TWI381862B - Method and method of hand - push intravenous injection of pharmacokinetic model - Google Patents

Description

Hand-push intravenous drug calculation system and method using pharmacokinetic model

The invention discloses a system and a method for calculating a hand-injected intravenous medicament using a pharmacokinetic model, which uses a pharmacokinetic model of a multi-chamber plus a working site to calculate a concentration of a drug at a working site of a patient, and is convenient for the user to control the dosage and master the medicament. Reaction time.

Taking anesthesia as an example, in the process of guiding anesthesia or short-term sedation, it is often necessary to push intravenous anesthesia drugs. Although the pharmacokinetic model has been developed, it has not been applied to the products of hand-pushing drugs, so that it still remains Subject to the experience of the clinician, there may be errors. There is currently no method for using the pharmacokinetic model to analyze the model parameters obtained from a large number of patients, and to estimate the drug concentration changes at the site of action after hand-pushing in a reliable and convenient way. This method allows the physician to precisely control the dosage of the hand push, make the anesthesia calm and safe, improve the quality of the medical treatment, and improve the efficiency of the surgical team.

The existing product line of the application of pharmacokinetic models and information is applied to the syringe pump. The system is applied to the situation of repeated hand-push injection, especially for guiding anesthesia, which can be introduced quickly and smoothly. Anesthesia.

Since the existing products need to be equipped with a syringe pump, a connection injection line and a connection power source, the steps can be started. If it is used to guide anesthesia or emergency treatment, the procedure is too complicated and time-consuming.

It can be seen that the above-mentioned conventional items are still missing, which is not a perfect design and needs to be improved.

In view of the shortcomings derived from the above-mentioned conventional anesthesia methods, the inventors of the present invention have improved and innovated, and after years of research, finally successfully developed a hand-injection intravenous drug calculation system and method for applying the pharmacokinetic model.

The main object of the present invention is to enable a hand-injected intravenous medicament to achieve a safe and effective range of drug concentrations in a simple, rapid and smooth manner.

The secondary objective of the present invention is to obtain information on the selected drug and pharmacokinetic model, input basic patient data, dose setting and drug administration record through the user interface, and calculate the drug at the action site of the individual by using the statistical results of the population pharmacokinetics. Concentration function.

A hand-injection intravenous drug calculation system and method using the pharmacokinetic model for achieving the above object, which provides a drug and model selection through a user interface, and inputs basic patient data (eg, gender, age, height and weight, etc.) ), dose setting (formulation concentration, dose per dose), and Ce reach peak warning setting, edit medication record, automatically add medication record setting, store the above relevant parameters in the storage unit, and then the above parameters are processed by the processing unit. The pharmacokinetic model was used to calculate the time function of the concentration of the site of action, Ce (t).

When pressed, the user's interface display unit will display the current concentration of the active site ( Ce ), the total dose, the Ce peak, the time to reach the Ce peak, the time required for Ce to fall to the bottom limit, etc., and cooperate with a timing unit. And an audio effect and signal warning unit, when Ce falls to the bottom limit, the user is notified by manual text, graphic display and sound effect, and light warning to inform the user whether the drug concentration is within the safe and effective range of the user's demand. Injecting the drug, the user can adjust the setting of the concentration limit of the action site, the peak of the concentration of the action site, and the automatic new drug administration record according to the clinical demand, so as to achieve convenient and effective control of the drug required by the patient. . In addition, the user can also administer and record according to the condition of the operation, or modify the relevant settings such as the Ce floor, or correct the basic data of the patient to achieve safe and accurate grasp and provide the dosage suitable for the patient.

Referring to FIG. 1 , FIG. 2 and FIG. 3 simultaneously, the present invention comprises: a storage unit 2, which provides storage of various setting parameters.

A drug and model module 10 is selected that provides a plurality of drug and pharmacokinetic models for selection by the user.

A patient basic data setting module 11 provides the user with input of basic patient parameters such as age, height, weight, and gender (see FIG. 2). The input result will be stored in the storage unit 2.

A dose setting module 12 provides a user setting dose parameter. The dose parameters include the formulation concentration and the amount of each dose (see Figure 2), and the results will be stored in the storage unit 2.

An automatic new medication record setting module 13 is provided to provide a user to set whether to perform an additional medication record in the automatic mode, and the result of the setting is stored in the storage unit 2.

A Ce bottom setting module 14 provides a user to set a bottom limit of the concentration of the working portion ( Ce ), and the setting result is stored in the storage unit 2.

A Ce reaches the peak alert setting module 15 to provide a user with a decision whether to issue a prompt via the sound effect and the light warning unit 6 when Ce reaches a local peak, and the setting result will be stored in the storage unit 2.

a processing unit 3, according to the pharmacokinetic model of the multi-chamber plus action site using the pharmacokinetics, and the input parameters stored in the storage unit 2 to calculate a change function of the concentration of the active site (for example, the concentration of the drug in the brain), The calculated data and the graphic outputted by the graphic creating unit 5 are displayed by the display unit 4, and the display unit 4 can be any display device.

A timing unit 31, which receives the calculation result of the processing unit 3, starts counting down the Ce front arrival time and the Ce bottom arrival time, and the timing is displayed for the display unit 4 and the graphic creation unit 5.

A display unit 4 receives the calculation result of the processing unit 3 and the countdown process of the timing unit 31, and displays it on the display device in real time.

a graphics making unit 5, after receiving the calculation result of the processing unit 3 and the counting process of the counting unit 31, plots the curve of the active part ( Ce ) function, and the time mark (refer to FIG. 6), and instantly displays it on the display device. on.

An audio effect and signal warning unit 6, when the countdown unit 31 counts down to zero, the processing unit 3 drives the sound effect and the light warning unit 6 to sound an alarm sound and a light.

A medication record editing unit 7 is when the sound effect and the light warning unit 6 issues a warning sound and the light number prompts the user to administer the medicine, the user should push the medicine once and manually add a medication record; in case the user inputs the error This unit can also be used to delete or correct the medication record.

As shown in Figure 4, the pharmacokinetic model of the three-chamber plus action site is taken as an example. When the dosage record is updated, the processing unit will calculate the change function of the concentration of the site ( Ce ). Further calculating the Ce peak, the Ce peak time, and the time when Ce falls to the bottom limit, and the instantaneous Ce value, the following describes the method of the present invention: first, according to the results of the group pharmacokinetic study, the patient parameters, such as gender, Height, weight, age and other data to calculate the volume and drug exchange rate constant of each chamber, drug metabolism rate constant, when the drug is injected into the vein by hand, the agent will be transported from the central part (plasma) ( V ₁ ) to the fast balance Site (muscle, gastrointestinal system, etc.) ( V ₂ ), slow-balanced site (fat, etc.) ( V ₃ ), site of action (eg, brain) ( V _e ), metabolic excretion site (liver, kidney, etc.), V ₁ V ₂ V ₃ V _e represents the volume of each chamber, and the drug exchange rate constants between the chambers are k ₁₂ , k ₂₁ , k ₁₃ , k ₃₁ , the drug metabolism rate constant is k ₁₀ , and the clearance constant of the site of action For k _eO and each time The upper limit of the time required for Ce to reach the peak is t _peak ; the above parameters can be extrapolated from the statistical results of population pharmacokinetics.

Let λ ₁ , λ ₂ , λ ₃ be the three solutions of the following polynomial:

x ³ + k ₁₀ k ₂₁ k ₃₁ x ² +( k ₁₀ k ₃₁ + k ₂₁ k ₃₁ + k ₂₁ k ₁₃ + k ₁₀ k ₂₁ + k ₃₁ k ₁₂ ) x +( k ₁₀ + k ₁₂ + k ₁₃ + k ₂₁ + k ₃₁ )=0

After each push of the drug, the Ce function can be expressed as:

Where t ₁ = moment of bolus, Bolus ₁ = bolus dose,

Since the concentration function is additive, after n bolus injections, the concentration function is added as:

Here t ≧ t _n

Because Bolus _i and t _i are known (from the drug administration record), the simplification is:

Where δ ₁ , δ ₂ , δ ₃ , δ ₄ are constant real numbers and Ce ' is a derivative of Ce .

Followed by dichotomy stars Ce peak (MaxCe) peak of Ce (t _max) approximation. Since Ce '=0 at Ce has a peak, the left of the peak is Ce '>0, and the right of the peak is Ce '<0, so t _max can be obtained by the binary approximation method. The algorithm is as follows:

Then use the binary approximation method to get the moment when Ce falls to the bottom limit. The example here is the upper limit of 24 hours. If the time required is more than one day, the algorithm returns the time after 24 hours as Ce falls to the bottom limit. time. Among them, LBCe is the user-defined Ce bottom limit, which can be adjusted according to clinical needs. Since Ce is decremented after t _max , t _LB can be obtained by the following algorithm:

Please refer to FIG. 5 and FIG. 6 at the same time, which is a flow chart of the implementation method of the hand-injection intravenous medicament for applying the pharmacokinetic model of the present invention: Step 1: The system receives the selected drug and the model module, and sets the basic data of the patient. The module, the dose setting module, the automatic new drug registration setting module, the Ce floor setting module, the Ce input peak warning setting module, and the medication record data 501 of the medication record editing unit.

Step 2: The storage unit stores various setting parameters 502.

Step 3: The processing unit calculates coefficients of the Ce function and its derivative function, Ce peak ( MaxCe ), Ce peak time ( t _max ), and Ce drop time ( t _LB ) 503.

Step Four: According Ce (t) is calculated after the three steps, the total amount of drug administered, MaxCe, t _max, t _LB and other data on the display unit 504 or the display unit by the pattern creating means.

Step 5: The display unit and the graphic creation unit arrive at the peak warning setting module according to the data t _max and t _{LB in} step 4 and the Ce in step 1. When the arrival of t _max and t _LB is notified by different warning sounds and lights 505.

Step 6: If the automatic new medication record setting module is set to on and Ce falls to the bottom limit ( now > t _LB ), a new medication record is automatically added. In this mode, the user will hear the warning sound or see the light signal, and then do not need to input the medication record 506; if the automatic new medication record is set to not add, proceed to step 7.

Step 7: If the user presses the end key, the program 507 is ended. If the end key is not pressed, the step 1 is repeated, and the instant data and graphics are continuously calculated and displayed until the user presses the end key.

Please refer to FIG. 6 , which is a schematic diagram of the output pattern of the graphic production unit of the hand-push intravenous drug calculation system and method using the pharmacokinetic model of the present invention.

The x-axis is time (sec), the y-axis is the concentration of the active site (mcg/ml), and there is a user-defined concentration limit ( LBCe ). After the start of the injection of the drug, Ce first increases, after a period of time, Ce will reach the peak ( Ce peak 1), the time to reach Ce peak 1 is t _max 1, then Ce will decrease, and the time to fall to LBCe is t _LB 1; The person hears the sound effect and the signal warning, if the drug is re-dosed, and the drug record is added; then Ce will rise to the new peak ( Ce peak 2), the arrival time is t _max 2, and then the time when Ce falls to LBCe is t _LB 2, so repeated until the user stops using it; the graphics production unit will continuously update the graphics in real time until the execution ends.

The system can be stored in a computer readable recording medium, and the present invention can be completed when the computer is loaded into the program and executed.

The system can also be integrated into a bedside monitor, an anesthesia machine, a mobile device, a computer, or an anesthesia recording software. Once the instrument is loaded into the program and executed, the present invention can be completed.

The invention has the following advantages when compared with other conventional technologies:

1. Apply pharmacokinetic multi-chamber plus action site pharmacokinetic model, infer the pharmacokinetic parameters according to group pharmacokinetics, and then calculate the drug dosage, the concentration of immediate action site ( Ce ), Ce peak and The time when Ce reaches the peak and the time required for Ce to fall to the bottom limit are displayed to the user at any time.

2. Provide the sound effect and signal warning unit. When the concentration of the active part falls to the Ce limit, the user will be reminded to add the medicine by means of ringing and signal warning.

3. Provide a Ce peak warning to indicate when the expected efficacy is achieved for the purpose of administering the drug (eg, starting surgery).

The detailed description of the preferred embodiments of the present invention is intended to be limited to the scope of the invention, and is not intended to limit the scope of the invention. The patent scope of this case.

To sum up, this case is not only innovative in terms of technical thinking, but also able to enhance the above-mentioned multiple functions compared with conventional articles. It should fully comply with the statutory invention patent requirements of novelty and progressiveness, and apply in accordance with the law. I urge you to approve this article. Invention patent application, in order to invent invention, to the sense of virtue.

10. . . Select drug and model module

11. . . Patient basic data setting module

12. . . Dose setting module

13. . . Automatically add medication record setting module

14. . . Ce floor setting module

15. . . Ce reaches the peak warning setting module

2. . . Storage unit

3. . . Processing unit

31. . . Timing unit

4. . . Display unit

5. . . Graphic production unit

6. . . Sound effect and light warning unit

7. . . Drug record editing unit

1 is an architectural diagram of a system and method for calculating a hand-injected intravenous medicament using a pharmacokinetic model;

2 is a schematic diagram of a user interface input module of a hand-push intravenous drug calculation system and method using a pharmacokinetic model according to the present invention;

3 is a schematic diagram of a user interface display unit of a hand-push intravenous drug calculation system and method using a pharmacokinetic model according to the present invention;

Figure 4 is a pharmacokinetic three-chamber plus action site pharmacokinetic model of a hand-push intravenous drug calculation system and method using a pharmacokinetic model;

Figure 5 is a schematic diagram of a graphic production unit of a hand-push intravenous drug calculation system and method using a pharmacokinetic model;

Figure 6 is a flow chart showing the system steps of a system and method for calculating a hand-injected intravenous drug using a pharmacokinetic model according to the present invention.

10. . . Drug and pharmacokinetic model module

11. . . Patient basic data setting module

12. . . Dose setting module

13. . . Automatically add medication record setting module

14. . . Ce floor setting module

15. . . Ce reaches the peak warning setting module

2. . . Storage unit

3. . . Processing unit

31. . . Timing unit

4. . . Display unit

5. . . Graphic production unit

6. . . Sound effect and light warning unit

7. . . Drug record editing unit

Claims (11)

A hand-push intravenous drug calculation system using a pharmacokinetic model includes: a selection drug and a model module, which provides a plurality of drug and pharmacokinetic models for the user to select; a patient basic data setting module, It provides the user with input of the patient's basic data parameters; a dose setting module, which provides the user to set the dose and formula concentration for each dose; an automatic new medication record setting module, which provides a choice whether to open the automatic new Adding drug recording mode; a concentration limit setting module for the action part, which is a function for adjusting the concentration limit of the action part; a concentration of the action part reaches the peak warning setting module, which is for selecting whether to turn on the sound effect and the light warning unit a storage unit for storing the above parameter settings for processing by the processing unit; a processing unit for applying a pharmacokinetic three-chamber plus action site drug model, in conjunction with parameter setting of the storage unit and calculation of the drug administration record The concentration function and real-time data of the action site are displayed, and the data is displayed on the display unit at any time, and can be The medication record editing unit displays the dosage and the administration time on the display unit; a display unit displays the real-time data calculated by the processing unit and the graphic drawn by the graphic creation unit; and a timing unit, which is counted in a countdown manner , showing the time required to reach the peak concentration of the action site and the time required for the concentration of the action site to fall to the bottom limit, and sound effect and light warning upon arrival; a sound effect and light warning unit, which is matched with the timing unit as the concentration of the action site When the limit is reached, the user is notified to manually inject the medicament, and when the concentration of the active site reaches a peak, the notification operation can be started; and a medication record editing unit is used to newly delete or correct the medication record. A hand-injection intravenous drug calculation system using a pharmacokinetic model according to claim 1, wherein the parameter of the patient basic data setting module comprises: age, height, weight and gender or other group drug dynamics Learn the parameters that may be used. A hand-injection drug calculation system using a pharmacokinetic model according to claim 1, wherein the dose setting parameter of the dose setting module further comprises a concentration of the administration formula and a dose per administration. The hand-push intravenous drug calculation system using the pharmacokinetic model described in claim 1, wherein the automatic record setting module of the automatic new drug-receiving record setting module can be selected according to requirements in an intensive drug-administration scenario. When the user hears the warning sound, the medicine is injected immediately. In this mode, the dosage record is automatically added to the medication record according to the set dosage. A hand-injection intravenous drug calculation system using a pharmacokinetic model according to claim 1, wherein the administration record editing unit includes a function of adding, deleting, and correcting a drug administration record. A hand-injection intravenous drug calculation system using a pharmacokinetic model according to claim 1, wherein the sound effect and the light warning unit are prompted by the warning sound and the light when the concentration limit of the action site is reached. The user can easily grasp the change of the concentration of the action part without looking at the display unit from time to time. A hand-injection intravenous drug calculation system using a pharmacokinetic model according to claim 1, wherein the current data calculated by the processing unit includes a current concentration of the active site, a total dose of the drug, a peak concentration of the site of action, and a site of action. Data such as concentration threshold and arrival time, and recalculate the above data as the user modifies the medication record. A hand-injection intravenous drug calculation system using a pharmacokinetic model according to claim 1, wherein the display unit displays the current data including the current site concentration, the total dose, the peak concentration and the peak of the site. The time, as well as the concentration of the site of action to the baseline time, are immediately recalculated and displayed based on the update of the dosing record. A hand-injection intravenous drug calculation system using a pharmacokinetic model according to claim 1, wherein the display unit can display the data on a mobile device such as a monitor, a screen, a computer, a mobile phone or a computer. A method for calculating a hand-injected intravenous medicament using a pharmacokinetic model comprises: step 1: receiving a drug and pharmacokinetic model selection, a patient basic data setting module, a dose setting module, and an automatic new medication recording setting mode The group, the concentration limit setting module of the action part or the concentration of the action part reaches the input record of the peak warning setting module and the administration record of the administration record editing unit; Step 2: the storage unit stores each setting parameter; Step 3: Processing unit calculation coefficient function of the site of action of Ce concentration peak (MaxCe), Ce to peak time (t _max) and Ce reduced floor time (t _LB); step IV: after the immediate site of action is calculated according to the concentration step three, the total administration The amount, the peak concentration of the action site, the time to reach the peak concentration of the action site, and the time when the concentration of the action site falls to the bottom limit, and the like are displayed on the display unit or displayed on the display unit after being formed by the graphic unit; Step 5: Display unit and graphic The production unit according to the data of step 4 and the concentration of the action part of the step 1 reaches the peak warning setting The module will notify the user with different warning sounds and lights when the peak of the concentration of the active part or the concentration of the active part falls to the bottom limit; Step 6: Determine if the automatic new medication record is set to ON and the concentration of the active site If it has dropped to the bottom limit, it will automatically add a new medication record; if it is off, proceed to step 7; Step 7: If the user presses the end button, the program ends. If the end button is not pressed, repeat step one six. Continuously calculate and display real-time data and graphics until the user presses the end key. A computer capable of reading a program can read the recording medium, and when the computer loads the program and executes it, the method of claim 10 can be completed.