Dynamic monitoring system for physical signs of subject in pharmaceutical test research laboratory
By setting up a dynamic monitoring system for physiological indicators and typical symptoms, the problem of lack of pertinence and comprehensiveness in physical sign monitoring in existing technologies is solved, and accurate monitoring and comprehensive feedback of drug subjects are achieved.
Patent Information
- Application Number
- CN202510814543.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-18
- Publication Date
- 2025-09-19
- Estimated Expiration
- 2045-06-18
AI Technical Summary
The existing dynamic monitoring system of vital signs is unable to set up several physiological indicators for characteristic test drugs to monitor multiple physiological indicators, and is unable to classify subjects according to the monitoring results, resulting in a lack of pertinence and comprehensiveness in vital sign monitoring.
The data acquisition module is used to obtain physiological indicators, the physical sign analysis module is used for type classification, the symptom analysis module is used for typical symptom overlap analysis, and the monitoring feedback module is used for result feedback. The subjects are dynamically monitored by setting several physiological indicators and typical symptoms.
It improves the pertinence and comprehensiveness of physical sign monitoring, and can conduct targeted monitoring and comprehensive feedback on different types of drug subjects to ensure the accuracy of monitoring results.
Smart Images

Figure CN120674104A_ABST
Abstract
Description
Technical Field
[0001] The invention belongs to the field of drug trials, relates to behavior monitoring technology, and specifically is a dynamic monitoring system for the vital signs of subjects in a drug trial laboratory. Background Art
[0002] The existing dynamic vital sign monitoring system has the following specific defects when monitoring the vital signs of drug subjects: Existing dynamic vital sign monitoring systems are unable to set up multiple physiological indicators for characteristic test drugs to monitor multiple physiological indicators of subjects. They are also unable to classify characteristic drug subjects according to the monitoring results, and thus are unable to conduct targeted vital sign monitoring for different types of drug subjects, resulting in a lack of targeted vital sign monitoring process. The existing dynamic vital sign monitoring system can only monitor the subjects' vital signs dynamically through physiological indicators. It is unable to divide the data according to the subject type and conduct typical symptom overlap analysis for characteristic drug subjects to comprehensively feedback the vital sign monitoring results, which easily leads to a lack of comprehensiveness in the dynamic vital sign monitoring results.
[0003] To this end, we propose a dynamic monitoring system for subjects' vital signs in drug trial laboratories. Summary of the Invention
[0004] In view of the shortcomings of the existing technology, the purpose of the present invention is to provide a dynamic monitoring system for the vital signs of subjects in a drug trial laboratory. The present invention aims to improve the comprehensiveness and pertinence of the dynamic monitoring process of the vital signs of subjects.
[0005] To achieve the above objectives, the present invention adopts the following technical solution: a system for dynamically monitoring the vital signs of subjects in a drug testing laboratory, wherein the specific working process of each module is as follows: Data acquisition module: acquires characteristic test drugs, sets several physiological indicators for the characteristic test drugs, monitors multiple physiological indicators of the subjects, obtains the abnormality of each physiological indicator according to the monitoring results, and obtains physiological indicator collection data; Physical sign analysis module: analyzes the physical sign indicators of characteristic drug subjects based on the collected physiological indicator data, and classifies the characteristic drug subjects into types based on the analysis results to obtain subject type classification data; Symptom analysis module: divides data according to subject type, sets several typical symptoms for subjects with normal physical signs, and performs typical symptom overlap analysis on subjects with normal physical signs, and obtains the typical symptom similarity coefficient based on the analysis results; Monitoring feedback module: Provides monitoring result feedback to characteristic drug subjects based on data divided by subject type and typical symptom similarity coefficient.
[0006] Furthermore, the physiological index data is acquired, as follows: Acquiring drug subjects in a drug testing laboratory, selecting a characteristic drug subject from the acquired multiple drug subjects, and acquiring the drug tested by the characteristic drug subject to obtain a characteristic test drug; Several different types of physiological indicators are set for characteristic test drugs, and the set physiological indicators are marked as L1 physiological indicators to La physiological indicators respectively; In the process of monitoring the physiological indicators of drug subjects, the time point corresponding to the current moment is used as the end time point of the cycle to mark a physiological indicator monitoring cycle of fixed duration; If the L1 physiological indicator is pulse, the pulse indicator of the characteristic drug subject who is in the physiological indicator monitoring period is monitored, and the abnormality of the L1 physiological indicator monitoring is obtained according to the monitoring result; Acquire the physiological indicator monitoring abnormality corresponding to the L2 physiological indicator to the La physiological indicator respectively, and obtain the L2 physiological indicator monitoring abnormality to the La physiological indicator monitoring abnormality; The physiological index monitoring abnormality degree L1 to the physiological index monitoring abnormality degree La are defined as the physiological index collection data.
[0007] Furthermore, the abnormality of L1 physiological indicators is monitored and obtained as follows: The physiological index monitoring cycle is divided into several index monitoring time points, and two adjacent index monitoring time points are continuous time points; Obtaining the concentration value of the characteristic test drug in the characteristic drug subject at each indicator monitoring time point, respectively, to obtain multiple test drug concentration values, and performing numerical comparison on the obtained multiple test drug concentration values, marking the test drug concentration value with the largest value as the first drug concentration value, and marking the test drug concentration value with the smallest value as the second drug concentration value; The first drug concentration value is used as the upper limit of the interval, and the second drug concentration value is used as the lower limit of the interval to mark it as a periodic in vivo drug concentration interval, and the periodic in vivo drug concentration interval is interpolated into a number of drug concentration subintervals with equal value ranges, and the obtained several drug concentration subintervals are respectively marked as N1 drug concentration subinterval to Nb drug concentration subinterval; The time period in which the test drug concentration value is within the N1 drug concentration subinterval to the Nb drug concentration subinterval is obtained to obtain the N1 drug concentration time period to the Nb drug concentration time period; Perform pulse index analysis on the characteristic drug subjects in the N1 drug concentration period, and obtain the N1 interval pulse deviation based on the analysis results; Obtain the pulse deviations corresponding to the N2 drug concentration subinterval to the Nb drug concentration subinterval, respectively, and obtain the pulse deviations from the N2 interval to the Nb interval; In the N1 drug concentration period, the duration of the index monitoring time points when the subject's pulse value is not in the subject's pulse baseline interval is accumulated to obtain the N1 pulse deviation duration. In the N2 drug concentration period, the duration of the index monitoring time points when the subject's pulse value is not in the subject's pulse baseline interval is accumulated to obtain the N2 pulse deviation duration. Similarly, in the Nb drug concentration period, the duration of the index monitoring time points when the subject's pulse value is not in the subject's pulse baseline interval is accumulated to obtain the Nb pulse deviation duration. The duration of the N1 drug concentration period to the Nb drug concentration period is obtained respectively, and the duration of the N1 drug concentration period to the Nb drug concentration period is obtained; Calculate the ratio of N1 pulse deviation duration to N1 drug concentration duration to obtain the N1 pulse deviation duration ratio to Nb pulse deviation duration ratio; The abnormality of L1 physiological index monitoring is obtained by calculating the pulse deviation degree of N1 interval to the pulse deviation degree of Nb interval and the pulse deviation duration ratio of N1 to Nb; The abnormality of L1 physiological index monitoring is calculated using the following formula: ; Among them, Ycl1 is the abnormality of L1 physiological index monitoring, Pci is the pulse deviation degree of Ni interval, Sci is the Ni pulse deviation time ratio, and b is the quantitative value corresponding to the drug concentration subinterval.
[0008] Furthermore, the pulse deviation degree in the N1 interval is obtained as follows: Acquire the indicator monitoring time points covered by the N1 drug concentration period, obtain the characteristic drug subject pulse value corresponding to each indicator monitoring time point, obtain multiple subject pulse values, obtain the subject pulse reference interval, if the subject pulse value is within the subject pulse reference interval, use the value 0 to parameterize the subject pulse deviation, if the subject pulse value is not within the subject pulse reference interval, calculate the deviation value between the subject pulse value and the subject pulse reference interval, and obtain multiple subject pulse reference deviations; The numerical value of the interval range corresponding to the subject's pulse reference interval is obtained to obtain the pulse reference interval range value, the average of the obtained subject's pulse reference deviation is calculated to obtain the subject's pulse reference deviation average value, and the ratio of the subject's pulse reference deviation average value to the pulse reference interval range value is calculated to obtain the N1 interval pulse deviation degree.
[0009] Furthermore, data on the classification of subjects is obtained, as follows: Acquire physiological indicator collection data, and respectively obtain L1 physiological indicator monitoring abnormality degree to La physiological indicator monitoring abnormality degree according to the physiological indicator collection data; Obtaining an indicator abnormality reference interval corresponding to the L1 physiological indicator to obtain the L1 indicator abnormality reference interval; if the L1 physiological indicator monitoring abnormality is not within the L1 indicator abnormality reference interval, classifying the L1 physiological indicator as a normal physiological indicator; if the L1 physiological indicator monitoring abnormality is within the L1 indicator abnormality reference interval, classifying the L1 physiological indicator as an abnormal physiological indicator; According to the abnormality of L2 physiological index monitoring to La physiological index monitoring, L2 physiological index to La physiological index are divided into normal physiological index and abnormal physiological index; If there are abnormal physiological indicators among the L1 physiological indicators to the La physiological indicators, the characteristic drug subjects are classified as subjects with abnormal physical signs. If there are no abnormal physiological indicators among the L1 physiological indicators to the La physiological indicators, the characteristic drug subjects are classified as subjects with normal physical signs, and the subject type classification data is obtained.
[0010] Furthermore, the typical symptom similarity coefficient is obtained as follows: Obtaining subject type classification data, and obtaining subjects with normal physical signs and subjects with abnormal physical signs according to the subject type classification data; In the process of symptom monitoring of subjects with normal physical signs, several different types of typical symptoms are set, and the set typical symptoms are marked as C1 typical symptoms to Cd typical symptoms respectively; Perform periodic blood drug concentration analysis on subjects with normal physical signs, and obtain multiple sample history subjects based on the analysis results; Compare and analyze the C1 typical symptoms of subjects with normal physical signs and multiple historical subjects. According to the analysis results, obtain the onset time deviation corresponding to the C1 typical symptoms and obtain the C1 symptom onset time deviation degree; Obtain the symptom onset time deviations corresponding to the typical symptoms of C2 and Cd respectively, and obtain the symptom onset time deviations of C2 and Cd; Among multiple sample historical subjects, the number of people with typical symptoms from C1 to Cd was obtained respectively, and the number of people with symptoms from C1 to Cd was obtained; The number of historical sample subjects was obtained to obtain the number of historical sample subjects, and the ratio of the number of people with C1 symptoms to the number of people with Cd symptoms to the number of historical sample subjects was calculated to obtain the C1 typical symptom appearance ratio to the Cd typical symptom appearance ratio; The typical symptom similarity coefficient was obtained by calculating the typical symptom appearance ratio of C1 to the typical symptom appearance ratio of Cd and the deviation degree of symptom onset time of C1 to the deviation degree of symptom onset time of Cd. The similarity coefficient of typical symptoms is calculated using the following formula: ; Among them, Jcd is the similarity coefficient of typical symptoms, Spi is the appearance ratio of Ci typical symptoms, Cxi is the deviation of Ci symptom onset time, and d is the quantity value corresponding to the typical symptoms.
[0011] Furthermore, the sample history subjects are obtained as follows: The time point when the characteristic test drug is injected into the body of a subject with normal physical signs is marked as the cycle start time point, the time point corresponding to the current moment is marked as the cycle end time point, and the period between the cycle start time point and the cycle end time point is marked as the drug clearance monitoring period; Marking a number of blood drug concentration time points with equal time intervals during the drug clearance monitoring period, and marking the obtained multiple blood drug concentration time points in chronological order as X1 blood drug concentration time point to Xe blood drug concentration time point; Obtain the blood drug concentration values corresponding to the X1 blood drug concentration time point to the Xe blood drug concentration time point of the subjects with normal physical signs, and obtain the X1 blood drug concentration value to the Xe blood drug concentration value; Create a blood drug concentration monitoring rectangular coordinate system based on the blood drug concentration values of X1 to Xe, and obtain the blood drug closed area value by analyzing the blood drug concentration monitoring rectangular coordinate system; The initial injection dose of the characteristic test drug in the body of a subject with normal physical signs is obtained to obtain the initial injection dose of the drug, and the ratio of the initial injection dose of the drug to the area value of the blood drug closed area is calculated to obtain the drug clearance rate of the subject; A drug clearance rate interval is set by taking the drug clearance rate of the subject as the middle value of the interval, and the drug clearance rates corresponding to multiple historical subjects are obtained respectively. The historical subjects whose drug clearance rates are within the drug clearance rate interval are marked as sample historical subjects, and multiple sample historical subjects are obtained.
[0012] Furthermore, the area value of the blood drug closed area is obtained as follows: In the existing plane rectangular coordinate system, the blood drug concentration time point is marked as the horizontal axis, and the blood drug concentration value is marked as the vertical axis to create a blood drug concentration monitoring rectangular coordinate system; In the rectangular coordinate system for monitoring blood drug concentration, the X1 blood drug concentration time point is used as the horizontal coordinate and the X1 blood drug concentration value is used as the vertical coordinate, and the coordinate point is marked as the X1 blood drug coordinate point. The X2 blood drug concentration time point is used as the horizontal coordinate and the X2 blood drug concentration value is used as the vertical coordinate, and so on. The Xe blood drug concentration time point is used as the horizontal coordinate and the Xe blood drug concentration value is used as the vertical coordinate, and the coordinate point is marked as the Xe blood drug coordinate point. The X1 blood drug coordinate point to the Xe blood drug coordinate point are connected to obtain a blood drug concentration curve. In the rectangular coordinate system for monitoring blood drug concentration, a straight line perpendicular to the x-axis is drawn through the X1 blood drug coordinate point to obtain the first area characteristic line, and a straight line perpendicular to the x-axis is drawn through the Xa blood drug coordinate point to obtain the second area characteristic line. The closed area surrounded by the first area characteristic line, the second area characteristic line, the blood drug concentration curve and the x-axis is marked as the blood drug closed area, and the area value of the blood drug closed area is obtained to obtain the area value of the blood drug closed area.
[0013] Furthermore, the deviation of the C1 symptom onset time is obtained as follows: Obtaining the initial onset time of the C1 typical symptom corresponding to the subject with normal physical signs to obtain the C1 symptom onset time point, obtaining the time point when the characteristic test drug is injected into the subject with normal physical signs to obtain the drug initial injection time point, calculating the time difference between the C1 symptom onset time point and the drug initial injection time point to obtain the C1 symptom onset time difference; Obtain the C1 symptom onset time difference corresponding to the sample history subjects respectively, mark the C1 symptom onset time difference with the largest value as the upper limit of the benchmark onset time difference interval, mark the C1 symptom onset time difference with the smallest value as the lower limit of the benchmark onset time difference interval, calculate the difference between the upper limit of the benchmark onset time difference interval and the lower limit of the benchmark onset time difference interval, and obtain the benchmark onset time difference interval range value; If the C1 symptom onset time difference is greater than the upper limit of the benchmark onset time difference interval, the difference between the C1 symptom onset time difference and the upper limit of the benchmark onset time difference interval is calculated to obtain the C1 symptom onset time deviation. If the C1 symptom onset time difference is less than the upper limit of the benchmark onset time difference interval, the difference between the lower limit of the benchmark onset time difference interval and the C1 symptom onset time difference is calculated to obtain the C1 symptom onset time deviation. If the C1 symptom onset time difference is within the benchmark onset time difference interval, the C1 symptom onset time deviation is parameterized with a value of 0. The ratio of the C1 symptom onset time deviation to the baseline onset time difference interval was calculated to obtain the C1 symptom onset time deviation degree.
[0014] Furthermore, the monitoring results of the characteristic drug subjects are fed back as follows: Obtaining subject type classification data, and obtaining subjects with normal physical signs and subjects with abnormal physical signs according to the subject type classification data; If the subject of the characteristic drug is a subject with abnormal vital signs, an abnormal vital sign warning will be issued to the subject of the characteristic drug; If the subject of the characteristic drug is a subject with normal physical signs, feedback on the symptom monitoring results will be provided to the subject of the characteristic drug; The details are as follows: Obtain the typical symptom similarity coefficient corresponding to subjects with normal physical signs and obtain the typical symptom benchmark similarity interval; If the typical symptom similarity coefficient is within the typical symptom benchmark similarity interval, it is judged that the subject with normal physical signs has abnormal symptoms; If the typical symptom similarity coefficient is not within the typical symptom benchmark similarity interval, it is judged that the subject with normal physical signs has no abnormal symptoms, and an abnormal symptom warning is issued.
[0015] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are: 1. The present invention sets several physiological indicators for characteristic test drugs to monitor multiple physiological indicators of subjects, and classifies the characteristic drug subjects into types according to the monitoring results. Targeted physical sign monitoring is performed on different types of drug subjects respectively, which can improve the lack of pertinence in the physical sign monitoring process; 2. The present invention uses physiological indicators to dynamically monitor the physical signs of the subjects, and divides the data according to the subject type to perform typical symptom overlap analysis for characteristic drug subjects to provide comprehensive feedback on the physical sign monitoring results, which can ensure the comprehensiveness of the dynamic physical sign monitoring results. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] To facilitate understanding by those skilled in the art, the present invention is further described below with reference to the accompanying drawings.
[0017] Figure 1 is a block diagram of the overall system of the present invention; Figure 2 This is the rectangular coordinate system for monitoring blood drug concentration of the present invention; Figure 3 Schematic diagram of the blood drug closed area of the present invention. DETAILED DESCRIPTION
[0018] The technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.
[0019] Example 1 See also Figure 1 The behavioral monitoring technology involved in the symptom monitoring process of the present invention now provides a technical solution: a dynamic monitoring system for vital signs of subjects in a drug trial laboratory, comprising a data acquisition module, a vital sign analysis module, a symptom analysis module, a monitoring feedback module and a server, wherein the data acquisition module, the vital sign analysis module, the symptom analysis module and the monitoring feedback module are respectively connected to the server, and the server controls the data acquisition module, the vital sign analysis module, the symptom analysis module and the monitoring feedback module respectively; The data acquisition module acquires characteristic test drugs, sets several physiological indicators for the characteristic test drugs, and monitors multiple physiological indicators of the subjects. According to the monitoring results, the abnormality of each physiological indicator corresponding to the physiological indicator is obtained to obtain physiological indicator collection data; The details are as follows: Acquiring drug subjects in a drug testing laboratory, selecting a characteristic drug subject from the acquired multiple drug subjects, and acquiring the drug tested by the characteristic drug subject to obtain a characteristic test drug; Several different types of physiological indicators are set for characteristic test drugs, and the set physiological indicators are marked as L1 physiological indicators to La physiological indicators respectively; It should be noted here that: In the present application, L1 mentioned here is the sign symbol corresponding to the physiological indicator, a mentioned here is the quantitative value corresponding to the physiological indicator, and a is an integer greater than 0.
[0020] It should be noted here that: In the present application, the L1 physiological indicator involved here may be a pulse value, the L2 physiological indicator may be a blood pressure value, and the L3 physiological indicator may be a respiratory rate value.
[0021] In the process of monitoring the physiological indicators of drug subjects, the time point corresponding to the current moment is used as the end time point of the cycle to mark a physiological indicator monitoring cycle of fixed duration; It should be noted here that: In this application, as the time point corresponding to the current moment changes, the end time point of the cycle also changes accordingly, and the duration of the physiological indicator monitoring cycle is fixed, so the physiological indicator monitoring cycle can be dynamically updated as the time value of the current moment changes.
[0022] If the L1 physiological indicator is pulse, the pulse indicator of the characteristic drug subject who is in the physiological indicator monitoring period is monitored, and the abnormality of the L1 physiological indicator monitoring is obtained according to the monitoring result; The details are as follows: The physiological index monitoring cycle is divided into several index monitoring time points, and two adjacent index monitoring time points are continuous time points; It should be noted here that: In the present application, the time interval between two consecutive indicator monitoring time points is a negligible time interval. Specifically, if the physiological indicator monitored here is pulse, the time interval between two consecutive indicator monitoring time points can be 10s.
[0023] Obtaining the concentration value of the characteristic test drug in the characteristic drug subject at each indicator monitoring time point, respectively, to obtain multiple test drug concentration values, and performing numerical comparison on the obtained multiple test drug concentration values, marking the test drug concentration value with the largest value as the first drug concentration value, and marking the test drug concentration value with the smallest value as the second drug concentration value; It should be noted here that: In the present application, the test drug concentration value involved here is specifically the blood concentration value of the characteristic test drug in the body of a characteristic subject.
[0024] The first drug concentration value is used as the upper limit of the interval, and the second drug concentration value is used as the lower limit of the interval to mark it as a periodic in vivo drug concentration interval, and the periodic in vivo drug concentration interval is interpolated into a number of drug concentration subintervals with equal value ranges, and the obtained several drug concentration subintervals are respectively marked as N1 drug concentration subinterval to Nb drug concentration subinterval; It should be noted here that: In the present application, N referred to herein is the sign symbol corresponding to the drug concentration sub-interval, b referred to herein is the numerical value corresponding to the drug concentration sub-interval, and b is an integer greater than 0.
[0025] The time period in which the test drug concentration value is within the N1 drug concentration subinterval to the Nb drug concentration subinterval is obtained to obtain the N1 drug concentration time period to the Nb drug concentration time period; Perform pulse index analysis on the characteristic drug subjects in the N1 drug concentration period, and obtain the N1 interval pulse deviation based on the analysis results; The details are as follows: Acquire the indicator monitoring time points covered by the N1 drug concentration period, obtain the characteristic drug subject pulse value corresponding to each indicator monitoring time point, obtain multiple subject pulse values, obtain the subject pulse reference interval, if the subject pulse value is within the subject pulse reference interval, use the value 0 to parameterize the subject pulse deviation, if the subject pulse value is not within the subject pulse reference interval, calculate the deviation value between the subject pulse value and the subject pulse reference interval, and obtain multiple subject pulse reference deviations; It should be noted here that: The deviation value between the pulse value of the subject of the characteristic drug involved here and the pulse reference interval of the subject is specifically the difference between the pulse value of the subject and the upper limit of the subject's pulse reference interval or the lower limit of the subject's pulse reference interval, and the absolute value of the obtained difference is taken.
[0026] The pulse baseline interval of the characteristic drug subject involved here is specifically [60, 100]. In a specific implementation, if the subject's pulse value is 45, the difference between 45 and the lower limit of the subject's pulse baseline interval of 60 is calculated, and the absolute value of the obtained difference is taken to obtain the subject's pulse baseline deviation of 15; In a specific implementation, if the subject's pulse value is 110, the difference between 110 and the lower limit of the subject's pulse reference interval 100 is calculated, and the absolute value of the obtained difference is taken to obtain the subject's pulse reference deviation of 10.
[0027] Obtaining a numerical value of the interval range corresponding to the subject's pulse reference interval to obtain a pulse reference interval range value, averaging the obtained subject's pulse reference deviations to obtain a subject's pulse reference deviation average value, and calculating a ratio of the subject's pulse reference deviation average value to the pulse reference interval range value to obtain an N1 interval pulse deviation degree; Repeat the process of obtaining the pulse deviation degree of the N1 interval to obtain the pulse deviation degrees corresponding to the N2 drug concentration subinterval to the Nb drug concentration subinterval, and obtain the pulse deviation degrees of the N2 interval to the Nb interval; In the N1 drug concentration period, the duration of the index monitoring time points when the subject's pulse value is not in the subject's pulse baseline interval is accumulated to obtain the N1 pulse deviation duration. In the N2 drug concentration period, the duration of the index monitoring time points when the subject's pulse value is not in the subject's pulse baseline interval is accumulated to obtain the N2 pulse deviation duration. Similarly, in the Nb drug concentration period, the duration of the index monitoring time points when the subject's pulse value is not in the subject's pulse baseline interval is accumulated to obtain the Nb pulse deviation duration. The duration of the N1 drug concentration period to the Nb drug concentration period is obtained respectively, and the duration of the N1 drug concentration period to the Nb drug concentration period is obtained; Calculate the ratio of N1 pulse deviation duration to N1 drug concentration duration to obtain the N1 pulse deviation duration ratio to Nb pulse deviation duration ratio; The abnormality of L1 physiological index monitoring is obtained by calculating the pulse deviation degree of N1 interval to the pulse deviation degree of Nb interval and the pulse deviation duration ratio of N1 to Nb; The abnormality of L1 physiological index monitoring is calculated using the following formula: ; Among them, Ycl1 is the abnormality of L1 physiological index monitoring, Pci is the pulse deviation degree of Ni interval, Sci is the Ni pulse deviation duration ratio, and b is the quantity value corresponding to the drug concentration subinterval; It should be noted here that: In the present application, the Ni interval pulse deviation degree involved here is any interval pulse deviation degree from the Ni interval pulse deviation degree to the Nb interval pulse deviation degree, and the Ni pulse deviation duration ratio involved here can be any Ni pulse deviation duration ratio from the N1 pulse deviation duration ratio to the Nb pulse deviation duration ratio; In this application, in a specific implementation, there are the following test data: The measured pulse deviation in the N1 interval is 0.21, the Ni pulse deviation time ratio is 0.4, the N2 pulse deviation is 0.31, the N2 pulse deviation time ratio is 0.52, the N3 pulse deviation is 0.37, the N3 pulse deviation time ratio is 0.58, and b is 3. It can be calculated that the abnormality of L1 physiological index monitoring is 1.797.
[0028] Repeat the process of obtaining the abnormality of the L1 physiological indicator monitoring, and obtain the abnormality of the physiological indicator monitoring corresponding to the L2 physiological indicator to the La physiological indicator, and obtain the abnormality of the L2 physiological indicator monitoring to the La physiological indicator monitoring; The abnormality of physiological index monitoring from L1 to La is defined as the physiological index collection data; The physical sign analysis module analyzes the physical sign indicators of the characteristic drug subjects based on the physiological indicator collection data, and classifies the characteristic drug subjects into types based on the analysis results to obtain subject type classification data; The details are as follows: Acquire physiological indicator collection data, and respectively obtain L1 physiological indicator monitoring abnormality degree to La physiological indicator monitoring abnormality degree according to the physiological indicator collection data; Obtaining an indicator abnormality reference interval corresponding to the L1 physiological indicator to obtain the L1 indicator abnormality reference interval; if the L1 physiological indicator monitoring abnormality is not within the L1 indicator abnormality reference interval, classifying the L1 physiological indicator as a normal physiological indicator; if the L1 physiological indicator monitoring abnormality is within the L1 indicator abnormality reference interval, classifying the L1 physiological indicator as an abnormal physiological indicator; It should be noted here that: The abnormal physiological indicators involved here include the situation where the abnormality of the L1 physiological indicator monitoring is at the boundary of the L1 indicator abnormality reference interval.
[0029] The L1 indicator abnormality benchmark interval is obtained as follows: Obtain historical test records corresponding to the characteristic test drug, obtain several historical subjects whose L1 physiological indicators are abnormal physiological indicators based on the historical test records, obtain the L1 physiological indicator monitoring abnormality corresponding to each historical subject, mark the L1 physiological indicator monitoring abnormality with the largest value as the upper limit of the L1 indicator abnormality reference interval, mark the L1 physiological indicator monitoring abnormality with the smallest value as the lower limit of the L1 indicator abnormality reference interval, and obtain the L1 indicator abnormality reference interval; According to the abnormality of L2 physiological index monitoring to La physiological index monitoring, L2 physiological index to La physiological index are divided into normal physiological index and abnormal physiological index; If there are abnormal physiological indicators among the L1 to La physiological indicators, the characteristic drug subjects are classified as subjects with abnormal physical signs. If there are no abnormal physiological indicators among the L1 to La physiological indicators, the characteristic drug subjects are classified as subjects with normal physical signs, thereby obtaining subject type classification data. It should be noted here that: In this application, the physical signs involved here are specifically vital signs, which include but are not limited to pulse, respiration, blood pressure, body temperature and blood oxygen saturation; The normal subjects involved here are specifically individuals whose various physiological indicators and symptoms are within the normal range and who have no obvious diseases or abnormal signs in situations such as medical research, clinical trials, and health examinations.
[0030] The physical sign analysis module obtains the data on the classification of subjects and transmits it to the symptom analysis module and the monitoring feedback module; The symptom analysis module divides the data according to the subject type, sets several typical symptoms for subjects with normal physical signs, and performs typical symptom overlap analysis on subjects with normal physical signs, and obtains the typical symptom similarity coefficient based on the analysis results; The details are as follows: Obtaining subject type classification data, and obtaining subjects with normal physical signs and subjects with abnormal physical signs according to the subject type classification data; In the process of symptom monitoring of subjects with normal physical signs, several different types of typical symptoms are set, and the set typical symptoms are marked as C1 typical symptoms to Cd typical symptoms respectively; It should be noted here that: In this application, C mentioned here is the symbol corresponding to the typical symptom, and d mentioned here is the numerical value corresponding to the typical symptom, and d is an integer greater than 0; In this application, the typical symptoms involved here need to be specifically set according to the type of characteristic test drug. The C1 typical symptom involved here can be fever, the C2 typical symptom can be cough, and the C3 typical symptom can be vomiting; Perform periodic blood drug concentration analysis on subjects with normal physical signs, and obtain multiple sample history subjects based on the analysis results; The details are as follows: The time point when the characteristic test drug is injected into the body of a subject with normal physical signs is marked as the cycle start time point, the time point corresponding to the current moment is marked as the cycle end time point, and the period between the cycle start time point and the cycle end time point is marked as the drug clearance monitoring period; Marking a number of blood drug concentration time points with equal time intervals during the drug clearance monitoring period, and marking the obtained multiple blood drug concentration time points in chronological order as X1 blood drug concentration time point to Xe blood drug concentration time point; It should be noted here that: In the present application, X referred to herein is the sign corresponding to the blood drug concentration time point, e referred to herein is the quantitative value corresponding to the blood drug concentration time point, and e is an integer greater than 0.
[0031] Obtain the blood drug concentration values corresponding to the X1 blood drug concentration time point to the Xe blood drug concentration time point of the subjects with normal physical signs, and obtain the X1 blood drug concentration value to the Xe blood drug concentration value; In the existing plane rectangular coordinate system, the blood drug concentration time point is marked as the horizontal axis, and the blood drug concentration value is marked as the vertical axis to create a blood drug concentration monitoring rectangular coordinate system; See also Figure 2 In the rectangular coordinate system for monitoring blood drug concentration, the X1 blood drug concentration time point is used as the horizontal coordinate and the X1 blood drug concentration value is used as the vertical coordinate, and the coordinate point is marked as the X1 blood drug coordinate point. The X2 blood drug concentration time point is used as the horizontal coordinate and the X2 blood drug concentration value is used as the vertical coordinate, and so on. The Xe blood drug concentration time point is used as the horizontal coordinate and the Xe blood drug concentration value is used as the vertical coordinate, and the coordinate point is marked as the Xe blood drug coordinate point. The X1 blood drug coordinate point to the Xe blood drug coordinate point are connected to obtain a blood drug concentration curve. See also Figure 3 In the rectangular coordinate system for blood drug concentration monitoring, a straight line perpendicular to the x-axis is drawn through the X1 blood drug coordinate point to obtain the first region characteristic line, and a straight line perpendicular to the x-axis is drawn through the Xa blood drug coordinate point to obtain the second region characteristic line. The closed area enclosed by the first region characteristic line, the second region characteristic line, the blood drug concentration curve, and the x-axis is marked as the blood drug closed area; The area value of the blood drug closed area is obtained to obtain the blood drug closed area area value, the initial injection dose of the characteristic test drug in the body of a subject with normal physical signs is obtained to obtain the initial injection dose of the drug, and the ratio of the initial injection dose of the drug to the blood drug closed area area value is calculated to obtain the subject drug clearance rate; It should be noted here that: In this application, drug clearance (CL) represents the theoretical volume of drug completely eliminated from the body per unit time, reflecting the body's ability to clear the drug. Its core formula is: CL = plasma drug concentration / drug elimination rate = dose / AUC, where AUC is the area under the concentration-time curve, reflecting the total drug exposure in the body, that is, the cumulative degree of drug entering the blood circulation; A drug clearance rate interval is set by taking the drug clearance rate of the subject as the middle value of the interval, and the drug clearance rates corresponding to multiple historical subjects are obtained respectively, and the historical subjects whose drug clearance rates are within the drug clearance rate interval are marked as sample historical subjects, thereby obtaining multiple sample historical subjects; It should be noted here that: The upper limit of the drug clearance rate interval involved here is Yql×(1+10%), and the lower limit of the drug clearance rate interval is Yql×(1-10%), and Yql is the drug clearance rate of the subject; It should be noted here that: The sample historical subjects involved here are all historical subjects with typical symptoms and no abnormalities.
[0032] The onset time of typical C1 symptoms was analyzed for subjects with normal physical signs. The onset time deviation corresponding to the typical C1 symptoms was obtained based on the analysis results, and the C1 symptom onset time deviation degree was obtained. The details are as follows: Obtaining the initial onset time of the C1 typical symptom corresponding to the subject with normal physical signs to obtain the C1 symptom onset time point, obtaining the time point when the characteristic test drug is injected into the subject with normal physical signs to obtain the drug initial injection time point, calculating the time difference between the C1 symptom onset time point and the drug initial injection time point to obtain the C1 symptom onset time difference; Obtain the C1 symptom onset time difference corresponding to the sample history subjects respectively, mark the C1 symptom onset time difference with the largest value as the upper limit of the benchmark onset time difference interval, mark the C1 symptom onset time difference with the smallest value as the lower limit of the benchmark onset time difference interval, calculate the difference between the upper limit of the benchmark onset time difference interval and the lower limit of the benchmark onset time difference interval, and obtain the benchmark onset time difference interval range value; If the C1 symptom onset time difference is greater than the upper limit of the benchmark onset time difference interval, the difference between the C1 symptom onset time difference and the upper limit of the benchmark onset time difference interval is calculated to obtain the C1 symptom onset time deviation. If the C1 symptom onset time difference is less than the upper limit of the benchmark onset time difference interval, the difference between the lower limit of the benchmark onset time difference interval and the C1 symptom onset time difference is calculated to obtain the C1 symptom onset time deviation. If the C1 symptom onset time difference is within the benchmark onset time difference interval, the C1 symptom onset time deviation is parameterized with a value of 0. Calculate the ratio of the C1 symptom onset time deviation to the baseline onset time difference interval value to obtain the C1 symptom onset time deviation degree; Repeat the process of obtaining the deviation degree of the onset time of the typical symptoms of C1, and obtain the deviation degrees of the onset time of the symptoms corresponding to the typical symptoms of C2 to the typical symptoms of Cd, and obtain the deviation degree of the onset time of the symptoms of C2 to the onset time of the symptoms of Cd; Among multiple sample historical subjects, the number of people with typical symptoms from C1 to Cd was obtained respectively, and the number of people with symptoms from C1 to Cd was obtained; The number of historical sample subjects was obtained to obtain the number of historical sample subjects, and the ratio of the number of people with C1 symptoms to the number of people with Cd symptoms to the number of historical sample subjects was calculated to obtain the C1 typical symptom appearance ratio to the Cd typical symptom appearance ratio; The typical symptom similarity coefficient was obtained by calculating the typical symptom appearance ratio of C1 to the typical symptom appearance ratio of Cd and the deviation degree of symptom onset time of C1 to the deviation degree of symptom onset time of Cd. The similarity coefficient of typical symptoms is calculated using the following formula: ; Among them, Jcd is the similarity coefficient of typical symptoms, Spi is the appearance ratio of Ci typical symptoms, Cxi is the deviation of Ci symptom onset time, and d is the quantity value corresponding to the typical symptoms; It should be noted here that: In the present application, the Ci typical symptom appearance ratio involved herein may be any typical symptom appearance ratio from the C1 typical symptom appearance ratio to the Cd typical symptom appearance ratio, and the Ci symptom onset time deviation degree involved herein may be any symptom onset time deviation degree from the C1 symptom onset time deviation degree to the Cd symptom onset time deviation degree; In specific clinical operations, the following test data exist: After testing, the typical symptom occurrence ratio of C1 was 0.87, the typical symptom occurrence ratio of C2 was 0.92, the typical symptom occurrence ratio of C3 was 0.85, the deviation of C1 symptom onset time was 0.2, the deviation of C2 symptom onset time was 0.24, and the deviation of C3 symptom onset time was 0.28. The typical symptom similarity coefficient can be calculated to be 1.79.
[0033] The symptom analysis module obtains the similarity coefficient of typical symptoms and transmits it to the monitoring feedback module; The monitoring feedback module provides monitoring result feedback to the characteristic drug subjects based on the data divided by subject type and the typical symptom similarity coefficient; The details are as follows: Obtaining subject type classification data, and obtaining subjects with normal physical signs and subjects with abnormal physical signs according to the subject type classification data; If the subject of the characteristic drug is a subject with abnormal vital signs, an abnormal vital sign warning will be issued to the subject of the characteristic drug; If the subject of the characteristic drug is a subject with normal physical signs, feedback on the symptom monitoring results will be provided to the subject of the characteristic drug; The details are as follows: Obtain the typical symptom similarity coefficient corresponding to the subjects with normal physical signs, and obtain the typical symptom benchmark similarity interval. If the typical symptom similarity coefficient is within the typical symptom benchmark similarity interval, it is determined that the subjects with normal physical signs have abnormal symptoms. If the typical symptom similarity coefficient is not within the typical symptom benchmark similarity interval, it is determined that the subjects with normal physical signs do not have abnormal symptoms, and an abnormal symptom warning is issued. It should be noted here that: In this application, the typical symptoms of subjects with normal physical signs are normal, including the situation where the typical symptom similarity coefficient is at the boundary of the typical symptom benchmark similarity interval; The typical symptom benchmark similarity interval is obtained as follows: Obtain historical test data corresponding to the characteristic test drug, obtain several subjects with normal historical symptoms based on the historical test data, obtain the typical symptom similarity coefficient corresponding to each subject with normal historical symptoms, and compare the numerical values of the multiple typical symptom similarity coefficients obtained, mark the typical symptom similarity coefficient with the largest value as the upper limit of the typical symptom benchmark similarity interval, and mark the typical symptom benchmark similarity interval with the smallest value as the lower limit of the typical symptom benchmark similarity interval.
[0034] In this application, if a corresponding calculation formula appears, the above calculation formula is dimensionless and its numerical calculation is performed. The weight coefficient, proportional coefficient and other coefficients in the formula are set to a result value obtained by quantifying each parameter. Regarding the size of the weight coefficient and the proportional coefficient, as long as it does not affect the proportional relationship between the parameter and the result value, it is acceptable.
[0035] The preferred embodiments of the present invention disclosed above are intended only to help illustrate the present invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the present invention to specific embodiments. Obviously, many modifications and variations are possible based on the contents of this specification. These embodiments are selected and described in detail in this specification to better explain the principles and practical applications of the present invention, thereby enabling those skilled in the art to better understand and utilize the present invention. The present invention is limited only by the claims and their full scope and equivalents.
Claims
1. A system for dynamic monitoring of vital signs of subjects in drug testing laboratories, characterized in that: include: Data acquisition module: acquires characteristic test drugs, and sets several physiological indicators for the characteristic test drugs to monitor the physiological indicators of the subjects, obtains the abnormality of each physiological indicator according to the monitoring results, and obtains the physiological indicator collection data; Physical sign analysis module: analyzes the physical sign indicators of characteristic drug subjects based on the collected physiological indicator data, and classifies the characteristic drug subjects into types based on the analysis results to obtain subject type classification data; Symptom analysis module: set several typical symptoms for subjects with normal physical signs, and perform typical symptom overlap analysis on subjects with normal physical signs, and obtain the typical symptom similarity coefficient based on the analysis results; Monitoring feedback module: Provides monitoring result feedback to characteristic drug subjects based on data divided by subject type and typical symptom similarity coefficient.
2. A system for dynamic monitoring of vital signs of subjects in drug testing laboratories according to claim 1, characterized in that: Acquire the physiological index data as follows: Acquiring characteristic drug subjects and acquiring drugs tested on the characteristic drug subjects to obtain characteristic test drugs; Set L1 physiological index to La physiological index for characteristic test drugs; During the process of monitoring physiological indicators of drug subjects, a physiological indicator monitoring cycle is marked; If the L1 physiological indicator is pulse, the pulse indicator of the characteristic drug subject who is in the physiological indicator monitoring period is monitored, and the abnormality of the L1 physiological indicator monitoring is obtained according to the monitoring result; Obtaining physiological indicator monitoring abnormality corresponding to the L2 physiological indicator to the La physiological indicator respectively, and obtaining the L2 physiological indicator monitoring abnormality to the La physiological indicator monitoring abnormality; The physiological index monitoring abnormality degree L1 to the physiological index monitoring abnormality degree La are defined as the physiological index collection data.
3. A system for dynamic monitoring of vital signs of subjects in drug testing laboratories according to claim 2, characterized in that: Obtain the abnormality of L1 physiological indicators monitoring, as follows: Dividing the physiological indicator monitoring cycle into a number of indicator monitoring time points, obtaining the in vivo concentration value of the characteristic drug subject at each indicator monitoring time point, obtaining a plurality of test drug concentration values, marking the test drug concentration value with the largest value as the first drug concentration value, and marking the test drug concentration value with the smallest value as the second drug concentration value; The first drug concentration value is used as the upper limit of the interval, and the second drug concentration value is used as the lower limit of the interval to mark the periodic in vivo drug concentration interval, and the periodic in vivo drug concentration interval is divided into drug concentration subintervals N1 to Nb; Obtain the time period in which the test drug concentration value is within the N1 to Nb drug concentration subinterval to obtain the N1 to Nb drug concentration time period; obtain the interval pulse deviation corresponding to the N1 to Nb drug concentration subintervals to obtain the N1 to Nb interval pulse deviation; During the N1 drug concentration period, the duration of the indicator monitoring time points at which the subject's pulse value is not within the subject's pulse baseline interval is accumulated to obtain the N1 pulse deviation duration, and so on to obtain the Nb pulse deviation duration; Obtain the duration of the drug concentration period from N1 to Nb respectively to obtain the drug concentration duration from N1 to Nb; The ratio of the N1 pulse deviation duration to the N1 drug concentration duration was calculated to obtain the N1 to Nb pulse deviation duration ratio; Calculate the abnormality of L1 physiological index monitoring; The specific formula is as follows: ; Among them, Ycl1 is the abnormality of L1 physiological index monitoring, Pci is the pulse deviation degree of Ni interval, Sci is the Ni pulse deviation time ratio, and b is the quantitative value corresponding to the drug concentration subinterval.
4. A system for dynamic monitoring of vital signs of subjects in drug testing laboratories according to claim 3, characterized in that: The pulse deviation degree in the N1 interval is obtained as follows: Acquire the indicator monitoring time points covered by the N1 drug concentration period, obtain the characteristic drug subject pulse value corresponding to each indicator monitoring time point, obtain multiple subject pulse values, obtain the subject pulse reference interval, if the subject pulse value is within the subject pulse reference interval, assign a parameter to the subject pulse deviation, if the subject pulse value is not within the subject pulse reference interval, calculate the deviation value between the subject pulse value and the subject pulse reference interval, and obtain multiple subject pulse reference deviations; The numerical value of the interval range corresponding to the subject's pulse reference interval is obtained to obtain the pulse reference interval range value, the average of the obtained subject's pulse reference deviation is calculated to obtain the subject's pulse reference deviation average value, and the ratio of the subject's pulse reference deviation average value to the pulse reference interval range value is calculated to obtain the N1 interval pulse deviation degree.
5. A system for dynamic monitoring of vital signs of subjects in drug testing laboratories according to claim 1, characterized in that: The data on the classification of subjects are obtained as follows: Acquire physiological indicator collection data, and respectively obtain L1 physiological indicator monitoring abnormality degree to La physiological indicator monitoring abnormality degree according to the physiological indicator collection data; Obtaining an indicator abnormality reference interval corresponding to the L1 physiological indicator to obtain the L1 indicator abnormality reference interval; if the L1 physiological indicator monitoring abnormality is not within the L1 indicator abnormality reference interval, classifying the L1 physiological indicator as a normal physiological indicator; if the L1 physiological indicator monitoring abnormality is within the L1 indicator abnormality reference interval, classifying the L1 physiological indicator as an abnormal physiological indicator; According to the abnormality of L2 physiological index monitoring to La physiological index monitoring, L2 physiological index to La physiological index are divided into normal physiological index and abnormal physiological index; If there are abnormal physiological indicators among the L1 physiological indicators to the La physiological indicators, the characteristic drug subjects are classified as subjects with abnormal physical signs. If there are no abnormal physiological indicators among the L1 physiological indicators to the La physiological indicators, the characteristic drug subjects are classified as subjects with normal physical signs, and the subject type classification data is obtained.
6. A system for dynamic monitoring of vital signs of subjects in a drug testing laboratory according to claim 1, characterized in that: The similarity coefficient of typical symptoms is obtained as follows: Obtaining subject type classification data, and obtaining subjects with normal physical signs and subjects with abnormal physical signs according to the subject type classification data; In the process of symptom monitoring of subjects with normal physical signs, several different types of typical symptoms are set, and the set typical symptoms are marked as C1 typical symptoms to Cd typical symptoms respectively; Perform periodic blood drug concentration analysis on subjects with normal physical signs, and obtain multiple sample history subjects based on the analysis results; Compare and analyze the C1 typical symptoms of subjects with normal physical signs and multiple historical subjects. According to the analysis results, obtain the onset time deviation corresponding to the C1 typical symptoms and obtain the C1 symptom onset time deviation degree; Obtain the symptom onset time deviations corresponding to the typical symptoms of C2 and Cd respectively, and obtain the symptom onset time deviations of C2 and Cd; Among multiple sample historical subjects, the number of people with typical symptoms from C1 to Cd was obtained respectively, and the number of people with symptoms from C1 to Cd was obtained; The number of historical sample subjects was obtained to obtain the number of historical sample subjects, and the ratio of the number of people with symptoms C1 to Cd to the number of historical sample subjects was calculated to obtain the typical symptom occurrence ratio of C1 to Cd; The similarity coefficient of typical symptoms was calculated; The specific formula is as follows: ; Among them, Jcd is the similarity coefficient of typical symptoms, Spi is the appearance ratio of Ci typical symptoms, Cxi is the deviation of Ci symptom onset time, and d is the quantity value corresponding to the typical symptoms.
7. A system for dynamic monitoring of vital signs of subjects in drug testing laboratories according to claim 6, characterized in that: The sample history subjects are obtained as follows: The time point when the characteristic test drug is injected into the body of a subject with normal physical signs is marked as the cycle start time point, the time point corresponding to the current moment is marked as the cycle end time point, and the period between the cycle start time point and the cycle end time point is marked as the drug clearance monitoring period; Marking a number of blood drug concentration time points with equal time intervals during the drug clearance monitoring period, and marking the obtained multiple blood drug concentration time points in chronological order as X1 blood drug concentration time point to Xe blood drug concentration time point; Obtain the blood drug concentration values corresponding to the X1 blood drug concentration time point to the Xe blood drug concentration time point of the subjects with normal physical signs, and obtain the X1 blood drug concentration value to the Xe blood drug concentration value; Create a blood drug concentration monitoring rectangular coordinate system based on the blood drug concentration values of X1 to Xe, and obtain the blood drug closed area value by analyzing the blood drug concentration monitoring rectangular coordinate system; The initial injection dose of the characteristic test drug in the body of a subject with normal physical signs is obtained to obtain the initial injection dose of the drug, and the ratio of the initial injection dose of the drug to the area value of the blood drug closed area is calculated to obtain the drug clearance rate of the subject; A drug clearance rate interval is set by taking the drug clearance rate of the subject as the middle value of the interval, and historical subjects whose drug clearance rates are within the drug clearance rate interval are obtained to obtain multiple sample historical subjects.
8. A system for dynamic monitoring of vital signs of subjects in drug testing laboratories according to claim 7, characterized in that: The area value of the blood drug closed area is obtained as follows: In the existing plane rectangular coordinate system, the blood drug concentration time point is marked as the horizontal axis, and the blood drug concentration value is marked as the vertical axis to create a blood drug concentration monitoring rectangular coordinate system; In the rectangular coordinate system for blood drug concentration monitoring, the X1 blood drug concentration time point is used as the horizontal coordinate and the X1 blood drug concentration value is used as the vertical coordinate, and the coordinate point is marked as the X1 blood drug coordinate point. Similarly, the Xe blood drug concentration time point is used as the horizontal coordinate and the Xe blood drug concentration value is used as the vertical coordinate, and the X1 blood drug coordinate point is connected to the Xe blood drug coordinate point to obtain the blood drug concentration curve; In the rectangular coordinate system for monitoring blood drug concentration, a straight line perpendicular to the x-axis is drawn through the X1 blood drug coordinate point to obtain the first area characteristic line, and a straight line perpendicular to the x-axis is drawn through the Xa blood drug coordinate point to obtain the second area characteristic line. The closed area surrounded by the first area characteristic line, the second area characteristic line, the blood drug concentration curve and the x-axis is marked as the blood drug closed area, and the area value of the blood drug closed area is obtained to obtain the area value of the blood drug closed area.
9. A system for dynamic monitoring of vital signs of subjects in drug testing laboratories according to claim 6, characterized in that: The deviation of C1 symptom onset time is obtained as follows: Obtaining the initial onset time of the C1 typical symptom corresponding to the subject with normal physical signs to obtain the C1 symptom onset time point, obtaining the time point when the characteristic test drug is injected into the subject with normal physical signs to obtain the drug initial injection time point, calculating the time difference between the C1 symptom onset time point and the drug initial injection time point to obtain the C1 symptom onset time difference; Obtain the C1 symptom onset time difference corresponding to the sample history subjects respectively, mark the C1 symptom onset time difference with the largest value as the upper limit of the benchmark onset time difference interval, mark the C1 symptom onset time difference with the smallest value as the lower limit of the benchmark onset time difference interval, calculate the difference between the upper limit of the benchmark onset time difference interval and the lower limit of the benchmark onset time difference interval, and obtain the benchmark onset time difference interval range value; The time difference between the C1 symptom onset time difference and the baseline onset time difference interval corresponding to the subjects with normal physical signs was calculated to obtain the C1 symptom onset time deviation; The ratio of the C1 symptom onset time deviation to the baseline onset time difference interval was calculated to obtain the C1 symptom onset time deviation degree.
10. A system for dynamic monitoring of vital signs of subjects in drug testing laboratories according to claim 1, characterized in that: Feedback on monitoring results of characteristic drug subjects is as follows: Obtaining subject type classification data, and obtaining subjects with normal physical signs and subjects with abnormal physical signs according to the subject type classification data; If the subject of the characteristic drug is a subject with abnormal vital signs, an abnormal vital sign warning will be issued to the subject of the characteristic drug; If the subject of the characteristic drug is a subject with normal physical signs, feedback on the symptom monitoring results will be provided to the subject of the characteristic drug; The details are as follows: Obtain the typical symptom similarity coefficient corresponding to subjects with normal physical signs and obtain the typical symptom benchmark similarity interval; If the typical symptom similarity coefficient is within the typical symptom benchmark similarity interval, it is judged that the subject with normal physical signs has abnormal symptoms; If the typical symptom similarity coefficient is not within the typical symptom benchmark similarity interval, it is judged that the subject with normal physical signs has no abnormal symptoms, and an abnormal symptom warning is issued.
Citation Information
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