the systolic blood pressure, as shown in the Fig. Figures 7A to 7D are shown. One result found was that four types currently exist in the correlation between systolic blood pressure and the urine Na / K ratio. The four types are: - as in Fig.Figure 7A shows or illustrates a type in which, on level 99, the blood pressure changes along a straight line L1 with respect to the Na / K ratio over a range from a lower limit sub-range DL1 to an upper limit sub-range DU1 where the data points are distributed (this is referred to as a "first type"). - as in Fig. Figure 7B shows a type in which, on level 99, the blood pressure changes with respect to the Na / K ratio over the range from a lower limit sub-range DL2 to an upper limit sub-range DU2, where the data points are distributed while being more convex (downward convex) than the straight line L2, which connects the lower limit sub-range DL2 and the upper limit sub-range DU2, with respect to the horizontal axis (x-axis) (this is referred to as a 'second type'. A curve which approximates the upper distribution, indicated by the symbol C2). - as in Fig.Figure 7C shows a type in which, on level 99, the blood pressure changes with respect to the Na / K ratio over the range from a lower limit sub-region DL3 to an upper limit sub-region DU3, where the data points are distributed while being more concave (upwardly convex) than a straight line L3 connecting the lower limit sub-region DL3 and the upper limit sub-region DU3 with respect to the horizontal axis (x-axis) (this is referred to as a 'third type'. A curve that approximates the above distribution, indicated by symbol C3), and - as in Fig. 7D is shown, a type which shows no correlation between the Na / K ratio and blood pressure (this is referred to as a “fourth type”).
[0009] Accordingly, if for each person it is determined which of the four types (this is appropriately referred to as the "sensitivity type") the correlation between the systolic blood pressure and the urine Na / K ratio belongs to, and if this determination result is reflected in the guide for the hypertension patient or similar, the accuracy of the guidance or instruction will be increased.
[0010] Accordingly, one object of the present invention is to provide a device that evaluates the Na / K ratio sensitivity of blood pressure and can determine the sensitivity type of the individual. A further object of the present invention is to provide a method for evaluating the Na / K ratio sensitivity of blood pressure and being able to determine the sensitivity type of the individual. A yet further object of the present invention is to provide a program that causes a computer to carry out the method. SOLUTIONS TO THE PROBLEMS
[0011] To achieve the above objective, a device of the present invention is a device which evaluates the Na / K ratio sensitivity of a blood pressure, wherein the device comprises: a blood pressure monitor that measures blood pressure data; a measuring instrument that measures urine Na / K ratio data; a data input unit which inputs blood pressure data and urine Na / K ratio data, which are measured multiple times over a certain period of time, relating to a specific person from the blood pressure monitor or measuring instrument, while the blood pressure data and the urine Na / K ratio data are correlated; a type determination unit which produces a scatter plot representing data points determined by the Na / K ratio data and the blood pressure data, which are mapped to each other, on a plane formed by a first coordinate axis representing a Na / K ratio and a second coordinate axis representing blood pressure, and determines the sensitivity type of the person as one of four predefined types that currently exist, corresponding to a distribution of the data points in the scatter plot; and an output unit that outputs information representing a determination result of the type determination unit.
[0012] Typically, the "first coordinate axis" is the horizontal axis (x-axis) and the "second coordinate axis" is the vertical axis (y-axis), and this can be reversed.
[0013] “Information indicating the determination result” can largely include information relating to the Na / K ratio sensitivity of blood pressure, such as a name indicating the specific sensitivity type, the image representing the scatter plot, and advice appropriate for each of the four types.
[0014] In the apparatus of the present invention for evaluating the Na / K ratio sensitivity of blood pressure, a data input unit inputs blood pressure data and urine Na / K ratio data, measured multiple times over a specific time period, for a particular individual, while the blood pressure data and the urine Na / K ratio data are correlated. A type determination unit generates a scatter plot representing the data points determined by the Na / K ratio data and the blood pressure data, which are correlated on a plane defined by a first coordinate axis representing a Na / K ratio and a second coordinate axis representing blood pressure. The unit determines the individual's sensitivity type as one of four previously determined types that currently exist according to the distribution of data points in the scatter plot.An output unit displays the information representing the result of the type determination unit. In this way, according to the setup of the present invention, the sensitivity type of the person can be determined. Therefore, if, for example, the result of the determination is reflected in the guideline for the hypertension patient, the accuracy of the guideline is increased.
[0015] In the setup of an embodiment are the four types A first type in which, on the plane, the blood pressure changes with respect to the Na / K ratio along a straight line, over a range from a lower limit sub-region to an upper limit sub-region, where the data points are distributed, a second type in which, on the plane, the blood pressure changes with respect to the Na / K ratio over the range from a lower limit sub-region to an upper limit sub-region, where the data points are distributed while being more convexly curved than a straight line connecting the lower limit sub-region and the upper limit sub-region with respect to the first coordinate axis, a third type in which, on the plane, the blood pressure changes with respect to the Na / K ratio over the range from a lower limit sub-region to an upper limit sub-region, where the data points are distributed while being more concavely curved than a straight line connecting the lower limit sub-region and the upper limit sub-region with respect to the first coordinate axis, and a fourth type, which has no correlation between the Na / K ratio and blood pressure.
[0016] In the description, the "lower limit" of the distribution is a tail region on the side where both the Na / K ratio and blood pressure are low, assuming that blood pressure changes with a positive correlation with the Na / K ratio. Similarly, the "upper limit" of the distribution is a tail region on the side where both the Na / K ratio and blood pressure are high, assuming that blood pressure changes with a positive correlation with the Na / K ratio. The "tail region" is not limited to a single point but can encompass a range of values.
[0017] As described above, the first through fourth types are currently existing sensitivity types. Consequently, depending on the design of an embodiment, the person's sensitivity type can be determined as any of the currently existing sensitivity types.
[0018] In one embodiment, the type-determining unit performs the regression analysis on the distribution, using a quadratic function to obtain a quadratic regression curve and a p-value indicating significance, and determines whether the person's sensitivity type belongs to a group of type two and type three or a group of type one and type four, based on whether the p-value is less than a predetermined threshold. determines whether the person's sensitivity type is the second type or the third type, corresponding to a sign of a coefficient of a second-order term of the quadratic regression curve, if the person's sensitivity type belongs to the group of the second and third types, and furthermore, it performs regression analysis on the distribution using a linear function to obtain a linear regression line and a p-value that indicates significance when the person's sensitivity type belongs to the first type and fourth type groups, and determines whether the person's sensitivity type is first type or fourth type based on whether the p-value is less than a predetermined second threshold.
[0019] The "first threshold" is typically set to 0.05. Similarly, the "second threshold" is typically set to 0.05.
[0020] In one embodiment, the type-determining unit performs regression analysis on the distribution, using a quadratic function to obtain a quadratic regression curve and a p-value indicating significance. It then determines whether the individual's sensitivity type belongs to a group of type two and type three, or to a group of type one and type four, based on whether the p-value is less than a predefined first threshold. Subsequently, the type-determining unit determines whether the individual's sensitivity type is type two or type three, according to the sign of a coefficient of a second-order term in the quadratic regression curve, if the individual's sensitivity type belongs to the group of type two and type three.On the other hand, the type-determining unit further performs regression analysis on the distribution, using a linear function to obtain a linear regression line and the p-value, which indicates significance, when the individual's sensitivity type belongs to the first or fourth type group. It determines whether the individual's sensitivity type is first or fourth based on whether the p-value is less than a predefined second threshold. According to the configuration of one embodiment, the individual's sensitivity type can be accurately determined through simple processing.
[0021] In one embodiment, the data input unit assigns the measured blood pressure data to the measured Na / K ratio data over a predetermined constant time difference.
[0022] Generally, the effects of sodium and potassium ingested through a meal are first reflected in blood pressure and appear in the urine sodium / potassium ratio approximately half a day (12 hours) later. Therefore, in one embodiment, the data input unit maps the measured blood pressure data to the measured sodium / potassium ratio data over a predetermined, constant time interval (typically 12 hours). This allows for easy input of the measured blood pressure data and the measured sodium / potassium ratio data while they are being mapped to each other.
[0023] The design of one embodiment further features: a time difference acquisition unit which acquires or obtains a time difference between a change over time in the measured blood pressure data and a change over time in the measured Na / K ratio data with respect to the person; and a data mapping unit that maps the measured blood pressure data to the measured Na / K ratio data over the time difference.
[0024] In one embodiment, the time-difference acquisition unit detects the time difference between a change over time in the measured blood pressure data and a change over time in the measured Na / K ratio data for a given individual. The data mapping unit maps the measured blood pressure data to the measured Na / K ratio data based on this time difference. Thus, the measured blood pressure data and the measured Na / K ratio data can be accurately mapped to each other for each individual.
[0025] In one embodiment, the output unit outputs an image representing the scatter plot.
[0026] In the description, the term "output of an image" in the broadest sense includes displaying the image on the display screen, printing the image on paper, and storing non-transient data that represents the image in a recording medium, such as a memory device.
[0027] In one embodiment, the output unit displays an image representing the scatter plot. This allows a user (typically a medical professional, such as a doctor or nurse) to intuitively identify, by viewing the image, which of the four sensitivity types applies to the individual.
[0028] The device of one embodiment further comprises a two-line approximation unit, which has a first straight line and a second straight line, which pass through the lower boundary part region and the upper boundary part region respectively, and they are connected and bent relative to each other at a certain transition point, along the quadratic regression curve, in order to approximate the quadratic regression curve to the plane when the sensitivity type of the person is the second type or the third type.
[0029] At this point, for example, the point furthest from the single line between the lower limit section and the upper limit section can be assumed to be the “determinate transition point” on the quadratic regression curve.
[0030] In one embodiment, a two-line approximation unit comprises a first straight line and a second straight line, each passing through the lower and upper boundary regions, respectively. These lines are connected and curved at a specific transition point along the quadratic regression curve to approximate the quadratic regression curve to the plane when the individual's sensitivity type is either type II or type III. Thus, the area from the lower boundary region to the transition point can be approximated by the first straight line, and the area from the transition point to the upper boundary region can be approximated by the second straight line. Consequently, the accuracy of the approximation can be improved compared to the case where the correlation between blood pressure and the urine Na / K ratio is simply approximated by a straight line.The user can easily recognize a slope in the correlation between blood pressure and urine Na / K ratio, while the slope of the correlation between blood pressure and urine Na / K ratio is divided into the range from the lower limit part range to the transition point and the range from the transition point to the upper limit part range.
[0031] In one embodiment, the output unit outputs an image representing the first and second straight lines on the plane when the person's sensitivity type is the second type or the third type.
[0032] In one embodiment, the output unit displays an image representing the first and second straight lines on the plane when the person's sensitivity type is either the second or third type. The user can then intuitively observe that the slope of the first straight line and the slope of the second straight line differ before and after the transition point. Specifically, if the person's sensitivity type is the second type, the user can intuitively see that the slope of the first straight line from the lower boundary region to the transition point is relatively small, and that the slope of the second straight line from the transition point to the upper boundary region is relatively large.On the other hand, if the person's sensitivity type is the third type, the user can intuitively recognize that the slope of the first straight line from the lower boundary part area to the transition point is relatively large and that the slope of the second straight line from the transition point to the upper boundary part area is relatively small.
[0033] In one embodiment, the output unit displays an image representing a blood pressure reference line on the plane.
[0034] In this description, the "reference line" for blood pressure, for example, means a line representing the blood pressure reference (including the hypertension reference of 135 mmHg and 85 mmHg at home) according to the "Guidelines for the Management of Hypertension 2014" from the Japanese Society of Hypertension. The "reference line" could also be a classification published by the World Health Organization (WHO) / International Society of Hypertension (ISH) or a classification published by the American Joint Committee on Hypertension (JNC) / American Heart Association (AHA).
[0035] In one embodiment, the output unit displays an image representing a blood pressure reference line on a plane. Therefore, if the user can intuitively identify the Na / K ratio range in which the person's blood pressure is lower than the reference line, they can do so by viewing the image.
[0036] In one embodiment, the output unit provides advice according to the person's sensitivity type within the four types.
[0037] In one embodiment, the output unit provides advice based on the individual's sensitivity level within the four categories. Consequently, appropriate advice can be provided to the individual.
[0038] The design of one embodiment further features: an advice table in which example sentences of the advice, corresponding to the four types, are stored, at least one of the example sentences of the advice which contains a field for which a value should be applied, corresponding to the distribution of the data points; and A suggestion generation unit that reads the sentence example, according to the person's sensitivity type, from the suggestion table and generates a suggestion by applying a value according to the distribution of data points to the field, if the sentence example includes the field.
[0039] One embodiment includes an advice table containing sample advice sentences corresponding to the four types, with at least one of the sample sentences containing a field for which a value should be applied according to the distribution of data points. An advice generation unit reads the sample sentence corresponding to the person's sensitivity type from the advice table and generates advice by applying a value corresponding to the distribution of data points in the field, if the sample sentence contains that field. Thus, the advice, corresponding to the distribution of data points, can be generated through simple processing. Consequently, the appropriate advice can be provided to the person.
[0040] The design of one embodiment further features: a table of advice in which sample sentences of the advice, corresponding to the four types, are stored, wherein the sample sentences of the second type include a field for which a value should be applied, corresponding to the transition point; and A suggestion generation unit that reads the sentence example of the second type from the suggestion table if the person's sensitivity type is the second type, and generates a suggestion by applying a value corresponding to the transition point for the sentence example field.
[0041] One embodiment includes an advice table containing sample advice sentences corresponding to the four types. The sample sentences of the second type include a field for which a value should be applied, corresponding to the transition point. An advice generation unit reads the sample sentence of the second type from the advice table when the individual's sensitivity type is the second type and generates advice by applying a value corresponding to the transition point to the sample sentence field. Thus, the advice can be provided according to the transition point through simple processing. Consequently, the most appropriate advice can be provided to the individual whose sensitivity type is the second type.
[0042] The design of one embodiment further features: a blood pressure monitor that measures blood pressure data; and a measuring instrument that measures the urine Na / K ratio data.
[0043] In this facility, blood pressure data is measured using a blood pressure monitor. Urine sodium / potassium ratio data is measured using a measuring instrument. Therefore, blood pressure and urine sodium / potassium ratio data are easily measured at numerous time points over a specific period.
[0044] Ideally, the input of blood pressure data from the blood pressure monitor via the data input unit and the input of urine Na / K ratio data from the monitor via the data input unit should be performed either wired or wirelessly.
[0045] From another perspective, a method of the present invention is a method for determining the Na / K ratio sensitivity of a blood pressure using the device according to the invention, wherein the method comprises: Input of blood pressure data and urine Na / K ratio data, which are measured at a large number of times over a specific period with respect to a specific person by the blood pressure monitor or measuring instrument, while the blood pressure data and the Na / K ratio data are correlated; Creating a scatter plot representing data points determined by the Na / K ratio data and the blood pressure data, which are mapped to each other on a plane formed by a first coordinate axis representing the Na / K ratio and a second coordinate axis representing blood pressure, and determining the individual's sensitivity type as one of four predefined types currently existing in the scatter plot, corresponding to a distribution of data points; and Output of information representing a determination result.
[0046] According to the method of the present invention, the sensitivity type of the person can be determined. Therefore, if the result of the determination is reflected in the instructions or guide for the hypertension patient, for example, the accuracy of the instructions is increased.
[0047] From another perspective, a program of the present invention is a program that causes a computer to carry out the method.
[0048] According to the program of the present invention, the method can be carried out by a computer.
[0049] Further devices according to the invention are defined by claims 15 to 17. ADVANTAGEOUS EFFECTS OF THE INVENTION
[0050] As is clearly evident from the above, according to the setup and method for evaluating the Na / K ratio sensitivity of blood pressure according to the present invention, the sensitivity type of a person can be determined. According to the program of the present invention, the method can be carried out by a computer. BRIEF DESCRIPTION OF THE DRAWINGS Fig. Figure 1 is a view that represents or illustrates a block configuration of a device that evaluates the Na / K ratio sensitivity of a blood pressure, according to an embodiment of the present invention. Fig. Figure 2 is a view which represents a workflow of a method for evaluating the Na / K ratio sensitivity of the blood pressure of the embodiment, wherein the method is carried out by the device in Fig. 1 is carried out. Fig.3 is a view that presents a detailed process for determining (type determination) a person's sensitivity type as one of four currently existing types, with the determination in the workflow in Fig. 2 is included. Fig. 4A is a scatter plot that represents a distribution of data points determined by urine Na / K ratio data and blood pressure data when the sensitivity type of the person is a first type (straight line type). Fig. Figure 4B is a scatter plot showing the distribution of data points determined by the urine Na / K ratio data and the blood pressure data when the person's sensitivity type is a second type (downward convex type). Fig.4C is a scatter plot that represents the distribution of data points determined by the urine Na / K ratio data and the blood pressure data when the person's sensitivity type is a third type (upward convex type). Fig. 4D is a scatter plot that represents the distribution of data points determined by the urine Na / K ratio data and the blood pressure data when the person's sensitivity type is a fourth type (not a correlation type). Fig. 5A is a view that represents a display example, which is output when the person's sensitivity type is the first type (straight line type). Fig. 5B is a view that represents a display example, which is output when the person's sensitivity type is the second type (downward convex type). Fig.5C is a view that represents a display example, which is output when the person's sensitivity type is the third type (upward convex type). Fig. 5D is a view that represents a display example, which is output when the person's sensitivity type is the fourth type (no correlation type). Fig. 6A is a view that represents a processing flow for setting a time difference that maps the measured blood pressure data to the measured Na / K ratio data for each person. Fig. 6B is a view that presents an example in which the measured blood pressure data and the measured Na / K ratio data change over time. Fig.Figure 7A is a scatter plot that represents the distribution of data points determined by the urine Na / K ratio data and the blood pressure data of the first type (straight line type) in the four types that currently exist as a correlation between systolic blood pressure and the urine Na / K ratio. Fig. Figure 7B is a scatter plot that represents the distribution of data points determined by the urine Na / K ratio data and the second type of blood pressure data (downward convex type) in the four types that currently exist as a correlation between systolic blood pressure and the urine Na / K ratio. Fig.7C is a scatter plot that represents the distribution of data points determined by the urine Na / K ratio data and the blood pressure data of the third type (upward convex type) in the four types that currently exist as a correlation between systolic blood pressure and the urine Na / K ratio. Fig. 7D is a scatter plot that represents the distribution of data points determined by the urine Na / K ratio data and the blood pressure data of the fourth type (no correlation type) in the four types that currently exist as a correlation between systolic blood pressure and the urine Na / K ratio. Fig. Figure 8 is a view that provides an example in which a horizontal axis with a scale indicating the Na / K ratio in food intake is parallel to the scatter plot in Fig. 5B has been added. Fig.9 is a view which represents a conventional way to evaluate or assess the correlation between blood pressure and the Na / K ratio in urine. DESCRIPTION OF THE EXECUTION FORMS
[0051] An embodiment of the present invention is described in detail below with reference to the drawings. (Schematic configuration of the facility)
[0052] Fig. Figure 1 represents a block configuration of a device 1 which evaluates the Na / K ratio sensitivity of a blood pressure, according to an embodiment of the present invention.
[0053] The device 1 includes a control element 11, a data input unit 12, an operating unit 13, a memory 14 and an output unit 18. In this example, a blood pressure monitor 30, which measures blood pressure data, and a Na / K meter 31, which serves as a measuring instrument that measures urine Na / K ratio data, are connected to the data input unit 12 by radio communication.
[0054] The Blood Pressure Monitor 30 measures a person's blood pressure data each time a measurement instruction is received from the person (spot measurement). In this example, the Blood Pressure Monitor 30 is a commercially available blood pressure monitor (in this example, the "OMRON Upper Arm Blood Pressure Monitor HEM-7511T", manufactured by OMRON Healthcare Co., Ltd.).
[0055] The Na / K meter 31 measures the urine Na / K ratio at any time, every time the measurement instruction is received from the person (spot measurement). In this example, the Na / K meter 31 is a commercially available measuring instrument (in this case, "OMRON Na"). + K + scan HEU-001F“, manufactured by OMRON Healthcare Co., Ltd.).
[0056] The control element 11 comprises a CPU (central processing unit) operated by software (computer program) and an auxiliary circuit of the CPU and performs various parts of the processing (which will be described later), according to a program and data which are stored in the memory 14.
[0057] The control unit 13 includes a familiar keyboard and mouse and functions for user input of commands and various information. Examples of commands include one to instruct input or the start of processing, and one to instruct the recording of image data.
[0058] The data input unit 12 is equipped with a known input interface and sequentially outputs the blood pressure data, measured multiple times by the blood pressure monitor 30 over a specific period, and the urine sodium / potassium ratio data, measured multiple times by the sodium / potassium meter 31 over essentially the same period, in real time for each measurement relating to a specific person, by processing the control element 11 in this example. The input blood pressure data and the urine sodium / potassium ratio data are correlated with each other by a 12-hour time difference through the processing of the control element 11 (to be described later) and are stored in the input data memory 15 together with the date and time of each measurement.
[0059] In this example, memory 14 includes input data memory 15, which consists of RAM (access memory), used as a workspace necessary for executing a program using control 11, a hard disk drive in which a basic program executed by control 11 is stored, an EEPROM (electrically rewritable non-volatile memory) in which data is stored non-temporarily, an image data memory 16, and an advice table 17.
[0060] The input data memory 15 stores blood pressure and urine sodium / potassium ratio data, measured multiple times over a certain period, relating to a specific individual, along with the date and time of each measurement, while the blood pressure and urine sodium / potassium ratio data are linked. When input data is stored for multiple individuals, an identification number (ID) is added for each person, and the input data is stored for each individual.
[0061] The image data storage 16 stores the output image data, which is produced during processing (to be described later), of the control element 11.
[0062] Advice table 17 stores sample sentences of the advice, corresponding to four types (first to fourth type), which represent the correlation between systolic blood pressure and the urine Na / K ratio, as described in Fig. 7A to 7D are described, which are described above (or Fig. 4A to 4D (to be described later). An example sentence of the instruction will be described later.
[0063] In this example, the output unit is 18 in Fig. The control unit 11 is equipped with an LCD (liquid crystal display element) and displays various pieces of information, such as the processing result of the control element 11, in this example specifically information that displays the determination result on the display screen. The output unit 18 can include a printer (driver), perform printing on paper, and output a processing result. (Method of evaluating the Na / K ratio sensitivity of blood pressure)
[0064] Under the control of control element 11, facility 1 operates as a whole in accordance with the processing sequence in Fig. 2. (1) Data entry
[0065] As in step S1 of the Fig.As shown in Figure 2, the control element 11 sequentially inputs the blood pressure data, measured multiple times by the blood pressure monitor 30 over a certain time period, and the urine sodium / potassium ratio data, measured multiple times by the sodium / potassium meter 31 over essentially the same period as the blood pressure data, or in real time for each measurement, to a specific person via the data input unit 12. In this example, the input blood pressure data and the urine sodium / potassium ratio data are correlated across the 12-hour time difference by the processing of the control element 11. That is, the input of blood pressure data at a specific time is linked to the input of the urine sodium / potassium ratio 12 hours later.The reason for the mapping over the 12-hour time difference is that, generally, the effect of sodium and potassium ingested by a person through a meal is first seen in blood pressure and appears in the urine sodium / potassium ratio approximately half a day (12 hours) later. Control element 11 stores the blood pressure data and the urine sodium / potassium ratio data in input data memory 15, along with the date and time of each measurement, while the blood pressure data and the urine sodium / potassium ratio data are linked or mapped to each other.
[0066] To accurately evaluate the Na / K ratio sensitivity of blood pressure, it is desirable that the period in which the person measures blood pressure data and urine Na / K ratio data be greater than or equal to several days, and that the number of measurement time points be greater than or equal to 20.
[0067] Subsequently, as shown in step S2, control element 11 creates a scatter plot in which data points (indicated by a symbol “◯”), determined by the Na / K ratio data and the blood pressure data that are mapped to each other, are represented on a plane 99, which is formed by a horizontal axis (x-axis) as a first coordinate axis representing the Na / K ratio, and a vertical axis (y-axis) as a second coordinate axis representing the blood pressure, as shown in Fig. The resulting scatter plot is displayed in sections 4A to 4D. The generated scatter plot is stored in image data storage 16. (2) Type determination
[0068] As in step S3 of the Fig.As shown in Figure 2, the control element 11 acts as a type determination unit and determines a sensitivity type of the person as one of four predefined types (first to fourth type) that currently exist, according to a distribution of the data points in the scatter plot (type determination).
[0069] In the same way as with reference to Fig. The four types are described in sections 7A to 7D. - as in Fig. Figure 4A shows the first type, in which the blood pressure changes in relation to the Na / K ratio at level 99 along a straight line L1 over the area from a lower limit sub-area DL1 to an upper limit sub-area DU1, on which the data points are distributed. - as in Fig.Figure 4B shows the second type, in which on level 99 the blood pressure changes with respect to the Na / K ratio, over the area from a lower limit sub-area DL2 to an upper limit sub-area DU2, on which the data points are distributed, while it is more convexly curved (downward convex) than a straight line L2, which connects the lower limit sub-area DL2 and the upper limit sub-area DU2 with respect to the horizontal axis (x-axis), - as in Fig. Figure 4C shows the third type, in which, on level 99, the blood pressure changes with respect to the Na / K ratio, across the range from a lower limit sub-region DL3 to an upper limit sub-region DU3, where the data points are distributed while being more concavely curved (upwardly convex) than a straight line L3 connecting the lower limit sub-region DL3 and the upper limit sub-region DU3 with respect to the horizontal axis (x-axis), and - as in Fig. The fourth type, shown in 4D, shows no correlation between the Na / K ratio and blood pressure. (Na / K) min and (Na / K) max, displayed on each horizontal axis (x-axis), represent a minimum and maximum value of the Na / K ratio data, respectively.
[0070] Fig. 3 represents a specific procedure for determining the type.
[0071] As in step S21 of the Fig. Figure 3 shows that a regression analysis is performed on the distribution, using a quadratic function to obtain a quadratic regression curve and a p-value indicating significance. In this example, a regression analysis is performed using the least squares method, where the quadratic function is y = ax². 2+ bx + c (where a, b, c represent a coefficient of a second-order term, a coefficient of a first-order term, and a constant, respectively) is used to obtain a quadratic regression curve that approximates the distribution above (that is, a, b, and c are preserved). A p-value, indicating the significance of the regression analysis, is then obtained.
[0072] Next, it is determined whether the p-value is less than a predefined first threshold (0.05 in this example), as shown in step S22. The determination that the person's sensitivity type belongs to the second or third type group is performed if the p-value is less than the first threshold (= 0.05) (YES in step S22). In this case, the distribution follows a curve C2, which is convex downwards, as shown in Fig.4B is shown, or one along a curve C3 which is upwardly convex, as shown in Fig. 4C is shown. For this reason, processing proceeds to step S23 in Fig. 3. To determine whether the person's sensitivity type is the second or third type, according to the sign of the coefficient a of the second-order term of the quadratic regression curve. That is, determining that the person's sensitivity type is the second type (i.e., the downward convex type), as in Fig. As shown in 4B, the procedure is carried out (step S24) if the coefficient a is greater than zero (YES in step S23). On the other hand, the determination that the person's sensitivity type is the third type (that is, the upward convex type), as in Fig. 4C shown (step S25), is performed if the coefficient a is less than zero (NO in step S23).
[0073] On the other hand, the determination is made that the person's sensitivity type belongs to the first and fourth types if the p-value is greater than or equal to the first threshold (= 0.05), in step S22 of the Fig.3 (NO in step S22). In this case, processing continues with step S26, and a regression analysis is performed on the distribution, using a linear function to obtain a linear regression line and the p-value, which indicates significance. In this example, the regression analysis is performed using the least squares method, employing a linear function y = dx + e (where d and e represent a coefficient of a first-order term and a constant, respectively) to obtain the linear regression line L1, which approximates the distribution above (that is, d and e are preserved). A p-value, indicating the significance of the regression analysis, is obtained.
[0074] Next, it is determined whether the p-value is less than a predefined second threshold (0.05 in this example), as shown in step S27. The determination that the person's sensitivity type is the first type (i.e., the straight line type), as in Fig. The procedure shown in 4A is carried out (step S28) if the p-value is less than the second threshold (= 0.05) (YES in step S27). On the other hand, in step S27 the Fig. 3. The determination was carried out that the person's sensitivity type is the fourth type (that is, the type with no correlation), as in Fig. 4D is displayed (step S29) if the p-value is greater than or equal to the first threshold (= 0.05) (NO in step S27).
[0075] The determination is carried out in this way. According to this method of determination, the person's sensitivity type, as one of the currently existing sensitivity types, can be precisely determined through simple processing. The person's sensitivity type, obtained as a result of this type determination, is stored in memory 14. A determination coefficient R 2 = 0.9031 in the example of the Fig. 4A, the coefficient of determination R 2 = 0.9031 in the example of the Fig. 4B and the coefficient of determination R 2 = 0.9074 in the example of the Fig. 4C. Then the processing returns to step S4 of the main process ( Fig. 2). (3) Two-line approximation
[0076] If the person's sensitivity type, obtained as a result of the type determination, is the second or third type (YES in step S4 of the Fig.2), processing continues to step S5, and control 11 acts as a two-line approximation unit to process the approximation of the quadratic regression curve C2 or C3 to the two straight lines on plane 99. Fig. 4B or Fig. to carry out 4C.
[0077] If, for example, the person's sensitivity type is the second type, a straight line L21 and a second straight line L22 will be obtained, which run through the lower limit subregion DL2 and the upper limit subregion DU2 respectively, and are joined and curved at a specific transition point P2 along the quadratic regression curve C2, in order to shape the quadratic regression curve C2 on the plane 99 in Fig.4B to approximate or approximate. In this example, the transition point P2 is one where the quadratic regression curve C2 is furthest separated from a straight line L2, which connects the lower limit region DL2 and the upper limit region DU2. Currently, a perpendicular line L20 is drawn from the straight line L2 to the curve C2, and a point on the curve C2 where the length of the perpendicular line L20 is maximal is obtained as the transition point P2. A straight line passing through the lower limit region DL2 (specifically, a point on the straight line L2 corresponding to the minimum value (Na / K) min of the Na / K ratio data) and the transition point P2 are obtained as the first straight line L21.A straight line passing through the transition point P2 and the upper limit subregion DU2 (specifically a point on the straight line L2 corresponding to the maximum value (Na / K) max of the Na / K ratio data) are obtained as the second straight line L22. The obtained first straight line L21 and the second straight line L22 are stored while they are on the scatter plot in . Fig. 4B, which is stored in image data storage 16, has been overwritten.
[0078] In this case, the area from the lower boundary sub-area DL2 to the transition point P2 can be approximated by the first straight line L21, and the area from the transition point P2 to the upper boundary sub-area DU2 can be approximated by the second straight line L22.
[0079] Consequently, the accuracy of the approximation can be improved compared to the case where the correlation between blood pressure and the urine Na / K ratio is simply approximated by a straight line L2. The user can easily recognize a slope in the correlation between blood pressure and the Na / K ratio, as the slope of the correlation between blood pressure and the urine Na / K ratio is divided into the range from the lower limit section DL2 to the transition point P2 and the range from the transition point P2 to the upper limit section DU2.
[0080] Similarly, if the person's sensitivity type is the third type, a first straight line L31 and a second straight line L32, which pass through the lower boundary subregion DL3 and the upper boundary subregion DU3 respectively, and are connected and curved at a certain transition point P3 along the quadratic regression curve C3, are obtained to approximate the quadratic regression curve C3 on the plane 99 in Fig.4C. In this example, the transition point P3 is one where the quadratic regression curve C3 is furthest separated from a straight line L3 connecting the lower limit region DL3 and the upper limit region DU3. Currently, a perpendicular line L30 is drawn from the straight line L3 to the curve C3, and a point on the curve C3 where the length of the perpendicular line L30 is maximal is obtained as the transition point P3. A straight line passing through the lower limit region DL3 (specifically, a point on the straight line L3 corresponding to the minimum value (Na / K) min of the Na / K ratio data) and the transition point P3 are obtained as the first straight line L31.A straight line passing through the transition point P3 and along the upper limit subregion DU3 (specifically, a point on the straight line L3 corresponding to the maximum value (Na / K) max of the Na / K ratio data) is obtained as the second straight line L32. The first straight line L31 and the second straight line L32 are stored while they are plotted on the scatter plot in . Fig. 4C are overwritten, which is stored in the image data memory 16.
[0081] In this case, the area from the lower boundary sub-area DL3 to the transition point P3 can be approximated by the first straight line L31, and the area from the transition point P3 to the upper boundary sub-area DU3 can be approximated by the second straight line L32. Consequently, the accuracy of the approximation can be improved compared to the case where the correlation between blood pressure and the urine Na / K ratio is simply approximated by a straight line L3. The user can easily recognize a slope in the correlation between blood pressure and the urine Na / K ratio, as the slope of the correlation between blood pressure and the urine Na / K ratio is divided into the area from the lower boundary sub-area DL3 to the transition point P3 and the area from the transition point P3 to the upper boundary sub-area DU3. (4) Drafting a recommendation
[0082] After that, the processing proceeds to step S6 in Fig. 2 continued, and the control element 11 functions as an advice generation unit or advice creation unit to create advice of the second or third type.
[0083] If the sensitivity type of the person, which is obtained as a result of the type determination, is the first type (NO in step S4 and YES in step S7 of the Fig. 2), processing continues to step S8, and control 11 acts as the advice creation unit for the advice, corresponding to the first type.
[0084] If the person's sensitivity type, obtained as a result of the type determination, is the fourth type (NO in step S4 and NO in step S7 of the Fig. 2), processing continues to step S9, and control 11 acts as the advice creation unit for the advice, corresponding to the fourth type.
[0085] Specifically, the advice for the four types (first to fourth types) is generated as follows.
[0086] For example, it is assumed that a sentence example of the advice for the first type stored in the advice table 1 is such as shown in Table 1. (Table 1) Example sentence of advice for the first type Her blood pressure was 135 mmHg (a hypertension reference value of a home blood pressure monitor) when her Na / K ratio was "AAA". ⇒ To keep your blood pressure within the reference range To maintain this, you should avoid meals with a Na / K ratio of "AAA" or higher. ⇒ The meal, which has a Na / K ratio of "AAA" possesses, was from the “□ / □□” (date).
[0087] At this point, a numerical value of the Na / K ratio (two significant figures) is applied to a field of "AAA" (to be described later). A numerical value representing the month / day is applied to a field in the "□ / □□" column.
[0088] If the person's sensitivity type is the first type used to determine the distribution of data points in Fig.To represent 4A, the x-coordinate (Na / K ratio coordinate) of an intersection point PX1 of a linear regression line L1 and a blood pressure reference value UL (= 135 mmHg) is equal to 3.3. Accordingly, control element 11 reads the sentence example in Table 1 from the advice table 17, applies a value corresponding to the distribution of the data points of the field of "AAA" in the sentence example, in this example applies the value of 3.3 of the x-coordinate of the intersection point PX1 to the field of "AAA" and generates the advice in Table 1-A. (Table 1-A) Advice for the first type Her blood pressure was 135 mmHg (the hypertension reference value of blood pressure at home) when the Na / K ratio was 3.3. ⇒ Take the meal which has a Na / K ratio If your blood pressure is 3.3 or higher, it is not recommended to keep it within the reference range. ⇒ The meal, which had a Na / K ratio of 3.3- It was sitting from 5 / 08 (date).
[0089] A sample sentence of the advice for the second type, which is stored in the advice table 17, includes (i) a sample advice sentence regarding the area from the lower boundary sub-area to the transition point and (ii) a sample advice sentence regarding the area from the transition point to the upper boundary sub-area, and is shown in Table 2. (Table 2) Example sentence of the advice for the second type (i) A significant increase in your blood pressure will Not recognized up to a Na / K ratio of "BBB". ⇒ You can confidently eat up to one meal. sen, which has a Na / K ratio of "BBB". ⇒ The meal, which has a Na / K ratio of "BBB" possesses, was from “◇ / ◇◇” and “∇ / ∇∇” (date). (ii)Reference relationship Her blood pressure became 135 mmHg (the high blood pressure reading at home) when there was a Na / K “CCC”. ⇒ To Keep your blood pressure within the reference range. You should avoid eating meals that have a Na / K ratio of "CCC" or higher. ⇒ The A meal which has a Na / K ratio of "CCC" possesses, was from the “□ / □□” (date).
[0090] Numerical values of the Na / K ratios (two significant digits) are applied to the fields "BBB" and "CCC" through processing (described later). Specifically, a value corresponding to a Na / K ratio coordinate of the transition point P2 is applied to the field "BBB". The numerical values of the month / day are applied to the field "◇ / ◇◇", the field "V / VV", and the field "□ / □□".
[0091] If the person's sensitivity type is the second type, to determine the distribution of data points in Fig. To illustrate 4B, the x-coordinate (Na / K ratio coordinate) of the transition point P2, where the first straight line L21 and the second straight line L22 are connected, is 2.5. The x-coordinate (Na / K ratio coordinate) of the intersection point PX2 between the second straight line L22 and the hypertension reference value UL (= 135 mmHg) is 3.5. Thus, control element 11 reads the sentence example in Table 2 from the advice table 17, applies the x-coordinate value of 2.5 at the transition point P2 and the x-coordinate value of 3.5 at the intersection point PX2 to the fields of "BBB" and "CCC" in the sentence example, respectively, and generates the advice in Table 2-A. (Table 2-A) Advice for the second type (i) A significant increase in your blood pressure will not be detected until your Na / K ratio reaches 2.5. ⇒Si They can eat confidently until the mealtime. which has a Na / K ratio of 2.5. ⇒ D The meal, which has a Na / K ratio of 2.5- It was sitting, from "5 / 09" and "5 / 20" (date). (ii) Her blood pressure was 135 mmHg (high blood pressure). (Reference value of blood pressure at home), when the Na / K ratio was 3.5. ⇒ U to keep your blood pressure within the reference range- ten, you should not eat a meal that has a Na / K ratio of 3.5 or more. ⇒ D The meal, which has a Na / K ratio of 3.5- It was sitting from 5 / 11 (date).
[0092] It is assumed that a sentence example of the advice for the third type, which is stored in the advice table 11, is one that is shown in Table 3. (Table 3) Example sentence of the advice for the third type (i) Her blood pressure was 135 mmHg (high blood pressure). (Reference value of blood pressure at home), if a Na / K ratio was “DDD”. ⇒ U to keep your blood pressure within the reference range To maintain this, you should avoid eating meals that have a Na / K ratio of "DDD" or higher. ⇒ The meal, which has a Na / K ratio of "DDD" possesses, was from the “□ / □□” (date). (ii) They have a significant impact on blood pressure, even when the Na / K ratio is low. ⇒ Your Blood pressure will be very high, even if you If you have a low Na / K ratio, be careful not to increase your Na / K ratio as much as possible.
[0093] At this point, a numerical value for the Na / K ratio (two significant digits) is created in the "DDD" field by the processing (to be described later). A numerical value representing the month / day is created in a field of the "□ / □□" column.
[0094] If the person's sensitivity type is the third type, to determine the distribution of data points in Fig.To illustrate 4C, the x-coordinate (Na / K ratio coordinate) of the intersection point PX3 of the first straight line L31 and the hypertension reference value UL (= 135 mmHg) is 3.0. The x-coordinate (Na / K ratio coordinate) of the transition point P3, where the first straight line L31 and the second straight line L32 are connected, is greater than the x-coordinate of 3.0 of the intersection point PX3. Therefore, control element 11 reads the sentence example in Table 3 from the advice table 17 and applies the x-coordinate value of 3.0 at the intersection point PX3 to the field of the "DDD" in the sentence example to generate the advice in Table 3-A. (Table 3-A) Advice for the third type (i) Her blood pressure was 135 mmHg (high blood pressure). (Reference value of blood pressure at home), when the Na / K ratio was 3.0. ⇒ To keep your blood pressure within the reference range- ten, you should not eat a meal that has a Na / K ratio of 3.0 or more. ⇒ The meal, which had a Na / K ratio of 3.0- It was sitting from 5 / 11 (date). (ii They have a significant influence on blood pressure, even when the Na / K ratio is low. ⇒ Your blood pressure will be very high, even if you do this. They have a low Na / K ratio, so be careful about the meal to avoid increasing your Na / K ratio as much as possible.
[0095] It is assumed that a sentence example of the advice for the fourth type, which is stored in the advice table 17, is such as is shown in Table 4. (Table 4) Example sentence of the advice for the fourth type No correlation was found between your Na / K ratio and blood pressure. ⇒ A sodium / potassium ratio does not seem to affect your blood pressure. Other lifestyle factors, such as exercise, sleep, and stress, are expected to be heavily involved in blood pressure fluctuations.
[0096] If the person's sensitivity type is the fourth type, to determine the distribution of data points in Fig. To display 4D, the control unit 11 reads the sentence example from Table 4 from the advice table 17 and uses the sentence example as advice, as shown in Table 4-A. (Table 4-A) Advice for the fourth type No correlation was found between your Na / K ratio and blood pressure. ⇒ A sodium / potassium ratio does not seem to affect your blood pressure. Other lifestyle factors, such as exercise, sleep, and stress, are expected to be heavily involved in blood pressure fluctuations.
[0097] In this way, the advice can be created by simply processing it by adding the value, according to the distribution of data points in the advice sentence example, which is stored in the advice table 17. (5) issue
[0098] Subsequently, in step S10 the Fig.2 the control element 11 via the output unit 18 the sensitivity type of the person, which is obtained as a result of the type determination, the scatter plot, which represents the distribution of the data points, and the advice, according to the sensitivity type of the person, as the image on the display screen as information which shows the determination result.
[0099] Fig. 5A to 5D represent a mode in which the person's sensitivity type and the scatter plot representing the distribution of data points are displayed on the display screen 50.
[0100] Fig.5A presents a display example when the person's sensitivity type is the first type. Although not shown for convenience, display screen 50 also displays the advice in Table 1-A. In this display example, a string 51 of the "straight line type" is displayed in an upper portion of display screen 50 as a name indicating that the person's sensitivity type is the first type. Below string 51, the scatter plot is displayed, showing the distribution of the data points in Fig.4A, together with the linear regression line L1 on level 99, is formed by the horizontal axis (x-axis), which represents the urine Na / K ratio, and the vertical axis (y-axis), which represents systolic blood pressure. Therefore, by viewing the image, the user can intuitively recognize that the person's sensitivity type is the first type (i.e., the straight line type). In this display example, it is shown that the x-coordinate (Na / K ratio coordinate) at the intersection point PX1 of the linear regression line L1 and the hypertension reference value UL (= 135 mmHg) of hypertension is 3.3, while the hypertension reference value UL (= 135 mmHg) is shown as a reference line parallel to the horizontal axis (x-axis). According to this, by looking at the image, the user can intuitively identify the Na / K ratio range at which the person's blood pressure is lower than the hypertension reference value UL.After reviewing the content of the advice in Table 1-A, the user can provide the correct advice for the person along with the content of the advice in Table 1-A.
[0101] Fig. 5B presents a display example when the person's sensitivity type is the second type. Although not shown for convenience, display screen 50 also displays the advice in Table 2-A. In this display screen, a string 52 of the "downward convex type" is displayed in the upper portion of display screen 50 as the name indicating that the person's sensitivity type is the second type. Below the string 52 is the scatter plot, which shows the distribution of the data points in Fig.4B, together with the quadratic regression curve C2, the first straight line L21, and the second straight line L22, are displayed on plane 99, which is formed by the horizontal axis (x-axis), representing the urine Na / K ratio, and the vertical axis (y-axis), representing systolic blood pressure. Therefore, by viewing the image, the user can intuitively recognize that the person's sensitivity type is the second type (i.e., the downward-pointing convex type). In this display example, it is shown that the x-coordinate (Na / K ratio coordinate) at the intersection point PX2 of the second straight line L22 and the hypertension reference value UL (= 135 mmHg) of the home blood pressure is 3.5, while the hypertension reference value UL (= 135 mmHg) is displayed as the reference line parallel to the horizontal axis (x-axis).Accordingly, by viewing the image, the user can intuitively identify the Na / K ratio range at which the person's systolic blood pressure is lower than the hypertension reference value UL. This example shows that the x-coordinate (Na / K ratio coordinate) at the transition point P2 between the first straight line L21 and the second straight line L22 is 2.5. This allows the user to intuitively recognize that the slope of the first straight line L21 and the slope of the second straight line L22 differ before and after the transition point P2. That is, the user can intuitively see that the slope of the first straight line L21 from the lower boundary region DL2 to the transition point P2 is relatively small, and that the slope of the second straight line L22 from the transition point P2 to the upper boundary region DU2 is relatively large.After reviewing the content of the advice in Table 2-A, the user can provide the correct advice to the individual based on the content of the advice in Table 2-A. At this point, the advice in Table 2-A includes (i) advice regarding the area from the lower boundary sub-area DL2 to the transition point P2 and (ii) advice regarding the area from the transition point P2 to the upper boundary sub-area DU2, so that the user can provide the specifically appropriate advice to the individual.
[0102] Fig.5C presents a display example when the person's sensitivity type is the third type. Although not shown for convenience, display screen 50 also displays the advice shown in Table 3-A. In this display example, an upward-facing convex string 53 is displayed in the upper portion of display screen 50 as the name indicating the person's sensitivity type, which is the third type. Below string 53 is the scatter plot showing the distribution of the data points in Fig.4C, together with the quadratic regression curve C3, the first straight line L31, and the second straight line L32, are displayed on plane 99, which is formed by the horizontal axis (x-axis), representing the urine Na / K ratio, and the vertical axis (y-axis), representing systolic blood pressure. This allows the user to intuitively recognize, by viewing the image, that the person's sensitivity type is the third type (i.e., the upward convex type). In this display example, the x-coordinate (Na / K ratio coordinate) at the intersection point PX3 of the first straight line L31 and the hypertension reference value UL (= 135 mmHg) of the home blood pressure is 3.0, while the hypertension reference value UL (= 135 mmHg) is displayed as the reference line parallel to the horizontal axis (x-axis).Accordingly, by examining the image, the user can intuitively identify the Na / K ratio range at which the person's systolic blood pressure is lower than the hypertension reference value (UL). The user can intuitively recognize that the slopes of the first straight line (L31) and the second straight line (L32) differ before and after the transition point (P3) between the first straight line (L31) and the second straight line (L32). That is, the user can intuitively recognize that the slope of the first straight line (L31) from the lower limit (DL3) to the transition point (P3) is relatively steep, and that the slope of the second straight line (L32) from the transition point (P3) to the upper limit (DU3) is relatively shallow. After reviewing the advice in Table 3-A, the user can provide the correct advice to the person based on the information in Table 3-A.At this point, the advice in Table 3-A corresponds to the fact that the slope of the first straight line L31 from the lower limit sub-area DL3 to the transition point P3 is relatively large and includes the advice that “(ii) They have a high effect on blood pressure even when a Na / K ratio is low”, so that the user can provide the specifically appropriate advice to the person.
[0103] Fig.5D presents a display example when the person's sensitivity type is type four. Although not shown for convenience, display screen 50 also displays the advice shown in Table 4-A. In this display example, a string 54 of "no correlation type" is displayed in the upper portion of display screen 50, indicating that the person's sensitivity type is type four. Below string 54 is the scatter plot showing the distribution of the data points in Fig.4D is represented, displayed on level 99, which is formed by the horizontal axis (x-axis), representing the urine Na / K ratio, and the vertical axis (y-axis), representing systolic blood pressure. Therefore, by viewing the image, the user can intuitively recognize that the person's sensitivity type is the fourth type (i.e., the type without correlation). After reviewing the advice in Table 4-A, the user can provide the appropriate advice to the person based on the information in Table 4-A.
[0104] As described above, according to the procedure performed by facility 1, which evaluates the Na / K ratio sensitivity of blood pressure, the individual's sensitivity type can be accurately determined. Therefore, the result of this determination can be incorporated into the management plan for a patient with high blood pressure or similar conditions, and appropriate advice can be provided to the individual to improve the accuracy of their care. (First modification)
[0105] In the example above, during data entry (step S1 in Fig. 2) The measured blood pressure data and the measured Na / K ratio data are correlated over a predetermined constant time difference (12 hours in the example). However, the present invention is not limited to this configuration; the time difference can be set for each individual.
[0106] For example, as in step S31 of the Fig. As shown in Figure 6A, the control element 11 measures the blood pressure data via the data input unit 12 multiple times over a specific time period with respect to a specific person and measures the urine Na / K ratio data multiple times over the same time period with respect to the person, as shown in step S32. At this point, as shown in Fig. As shown in Figure 6B, blood pressure data and measured Na / K ratio data typically change over time due to the influence of the Na / K ratio in the ingested food. Fig.In 6B, the measured blood pressure data for each time point are represented by the symbol “◯”, and the change over time in the blood pressure data is represented by a line graph B1. The measured urine Na / K ratio data for each time point are represented by the symbol “□”, and the change over time in the urine Na / K ratio data is represented by a line graph U1. In the example of the Fig. 6B shows the blood pressure data a maximum from the third measurement to the fifth measurement, and the urine Na / K ratio data shows the maximum from the sixth measurement to the eighth measurement after a time difference Δt.
[0107] As in step S33 of the Fig.As shown in Figure 6A, control element 11 acts as a time difference acquisition unit to capture the time difference Δt between the change over time in the measured blood pressure data and the change over time in the measured Na / K ratio data with respect to the individual. In this example, the time difference Δt is assumed to be 11 hours.
[0108] As shown in step S34, control element 11 acts as a data association unit to link the measured blood pressure data and the measured Na / K ratio data, which are correlated by the time difference Δt (11 hours in this example). Consequently, the measured blood pressure data and the measured Na / K ratio data can be precisely linked or assigned to each individual. (Second modification)
[0109] In the above embodiment, during output (step S10 in Fig. 2), as in Fig.5A and Fig. In 5D representation, a scale representing the urine Na / K ratio is added to the horizontal axis (x-axis) of the scatter plot displayed on screen 50. However, the present invention is not limited to this embodiment. As, for example, in Fig. 8 in the scatter plot of the Fig.As shown in Figure 5B, a horizontal axis (x'-axis) with a scale indicating the Na / K ratio in ingested food can be added and displayed in parallel. This scale is based on the finding that the ratios of sodium and potassium ingested by humans through food and excreted in urine are 86% and 77%, respectively (non-patent literature 2). In this example, the urine Na / K ratios of 3.5 and 2.5 are converted into the Na / K ratios of 3.1 and 2.2 in the ingested food. In such a case, the user can more easily guide the individual to limit the Na / K ratio in the ingested food. (Third modification)
[0110] In the embodiment described above, the device 1 includes the blood pressure monitor 30 and the Na / K meter 31. However, the device 1 is not limited to this configuration. For example, the device 1 includes a communication unit (not shown) that can communicate with an external network in a wired or wireless manner, and the blood pressure data and the urine Na / K ratio data, measured multiple times over a specific period for each individual, can be input from the external network while being correlated. In this case, as in the example above, the individual's sensitivity type can be determined, and therefore the accuracy of monitoring for hypertensive patients and similar conditions can be improved.
[0111] The method for evaluating the Na / K ratio sensitivity of blood pressure can be recorded as a computer program on a non-transient recording medium, such as a CD (Compact Disc) or DVD (Digital Universal Disc), or on an EEPROM (Electronically Rewritable Non-Volatile Memory). In such a case, by prompting a substantial computer device, such as a personal computer, a smartphone, or similar device, to read the program recorded on the medium, the computer device can be enabled to perform the procedure.
[0112] In the embodiment described above, the correlation between systolic blood pressure and the urine sodium / potassium ratio is evaluated as the sodium / potassium ratio sensitivity of blood pressure. However, the present invention is not limited to this embodiment. The present invention can also be applied to the correlation between diastolic blood pressure (DBP) and the urine sodium / potassium ratio, and the correlation between pulse pressure and the urine sodium / potassium ratio.
[0113] The embodiments described above are for illustrative purposes only and can be modified in a variety of ways depending on the scope of this invention. It should be noted that the various embodiments described above can be individually evaluated within each embodiment, but the embodiments can also be combined with one another. It should also be noted that the various features in different embodiments can be individually evaluated on their own, but the features can also be combined in different embodiments. REFERENCE MARK LIST 1. Facility 11 Control element 12 Data input unit 13 Control unit 14 storage 18 output units 50 Display screen
Claims
[1] Device (1) which evaluates Na / K ratio sensitivity of a blood pressure, wherein the device has: a blood pressure monitor (30) which measures the blood pressure data; a measuring instrument (31) which measures the urine Na / K ratio data; a data input unit (12) which inputs blood pressure data and urine Na / K ratio data, which are measured multiple times over a specific time period with respect to a specific person by the blood pressure monitor (30) or the measuring instrument (31), while the blood pressure data and the urine Na / K ratio data are matched to each other; a type determination unit (11) which produces a scatter plot representing data points determined by the Na / K ratio data and the blood pressure data, which are mapped to each other on a plane (99) formed by a first coordinate axis (x) representing a Na / K ratio and a second coordinate axis (y) representing blood pressure, and determines the sensitivity type of the person as one of four predefined types currently existing, corresponding to a distribution of the data points in the scatter plot; and an output unit (18) which outputs information which represents a determination result of the type determination unit (11). [2] Device (1) according to claim 1, wherein the four types are: a first type in which, on level (99), the blood pressure changes with respect to the Na / K ratio along a straight line (L1) over a range from a lower limit sub-region (DL1) to an upper limit sub-region (DU1), in which the data points are distributed, a second type in which, on the plane (99), the blood pressure changes with respect to the Na / K ratio over the area from a lower limit sub-area (DL2) to an upper limit sub-area (DU2), where the data points are distributed while being more convexly curved than a straight line (L2) connecting the lower limit sub-area (DL2) and the upper limit sub-area (DU2) with respect to the first coordinate axis (x), a third type in which, on level (99), the blood pressure changes with respect to the Na / K ratio over the range from a lower limit sub-region (DL3) to an upper limit sub-region (DU3), where the data points are distributed while being more concavely curved than a straight line (L3) connecting the lower limit sub-region (DL3) and the upper limit sub-region (DU3) with respect to the first coordinate axis (x), and a fourth type, which has no correlation between the Na / K ratio and blood pressure. [3] Device (1) according to claim 2, wherein the type determination unit (11) performs a regression analysis on the distribution by using a quadratic function (C2, C3) to obtain a quadratic regression curve and a p-value indicating significance, and determines whether the person's sensitivity type belongs to a group of type two and type three or to a group of type one and type four, based on whether the p-value is less than a pre-defined first threshold. determines whether the person's sensitivity type is the second type or the third type, corresponding to a sign of a coefficient of a second-order term of the quadratic regression curve (C2, C3) if the person's sensitivity type belongs to the group of the second and third types, and furthermore, the regression analysis is performed on the distribution, using a linear function (L1) to obtain a linear regression line and a p-value indicating significance when the person's sensitivity type belongs to the group of the first type and the fourth type, and determining whether the person's sensitivity type is the first type or the fourth type based on whether the p-value is less than a previously defined second threshold. [4] Device (1) according to any one of claims 1 to 3, wherein the data input unit (12) assigns the measured blood pressure data to the measured Na / K ratio data by or via a predetermined constant time difference. [5] Device (1) according to any one of claims 1 to 3, which further comprises: a time difference detection unit (11) which detects a time difference (Δt) between a time-dependent change in the measured blood pressure data and a time-dependent change in the measured Na / K ratio data with respect to the person; and a data association unit (11) which associates the measured blood pressure data with the measured Na / K ratio data by the time difference (Δt). [6] Device (1) according to any one of claims 1 to 5, wherein the output unit (18) outputs an image representing the scatter plot. [7] Device (1) according to claim 3, which further comprises a two-line approximation unit (11) comprising a first straight line (L21, L31) and a second straight line (L22, L32) passing through the lower boundary section (DL2, DL3) and the upper boundary section (DU2, DU3), respectively, and being joined and bent at a certain transition point (P2, P3) along the quadratic regression curve (C2, C3) to approximate the quadratic regression curve (C2, C3) in the plane (99) when the sensitivity type of the person is the second type or the third type. [8] Device (1) according to claim 7, wherein the output unit (18) outputs an image representing the first and second straight lines (L21, L31, L22, L32) on the plane (99) when the sensitivity type of the person is the second type or the third type. [9] Device (1) according to any one of claims 6 to 8, wherein the output unit (18) outputs an image which represents a reference line (UL) of the blood pressure on the plane (99). [10] Device (1) according to any one of claims 1 to 9, wherein the output unit (18) provides advice regarding the sensitivity type of the person within the four types. [11] Device (1) according to claim 10, which further comprises: an advice table (17) in which sentence examples of the advice, corresponding to the four types, are stored, wherein at least one of the sentence examples of the advice includes a field for which a value should be applied according to the distribution of the data points; and a advice generation unit (11) which generates the sentence example according to the sensitivity type of the person, reads from the advice table (17) and makes an advice by applying a value, according to the distribution of data points for the field, if the sentence example includes the field. [12] Device (1) according to claim 7 or 8, which further comprises: a table of advice (17) in which sentence examples of the advice, corresponding to the four types, are stored, wherein the sentence examples of the second type include a field for which a value, corresponding to the transition point (P2, P3), should be applied; and a Advice generation unit (11) which reads the sentence example of the second type from the Advice table if the sensitivity type of the person is the second type, and generates advice by applying a value corresponding to the transition point (P2, P3) for the field of the sentence example. [13] Method for assessing the Na / K ratio sensitivity of a blood pressure using a device according to claim 1, wherein the method comprises: Input of blood pressure data and urine Na / K ratio data, which are measured multiple times over a specific time period by the blood pressure monitor (30) or the measuring instrument (31), respectively, relating to a specific person, while the blood pressure data and the urine Na / K ratio data are matched to each other; Generating a scatter plot representing data points determined by the Na / K ratio data and the corresponding blood pressure data on a plane (99) formed by a first coordinate axis (x) representing a Na / K ratio and a second coordinate axis (y) representing blood pressure, and determining the sensitivity type of the person as one of the previously defined four types that currently exist according to a distribution of the data points in the scatter plot; and Output of information representing a determination result. [14] Program which causes a computer to perform the method according to claim 13. [15] Device (1) which evaluates Na / K ratio sensitivity of a blood pressure, wherein the device has: a data input unit (12) which receives blood pressure data and Enters urine Na / K ratio data, which has been measured multiple times over a specific time period for a specific person, while the blood pressure data and the urine Na / K ratio data are correlated; a type determination unit (11) which produces a scatter plot representing data points determined by the Na / K ratio data and the blood pressure data, which are mapped to each other on a plane (99) formed by a first coordinate axis (x) representing a Na / K ratio and a second coordinate axis (y) representing blood pressure, and determines the sensitivity type of the person as one of four predefined types currently existing, corresponding to a distribution of the data points in the scatter plot; and an output unit (18) which outputs information which represents a determination result of the type determination unit (11), wherein The four types are: a first type in which, on level (99), the blood pressure changes with respect to the Na / K ratio along a straight line over a range from a lower limit sub-region (DL1) to an upper limit sub-region (DU1), in which the data points are distributed, a second type in which, on the plane (99), the blood pressure changes with respect to the Na / K ratio over the area from a lower limit sub-area (DL2) to an upper limit sub-area (DU2), where the data points are distributed while being more convexly curved than a straight line (L2) connecting the lower limit sub-area (DL2) and the upper limit sub-area (DU2) with respect to the first coordinate axis (x), a third type in which, on level (99), the blood pressure changes with respect to the Na / K ratio over the range from a lower limit sub-region (DL3) to an upper limit sub-region (DU3), where the data points are distributed while being more concavely curved than a straight line (L3) connecting the lower limit sub-region (DL3) and the upper limit sub-region (DU3) with respect to the first coordinate axis (x), and a fourth type, which has no correlation between the Na / K ratio and blood pressure, characterized by , that the type determination unit (11) performs a regression analysis on the distribution by using a quadratic function (C2, C3) to obtain a quadratic regression curve and a p-value indicating significance, and determines whether the person's sensitivity type belongs to a group of the second and third types or to a group of the first and fourth types, based on whether the p-value is less than a pre-defined first threshold, determines whether the person's sensitivity type is the second type or the third type, corresponding to a sign of a coefficient of a second-order term of the quadratic regression curve (C2, C3) if the person's sensitivity type belongs to the group of the second and third types, and Furthermore, the regression analysis is performed on the distribution, using a linear function (L1) to obtain a linear regression line and a p-value indicating significance when the person's sensitivity type belongs to the group of the first type and of the fourth type, and determining whether the person's sensitivity type is the first type or the fourth type based on whether the p-value is less than a previously set second threshold. [16] Device (1) which evaluates Na / K ratio sensitivity of a blood pressure, wherein the device has: a data input unit (12) which receives blood pressure data and Enters urine Na / K ratio data, which has been measured multiple times over a specific time period for a specific person, while the blood pressure data and the urine Na / K ratio data are correlated; a type determination unit (11) which produces a scatter plot representing data points determined by the Na / K ratio data and the blood pressure data, which are mapped to each other on a plane (99) formed by a first coordinate axis (x) representing a Na / K ratio and a second coordinate axis (y) representing blood pressure, and determines the sensitivity type of the person as one of four predefined types currently existing, corresponding to a distribution of the data points in the scatter plot; and an output unit (18) which outputs information which represents a determination result of the type determination unit (11), characterized by , that the facility (1) further exhibits: a time difference detection unit (11) which detects a time difference (Δt) between a time-dependent change in the measured blood pressure data and a time-dependent change in the measured Na / K ratio data with respect to the person; and a data association unit (11) which associates the measured blood pressure data with the measured Na / K ratio data by the time difference (Δt). [17] Device (1) which evaluates Na / K ratio sensitivity of a blood pressure, wherein the device has: a data input unit (12) which inputs blood pressure data and urine Na / K ratio data which are measured multiple times over a specific time period with respect to a specific person, while the blood pressure data and the urine Na / K ratio data are matched to each other; a type determination unit (11) which produces a scatter plot representing data points determined by the Na / K ratio data and the blood pressure data, which are mapped to each other on a plane (99) formed by a first coordinate axis (x) representing a Na / K ratio and a second coordinate axis (y) representing blood pressure, and determines the sensitivity type of the person as one of four predefined types currently existing, corresponding to a distribution of the data points in the scatter plot; and an output unit (18) which outputs information which represents a determination result of the type determination unit (11), wherein the output unit (18) provides advice regarding the person's sensitivity type within the four types, characterized by , that the facility (1) further exhibits: an advice table (17) in which sentence examples of the advice, corresponding to the four types, are stored, wherein at least one of the sentence examples of the advice includes a field for which a value should be applied according to the distribution of the data points; and a suggestion generation unit (11) which reads the sentence example, according to the sensitivity type of the person, from the suggestion table (17) and produces a suggestion by applying a value, according to the distribution of data points for the field, if the sentence example includes the field.
Citation Information
Patent Citations
Device for analyzing urine components and method for analyzing urine components
DE112012003248T5