Radiopharmaceutical dosage control system and method
By collecting drug and patient parameters, and combining decay algorithms and temperature data, the flow rate is dynamically adjusted, which solves the shortcomings of traditional radiopharmaceutical dosage control and achieves precise and safe radiopharmaceutical infusion.
Patent Information
- Application Number
- CN202511066076.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-31
- Publication Date
- 2025-10-24
AI Technical Summary
Existing radiopharmaceutical dosage control technologies rely on traditional manual operation and semi-automated equipment, which cannot accurately adapt to changes in drug concentration, temperature, and activity loss caused by pipeline aging, resulting in poor treatment effects or side effects.
By collecting inherent drug parameters and patient physiological parameters, combined with decay algorithms and temperature data, the drug flow rate is dynamically adjusted to compensate for adsorption losses in the pipeline in real time, thereby achieving precise control of the radiopharmaceutical dosage.
It significantly improves the dosage accuracy of radiopharmaceutical infusion, reduces latent errors caused by environmental fluctuations or operational delays, and ensures the precision and safety of radiotherapy.
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Figure CN120827655A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of radiopharmaceuticals, in particular to a radiopharmaceutical dose control system and method. BACKGROUND
[0002] Radiopharmaceuticals play an irreplaceable role in tumor targeted therapy, cardiovascular disease diagnosis and other fields, and the core is to achieve the goal of maximizing the therapeutic dose and minimizing the damage to normal tissues by accurately controlling the activity (such as the radioactivity intensity of 177Lu, 90Y and other nuclides).
[0003] In clinical practice, the infusion of radiopharmaceuticals needs to meet the requirements of activity accuracy, process safety and traceability, especially in the precise radiotherapy of prostate cancer, neuroendocrine tumors and other scenes. A dose deviation of more than 10% may directly lead to treatment failure or cause serious side effects (such as bone marrow suppression). However, the current dose control of radiopharmaceuticals still relies on the combination of traditional manual operation and semi-automatic equipment, and its technical limitations have become a key bottleneck restricting the improvement of treatment accuracy.
[0004] In the prior art, the dose control of radiopharmaceuticals is mainly achieved by presetting the flow rate and manual monitoring. Medical staff manually calculates the infusion time, sets a fixed flow rate through a mechanical pump, and measures the residual activity every 5-10 minutes during infusion using a portable activity meter to indirectly calculate the actual dose. In order to cope with the activity loss caused by pipe adsorption, an empirical compensation method is usually used - a fixed compensation value (such as an additional 10% activity) is preset according to the pipe material. However, this method cannot adapt to the differences in adsorption rate caused by different drug concentrations, temperature changes or pipe aging, which not only affects the treatment effect, but also may lead to tumor control failure or toxicity due to insufficient dose or excessive dose.
[0005] Therefore, it is necessary to improve the prior art to solve the above problems. SUMMARY
[0006] The present application overcomes the shortcomings of the prior art and provides a radiopharmaceutical dose control system and method.
[0007] To achieve the above purpose, the technical solution adopted by the present application is as follows: a radiopharmaceutical dose control method, comprising the following steps:
[0008] A radiopharmaceutical dose control method, characterized in that it comprises the following steps:
[0009] S1, collect the inherent parameters of the drug, obtain the real-time physiological parameters of the patient, and read the system preset threshold value;
[0010] S2, calculates the remaining activity in real time based on the decay algorithm and temperature data, and dynamically adjusts the drug flow rate according to the deviation from the target activity;
[0011] S3, by comparing the upstream and downstream activity differences to identify pipeline adsorption losses, and dynamically adjust the flow rate to compensate for the deviation;
[0012] S4. Obtain key infusion parameters and record data, and respond to the emergency stop signal to interrupt the infusion.
[0013] In a preferred embodiment of the present invention, in step S1, the inherent parameters of the drug include: nuclide type, initial activity, half-life and target dosing activity; the physiological parameters include: body weight, body surface area, liver and kidney function indicators and tumor target volume.
[0014] In a preferred embodiment of the present invention, in step S1, the system preset thresholds include: a physical constant class consisting of a decay constant and a temperature compensation coefficient, a safety control class consisting of a pipeline adsorption rate threshold, a safety radiation dose upper limit, and a flow rate adjustment range, and an abnormal response class consisting of an emergency stop trigger threshold and a data verification error range.
[0015] In a preferred embodiment of the present invention, in step S2, the residual activity is calculated based on the physical properties of the nuclides. The residual activity decays exponentially over time, and the formula is expressed as:
[0016] N(t)=N0×e -λt ; Where N(t) is the theoretical remaining activity at time t; N0 is the initial activity of the drug; e is a natural constant; λ is the decay constant;
[0017] Each time the ambient temperature deviates from the reference temperature, the activity needs to be additionally corrected. The formula for temperature-corrected residual activity is:
[0018] N cal (t)=N(t)×[1+k T ×(T-T0)]; where N cal (t) is the real-time residual activity after temperature correction; k T is the coefficient of influence of temperature on radioactive decay; T is the real-time temperature; T0 is the reference temperature.
[0019] In a preferred embodiment of the present invention, in step S2, during the dynamic adjustment of the flow rate, the residual activity after correction is compared with the target activity to calculate the deviation ratio, which is expressed as follows:
[0020] Where ΔA is the relative deviation; A target is the target drug delivery activity;
[0021] The flow rate is inversely adjusted in a deviation ratio, and the formula for dynamically adjusting the drug flow rate is expressed as:
[0022] Wherein, u new is the new flow rate after adjustment; u current is the current flow rate.
[0023] In a preferred embodiment of the present application, in the step of S3, the upstream and downstream activity difference is expressed as a formula of adsorption loss rate as follows:
[0024] Wherein, p is the adsorption rate, that is, the activity loss percentage caused by the adsorption of the pipeline material to the drug; A up is the real-time activity of the upstream; A down is the real-time activity of the downstream.
[0025] In a preferred embodiment of the present application, based on the adsorption loss rate, a flow rate compensation coefficient is calculated, and the formula is expressed as:
[0026] Wherein, k comp is the flow rate compensation coefficient;
[0027] The drug infusion flow rate is adjusted through the flow rate compensation coefficient, and the formula is expressed as:
[0028] υ new = u current × k comp ; wherein, u new is the new flow rate after compensation; u current is the current infusion flow rate.
[0029] In a preferred embodiment of the present application, in the step of S4, the infusion key parameters include dynamic process parameters composed of real-time activity, infusion flow rate, pipeline pressure and environmental temperature, cumulative result parameters composed of cumulative drug activity, infusion time and deviation rate, and safety monitoring parameters composed of patient heart rate, blood oxygen saturation and radiation dose rate.
[0030] In a preferred embodiment of the present application, in the step of S4, the emergency stop triggering scene includes one of dose over-standard, pressure anomaly, equipment failure, patient anomaly or manual triggering.
[0031] The present application provides a control system of a radioactive drug dose control method, comprising:
[0032] A parameter acquisition module is configured to acquire drug inherent parameters, real-time physiological parameters of a patient, and read system preset threshold values;
[0033] An activity calculation module is configured to dynamically calculate the remaining activity of the radiopharmaceutical based on a decay algorithm and real-time temperature data, and output an activity deviation value.
[0034] A flow rate adjustment module is configured to receive the deviation value output by the activity calculation module, dynamically adjust the drug infusion flow rate, and make the remaining activity approach the target activity.
[0035] An adsorption loss monitoring module is configured to collect real-time activities upstream and downstream of the pipeline, calculate the activity difference value, and identify the degree of pipeline adsorption loss.
[0036] A compensation adjustment module is configured to dynamically generate a flow rate compensation coefficient according to the loss degree identified by the adsorption loss monitoring module, and adjust the infusion flow rate to offset the activity loss caused by pipeline adsorption.
[0037] A data recording response module is configured to obtain key infusion parameters and record data, and interrupt the infusion in response to an emergency stop signal.
[0038] The present application solves the defects in the background art, and has the following beneficial effects:
[0039] (1) The present application provides a radiopharmaceutical dose control system and method, which acquires the initial activity and half-life parameters of the drug, combines with the environmental temperature feedback data, couples the exponential law of nuclide decay with the temperature influence coefficient, automatically corrects the activity decay of the radionuclide caused by time lapse and temperature change, breaks through the limitation of ignoring temperature influence in traditional manual calculation, makes the calculated value of the remaining activity always close to the actual physical state, realizes active compensation of activity deviation during drug administration, significantly improves the dose accuracy of short half-life drug infusion compared with the method relying on static experience, thereby reducing the implicit errors caused by environmental fluctuations or operation delays, and provides a core guarantee for precise radiotherapy.
[0040] (2) In the present application, the activity loss difference value when the drug flows through the pipeline is dynamically captured, the adsorption effect of the pipeline on the specific nuclide is accurately quantified, the traditional empirical mode of preset fixed compensation coefficient is replaced, the problem of adsorption rate fluctuation caused by drug composition difference, pipeline aging or temperature change is solved, the on-demand compensation of pipeline adsorption loss is realized, the activity fluctuation range actually reaching the patient's body is compressed to within the clinical safety threshold, thereby further avoiding the risk of normal tissue toxicity caused by insufficient adsorption compensation or excessive compensation of the tumor target area dose. BRIEF DESCRIPTION OF DRAWINGS
[0041] In order to make the technical solutions in the embodiments of the present application or the prior art clearer, the accompanying drawings needed in the embodiments or prior art description will be briefly introduced. Obviously, the accompanying drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained without creative labor on the basis of these drawings.
[0042] Figure 1 A radioactive drug dose control method flow chart is a preferred embodiment of the present application. DETAILED DESCRIPTION
[0043] The technical solutions in the embodiments of the present application will be described clearly and completely in the following description with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the protection scope of the present application.
[0044] In the following description, many specific details are set forth in order to provide a thorough understanding of the present application, but the present application can also be implemented in other ways different from those described herein, therefore, the protection scope of the present application is not limited by the specific embodiments disclosed below.
[0045] As shown in the figure, a radioactive drug dose control method comprises the following steps: Figure 1
[0046] S1, collecting drug inherent parameters, acquiring real-time physiological parameters of a patient, and reading system preset threshold values;
[0047] S2, calculating residual activity in real time based on decay algorithm and temperature data, and dynamically adjusting drug flow rate according to deviation from target activity;
[0048] S3, identifying pipeline adsorption loss by comparing upstream and downstream activity difference, and dynamically adjusting flow rate to compensate for deviation;
[0049] S4, acquiring infusion key parameters and recording data, and interrupting infusion in response to emergency stop signal.
[0050] In some specific embodiments, the S1 step is implemented in the outpatient large-dose infusion scene of a radioactive drug (such as 177Lu-PSMA-617), the drug activity is dynamically attenuated by factors such as half-life (6.7 days) and temperature, and the actual drug precision is directly affected by patient individual differences and system preset parameters; traditional manual parameter input is easy to cause nuclide type mismatch, initial activity deviation or patient physiological data lag, and then cause subsequent decay compensation calculation error, and finally cause prescription deviation of the drug dose, and increase the radiation safety risk.
[0051] Further, by focusing on data source precision, receiving drug inherent parameters to ensure consistency with prescriptions, and extracting patient physiological parameters to avoid manual transcription errors, the system reads the pre-set threshold to form a parameter closed loop of drugs, patients, and the system, providing a high-credibility data foundation for subsequent decay compensation and flow rate adjustment, indirectly controlling the final drug delivery deviation, and meeting the clinical radiation safety requirements.
[0052] Furthermore, the drug inherent parameters include: nuclide type, such as 177Lu and 90Y; initial activity, such as 3.7 GBq; half-life, such as 6.7 days for 177Lu; and target drug activity, such as a patient's prescribed dose of 2.8 GBq.
[0053] The physiological parameters include: body weight, body surface area, liver and kidney function indicators, such as serum creatinine 80 μmol / L and bilirubin 15 μmol / L; and tumor target volume (TV).
[0054] Optionally, the drug inherent parameters are collected by scanning the code for automatic input: medical staff use the integrated code scanning gun of the device to scan the two-dimensional code on the drug label, directly reading the factory data such as nuclide type, initial activity, and half-life (such as scanning the 177Lu drug bottle label, automatically filling in "nuclide type: 177Lu, initial activity: 3.7 GBq, half-life: 6.7 days");
[0055] Or manually check and supplement: if the label is damaged or the two-dimensional code is blurred, the parameters can be manually input through the touch screen, and the system real-time checks the format (such as the activity unit needs to be GBq / mCi, and the half-life needs to meet the physical properties of the nuclide), for example, when "90Y" is input, the system automatically matches the default half-life "64.1 hours" and prompts for confirmation.
[0056] The physiological parameters are obtained by directly connecting to the HIS / LIS system: the device connects to the hospital information system (HIS) and laboratory information system (LIS) through the HL7 FHIR protocol, and real-time pulls the latest patient data, such as automatically obtaining "body weight 75 kg, BSA 1.8 m 2 , serum creatinine 80 μmol / L" 5 minutes before drug delivery;
[0057] Or synchronize data from bedside equipment: for dynamic parameters that cannot be obtained through HIS (such as real-time heart rate and blood oxygen), the device connects to the electrocardiograph through Bluetooth to update the data at a frequency of 1 Hz, ensuring the timeliness of the parameters in extreme cases (such as sudden heart rate abnormalities in patients);
[0058] At the same time, the built-in physiological parameter normal range library (such as adult serum creatinine reference value 53-106 μmol / L) is provided, and if the read value exceeds the range (such as bilirubin 35 μmol / L), the "abnormal liver function" is automatically marked and the medical staff is prompted to confirm, so as to avoid the error data flowing into the subsequent steps.
[0059] In the embodiment, the system preset threshold includes: physical constant type composed of decay constant and temperature compensation coefficient, safety control type composed of pipeline adsorption rate threshold, upper limit of safe radiation dose and flow rate adjustment range, and abnormal response type composed of emergency stop triggering threshold and data verification error range.
[0060] For example, the physical constant is preset by importing the International Atomic Energy Agency (IAEA) nuclide database; the safety threshold (such as the upper limit of radiation, the flow rate range) is preset according to the "Guidelines for Clinical Application of Radiopharmaceuticals", for example, the upper limit of bone marrow dose is set to 2Gy according to the recommendation of the American Nuclear Medicine Society (SNM); the pipeline adsorption rate threshold is determined by clinical experiment, 1000 cases of 177Lu infusion data are collected, the median of pipeline adsorption rate is 3.2%, and the threshold of 95% percentile is 5%, which is stored in the system configuration table;
[0061] The scene is preset according to the type of nuclide, for example, when switching to 90Y mode, the system automatically loads the decay constant of 0.0108 / hour and the exclusive threshold of flow rate range 0.5-8mL / min; when starting, the threshold integrity verification is performed, if the key threshold is missing (such as not presetting the emergency stop pressure threshold), the system is locked and prompts to complete the initialization configuration.
[0062] In some specific embodiments, the S2 step implements the activity of the radiopharmaceutical which decays exponentially with half-life, and is affected by the environmental temperature, and the traditional manual calculation of the remaining activity has an error of 5-15%, and the flow rate adjustment depends on experience, which may cause deviation between the actual administration activity and the target, and may cause insufficient efficacy or radiation damage.
[0063] Further, by taking real-time calculation and dynamic compensation as the core, the dynamic change of radioactivity is converted into quantifiable flow rate adjustment instructions, the deviation between the end activity of administration and the target is reduced, the dose error caused by decay and temperature is significantly reduced, and the radiotherapy accuracy is ensured.
[0064] Further, the remaining activity calculation is based on the physical properties of nuclides, and the remaining activity decays exponentially with time, which is expressed by the formula:
[0065] N(t) = N0 x e -λt ; Wherein, N(t) is the theoretical remaining activity at time t; N0 is the initial activity of the drug; e is the natural constant; λ is the decay constant.
[0066] The activity needs to be additionally corrected for each deviation of the ambient temperature from the reference temperature. The formula for temperature correction of the residual activity is expressed as:
[0067] N cal (t) = N(t) x [1 + k T x (T - T0)]; wherein N cal (t) is the real-time residual activity after temperature correction; k T is the temperature influence coefficient on radioactive decay; T is the real-time temperature; and T0 is the reference temperature.
[0068] In this embodiment, in the flow rate dynamic adjustment, the deviation ratio is calculated by comparing the corrected residual activity with the target activity, which is expressed in the formula as:
[0069] wherein ΔA is the relative deviation (a positive value indicates that the activity is excessive, and a negative value indicates that the activity is insufficient); A target is the target activity for administration.
[0070] For example, if the current residual activity is 3.71 GBq and the target activity for administration is 2.8 GBq, then the relative deviation is (3.71 - 2.8) / 2.8 ≈ 32.5%, which means that the activity is excessive.
[0071] The flow rate is adjusted in the opposite direction according to the deviation ratio, and the formula for dynamic adjustment of the drug flow rate is expressed as:
[0072] wherein υ new is the new flow rate after adjustment; and υ current is the current flow rate.
[0073] In some specific embodiments, the S3 step is implemented to address the activity loss caused by the physical adsorption of the radioactive drug when flowing through the infusion pipeline due to the physical adsorption of the pipeline material. In traditional manual operation, only a preset fixed compensation value is used to cope with it, but the adsorption rate of different pipeline materials and drug concentrations can differ by 3%-8%. The fixed compensation cannot be adapted in real time, resulting in a large deviation between the actual activity reaching the patient and the target, which can cause insufficient tumor dose or excessive radiation of normal tissues.
[0074] Further, the adsorption loss is immediately corrected by real-time monitoring and dynamic compensation coefficient at two points, so as to replace the empirical estimation with physical measurement, directly capture the dynamic changes of pipeline adsorption, reduce the activity loss caused by adsorption, break through the limitation of fixed compensation that cannot adapt to the differences in material and concentration, ensure that the activity entering the patient is highly consistent with the target value, provide reliable protection for precise radiotherapy, and at the same time reduce the waste of drugs and the risk of side effects caused by excessive compensation.
[0075] Further, in the pipeline adsorption loss identification, β-ray detector arrays (composed of plastic scintillator and silicon photomultiplier) are installed upstream (outlet of the drug container) and downstream (before the patient end inlet) of the infusion pipeline, respectively. The upstream detector is used to monitor the real-time activity when the drug flows out of the container, and the downstream detector is used to monitor the real-time activity after the drug flows through the pipeline and before it enters the patient.
[0076] Optionally, through a multi-channel pulse amplitude analyzer, the drug activity signal and background noise are distinguished in real time at a sampling frequency of 1 kHz, ensuring data accuracy.
[0077] The difference between the upstream and downstream activities is expressed as the formula of the adsorption loss rate:
[0078] Where p is the adsorption rate, i.e. the percentage of activity loss caused by the adsorption of the pipeline material to the drug; A up is the real-time activity upstream; A down is the real-time activity downstream.
[0079] Through the preset adsorption threshold of S1 step, it is judged whether to trigger compensation. If the adsorption rate is greater than the adsorption threshold, the flow rate compensation is started; if it is less than or equal to the adsorption threshold, the current flow rate is maintained.
[0080] In this embodiment, based on the adsorption loss rate, the flow rate compensation coefficient is calculated, and the formula is expressed as:
[0081] Where k comp is the flow rate compensation coefficient (reflected as the multiple of the flow rate that needs to be improved to offset the adsorption loss);
[0082] Through the flow rate compensation coefficient, the drug infusion flow rate is adjusted, and the formula is expressed as:
[0083] υ new = υ current × k comp ; Where υ new is the new flow rate after compensation; υ current is the current infusion flow rate.
[0084] For example, taking 177Lu-PSMA-617 drug infusion as an example:
[0085] The known conditions (preset in S1 step) are: the adsorption threshold is 5%, the current flow rate υ current is 8 mL / min; in the real-time monitoring data, the upstream activity A up is 2.5 GBq, and the downstream activity A down is 2.3 GBq.
[0086] Adsorption rate calculation: (2.5-2.3) / 2.5x100% = 8%, 8%>5%, trigger compensation;
[0087] Compensation coefficient calculation: 2.5 / 2.3≈1.087;
[0088] New flow rate adjustment: 8x1.087≈8.7mL / min;
[0089] Effect after compensation: After adjusting the flow rate, the downstream activity is increased to 2.5 / 1.087≈2.3x1.087≈2.499GBq, and the adsorption rate is reduced to (2.5-2.499) / 2.5x100% = 0.04% (≤5%, stop compensation).
[0090] In some specific embodiments, in the step of S4, the infusion key parameter refers to the core indicator reflecting the safety and accuracy of the drug infusion process, including: dynamic process parameters composed of real-time activity, infusion flow rate, pipeline pressure and environmental temperature, cumulative result parameters composed of cumulative drug activity, infusion time and deviation rate, safety monitoring parameters composed of patient heart rate, blood oxygen saturation and radiation dose rate.
[0091] Optionally, after data recording, local encrypted storage, system uploading and report generation operations are performed in turn. Specifically, local encrypted storage is to store parameters in an encrypted database of the dose control device according to time stamp (accurate to seconds), to generate a unique infusion record ID, such as "RX20250725-001"; system uploading is to synchronize to the hospital information system (HIS) and the radiation safety management platform through the HL7FHIR protocol, for clinical traceability and regulatory audit; report generation is to automatically generate a radioactive drug infusion verification report, including parameter curves (flow rate-time, activity-time) and deviation analysis, as a basis for radiotherapy efficacy evaluation.
[0092] In this embodiment, the emergency stop triggering scenario includes one of dose overage, pressure anomaly, device failure, patient anomaly or manual triggering.
[0093] Among them, the dose overage is that the cumulative drug activity>105% of the target activity (such as target 2.8GBq, actual 2.94GBq); the pressure anomaly is that the pipeline pressure>300kPa (indicating pipeline blockage) or<50kPa (indicating pipeline shedding); the device failure is that the detector signal is lost or the micro pump motor is abnormal; the patient anomaly is that the heart rate>120 times / min or<50 times / min, and the blood oxygen saturation is<90%; the manual triggering is that the medical staff presses the physical emergency stop button or the emergency interrupt key of the touch screen.
[0094] Further, the implementation steps of emergency stop response include: real-time monitoring and judgment, triggering interrupt instruction, safety state maintenance, event recording and alarm, and manual confirmation and reset.
[0095] It should be noted that the multi-parameter real-time monitoring, hierarchical threshold judgment and rapid mechanical response realize the infusion safety closed-loop control, which can convert passive artificial monitoring into active intelligent intervention, cover the full-dimensional risk points of equipment, drugs and patients, ensure that the drug infusion can be quickly interrupted when an abnormality occurs, avoid risk expansion, break through the limitations of traditional reliance on artificial observation and single parameter monitoring, thereby providing monitoring, judgment, response and recording of the whole process safety guarantee for radiopharmaceutical infusion, strengthening the standardization and traceability of medical operations, and reducing the work burden of medical staff.
[0096] The application provides a control system of a radiopharmaceutical dose control method, comprising:
[0097] A parameter acquisition module is configured to acquire inherent parameters of the drug and real-time physiological parameters of the patient, and read preset threshold values of the system.
[0098] An activity calculation module is configured to dynamically calculate the residual activity of the radiopharmaceutical based on a decay algorithm and real-time temperature data, and output an activity deviation value.
[0099] A flow rate adjustment module is configured to receive the deviation value output by the activity calculation module, dynamically adjust the flow rate of the drug infusion, and make the residual activity approach the target activity.
[0100] An adsorption loss monitoring module is configured to acquire real-time activities upstream and downstream of the pipeline, calculate an activity difference value, and identify the degree of adsorption loss of the pipeline.
[0101] A compensation adjustment module is configured to dynamically generate a flow rate compensation coefficient according to the loss degree identified by the adsorption loss monitoring module, and adjust the infusion flow rate to offset the activity loss caused by the adsorption of the pipeline.
[0102] A data recording and response module is configured to acquire key parameters of the infusion and record data, and interrupt the infusion in response to an emergency stop signal.
[0103] It should be noted that the radiopharmaceutical dose control system can realize the steps in the radiopharmaceutical dose control method in the above-mentioned embodiments, and can achieve the same technical effects, and the descriptions in the above-mentioned embodiments are referred to, and no detailed description is given here.
[0104] The above is based on the ideal embodiment of the present application, through the above description, for those skilled in the art, it is obvious that the present application is not limited to the details of the above exemplary embodiments, and the present application can be realized in other specific forms without departing from the spirit or basic characteristics of the present application. Therefore, no matter from which point of view, the embodiments should be regarded as exemplary and non-limiting, the scope of the present application is defined by the appended claims rather than the above description, therefore all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present application. Any reference signs in the claims should not be regarded as limiting the claims involved.
[0105] In addition, it should be understood that although the present specification is described in terms of embodiments, not every embodiment contains only one independent technical solution, and the description of the specification is only for the sake of clarity, those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that those skilled in the art can understand.
Claims
1. A radiopharmaceutical dose control method, characterized by, The method comprises the following steps: S1, collecting drug inherent parameters, obtaining real-time physiological parameters of a patient, and reading system preset threshold values; S2, calculating residual activity in real time based on a decay algorithm and temperature data, and dynamically adjusting a drug flow rate according to a deviation from a target activity; S3, identifying pipeline adsorption loss by comparing upstream and downstream activity difference values, and dynamically adjusting the flow rate to compensate for the deviation; S4, obtaining key infusion parameters and recording data, and interrupting the infusion in response to an emergency stop signal.
2. A radiopharmaceutical dose control method according to claim 1, characterized in that: In the step S1, the drug inherent parameters include: nuclide type, initial activity, half-life, and target administration activity; and the physiological parameters include: body weight, body surface area, liver and kidney function indicators, and tumor target volume.
3. The method of claim 1, wherein: In the step S1, the system preset threshold values include: physical constants such as decay constant and temperature compensation coefficient, safety control such as pipeline adsorption rate threshold value, upper limit of safe radiation dose, and flow rate adjustment range, and abnormal response such as emergency stop triggering threshold value and data verification error range.
4. The method of claim 1, wherein: In the step S2, the residual activity calculation is based on the physical properties of the nuclide, and the residual activity decays exponentially over time, which can be expressed by the formula: N(t) = N0 x e -λt ; wherein N(t) is the theoretical residual activity at time t; N0 is the initial activity of the drug; e is the natural constant; and λ is the decay constant. For each deviation of the environmental temperature from the reference temperature, the activity needs to be additionally corrected, and the formula for correcting the residual activity by temperature is: N cal (t) = N(t) x [1 + k T x (T - T0)]; wherein N cal (t) is the real-time residual activity after temperature correction; k T is the temperature influence coefficient on radioactive decay; T is the real-time temperature; and T0 is the reference temperature.
5. The method of claim 1, wherein: In the step S2, the flow rate dynamic adjustment compares the corrected residual activity with the target activity, calculates the deviation ratio, and the formula is: where ΔA is the relative deviation; A target is the target administered activity; The flow rate is adjusted in the reverse direction according to the deviation ratio, and the formula for dynamically adjusting the drug flow rate is: wherein υ new is the adjusted new flow rate; υ current is the current flow rate.
6. The radiopharmaceutical dose control method of claim 1, wherein: In the step S3, the upstream and downstream activity difference value is expressed as the adsorption loss rate, and the formula is: where p is the adsorption rate, i.e. the percentage of activity loss due to adsorption of the drug by the tubing material; A up is the upstream real-time activity; A down is the downstream real-time activity.
7. A radiopharmaceutical dose control method according to claim 6, characterized in that: Based on the adsorption loss rate, the flow rate compensation coefficient is calculated, and the formula is: Among them, k comp is the flow rate compensation coefficient; The drug infusion flow rate is adjusted by the flow rate compensation coefficient, and the formula is: υ new = υ current × k comp ; where υ new is the compensated new flow rate; υ current is the current infusion flow rate.
8. The radiopharmaceutical dose control method of claim 1, wherein: In the step S4, the key infusion parameters include: dynamic process parameters such as real-time activity, infusion flow rate, pipeline pressure, and environmental temperature, cumulative result parameters such as cumulative administration activity, infusion duration, and deviation rate, and safety monitoring parameters such as patient heart rate, blood oxygen saturation, and radiation dose rate.
9. The radiopharmaceutical dose control method of claim 1, wherein: In the step S4, the emergency stop triggering scenarios include: one of dose overage, pressure anomaly, equipment failure, patient anomaly, or manual triggering.
10. A control system for a radiopharmaceutical dose control method according to any one of claims 1 to 9, characterized in that It comprises: a parameter acquisition module for acquiring drug inherent parameters, real-time physiological parameters of a patient, and reading system preset threshold values; an activity calculation module for dynamically calculating the residual activity of a radioactive drug based on a decay algorithm and real-time temperature data, and outputting an activity deviation value; a flow rate adjustment module for receiving the deviation value output by the activity calculation module, dynamically adjusting the drug infusion flow rate, and making the residual activity approach the target activity; an adsorption loss monitoring module for acquiring real-time activities upstream and downstream of the pipeline, calculating activity difference values, and identifying the degree of pipeline adsorption loss; a compensation adjustment module for dynamically generating a flow rate compensation coefficient according to the loss degree identified by the adsorption loss monitoring module, and adjusting the infusion flow rate to offset the activity loss caused by pipeline adsorption; a data recording and response module for obtaining key infusion parameters and recording data, and interrupting the infusion in response to an emergency stop signal.