A dynamic monitoring system for physical signs of subjects in a drug trial research laboratory

Abstract

The application discloses a kind of for drug test research room subject sign dynamic monitoring system, it is related to the field of drug test, solve the problem that drug test research room subject sign dynamic monitoring monitoring effect is poor, including data acquisition module: a plurality of physiological indexes are set to the physiological index monitoring of subject for characteristic test drug, obtain physiological index acquisition data, sign analysis module: according to physiological index acquisition data, sign index analysis is carried out to characteristic drug subject, according to the type division of subject is carried out to analysis result, obtains subject type division data, symptom analysis module: the typical symptom coincidence degree analysis is carried out to normal subject, according to analysis result, obtain typical symptom similarity coefficient, monitoring feedback module: according to subject type division data and typical symptom similarity coefficient, monitoring result feedback is carried out to characteristic drug subject, the accuracy and pertinence of subject sign dynamic monitoring process can be improved by the application.

Description

Technical Field

[0001] This invention belongs to the field of drug testing and relates to behavioral monitoring technology, specifically a dynamic monitoring system for the vital signs of subjects in drug testing laboratories. Background Technology

[0002] Existing dynamic vital sign monitoring systems have the following specific shortcomings when monitoring the vital signs of drug subjects:

[0003] Existing dynamic monitoring systems for vital signs cannot set up several physiological indicators for characteristic test drugs to monitor multiple physiological indicators of subjects, nor can they classify subjects for characteristic drugs based on monitoring results. As a result, they cannot conduct targeted monitoring of vital signs for subjects of different types of drugs, leading to a lack of specificity in the monitoring process.

[0004] Existing dynamic monitoring systems for vital signs can only monitor subjects' vital signs through physiological indicators. They cannot classify data according to subject type and conduct typical symptom overlap analysis for subjects taking specific medications to comprehensively provide feedback on vital sign monitoring results, which easily leads to a lack of comprehensiveness in the dynamic monitoring results for vital signs.

[0005] Therefore, we propose a dynamic monitoring system for the vital signs of subjects in drug trial research laboratories. Summary of the Invention

[0006] In view of the shortcomings of existing technologies, the purpose of this invention is to provide a dynamic monitoring system for the vital signs of subjects in drug trial research laboratories. This invention aims to improve the comprehensiveness and pertinence of the dynamic monitoring process of subjects' vital signs.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: a dynamic monitoring system for the vital signs of subjects in drug trial research laboratories, the specific working process of each module is as follows:

[0008] Data acquisition module: Acquires the characteristic test drug, sets several physiological indicators for the characteristic test drug, monitors multiple physiological indicators of the subject, obtains the abnormality of each physiological indicator based on the monitoring results, and obtains physiological indicator acquisition data.

[0009] Vital signs analysis module: Analyzes vital signs of subjects using physiological indicators based on collected data, and classifies subjects based on the analysis results to obtain subject classification data;

[0010] Symptom Analysis Module: Based on the subject type, several typical symptoms are set for subjects with normal physical signs, and the overlap of typical symptoms is analyzed for subjects with normal physical signs. The similarity coefficient of typical symptoms is obtained based on the analysis results.

[0011] Monitoring and feedback module: Based on the subject type classification data and the similarity coefficient of typical symptoms, the monitoring results of subjects taking characteristic drugs are fed back.

[0012] Furthermore, physiological indicator data were collected, specifically as follows:

[0013] Drug subjects are acquired in the drug trial research laboratory, and a characteristic drug subject is selected from the acquired multiple drug subjects. The drug tested by the characteristic drug subject is then acquired to obtain the characteristic test drug.

[0014] Several different types of physiological indicators were set for the characteristic test drug, and these physiological indicators were labeled as L1 physiological indicators to La physiological indicators respectively.

[0015] During the monitoring of physiological indicators of drug subjects, the current time point is marked as the end time point of the cycle to mark a physiological indicator monitoring cycle of fixed duration.

[0016] If the L1 physiological indicator is pulse, then pulse indicators are monitored for characteristic drug subjects in the physiological indicator monitoring period, and the abnormality of L1 physiological indicator monitoring is obtained based on the monitoring results.

[0017] The abnormality rates of physiological indicators from L2 to La were obtained respectively, and the abnormality rates of physiological indicators from L2 to La were obtained.

[0018] The abnormality of physiological indicators from L1 to La is defined as the physiological indicator data.

[0019] Furthermore, the abnormality rate of L1 physiological indicators was obtained, as detailed below:

[0020] The physiological indicator monitoring cycle is divided into several indicator monitoring time points, and two adjacent indicator monitoring time points are consecutive time points.

[0021] For each indicator monitoring time point, the concentration value of the characteristic test drug in the characteristic drug subject is obtained, resulting in multiple test drug concentration values. The multiple test drug concentration values ​​are compared, and the test drug concentration value with the largest value is marked as the first drug concentration value, and the test drug concentration value with the smallest value is marked as the second drug concentration value.

[0022] 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 drug concentration interval in the periodic body. The drug concentration interval in the periodic body is interpolated into several drug concentration sub-intervals with equal numerical ranges. The obtained drug concentration sub-intervals are marked as N1 drug concentration sub-interval to Nb drug concentration sub-interval respectively.

[0023] The time period from N1 to Nb drug concentration sub-intervals is obtained by acquiring the drug concentration value of the test drug;

[0024] Pulse index analysis was performed on characteristic drug subjects in the N1 drug concentration period, and the pulse deviation of the N1 interval was obtained based on the analysis results.

[0025] Obtain the pulse deviation values ​​corresponding to the N2 drug concentration sub-interval to the Nb drug concentration sub-interval respectively, and obtain the pulse deviation values ​​from the N2 interval to the Nb interval.

[0026] During the N1 drug concentration period, the duration of monitoring points where the subject's pulse value was not within the subject's pulse baseline range was accumulated to obtain the N1 pulse deviation duration. During the N2 drug concentration period, the duration of monitoring points where the subject's pulse value was not within the subject's pulse baseline range was accumulated to obtain the N2 pulse deviation duration. And so on, during the Nb drug concentration period, the duration of monitoring points where the subject's pulse value was not within the subject's pulse baseline range was accumulated to obtain the Nb pulse deviation duration.

[0027] The duration of drug concentration periods from N1 to Nb was obtained separately to obtain the duration of drug concentration from N1 to Nb.

[0028] Calculate the ratio of N1 pulse deviation duration to N1 drug concentration duration to obtain the N1 pulse deviation duration ratio to the Nb pulse deviation duration ratio;

[0029] The abnormality of L1 physiological indicators is obtained by calculating the pulse deviation from N1 interval to Nb interval and the pulse deviation duration ratio from N1 to Nb.

[0030] The abnormality rate of L1 physiological indicators is calculated using the following formula:

[0031] ;

[0032] Where 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 quantitative value corresponding to the drug concentration sub-interval.

[0033] Furthermore, the pulse deviation in the N1 interval is obtained, as follows:

[0034] The monitoring time points of the indicators covered by the N1 drug concentration period were obtained. The pulse value of the subject corresponding to the characteristic drug was obtained for each indicator monitoring time point. Multiple subjects' pulse values ​​were obtained, and the subject's pulse reference interval was obtained. If the subject's pulse value is within the subject's pulse reference interval, the parameter value of 0 is used to assign the subject's pulse deviation. If the subject's pulse value is not within the subject's pulse reference interval, the deviation value between the subject's pulse value and the subject's pulse reference interval is calculated, and multiple subjects' pulse reference deviations are obtained.

[0035] The range of the pulse baseline interval corresponding to the subject is numerically obtained to obtain the pulse baseline interval range value. The average value of the obtained pulse baseline deviation of the subject is calculated to obtain the average value of the pulse baseline deviation of the subject. The ratio of the average value of the pulse baseline deviation of the subject to the pulse baseline interval range value is calculated to obtain the pulse deviation degree of the N1 interval.

[0036] Furthermore, data on the classification of subject types was obtained, as follows:

[0037] Acquire physiological index data, and obtain the abnormality of physiological index monitoring from L1 to La based on the physiological index data.

[0038] Obtain the benchmark interval of the abnormality of the L1 physiological index. If the abnormality of the L1 physiological index is not within the benchmark interval of the L1 physiological index, the L1 physiological index is classified as a normal physiological index. If the abnormality of the L1 physiological index is within the benchmark interval of the L1 physiological index, the L1 physiological index is classified as an abnormal physiological index.

[0039] Based on the abnormality of L2 physiological indicators to La physiological indicators, the L2 physiological indicators to La physiological indicators are divided into normal physiological indicators and abnormal physiological indicators.

[0040] If there are abnormal physiological indicators among the L1 to La physiological indicators, the subject of the characteristic drug is classified as a subject with abnormal signs. If there are no abnormal physiological indicators among the L1 to La physiological indicators, the subject of the characteristic drug is classified as a subject with normal signs, thus obtaining subject type classification data.

[0041] Furthermore, the similarity coefficient of typical symptoms was obtained, as follows:

[0042] Obtain subject type classification data, and then identify subjects with normal physical signs and subjects with abnormal physical signs based on the subject type classification data.

[0043] During the symptom monitoring of subjects with normal vital signs, several different types of typical symptoms were set up and labeled as C1 typical symptoms to Cd typical symptoms.

[0044] Periodic blood drug concentration analysis was performed on subjects with normal vital signs, and multiple historical samples of subjects were obtained based on the analysis results;

[0045] The typical symptoms of C1 were compared and analyzed between subjects with normal physical signs and subjects with multiple historical samples. The onset time deviation corresponding to the typical symptoms of C1 was obtained based on the analysis results, and the onset time deviation degree of C1 symptoms was obtained.

[0046] Obtain the symptom onset time deviation corresponding to the typical symptoms of C2 to Cd respectively, and obtain the symptom onset time deviation from C2 to Cd.

[0047] In multiple historical subjects, the number of people who had typical symptoms of C1 to Cd was obtained, and the number of people who had symptoms of C1 to Cd was obtained.

[0048] The sample historical subjects were obtained to obtain the sample historical subject number value. The ratio of the number of people with C1 symptoms to the number of people with Cd symptoms to the sample historical subject number value was calculated to obtain the C1 typical symptom occurrence ratio to the Cd typical symptom occurrence ratio.

[0049] The typical symptom similarity coefficient is obtained by calculating the ratio of the occurrence of typical symptoms of C1 to that of Cd and the deviation of the onset time of C1 symptoms to that of Cd symptoms.

[0050] The similarity coefficient of typical symptoms is calculated using the following formula:

[0051] ;

[0052] Where Jcd is the typical symptom similarity coefficient, Spi is the ratio of typical symptoms to Ci, Cxi is the deviation of Ci symptom onset time, and d is the numerical value corresponding to typical symptoms.

[0053] Furthermore, the historical data of the sample participants was obtained, as follows:

[0054] The time point at which the characteristic test drug is injected into a subject with normal vital signs is marked as the start time point of the cycle, the time point corresponding to the current moment is marked as the end time point of the cycle, and the time period between the start time point and the end time point of the cycle is marked as the drug clearance monitoring cycle.

[0055] Several time points with equal time intervals for blood drug concentration were marked within the drug clearance monitoring period, and the multiple blood drug concentration time points obtained were sequentially marked as X1 blood drug concentration time point to Xe blood drug concentration time point in chronological order.

[0056] Blood drug concentration values ​​were obtained for subjects with normal vital signs at time points X1 to Xe, respectively, to obtain the blood drug concentration values ​​from X1 to Xe.

[0057] A rectangular coordinate system for monitoring blood drug concentration was created based on the blood drug concentration values ​​from X1 to Xe, and the area of ​​the blood drug closed region was obtained by analyzing the blood drug concentration monitoring rectangular coordinate system.

[0058] The initial injection dose of the characteristic test drug in subjects with normal vital signs was obtained, and the ratio of the initial injection dose to the area of ​​the blood drug-blocked region was calculated to obtain the drug clearance rate of the subject.

[0059] A drug clearance rate interval was set by using the subject's drug clearance rate as the midpoint of the interval. The drug clearance rates of multiple historical subjects were obtained. Historical subjects whose drug clearance rates were within the drug clearance rate interval were marked as sample historical subjects, thus obtaining multiple sample historical subjects.

[0060] Furthermore, the area of ​​the blood-drug-blocked region is obtained, as follows:

[0061] In the existing Cartesian coordinate system, the time points of blood drug concentration are marked as the horizontal axis and the blood drug concentration values ​​are marked as the vertical axis to create a Cartesian coordinate system for blood drug concentration monitoring;

[0062] In the rectangular coordinate system for blood drug concentration monitoring, the point where the X1 blood drug concentration time point is used as the abscissa and the X1 blood drug concentration value is used as the ordinate is marked as the X1 blood drug coordinate point. Similarly, the point where the X2 blood drug concentration time point is used as the abscissa and the X2 blood drug concentration value is used as the ordinate is marked as the X2 blood drug coordinate point. And so on, the point where the Xe blood drug concentration time point is used as the abscissa and the Xe blood drug concentration value is used as the ordinate is marked as the Xe blood drug coordinate point. Connecting the X1 blood drug coordinate point to the Xe blood drug coordinate point yields the blood drug concentration curve.

[0063] 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. 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 region 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 region. The area value of the blood drug closed region is obtained by calculating the area value of the blood drug closed region.

[0064] Furthermore, the deviation in the onset time of C1 symptoms was obtained, as detailed below:

[0065] Obtain the initial onset time of typical C1 symptoms for subjects with normal vital signs, and obtain the onset time of C1 symptoms. Obtain the time point when the characteristic test drug is injected into the body of subjects with normal vital signs, and obtain the initial injection time point of the drug. Calculate the time difference between the onset time of C1 symptoms and the initial injection time point of the drug, and obtain the onset time difference of C1 symptoms.

[0066] The C1 symptom onset time difference for each historical subject in the sample is obtained. The C1 symptom onset time difference with the largest value is marked as the upper limit of the baseline onset time difference interval, and the C1 symptom onset time difference with the smallest value is marked as the lower limit of the baseline onset time difference interval. The difference between the upper limit and the lower limit of the baseline onset time difference interval is calculated to obtain the range value of the baseline onset time difference interval.

[0067] If the C1 symptom onset time difference is greater than the upper limit of the baseline onset time difference interval, the difference between the C1 symptom onset time difference and the upper limit of the baseline 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 baseline onset time difference interval, the difference between the lower limit of the baseline 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 baseline onset time difference interval, the parameter value 0 is used to assign a value to the C1 symptom onset time deviation.

[0068] The C1 symptom onset time deviation is calculated by comparing it with the baseline onset time difference range.

[0069] Furthermore, the monitoring results of subjects receiving the characteristic drug were fed back, as follows:

[0070] Obtain subject type classification data, and then identify subjects with normal physical signs and subjects with abnormal physical signs based on the subject type classification data.

[0071] If the subject of the characteristic drug has abnormal vital signs, an early warning of abnormal vital signs will be issued for the subject of the characteristic drug.

[0072] If the subject of the characteristic drug is a subject with normal physical signs, then the symptom monitoring results of the subject of the characteristic drug will be fed back.

[0073] Specifically as follows:

[0074] Obtain the similarity coefficient of typical symptoms for subjects with normal physical signs, and obtain the baseline similarity interval of typical symptoms;

[0075] If the similarity coefficient of typical symptoms is within the baseline similarity range of typical symptoms, then it is determined that the subject with normal physical signs has abnormal symptoms.

[0076] If the similarity coefficient of typical symptoms is not within the typical symptom baseline similarity range, it is determined that the subjects with normal physical signs do not have abnormal symptoms, and an abnormal symptom warning is issued.

[0077] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0078] 1. This invention sets up several physiological indicators for characteristic test drugs to monitor multiple physiological indicators of subjects, and classifies subjects of characteristic drugs according to the monitoring results. Targeted vital sign monitoring is carried out for subjects of different types of drugs, which can improve the lack of specificity in the vital sign monitoring process.

[0079] 2. This invention uses physiological indicators to dynamically monitor the vital signs of subjects, and performs typical symptom overlap analysis on subjects with specific drugs according to subject type to provide comprehensive feedback on the vital sign monitoring results, which can ensure the comprehensiveness of the dynamic monitoring results. Attached Figure Description

[0080] To facilitate understanding by those skilled in the art, the present invention will be further described below with reference to the accompanying drawings.

[0081] Figure 1 This is an overall system block diagram of the present invention;

[0082] Figure 2 This is the rectangular coordinate system for monitoring blood drug concentration in this invention;

[0083] Figure 3 This is a schematic diagram of the blood drug blocking region of the present invention. Detailed Implementation

[0084] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0085] Example 1

[0086] Please see Figure 1 The behavioral monitoring technology involved in the symptom monitoring process of this invention provides a technical solution: a dynamic monitoring system for the vital signs of subjects in a drug trial research laboratory, comprising a data acquisition module, a vital sign analysis module, a symptom analysis module, a monitoring feedback module, and a server. The data acquisition module, vital sign analysis module, symptom analysis module, and monitoring feedback module are respectively connected to the server, and the server controls the data acquisition module, vital sign analysis module, symptom analysis module, and monitoring feedback module respectively.

[0087] The data acquisition module acquires the characteristic test drug, sets several physiological indicators for the characteristic test drug, and monitors multiple physiological indicators of the subject. Based on the monitoring results, it obtains the abnormality of each physiological indicator and obtains the physiological indicator acquisition data.

[0088] Specifically as follows:

[0089] Drug subjects are acquired in the drug trial research laboratory, and a characteristic drug subject is selected from the acquired multiple drug subjects. The drug tested by the characteristic drug subject is then acquired to obtain the characteristic test drug.

[0090] Several different types of physiological indicators were set for the characteristic test drug, and these physiological indicators were labeled as L1 physiological indicators to La physiological indicators respectively.

[0091] It should be noted here that:

[0092] In this application, L1 refers to the symbol corresponding to the physiological indicator, and a refers to the quantitative value corresponding to the physiological indicator, where a is an integer greater than 0.

[0093] It should be noted here that:

[0094] In this application, the L1 physiological indicator can be the pulse value, the L2 physiological indicator can be the blood pressure value, and the L3 physiological indicator can be the respiratory rate value.

[0095] During the monitoring of physiological indicators of drug subjects, the current time point is marked as the end time point of the cycle to mark a physiological indicator monitoring cycle of fixed duration.

[0096] It should be noted here that:

[0097] 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. Therefore, the physiological indicator monitoring cycle can be dynamically updated as the time value of the current moment changes.

[0098] If the L1 physiological indicator is pulse, then pulse indicators are monitored for characteristic drug subjects in the physiological indicator monitoring period, and the abnormality of L1 physiological indicator monitoring is obtained based on the monitoring results.

[0099] Specifically as follows:

[0100] The physiological indicator monitoring cycle is divided into several indicator monitoring time points, and two adjacent indicator monitoring time points are consecutive time points.

[0101] It should be noted here that:

[0102] In this application, the time interval between two consecutive monitoring points of an indicator is a negligible time interval. Specifically, if the physiological indicator being monitored is the pulse, the time interval between two consecutive monitoring points of an indicator can be 10 seconds.

[0103] For each indicator monitoring time point, the concentration value of the characteristic test drug in the characteristic drug subject is obtained, resulting in multiple test drug concentration values. The multiple test drug concentration values ​​are compared, and the test drug concentration value with the largest value is marked as the first drug concentration value, and the test drug concentration value with the smallest value is marked as the second drug concentration value.

[0104] It should be noted here that:

[0105] In this application, the test drug concentration value referred to herein is specifically the blood concentration value of the characteristic test drug in the characteristic subject.

[0106] 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 drug concentration interval in the periodic body. The drug concentration interval in the periodic body is interpolated into several drug concentration sub-intervals with equal numerical ranges. The obtained drug concentration sub-intervals are marked as N1 drug concentration sub-interval to Nb drug concentration sub-interval respectively.

[0107] It should be noted here that:

[0108] In this application, N is the symbol corresponding to the drug concentration sub-interval, b is the quantity value corresponding to the drug concentration sub-interval, and b is an integer greater than 0.

[0109] The time period from N1 to Nb drug concentration sub-intervals is obtained by acquiring the drug concentration value of the test drug;

[0110] Pulse index analysis was performed on characteristic drug subjects in the N1 drug concentration period, and the pulse deviation of the N1 interval was obtained based on the analysis results.

[0111] Specifically as follows:

[0112] The monitoring time points of the indicators covered by the N1 drug concentration period were obtained. The pulse value of the subject corresponding to the characteristic drug was obtained for each indicator monitoring time point. Multiple subjects' pulse values ​​were obtained, and the subject's pulse reference interval was obtained. If the subject's pulse value is within the subject's pulse reference interval, the parameter value of 0 is used to assign the subject's pulse deviation. If the subject's pulse value is not within the subject's pulse reference interval, the deviation value between the subject's pulse value and the subject's pulse reference interval is calculated, and multiple subjects' pulse reference deviations are obtained.

[0113] It should be noted here that:

[0114] The deviation between the subject's pulse value and the subject's pulse reference range, as referred to here, is specifically the difference between the subject's pulse value and the upper limit or lower limit of the subject's pulse reference range, and the absolute value of the obtained difference is taken.

[0115] The specific pulse reference interval for the subject involved in this characteristic drug is [60, 100]. In specific implementation, if the subject's pulse value is 45, the difference between 45 and the lower limit of the subject's pulse reference interval 60 is calculated, and the absolute value of the obtained difference is taken to obtain the subject's pulse reference deviation as 15.

[0116] In practice, if the subject's pulse value is 110, the difference between 110 and the lower limit of the subject's pulse reference interval of 100 is calculated, and the absolute value of the obtained difference is taken to obtain the subject's pulse reference deviation as 10.

[0117] The range of the pulse baseline interval corresponding to the subject is numerically obtained to obtain the pulse baseline interval range value. The average value of the obtained pulse baseline deviation of the subject is calculated to obtain the average value of the pulse baseline deviation of the subject. The ratio of the average value of the pulse baseline deviation of the subject to the pulse baseline interval range value is calculated to obtain the N1 interval pulse deviation degree.

[0118] Repeat the process of obtaining the pulse deviation in the N1 interval, and obtain the pulse deviation in the intervals corresponding to the N2 drug concentration sub-interval to the Nb drug concentration sub-interval respectively, to obtain the pulse deviation in the N2 interval to the Nb interval.

[0119] During the N1 drug concentration period, the duration of monitoring points where the subject's pulse value was not within the subject's pulse baseline range was accumulated to obtain the N1 pulse deviation duration. During the N2 drug concentration period, the duration of monitoring points where the subject's pulse value was not within the subject's pulse baseline range was accumulated to obtain the N2 pulse deviation duration. And so on, during the Nb drug concentration period, the duration of monitoring points where the subject's pulse value was not within the subject's pulse baseline range was accumulated to obtain the Nb pulse deviation duration.

[0120] The duration of drug concentration periods from N1 to Nb was obtained separately to obtain the duration of drug concentration from N1 to Nb.

[0121] Calculate the ratio of N1 pulse deviation duration to N1 drug concentration duration to obtain the N1 pulse deviation duration ratio to the Nb pulse deviation duration ratio;

[0122] The abnormality of L1 physiological indicators is obtained by calculating the pulse deviation from N1 interval to Nb interval and the pulse deviation duration ratio from N1 to Nb.

[0123] The abnormality rate of L1 physiological indicators is calculated using the following formula:

[0124] ;

[0125] Where 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 numerical value corresponding to the drug concentration sub-interval.

[0126] It should be noted here that:

[0127] In this application, the Ni interval pulse deviation degree involved here refers to 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.

[0128] In this application, the following test data exists in specific implementations:

[0129] The measured pulse deviation in the N1 interval is 0.21, the pulse deviation duration ratio in the Ni interval is 0.4, the pulse deviation in the N2 interval is 0.31, the pulse deviation duration ratio in the N2 interval is 0.52, the pulse deviation in the N3 interval is 0.37, the pulse deviation duration ratio in the N3 interval is 0.58, and b is 3. Therefore, the abnormality rate of the L1 physiological indicator monitoring can be calculated to be 1.797.

[0130] Repeat the process of obtaining the abnormality of L1 physiological indicators, and obtain the abnormality of physiological indicators corresponding to L2 physiological indicators to La physiological indicators respectively, to obtain the abnormality of L2 physiological indicators to La physiological indicators.

[0131] The abnormality rate of L1 physiological indicator monitoring to La physiological indicator monitoring is defined as the physiological indicator collection data;

[0132] The vital signs analysis module analyzes the vital signs of subjects using physiological indicators collected from the subject, and classifies the subjects based on the analysis results to obtain subject classification data.

[0133] Specifically as follows:

[0134] Acquire physiological index data, and obtain the abnormality of physiological index monitoring from L1 to La based on the physiological index data.

[0135] Obtain the benchmark interval of the abnormality of the L1 physiological index. If the abnormality of the L1 physiological index is not within the benchmark interval of the L1 physiological index, the L1 physiological index is classified as a normal physiological index. If the abnormality of the L1 physiological index is within the benchmark interval of the L1 physiological index, the L1 physiological index is classified as an abnormal physiological index.

[0136] It should be noted here that:

[0137] The abnormal physiological indicators involved here include situations where the abnormality of L1 physiological indicators falls within the boundary of the L1 indicator abnormality baseline interval.

[0138] The baseline interval for the L1 index anomaly is obtained as follows:

[0139] Obtain the historical test records corresponding to the characteristic test drugs, and obtain several historical subjects with abnormal L1 physiological indicators based on the historical test records. Obtain the L1 physiological indicator monitoring abnormality degree corresponding to each historical subject, mark the L1 physiological indicator monitoring abnormality degree with the largest value as the upper limit of the L1 indicator abnormality degree benchmark interval, and mark the L1 physiological indicator monitoring abnormality degree with the smallest value as the lower limit of the L1 indicator abnormality degree benchmark interval to obtain the L1 indicator abnormality degree benchmark interval.

[0140] Based on the abnormality of L2 physiological indicators to La physiological indicators, the L2 physiological indicators to La physiological indicators are divided into normal physiological indicators and abnormal physiological indicators.

[0141] If there are abnormal physiological indicators among the L1 to La physiological indicators, the subject of the characteristic drug is classified as a subject with abnormal signs; if there are no abnormal physiological indicators among the L1 to La physiological indicators, the subject of the characteristic drug is classified as a subject with normal signs, thus obtaining subject type classification data.

[0142] It should be noted here that:

[0143] In this application, the vital signs referred to herein are specifically vital signs, including but not limited to pulse, respiration, blood pressure, body temperature, and blood oxygen saturation.

[0144] The subjects with normal physical signs mentioned here are 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 checkups.

[0145] The vital signs analysis module acquires data on the classification of subject types and sends it to the symptom analysis module and the monitoring feedback module;

[0146] The symptom analysis module categorizes data based on subject type, sets several typical symptoms for subjects with normal physical signs, and performs a typical symptom overlap analysis on subjects with normal physical signs, obtaining the typical symptom similarity coefficient based on the analysis results.

[0147] Specifically as follows:

[0148] Obtain subject type classification data, and then identify subjects with normal physical signs and subjects with abnormal physical signs based on the subject type classification data.

[0149] During the symptom monitoring of subjects with normal vital signs, several different types of typical symptoms were set up and labeled as C1 typical symptoms to Cd typical symptoms.

[0150] It should be noted here that:

[0151] In this application, C is the symbol corresponding to the typical symptoms, d is the quantity value corresponding to the typical symptoms, and d is an integer greater than 0;

[0152] In this application, the typical symptoms mentioned herein need to be specifically set according to the type of characteristic test drug. The typical symptoms C1 mentioned herein may be fever, the typical symptoms C2 may be cough, and the typical symptoms C3 may be vomiting.

[0153] Periodic blood drug concentration analysis was performed on subjects with normal vital signs, and multiple historical samples of subjects were obtained based on the analysis results;

[0154] Specifically as follows:

[0155] The time point at which the characteristic test drug is injected into a subject with normal vital signs is marked as the start time point of the cycle, the time point corresponding to the current moment is marked as the end time point of the cycle, and the time period between the start time point and the end time point of the cycle is marked as the drug clearance monitoring cycle.

[0156] Several time points with equal time intervals for blood drug concentration were marked within the drug clearance monitoring period, and the multiple blood drug concentration time points obtained were sequentially marked as X1 blood drug concentration time point to Xe blood drug concentration time point in chronological order.

[0157] It should be noted here that:

[0158] In this application, X is the symbol corresponding to the time point of blood drug concentration, and e is the quantity value corresponding to the time point of blood drug concentration, and e is an integer greater than 0.

[0159] Blood drug concentration values ​​were obtained for subjects with normal vital signs at time points X1 to Xe, respectively, to obtain the blood drug concentration values ​​from X1 to Xe.

[0160] In the existing Cartesian coordinate system, the time points of blood drug concentration are marked as the horizontal axis and the blood drug concentration values ​​are marked as the vertical axis to create a Cartesian coordinate system for blood drug concentration monitoring;

[0161] Please see Figure 2 In the rectangular coordinate system for blood drug concentration monitoring, the point where the X1 blood drug concentration time point is used as the abscissa and the X1 blood drug concentration value is used as the ordinate is marked as the X1 blood drug coordinate point. Similarly, the point where the X2 blood drug concentration time point is used as the abscissa and the X2 blood drug concentration value is used as the ordinate is marked as the X2 blood drug coordinate point. And so on, the point where the Xe blood drug concentration time point is used as the abscissa and the Xe blood drug concentration value is used as the ordinate is marked as the Xe blood drug coordinate point. Connecting the X1 blood drug coordinate point to the Xe blood drug coordinate point yields the blood drug concentration curve.

[0162] Please see 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 region 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 region.

[0163] The area of ​​the blood-drug-blocked region is obtained, and the initial injection dose of the characteristic test drug in a normal subject is obtained. The ratio of the initial injection dose to the area of ​​the blood-drug-blocked region is calculated to obtain the drug clearance rate of the subject.

[0164] It should be noted here that:

[0165] In this application, drug clearance (CL) represents the theoretical volume of drug completely cleared from the body per unit time, reflecting the body's ability to clear drugs. Its core formula is: CL = blood drug concentration / drug elimination rate = dose / AUC, where AUC is the area under the drug-time curve, reflecting the total amount of drug exposure in the body, i.e., the cumulative degree of drug entry into the bloodstream.

[0166] A drug clearance rate interval was set by using the drug clearance rate of the subjects as the midpoint of the interval. The drug clearance rates of multiple historical subjects were obtained. Historical subjects whose drug clearance rates were within the drug clearance rate interval were marked as sample historical subjects, thus obtaining multiple sample historical subjects.

[0167] It should be noted here that:

[0168] The upper limit of the drug clearance rate interval mentioned here is Yql×(1+10%), and the lower limit of the drug clearance rate interval is Yql×(1-10%), where Yql is the drug clearance rate of the subject;

[0169] It should be noted here that:

[0170] The historical subjects involved in this sample are all historical subjects with typical symptoms and no abnormalities.

[0171] The onset time of typical C1 symptoms was analyzed in subjects with normal physical signs. Based on the analysis results, the onset time deviation corresponding to the typical C1 symptoms was obtained, and the C1 symptom onset time deviation degree was obtained.

[0172] Specifically as follows:

[0173] Obtain the initial onset time of typical C1 symptoms for subjects with normal vital signs, and obtain the onset time of C1 symptoms. Obtain the time point when the characteristic test drug is injected into the body of subjects with normal vital signs, and obtain the initial injection time point of the drug. Calculate the time difference between the onset time of C1 symptoms and the initial injection time point of the drug, and obtain the onset time difference of C1 symptoms.

[0174] The C1 symptom onset time difference for each historical subject in the sample is obtained. The C1 symptom onset time difference with the largest value is marked as the upper limit of the baseline onset time difference interval, and the C1 symptom onset time difference with the smallest value is marked as the lower limit of the baseline onset time difference interval. The difference between the upper limit and the lower limit of the baseline onset time difference interval is calculated to obtain the range value of the baseline onset time difference interval.

[0175] If the C1 symptom onset time difference is greater than the upper limit of the baseline onset time difference interval, the difference between the C1 symptom onset time difference and the upper limit of the baseline 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 baseline onset time difference interval, the difference between the lower limit of the baseline 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 baseline onset time difference interval, the parameter value 0 is used to assign a value to the C1 symptom onset time deviation.

[0176] The C1 symptom onset time deviation is calculated by comparing it with the baseline onset time difference range.

[0177] Repeat the process of obtaining the deviation of the onset time of typical symptoms of C1, and obtain the deviation of the onset time of symptoms corresponding to typical symptoms of C2 to Cd respectively, to obtain the deviation of the onset time of symptoms of C2 to Cd.

[0178] In multiple historical subjects, the number of people who had typical symptoms of C1 to Cd was obtained, and the number of people who had symptoms of C1 to Cd was obtained.

[0179] The sample historical subjects were obtained to obtain the sample historical subject number value. The ratio of the number of people with C1 symptoms to the number of people with Cd symptoms to the sample historical subject number value was calculated to obtain the C1 typical symptom occurrence ratio to the Cd typical symptom occurrence ratio.

[0180] The typical symptom similarity coefficient is obtained by calculating the ratio of the occurrence of typical symptoms of C1 to that of Cd and the deviation of the onset time of C1 symptoms to that of Cd symptoms.

[0181] The similarity coefficient of typical symptoms is calculated using the following formula:

[0182] ;

[0183] Where Jcd is the typical symptom similarity coefficient, Spi is the ratio of typical symptoms to Ci, Cxi is the deviation of Ci symptom onset time, and d is the numerical value corresponding to typical symptoms.

[0184] It should be noted here that:

[0185] In this application, the Ci typical symptom occurrence ratio can be any one of the typical symptom occurrence ratios from C1 to Cd, and the Ci symptom onset time deviation can be any one of the symptom onset time deviations from C1 to Cd.

[0186] In specific clinical practice, the following test data exists:

[0187] The test results showed that the occurrence rate of typical symptoms was 0.87 for C1, 0.92 for C2, and 0.85 for C3. The deviation of the onset time of symptoms was 0.2 for C1, 0.24 for C2, and 0.28 for C3. Therefore, the similarity coefficient of typical symptoms can be calculated to be 1.79.

[0188] The symptom analysis module acquires the similarity coefficient of typical symptoms and sends it to the monitoring feedback module;

[0189] The monitoring and feedback module provides feedback on the monitoring results of subjects using characteristic drugs based on subject type classification data and typical symptom similarity coefficients.

[0190] Specifically as follows:

[0191] Obtain subject type classification data, and then identify subjects with normal physical signs and subjects with abnormal physical signs based on the subject type classification data.

[0192] If the subject of the characteristic drug has abnormal vital signs, an early warning of abnormal vital signs will be issued for the subject of the characteristic drug.

[0193] If the subject of the characteristic drug is a subject with normal physical signs, then the symptom monitoring results of the subject of the characteristic drug will be fed back.

[0194] Specifically as follows:

[0195] Obtain the typical symptom similarity coefficient corresponding to the subjects with normal vital signs, obtain the typical symptom baseline similarity interval, if the typical symptom similarity coefficient is within the typical symptom baseline similarity interval, it is determined that the subjects with normal vital signs have abnormal symptoms, if the typical symptom similarity coefficient is not within the typical symptom baseline similarity interval, it is determined that the subjects with normal vital signs do not have abnormal symptoms, and issue a symptom abnormality warning.

[0196] It should be noted here that:

[0197] In this application, the absence of abnormal typical symptoms in subjects with normal physical signs includes cases where the similarity coefficient of typical symptoms is at the boundary of the baseline similarity interval of typical symptoms.

[0198] The baseline similarity intervals for typical symptoms were obtained as follows:

[0199] 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, compare the numerical values ​​of the obtained typical symptom similarity coefficients, 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.

[0200] In this application, if a corresponding calculation formula appears, the above calculation formula is a dimensionless calculation. The weighting coefficient, proportional coefficient and other coefficients in the formula are set to quantify each parameter to obtain a result value. The size of the weighting coefficient and proportional coefficient is only required to not affect the proportional relationship between the parameter and the result value.

[0201] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to any specific implementation. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A system for dynamic monitoring of signs in a subject in a pharmaceutical test research laboratory, characterized in that, Comprise: Data acquisition module: the characteristic test drug is obtained, and a plurality of physiological indexes are set for the characteristic test drug to monitor the physiological indexes of the subjects, the physiological index abnormality degree corresponding to each physiological index is obtained according to the monitoring result, and the physiological index acquisition data is obtained; The physiological index acquisition data is obtained, and the specific process is as follows: Obtain the characteristic drug subjects, and obtain the drugs tested by the characteristic drug subjects to obtain the characteristic test drug; L1 physiological index to La physiological index is set for the characteristic test drug; In the process of monitoring the physiological indexes of the drug subjects, a physiological index monitoring period is marked; If L1 physiological index is pulse, the pulse index of the characteristic drug subjects in the physiological index monitoring period is monitored, and L1 physiological index monitoring abnormality degree is obtained according to the monitoring result; L1 physiological index monitoring abnormality degree is calculated; The specific formula is as follows: ； Wherein, Ycl1 is L1 physiological index monitoring abnormality degree, Pci is Ni interval pulse deviation degree, Sci is Ni pulse deviation time length ratio, and b is the number value corresponding to the drug concentration subinterval; L2 physiological index to La physiological index corresponding physiological index monitoring abnormality degree is obtained, and L2 physiological index monitoring abnormality degree to La physiological index monitoring abnormality degree is obtained; L1 physiological index monitoring abnormality degree to La physiological index monitoring abnormality degree is defined as physiological index acquisition data; Physical sign analysis module: according to the physiological index acquisition data, the physical sign index of the characteristic drug subjects is analyzed, the type of the characteristic drug subjects is divided according to the analysis result, and the subject type division data is obtained; Symptom analysis module: a plurality of typical symptoms are set for the subjects with normal physical signs, and the typical symptom coincidence degree of the subjects with normal physical signs is analyzed, and the typical symptom similarity coefficient is obtained according to the analysis result; Monitoring feedback module: according to the subject type division data and the typical symptom similarity coefficient, the monitoring result of the characteristic drug subjects is fed back.

2. The system for dynamic monitoring of subject's physical signs in a drug testing research laboratory of claim 1, wherein, L1 physiological index monitoring abnormality degree is obtained, and the specific process is as follows: The physiological index monitoring period is divided into a plurality of index monitoring time points, the in vivo concentration value of the characteristic drug subjects at each index monitoring time point is obtained, a plurality of test drug concentration values are obtained, the maximum test drug concentration value is marked as the first drug concentration value, and the minimum test drug concentration value is marked as the second drug concentration value; The first drug concentration value is taken as the upper limit of the interval, the second drug concentration value is taken as the lower limit of the interval, the period in vivo drug concentration interval is marked, and the period in vivo drug concentration interval is divided into N1 to Nb drug concentration subintervals; The time period of the test drug concentration value in N1 to Nb drug concentration subinterval is obtained, and N1 to Nb drug concentration time period is obtained; The interval pulse deviation degree corresponding to N1 to Nb drug concentration subinterval is obtained, and N1 to Nb interval pulse deviation degree is obtained; In N1 drug concentration time period, the index monitoring time points of the subject pulse value not in the subject pulse reference interval are accumulated in time length, and N1 pulse deviation time length is obtained, and Nb pulse deviation time length is obtained in the same way. The N1 to Nb drug concentration time periods are respectively acquired to obtain N1 to Nb drug concentration time lengths; The ratio of the N1 pulse deviation time length to the N1 drug concentration time length is calculated to obtain N1 to Nb pulse deviation time length ratios.

3. A system for dynamic monitoring of subject's vital signs in a drug trial research laboratory according to claim 2, wherein, The N1 interval pulse deviation degree is acquired as follows: The index monitoring time points covered by the N1 drug concentration time period are acquired, the pulse values of the feature drug subjects corresponding to each index monitoring time point are respectively acquired to obtain a plurality of subject pulse values, a subject pulse reference interval is acquired, if the subject pulse value is in the subject pulse reference interval, the subject pulse deviation is parameterized, if the subject pulse value is not in the subject pulse reference interval, the deviation value of the subject pulse value from the subject pulse reference interval is calculated to obtain a plurality of subject pulse reference deviations; The interval range corresponding to the subject pulse reference interval is numerically acquired to obtain a pulse reference interval range value, the mean of the obtained subject pulse reference deviations is calculated to obtain a subject pulse reference deviation average value, the ratio of the subject pulse reference deviation average value to the pulse reference interval range value is calculated to obtain the N1 interval pulse deviation degree.

4. The system for dynamic monitoring of subject's vital signs in a drug trial research lab of claim 1, wherein, The subject type classification data is acquired as follows: The physiological index collection data is acquired, and the L1 physiological index monitoring abnormality degree to the La physiological index monitoring abnormality degree is respectively acquired according to the physiological index collection data; The index abnormality degree reference interval corresponding to the L1 physiological index is acquired to obtain an L1 index abnormality degree reference interval, if the L1 physiological index monitoring abnormality degree is not in the L1 index abnormality degree reference interval, the L1 physiological index is classified as a normal physiological index, if the L1 physiological index monitoring abnormality degree is in the L1 index abnormality degree reference interval, the L1 physiological index is classified as an abnormal physiological index; The L2 physiological index to the La physiological index is classified as a normal physiological index and an abnormal physiological index according to the L2 physiological index monitoring abnormality degree to the La physiological index monitoring abnormality degree; If there is an abnormal physiological index among the L1 physiological index to the La physiological index, the feature drug subject is classified as a sign abnormal subject, if there is no abnormal physiological index among the L1 physiological index to the La physiological index, the feature drug subject is classified as a sign normal subject, and the subject type classification data is obtained.

5. The system for dynamic monitoring of subject's vital signs in a drug trial research lab of claim 1, wherein, The typical symptom similarity coefficient is acquired as follows: The subject type classification data is acquired, and the sign normal subject and the sign abnormal subject are respectively acquired according to the subject type classification data; In the process of monitoring the symptoms of the sign normal subject, a plurality of different types of typical symptoms are set, and the plurality of typical symptoms are respectively marked as C1 typical symptom to Cd typical symptom; The sign normal subject is subjected to periodic blood drug concentration analysis, and a plurality of sample historical subjects are acquired according to the analysis results; The sign normal subject and the plurality of sample historical subjects are compared and analyzed for the C1 typical symptom, and the onset time deviation of the C1 typical symptom is acquired according to the analysis results to obtain the C1 symptom onset time deviation degree; respectively, to obtain the symptom onset time deviation degrees of C2 to Cd; respectively, to obtain the symptom occurrence numbers of C1 to Cd; The number of sample historical subjects is obtained, to obtain a sample historical subject number value, and the ratios of the symptom occurrence numbers of C1 to Cd to the sample historical subject number value are calculated, to obtain the symptom occurrence ratios of C1 to Cd; The typical symptom similarity coefficient is calculated; The specific formula is as follows: ； wherein, Jcd is the typical symptom similarity coefficient, Spi is the Ci typical symptom occurrence ratio, Cxi is the Ci symptom onset time deviation degree, and d is the number value corresponding to the typical symptom.

6. A system for dynamic monitoring of subject's vital signs in a drug trial research laboratory according to claim 5, wherein, The sample historical subjects are obtained, specifically as follows: The time point when the characteristic test drug is injected into the body of the subject with normal signs is marked as the cycle start time point, the time point corresponding to the current time 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; A plurality of blood drug concentration time points with equal time intervals are marked within the drug clearance monitoring period, and the obtained plurality of blood drug concentration time points are sequentially marked as X1 blood drug concentration time point to Xe blood drug concentration time point according to time sequence; The blood drug concentration values of the subject with normal signs corresponding to X1 blood drug concentration time point to Xe blood drug concentration time point are obtained, to obtain X1 blood drug concentration value to Xe blood drug concentration value; A blood drug concentration monitoring rectangular coordinate system is created according to X1 blood drug concentration value to Xe blood drug concentration value, and the blood drug closed area value is obtained by analyzing the blood drug concentration monitoring rectangular coordinate system; The initial injection dose of the characteristic test drug in the body of the subject with normal signs is obtained, to obtain the drug initial injection dose, and the ratio of the drug initial injection dose to the blood drug closed area value is calculated, to obtain the subject drug clearance rate; The subject drug clearance rate is set as the interval middle value to set a drug clearance rate interval, and the historical subjects with drug clearance rates in the drug clearance rate interval are obtained, to obtain a plurality of sample historical subjects.

7. A system for dynamic monitoring of subject's vital signs in a drug trial research laboratory according to claim 6, wherein, The blood drug closed area value is obtained, specifically as follows: In the existing plane rectangular coordinate system, the blood drug concentration time point is marked as the horizontal coordinate, and the blood drug concentration value is marked as the vertical coordinate, to create a blood drug concentration monitoring rectangular coordinate system; In the blood drug concentration monitoring rectangular coordinate system, the X1 blood drug concentration time point is taken as the horizontal coordinate, and the X1 blood drug concentration value is taken as the vertical coordinate, to mark the coordinate point as X1 blood coordinate point, and similarly, the Xe blood drug concentration time point is taken as the horizontal coordinate, and the Xe blood drug concentration value is taken as the vertical coordinate, to mark the coordinate point as Xe blood coordinate point, and the X1 blood coordinate point to Xe blood coordinate point are connected, to obtain the blood drug concentration curve; In the blood concentration monitoring rectangular coordinate system, a straight line perpendicular to the coordinate x-axis is drawn through the X1 blood concentration coordinate point to obtain a first regional characteristic straight line, and a straight line perpendicular to the coordinate x-axis is drawn through the Xa blood concentration coordinate point to obtain a second regional characteristic straight line; an enclosed area formed by the first regional characteristic straight line, the second regional characteristic straight line, the blood concentration curve and the coordinate x-axis is marked as a blood enclosed area, and an area value of the blood enclosed area is obtained to obtain a blood enclosed area value.

8. The system for dynamic monitoring of subject's vital signs in a drug trial research lab of claim 5, wherein, The C1 symptom onset time deviation degree is obtained as follows: The C1 typical symptom initial onset time point corresponding to the normal sign subject is obtained to obtain a C1 symptom onset time point, the time point at which the feature test drug is injected into the normal sign subject is obtained to obtain a drug initial injection time point, and the time difference between the C1 symptom onset time point and the drug initial injection time point is calculated to obtain a C1 symptom onset time difference; The C1 symptom onset time differences corresponding to the sample historical subjects are obtained respectively, the largest C1 symptom onset time difference is marked as the upper limit of the reference onset time difference interval, the smallest C1 symptom onset time difference is marked as the lower limit of the reference onset time difference interval, and the difference between the upper limit of the reference onset time difference interval and the lower limit of the reference onset time difference interval is calculated to obtain a reference onset time difference interval range value; The time difference between the C1 symptom onset time difference corresponding to the normal sign subject and the reference onset time difference interval is calculated to obtain a C1 symptom onset time deviation; The ratio of the C1 symptom onset time deviation to the reference onset time difference interval range value is calculated to obtain a C1 symptom onset time deviation degree.

9. The system for dynamic monitoring of subject's vital signs in a drug trial research lab of claim 1, wherein, The monitoring result feedback of the feature drug subject is as follows: The subject type classification data is obtained, and the normal sign subjects and the abnormal sign subjects are obtained respectively according to the subject type classification data; If the feature drug subject is an abnormal sign subject, the abnormal vital sign warning is issued to the feature drug subject; If the feature drug subject is a normal sign subject, the symptom monitoring result feedback is given to the feature drug subject; Specifically as follows: The typical symptom similarity coefficient corresponding to the normal sign subject is obtained, and a typical symptom reference similarity interval is obtained; If the typical symptom similarity coefficient is in the typical symptom reference similarity interval, it is judged that the normal sign subject has a symptom abnormality; If the typical symptom similarity coefficient is not in the typical symptom reference similarity interval, it is judged that the normal sign subject does not have a symptom abnormality, and a symptom abnormality warning is issued.

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