A method for evaluating clinical efficacy of a radiopharmaceutical, an electronic device and a storage medium

Abstract

This application relates to the field of radiopharmaceutical clinical evaluation technology, specifically providing a method, electronic device, and storage medium for evaluating the clinical efficacy of radiopharmaceuticals. The method includes the following steps: determining an activity function modeling method and contribution factors based on the composition and half-life of the drug to be evaluated; using the activity function modeling method to obtain the activity function of the tumor lesion region and the activity function of the risk organ based on spatiotemporal distribution data; calculating a first absorbed radiation dose based on the activity function of the tumor lesion region, the total drug activity, and the contribution factors corresponding to the tumor lesion region; calculating a second absorbed radiation dose based on the activity function of the risk organ, the total drug activity, and the contribution factors corresponding to the risk organ; and generating an efficacy evaluation index based on the ratio of the first absorbed radiation dose to the second absorbed radiation dose. This method can effectively reduce resource waste, shorten the new drug launch cycle, and prevent promising drugs from being shelved due to failure to pass Phase III clinical trials.

Description

Technical Field

[0001] This application relates to the field of clinical evaluation technology for radiopharmaceuticals, and more specifically, to a method, electronic device, and storage medium for evaluating the clinical efficacy of radiopharmaceuticals. Background Technology

[0002] In recent years, targeted radiopharmaceuticals have become a research hotspot and a key area for industrialization in the field of cancer treatment. These drugs typically consist of four parts: a radioactive isotope, a chelating agent, a targeting ligand, and a linker. The drug binds specifically to the tumor target through the targeting ligand, while the radioactive isotope releases charged particles to kill tumor cells, or releases photons for in vitro imaging and localization. The killing effect of radiopharmaceuticals on tumor cells and the degree of damage to normal tissues mainly depend on the absorbed dose distribution of the released ionizing radiation in the target and non-target areas.

[0003] Currently, a significant technical problem exists in the development of radiopharmaceuticals, particularly radiopharmaceuticals for cancer treatment: traditionally, the clinical efficacy evaluation of drugs relies heavily on time-consuming, expensive, and high-failure-rate Phase III controlled clinical trials. Because there are numerous radiopharmaceuticals on the market targeting the same indications, this late-stage evaluation model leads to a huge waste of resources, prolongs the drug launch cycle, and may cause promising drugs to be shelved due to failure to pass high-risk Phase III trials, thus reducing the efficiency and success rate of drug development.

[0004] There is currently no effective technical solution to the above problems. Summary of the Invention

[0005] The purpose of this application is to provide a method, electronic device and storage medium for evaluating the clinical efficacy of radiopharmaceuticals, which can effectively reduce the waste of resources, shorten the new drug launch cycle and prevent promising drugs from being shelved due to failure to pass Phase III clinical trials.

[0006] In a first aspect, this application provides a method for evaluating the clinical efficacy of radiopharmaceuticals, which includes the following steps: S1. Obtain the spatiotemporal distribution data and total drug activity of the drug to be evaluated based on the imaging data; the imaging data includes any one or more of the following: SPECT imaging data of the drug to be evaluated collected in early investigator-initiated, Phase I or Phase II, PET imaging data of the drug to be evaluated, SPECT imaging data of diagnostic drugs with the same target and similar targeting ligands as the drug to be evaluated, and PET imaging data of diagnostic drugs with the same target and similar targeting ligands as the drug to be evaluated. S2. Determine the activity function modeling method, the contribution factors corresponding to the tumor lesion area, and the contribution factors corresponding to the risk organs based on the composition and half-life of the drug to be evaluated. S3. Using the activity function modeling method, obtain the activity function of the tumor lesion area and the activity function of the risk organ based on the spatiotemporal distribution data; the activity function of the tumor lesion area is a function of the ratio of the uptake activity of the tumor lesion area to the total drug activity over time, and the activity function of the risk organ is a function of the ratio of the uptake activity of the risk organ to the total drug activity over time. S4. Calculate the first absorbed radiation dose based on the activity function of the tumor lesion area, the total drug activity, and the contribution factor corresponding to the tumor lesion area. S5. Calculate the second absorbed radiation dose based on the risk organ activity function, total drug activity, and contribution factor corresponding to the risk organ. S6. Generate an effectiveness evaluation index based on the ratio of the first absorbed radiation dose to the second absorbed radiation dose.

[0007] This application provides a method for evaluating the clinical efficacy of radiopharmaceuticals. By introducing a tumor lesion area activity function and a risk organ activity function, and calculating the first and second absorbed radiation doses respectively, a efficacy evaluation index is generated. This method enables accurate evaluation of drug efficacy based on early investigator-initiated or Phase I and II clinical data. In other words, this application can accurately evaluate drug performance without Phase III clinical trials. Therefore, this application can effectively reduce the waste of resources, shorten the new drug launch cycle, and prevent promising drugs from being shelved due to failure to pass Phase III clinical trials. This effectively improves the efficiency and success rate of drug development. In other words, this application provides scientific and economic decision support for the clinical application of radiopharmaceuticals.

[0008] Optionally, when there are multiple drugs to be evaluated and different types of drugs to be evaluated, step S6 includes: S61. For each drug to be evaluated, obtain the biological response factors corresponding to the tumor lesion area and the biological response factors corresponding to the risk organs according to the type of drug to be evaluated. Then, the ratio of the product of the first absorbed radiation dose and the biological response factor corresponding to the tumor lesion area to the product of the second absorbed radiation dose and the biological response factor corresponding to the risk organs is used as the efficacy evaluation index.

[0009] This technical solution introduces biological response factors, enabling efficacy assessment indicators to more precisely consider the biological effects of different types of drugs. Therefore, this technical solution can effectively improve the accuracy and comprehensiveness of efficacy assessment indicators, thereby allowing them to more precisely reflect the actual impact of different drug types on tumors and organs at risk.

[0010] Optionally, the components of the drug to be evaluated include 177 Lu、 131 I, 90 Y or161 At time Tb, the formula for calculating the first absorbed radiation dose is as follows: ; in, Indicates the first absorbed radiation dose. Indicates the contributing factors corresponding to the tumor lesion area. Indicates the total drug activity. This represents the specific value of the activity function of the tumor lesion region at time t=0. This represents the physical decay time coefficient of the drug being evaluated. This represents the time coefficient of the biological metabolic decay of the drug to be evaluated within the tumor lesion area; The formula for calculating the second absorbed radiation dose is as follows: ; in, Indicates the second absorbed radiation dose. This indicates the contribution factor corresponding to the risk organ. This represents the specific value of the risk organ activity function at time t=0. This represents the time coefficient of the biological metabolic decay of the drug to be evaluated in the organs at risk.

[0011] Optionally, when there are multiple drugs to be evaluated and all of them are of the same type, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators, Indicates the physical half-life of the drug to be evaluated. and These represent the biological half-life of the drug under evaluation within the tumor lesion area and within the risk organ, respectively. When there are multiple drugs to be evaluated and different types of drugs to be evaluated, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators, This represents the biological response factors corresponding to the tumor lesion area. This represents the biological response factors corresponding to the organs at risk. These represent the model parameters of the LQ model corresponding to the tumor lesion region. The parameters represent the LQ model parameters corresponding to the organs at risk, and X represents the fractionated dose value of external X-ray radiotherapy under the same radiation biological effects. This indicates the cell repair rate corresponding to the tumor lesion area. This indicates the cell repair rate corresponding to the organ at risk.

[0012] Optionally, the components of the drug to be evaluated include 225 When Ac, the formula for calculating the first absorbed radiation dose is as follows: ; in, Indicates the first absorbed radiation dose. Indicates the total drug activity. , and They represent 225 Ac、 221 Fr or 217 At and 213 Bior 213 Po corresponds to the contributing factor of the tumor lesion region. express 225 The specific value of the activity function of the tumor lesion region corresponding to Ac at time t=0. and They represent 221 Fr and 217 The specific value of the activity function of the tumor lesion region corresponding to At at time t=0. and They represent 213 Bihe 213 The specific value of the activity function of the tumor lesion region corresponding to Po at time t=0. express 225 The time coefficient of biochemical decay of Ac within the tumor lesion area. and They represent 221 Fr and 217 At represents the time coefficient of biological metabolic decay within the tumor lesion area. and They represent 213 Bihe 213 Po is the time factor of biological metabolic decay in the tumor lesion area; The formula for calculating the second absorbed radiation dose is as follows: ; in, Indicates the second absorbed radiation dose. , and They represent 225 Ac、 221 Fr or 217 At and 213 Bior 213 Po corresponds to the risk organ contribution factor. express 225 The specific value of the risk organ activity function corresponding to Ac at time t=0. and They represent 221 Fr and 217 The specific value of the risk organ activity function corresponding to At at time t=0. and They represent 213 Bihe 213 The specific value of the risk organ activity function corresponding to Po at time t=0. express 225 Ac is the time factor for biological metabolic decay in organs at risk. and They represent 221 Fr and 217 At is the time factor for biological metabolic decay in organs at risk. and They represent 213 Bihe 213 Po is the time factor for biological metabolic decay in organs at risk.

[0013] Optionally, when there are multiple drugs to be evaluated and all of them are of the same type, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators; When there are multiple drugs to be evaluated and different types of drugs to be evaluated, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators, This represents the biological response factors corresponding to the tumor lesion area. This represents the biological response factors corresponding to the organs at risk. These represent the model parameters of the LQ model corresponding to the tumor lesion region. The parameters represent the LQ model parameters corresponding to the organs at risk, and X represents the fractionated dose value of external X-ray radiotherapy under the same radiation biological effects. The logarithmic factor representing the survival curve of cells within the tumor lesion region in response to high linear metastatic radiation. The logarithmic factor representing the survival curve of cells in a high-linear-transfer-energy radiation response within a risk organ.

[0014] Optionally, the components of the drug to be evaluated include 211 At or212 When Pb is present, the formula for calculating the first absorbed radiation dose is as follows: ; in, Indicates the first absorbed radiation dose. Indicates the contributing factors corresponding to the tumor lesion area. Indicates the total drug activity. and They represent 211 At and 212 The specific value of the activity function of the tumor lesion region corresponding to Pb at time t=0. This represents the physical decay time coefficient of the drug being evaluated. and They represent 211 At and 212 The time coefficient of Pb's biological metabolic decay in the tumor lesion area; The formula for calculating the second absorbed radiation dose is as follows: ; in, Indicates the second absorbed radiation dose. This indicates the contribution factor corresponding to the risk organ. and They represent 211 At and 212 The specific value of the risk organ activity function corresponding to Pb at time t=0. and They represent 211 At and 212 The time factor of Pb's biological metabolic decay in organs at risk.

[0015] Optionally, when there are multiple drugs to be evaluated and all of them are of the same type, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators; When there are multiple drugs to be evaluated and different types of drugs to be evaluated, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators, This represents the biological response factors corresponding to the tumor lesion area. This represents the biological response factors corresponding to the organs at risk. These represent the model parameters of the LQ model corresponding to the tumor lesion region. The parameters represent the LQ model parameters corresponding to the organs at risk, and X represents the fractionated dose value of external X-ray radiotherapy under the same radiation biological effects. The logarithmic factor representing the survival curve of cells within the tumor lesion region in response to high linear metastatic radiation. The logarithmic factor representing the survival curve of cells in a high-linear-transfer-energy radiation response within a risk organ.

[0016] Secondly, this application provides an electronic device including a processor and a memory, the memory storing computer-readable instructions, which, when executed by the processor, perform the steps of the method provided in the first aspect above.

[0017] Thirdly, this application provides a computer-readable storage medium having a computer program stored thereon, which, when executed by a processor, performs the steps of the method provided in the first aspect above.

[0018] As can be seen from the above, the radiopharmaceutical clinical efficacy assessment method, electronic device, and storage medium provided in this application, by introducing the tumor lesion area activity function and the risk organ activity function, and calculating the first and second absorbed radiation doses respectively, and finally generating efficacy assessment indicators, achieves accurate assessment of drug efficacy based on early investigator-initiated or Phase I and Phase II clinical data. That is, this application can accurately assess drug performance without Phase III clinical trials. Therefore, this application can effectively reduce the waste of resources, shorten the new drug launch cycle, and avoid the shelving of promising drugs due to failure to pass Phase III clinical trials, thereby effectively improving the efficiency and success rate of drug development. In other words, this application is equivalent to providing scientific and economic decision support for the clinical application of radiopharmaceuticals. Attached Figure Description

[0019] Figure 1 A flowchart illustrating a method for evaluating the clinical efficacy of radiopharmaceuticals, provided as an embodiment of this application.

[0020] Figure 2 This is a schematic diagram of the structure of an electronic device provided in an embodiment of this application.

[0021] Reference numerals: 101, processor; 102, memory; 103, communication bus. Detailed Implementation

[0022] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely represents selected embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0023] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, terms such as "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0024] In traditional radiopharmaceutical development, assessing drug efficacy based on early clinical imaging data faces significant challenges. Specifically, current technologies cannot accurately quantify the radiation dose relationship between tumor lesions and risk organs using SPECT or PET imaging data obtained from investigator-initiated or Phase I / II clinical trials. This necessitates relying on Phase III controlled clinical trials for development decisions. The core issue lies in the lack of an assessment mechanism that combines the spatiotemporal distribution information in imaging data with the radionuclide decay characteristics, preventing the objective characterization of drug efficacy and side effect risks at an early stage. Consequently, the development cycle is forced to lengthen, resource allocation efficiency is reduced, and candidates lacking commercial viability cannot be identified in a timely manner, resulting in unnecessary resource consumption.

[0025] For example, in the specific scenario of PSMA-targeted drug development for prostate cancer, multiple radiopharmaceuticals with the same target and indication are in clinical trials. The research team obtained millimeter-scale spatiotemporal distribution data of 177Lu-labeled drugs in patients using SPECT imaging and recorded the change in total drug activity over time. However, due to the significant differences in the decay chain characteristics of different radionuclides—for example, 225Ac involves complex kinetics of the parent nucleus and decay products, while 177Lu only exhibits a single exponential decay—existing methods cannot adapt activity function modeling strategies for nuclide components. This results in the inability to functionally express the proportion of uptake activity in the tumor lesion area and the proportion of uptake activity in at-risk organs, making it difficult to calculate the relative relationship of absorbed radiation dose. In this scenario, the research team cannot determine whether the drug has a sufficient therapeutic window based on early data, thus facing high uncertainty when advancing to phase III trials and potentially investing resources in projects with a higher risk of subsequent clinical failure.

[0026] If the aforementioned problems are not addressed, the development of radiopharmaceuticals will continue to rely on costly and lengthy Phase III clinical trials for efficacy verification. Consequently, a large number of early-stage candidate drugs will not be screened or optimized in a timely manner, leading to a continuous flow of ineffective resources to drugs lacking therapeutic advantages. Furthermore, drug approval processes will be hampered, delaying the launch of new drugs and ultimately impacting patients' access to effective treatments. The long-term existence of this technological bottleneck will severely restrict the efficiency and speed of innovation in the field of radiopharmaceutical development.

[0027] In this regard, firstly, such as Figure 1 As shown, this application provides a method for evaluating the clinical efficacy of radiopharmaceuticals, which includes the following steps: S1. Obtain the spatiotemporal distribution data and total drug activity of the drug to be evaluated based on the imaging data; the imaging data includes any one or more of the following: SPECT imaging data of the drug to be evaluated collected in early investigator-initiated, Phase I or Phase II, PET imaging data of the drug to be evaluated, SPECT imaging data of diagnostic drugs with the same target and similar targeting ligands as the drug to be evaluated, and PET imaging data of diagnostic drugs with the same target and similar targeting ligands as the drug to be evaluated. S2. Determine the activity function modeling method, the contribution factors corresponding to the tumor lesion area, and the contribution factors corresponding to the risk organs based on the composition and half-life of the drug to be evaluated. S3. Using the activity function modeling method, obtain the activity function of the tumor lesion area and the activity function of the risk organ based on the spatiotemporal distribution data; the activity function of the tumor lesion area is a function of the ratio of the uptake activity of the tumor lesion area to the total drug activity over time, and the activity function of the risk organ is a function of the ratio of the uptake activity of the risk organ to the total drug activity over time. S4. Calculate the first absorbed radiation dose based on the activity function of the tumor lesion area, the total drug activity, and the contribution factor corresponding to the tumor lesion area. S5. Calculate the second absorbed radiation dose based on the risk organ activity function, total drug activity, and contribution factor corresponding to the risk organ. S6. Generate an effectiveness evaluation index based on the ratio of the first absorbed radiation dose to the second absorbed radiation dose.

[0028] For ease of understanding, some key terms in this embodiment are explained below. The spatiotemporal distribution data in this embodiment refers to the concentration or activity information of the radiopharmaceutical at different time points and spatial locations within the patient's body. This spatiotemporal distribution data is acquired based on imaging data. This data reflects the absorption, distribution, metabolism, and excretion processes of the radiopharmaceutical within the body. Therefore, spatiotemporal distribution data is fundamental for evaluating drug efficacy and safety. It should be understood that acquiring spatiotemporal distribution data based on imaging data is prior art, and its working principle and workflow are not discussed in detail here. The total drug activity in this embodiment refers to the total radioactivity intensity of the radiopharmaceutical injected into the patient's body. Total drug activity is one of the key parameters for calculating the absorbed radiation dose. The total drug activity, together with the distribution of the radiopharmaceutical within the body, determines the radiation dose received by the tumor lesion tissue and organs. It should be understood that acquiring total drug activity based on imaging data is prior art, and its working principle and workflow are not discussed in detail here. The activity function modeling method in this embodiment refers to a mathematical model used to describe the change in the activity of radiopharmaceuticals over time in tumor lesions and organs at risk. Different radionuclides have different decay characteristics and biological metabolic processes, therefore different modeling methods are needed to accurately describe their activity changes. For example, single-exponential modeling is suitable for nuclides with relatively simple decay processes (e.g., 177 Lu、 131 I, 90 Y or 161 Tb), while bi-exponential or multi-exponential modeling is suitable for nuclides with complex decay chains or multi-stage biological metabolic processes (e.g., Tb). 211 At or 212(Pb). The contribution factor in this embodiment refers to the radiation absorbed dose produced by a unit activity of radiopharmaceutical in a specific tissue or organ. The contribution factor is related to factors such as the physical decay characteristics of the nuclide, the type of radiation, and the geometry and density of the tissue or organ. This embodiment can convert drug activity into actual radiation absorbed dose through the contribution factor. The contribution factor in this embodiment is preferably obtained by referring to the reference "Electron Absorbed Fractions and S Factors for Intermediate Size Target Volumes: Comparison of Analytic Calculations and Monte Carlo Simulations | MDPI". The tumor lesion area activity function in this embodiment refers to the function of the ratio of radiopharmaceutical uptake activity to total drug activity in the tumor lesion area over time. This function reflects the accumulation and clearance dynamics of the drug in the tumor area and is an important basis for evaluating the drug's tumor-killing effect. The risk organ activity function in this embodiment refers to the function of the ratio of radiopharmaceutical uptake activity to total drug activity in the risk organ over time. This function reflects the distribution and clearance dynamics of the drug in normal sensitive organs and is an important basis for evaluating the potential damage of the drug to normal tissues. The first absorbed radiation dose in this embodiment refers to the absorbed radiation dose received by the tumor lesion area, which directly reflects the radiopharmaceutical's ability to kill tumor cells. The second absorbed radiation dose in this embodiment refers to the absorbed radiation dose received by the at-risk organ, which reflects the potential toxicity of the radiopharmaceutical to normal sensitive organs. The efficacy evaluation index in this embodiment is a quantitative index obtained by the ratio of the first absorbed radiation dose to the second absorbed radiation dose or other comprehensive calculation methods. This efficacy evaluation index is used to assess the clinical therapeutic efficacy and safety of the radiopharmaceutical. This efficacy evaluation index can comprehensively reflect the therapeutic effect and side effect risk of the drug, providing a basis for decision-making in drug development and clinical application.

[0029] This application proposes a method for evaluating the clinical efficacy of radiopharmaceuticals. This method aims to assess the efficacy of radiopharmaceuticals using early clinical imaging data, thereby avoiding unnecessary waste of resources in phase III clinical trials. Specifically, the method for evaluating the clinical efficacy of radiopharmaceuticals provided in this application includes the following steps: In step S1, the spatiotemporal distribution data and total drug activity of the drug to be evaluated are acquired based on the imaging data. This step is fundamental to the entire evaluation process, and its purpose is to provide the necessary input data for subsequent dose calculation. Imaging data can be obtained through various medical imaging devices, such as SPECT (single-photon emission computed tomography) or PET (positron emission tomography). These devices can capture the distribution of radiopharmaceuticals at different time points and spatial locations within the patient's body. For example, during a PET scan, after the patient is injected with a radioactive tracer, the PET scanner detects the positron annihilation gamma rays generated during the decay of the tracer and reconstructs a three-dimensional distribution image of the drug within the body. By quantitatively analyzing these images, the curve of drug activity over time in a specific tissue or organ (i.e., spatiotemporal distribution data) can be extracted. Simultaneously, by integrating the whole-body images, the total drug activity injected into the patient's body is calculated. The accurate acquisition of this data is crucial for subsequent dose calculation.

[0030] In step S2, the activity function modeling method, contribution factors corresponding to the tumor lesion region, and contribution factors corresponding to the organs at risk are determined based on the composition and half-life of the drug to be evaluated. This step aims to select an appropriate mathematical model to describe the behavior of different radionuclides in vivo and determine their radiation effects on tissues and organs, based on the characteristics of different radionuclides. For example, for 177 Lu、 131 I, 90Y or 161 Beta radionuclides with a half-life of Tb have relatively simple decay processes, and the time from injection to peak organ uptake is usually shorter than the drug's residence time in organs and lesions. Therefore, a single-exponential modeling method can be used to describe their activity function. The single-exponential model can effectively capture the exponential decay trend of drug activity over time. However, for... 225 Ac nuclides, which have complex decay chains, have decay products (such as...) 221 Fr、 217 At、 213 Bi、 213 Po) is also radioactive and can be redistributed within the body; therefore, for 225 Ac, the activity function modeling method needs to... 225 Ac is modeled using a single-exponential method, while its decay products are modeled using a double-exponential method to more accurately describe its multi-stage activity changes. For 211 At or 212For radionuclides like Pb with short physical half-lives, the effect of the first peak uptake time after drug injection is not negligible compared to the physical half-life. Therefore, bi-exponential or multi-exponential modeling is required to accurately include the effect during this time period, thereby precisely calculating the absorbed radiation dose. The contribution factor is predetermined based on the physical decay characteristics of the radionuclide corresponding to the radiopharmaceutical and the characteristics of the tissues and organs, for example, calculated using methods such as Monte Carlo simulation.

[0031] In step S3, the activity function of the tumor lesion region and the activity function of the risk organ are obtained based on the spatiotemporal distribution data using an activity function modeling method. This step aims to apply the modeling method determined in the previous step to the actually acquired spatiotemporal distribution data, thereby obtaining mathematical functions describing the dynamic changes in the activity of the radiopharmaceutical in the tumor lesion region and the risk organ. For example, by curve fitting the measured values ​​of the activity of the tumor lesion region obtained in step S1 over time, and combining them with the single-exponential, double-exponential, or multi-exponential modeling method determined in step S2, the activity function of the tumor lesion region can be obtained. This function represents the ratio of the uptake activity (the activity of the uptaken radiopharmaceutical) of the tumor lesion region to the total drug activity over time. Similarly, the activity function of the risk organ can be obtained, which represents the ratio of the uptake activity of the risk organ to the total drug activity over time. These activity functions provide continuous and quantitative input for subsequent radiation absorbed dose calculations.

[0032] In step S4, the first absorbed radiation dose is calculated based on the tumor lesion region activity function, the total drug activity, and the contribution factor corresponding to the tumor lesion region. This step aims to quantify the actual radiation effect of the radiopharmaceutical on the tumor lesion. For example, by substituting the value of the tumor lesion region activity function at a specific time point, the total drug activity, and the contribution factor corresponding to the tumor lesion region into the corresponding dose calculation formula (shown below), the absorbed radiation dose received by the tumor lesion region can be calculated.

[0033] In step S5, the second absorbed radiation dose is calculated based on the risk organ activity function, the total drug activity, and the contribution factor corresponding to the risk organ. This step aims to quantify the potential damage of the radiopharmaceutical to normal sensitive organs. For example, the absorbed radiation dose received by the risk organ can be calculated by substituting the value of the risk organ activity function at a specific time point, the total drug activity, and the contribution factor corresponding to the risk organ into the corresponding dose calculation formula (shown below).

[0034] In step S6, a efficacy assessment index is generated based on the ratio of the first absorbed radiation dose to the second absorbed radiation dose. This step aims to comprehensively evaluate the therapeutic efficacy and safety of radiopharmaceuticals and provide a quantitative indicator for decision-making. For example, by calculating the ratio of the first absorbed radiation dose to the second absorbed radiation dose to the at-risk organ, an intuitive efficacy assessment index can be obtained. Specifically, a higher ratio means that, given the same absorbed radiation dose to the at-risk organ (second absorbed radiation dose), the absorbed radiation dose to the tumor lesion area (first absorbed radiation dose) is greater. Therefore, a higher ratio indicates a better tumor-killing effect of the radiopharmaceutical, thus demonstrating superior clinical efficacy. Efficacy assessment indices can be used to compare the performance of different drugs, guide drug optimization, and provide a basis for subsequent clinical trial decisions.

[0035] The following example provides a more detailed explanation of the above technical solution: Suppose a pharmaceutical company is developing radiopharmaceutical A and radiopharmaceutical B for the treatment of a certain solid tumor. Radiopharmaceutical A uses a radionuclide... 177 Lu, radiopharmaceutical B uses the radionuclide 90Y and is currently in Phase I clinical trials. To assess the clinical efficacy of this drug at an early stage and determine whether to continue investing significant resources in subsequent Phase III clinical trials, the company has decided to adopt the assessment method proposed in this application. First, in step S1, SPECT imaging is performed on patients participating in the Phase I clinical trial. Multiple scans are used to obtain... 177 Spatiotemporal distribution data of Lu and 90Y in tumor lesions and major risk organs (e.g., liver, kidney) within the patient. These imaging data underwent image processing and quantitative analysis to obtain raw data on the time-varying activities of these two radiopharmaceuticals in tumors and risk organs. Next, in step S2, since the radionuclides used for the drugs to be evaluated are... 177 Lu and 90Y are both long-half-lived beta radionuclides; therefore, the activity function modeling method for these two drugs under evaluation was determined to be single-exponential modeling. Simultaneously, it was determined that... 177 The contribution factors corresponding to the tumor lesion regions and risk organs for Lu and 90Y are determined in advance through physical simulation or experimental data. Then, in step S3, the spatiotemporal distribution data of the tumor lesion regions and risk organs corresponding to the two drugs to be evaluated, obtained in step S1, are fitted using a single-exponential modeling method to obtain the tumor lesion region activity function and risk organ activity function corresponding to the two drugs. These functions can accurately describe... 177 The dynamic process of the ratio of Lu and 90Y uptake activity to total drug activity in tumors and at-risk organs over time. Subsequently, in step S4, according to... 177Calculate the tumor lesion region activity function corresponding to Lu and 90Y, the total drug activity, and the contribution factor corresponding to the tumor lesion region. 177 The first absorbed radiation dose corresponding to Lu and the first absorbed radiation dose corresponding to 90Y. Next, in step S5, according to... 177 The activity functions of risk organs corresponding to Lu and 90Y, the total drug activity, and the contribution factors corresponding to risk organs are calculated. 177 The second absorbed radiation dose corresponding to Lu and the second absorbed radiation dose corresponding to 90Y. Finally, in step S6, the second absorbed radiation dose corresponding to Lu and 90Y is determined. 177 The first absorbed radiation dose corresponding to Lu and 177 The ratio of Lu to the second absorbed radiation dose is used as 177 The effectiveness evaluation index corresponding to Lu is used, and the ratio of the first absorbed radiation dose corresponding to 90Y to the second absorbed radiation dose corresponding to 90Y is used as the effectiveness evaluation index corresponding to 90Y. For example... 177 The efficacy evaluation index for Lu is 6.5, and for 90Y it is 4.2. This means that at the same risk organ dose, radiopharmaceutical A has a better tumor-killing effect than radiopharmaceutical B. Compared to traditional methods, which typically require three phase-controlled clinical trials to demonstrate that radiopharmaceutical A is more effective than radiopharmaceutical B, a process that demands substantial financial investment and years of time. The method described in this application can accurately assess drug efficacy based on early investigator-initiated (IIT) or Phase I / II clinical data, allowing for decisions on drug optimization or abandoning Phase III clinical trials, thus avoiding ineffective resource investment and waste. For example, based on the aforementioned early assessment results, the company decided to prioritize investing more resources in optimizing the dosage regimen of radiopharmaceutical A and advancing it to Phase III clinical trials. For radiopharmaceutical B, the company may consider optimizing its ligand structure or adjusting the chelating agent to improve its pharmacokinetic distribution in tumors and the kidneys, or temporarily shelve its development, thereby avoiding the need for substantial later-stage, high-risk Phase III trials.

[0036] Therefore, the clinical efficacy evaluation method for radiopharmaceuticals provided in this application, by introducing the activity function of the tumor lesion area and the activity function of the risk organ, and calculating the first and second absorbed radiation doses respectively, and finally generating efficacy evaluation indicators, achieves accurate evaluation of drug efficacy based on early investigator-initiated or Phase I and Phase II clinical data. That is, this application can accurately evaluate drug performance without Phase III clinical trials. Therefore, this application can effectively reduce the waste of resources, shorten the new drug launch cycle, and avoid the shelving of promising drugs due to failure to pass Phase III clinical trials, thereby effectively improving the efficiency and success rate of drug development. In other words, this application is equivalent to providing scientific and economic decision support for the clinical application of radiopharmaceuticals.

[0037] In some preferred embodiments, when there are multiple drugs to be evaluated and different types of drugs to be evaluated, step S6 includes: S61. For each drug to be evaluated, obtain the biological response factors corresponding to the tumor lesion area and the biological response factors corresponding to the risk organs according to the type of drug to be evaluated. Then, the ratio of the product of the first absorbed radiation dose and the biological response factor corresponding to the tumor lesion area to the product of the second absorbed radiation dose and the biological response factor corresponding to the risk organs is used as the efficacy evaluation index.

[0038] The biological response factor in this embodiment is a parameter used to quantify the biological effects of different types of radiopharmaceuticals in tumor lesions and at-risk organs. This factor considers the particle type of the radionuclide, the radiation dose rate, and the level of cellular biological response to radiation. Its role is to convert the physically absorbed dose into a more biologically meaningful equivalent dose, thereby more accurately reflecting the therapeutic efficacy and potential toxicity of the drug. Specifically, when the type of drug to be evaluated is Beta radiation, the formula for calculating the biological response factor corresponding to the tumor lesion area is as follows: ;in, This represents the biological response factors corresponding to the tumor lesion area. These represent the model parameters of the LQ model corresponding to the tumor lesion region. This represents the linear correlation factor between cell survival rate and radiation dose series under low dose rate conditions and after considering cell repair effects. Let X represent the first absorbed radiation dose, and X represent the linear correlation factor between cell viability and the series of radiation doses. The formula for calculating this factor is: ;in, Indicates the cell repair rate, and D represents the radiation dose. This represents the radiation dose rate at time t. Let w be the radiation dose rate at time w, where w is the integral substitution variable for time. The formula for calculating the biological response factor corresponding to the at-risk organ is similar to that for the tumor lesion region. When the type of drug to be evaluated is alpha radiation, the formula for calculating the biological response factor corresponding to the tumor lesion region is: Where k represents the logarithmic factor of the cell survival curve in response to high linear transfer energy radiation (obtainable from relevant literature based on in vitro cell radiation irradiation experiments), and the calculation formula for the biological response factor corresponding to the risk organ is similar to that for the tumor lesion region. This embodiment is equivalent to obtaining a biologically effective dose by multiplying the absorbed radiation dose (first and second absorbed radiation doses) by the biological response factors (the biological response factors corresponding to the tumor lesion region and the risk organ). This dose more accurately reflects the actual biological effect; for example, if a drug induces a stronger biological response in the tumor region, its biologically effective dose will be higher even with the same absorbed radiation dose. By calculating the biologically effective doses corresponding to the tumor lesion region and the risk organ, and then calculating the ratio of these two biologically effective doses, a comprehensive efficacy evaluation index considering both radiation dose and biological response can be obtained. This index can more comprehensively and accurately reflect the combined efficacy of different types of radiopharmaceuticals in treating tumors and protecting normal tissues.

[0039] This embodiment addresses the problem that when there are multiple drugs to be evaluated, and different types of drugs are involved, a simple ratio cannot fully account for the potential differences in biological responses of different types of drugs in tumor lesions and at-risk organs. This results in insufficient accuracy and comprehensiveness of efficacy assessment indicators, failing to more precisely reflect the actual impact of different drug types on tumors and at-risk organs. Specifically, this embodiment introduces biological response factors, enabling the efficacy assessment indicators to more precisely consider the biological effects of different drug types. Therefore, this embodiment effectively improves the accuracy and comprehensiveness of efficacy assessment indicators, allowing them to more precisely reflect the actual impact of different drug types on tumors and at-risk organs.

[0040] In some preferred embodiments, the components of the drug to be evaluated include 177 Lu、 131 I, 90 Y or 161 At time Tb, the formula for calculating the first absorbed radiation dose is as follows: ; in, Indicates the first absorbed radiation dose. Indicates the contributing factors corresponding to the tumor lesion area. Indicates the total drug activity. This represents the specific value of the activity function of the tumor lesion region at time t=0. This represents the physical decay time coefficient of the drug being evaluated. This represents the time coefficient of the biological metabolic decay of the drug to be evaluated within the tumor lesion area; The formula for calculating the second absorbed radiation dose is as follows: ; in, Indicates the second absorbed radiation dose. This indicates the contribution factor corresponding to the risk organ. This represents the specific value of the risk organ activity function at time t=0. This represents the time coefficient of the biological metabolic decay of the drug to be evaluated in the organs at risk.

[0041] This embodiment , and All of these can be obtained by consulting relevant literature on in vitro cell radiation irradiation experiments.

[0042] In some preferred embodiments, when there are multiple drugs to be evaluated and the types of drugs to be evaluated are the same, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators, Indicates the physical half-life of the drug to be evaluated. and These represent the biological half-life of the drug under evaluation within the tumor lesion area and within the risk organ, respectively. When there are multiple drugs to be evaluated and different types of drugs to be evaluated, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators, This represents the biological response factors corresponding to the tumor lesion area. This represents the biological response factors corresponding to the organs at risk. These represent the model parameters of the LQ model corresponding to the tumor lesion region. The parameters represent the LQ model parameters corresponding to the organs at risk, and X represents the fractionated dose value of external X-ray radiotherapy under the same radiation biological effects. This indicates the cell repair rate corresponding to the tumor lesion area. This indicates the cell repair rate corresponding to the organ at risk.

[0043] This embodiment and All of these can be obtained by consulting relevant literature on in vitro cell radiation irradiation experiments. The formula for calculating the physical half-life of the drug to be evaluated in this embodiment is: The formula for calculating the biological half-life of the drug to be evaluated within the tumor lesion area in this embodiment is as follows: The formula for calculating the biological half-life of the drug to be evaluated within the tumor lesion area in this embodiment is as follows: .

[0044] In some preferred embodiments, the components of the drug to be evaluated include 225 When Ac, the formula for calculating the first absorbed radiation dose is as follows: ; in, Indicates the first absorbed radiation dose. Indicates the total drug activity. , and They represent 225 Ac、 221 Fr or 217 At and 213 Bior 213 Po corresponds to the contributing factor of the tumor lesion region. express 225 The specific value of the activity function of the tumor lesion region corresponding to Ac at time t=0. and They represent 221 Fr and 217 The specific value of the activity function of the tumor lesion region corresponding to At at time t=0. and They represent 213 Bihe 213 The specific value of the activity function of the tumor lesion region corresponding to Po at time t=0. express 225 The time coefficient of biochemical decay of Ac within the tumor lesion area. and They represent 221 Fr and 217 At represents the time coefficient of biological metabolic decay within the tumor lesion area. and They represent 213 Bihe 213 Po is the time factor of biological metabolic decay in the tumor lesion area; The formula for calculating the second absorbed radiation dose is as follows: ; in, Indicates the second absorbed radiation dose. , and They represent 225 Ac、 221 Fr or 217 At and 213 Bior 213 Po corresponds to the risk organ contribution factor. express 225 The specific value of the risk organ activity function corresponding to Ac at time t=0. and They represent 221 Fr and 217 The specific value of the risk organ activity function corresponding to At at time t=0. and They represent 213 Bihe 213 The specific value of the risk organ activity function corresponding to Po at time t=0. express 225 Ac is the time factor for biological metabolic decay in organs at risk. and They represent 221 Fr and 217 At is the time factor for biological metabolic decay in organs at risk. and They represent 213 Bihe 213 Po is the time factor for biological metabolic decay in organs at risk.

[0045] This embodiment , , , , , , , , and All of these can be obtained by consulting relevant literature based on in vitro cell radiation irradiation experiments. This embodiment is equivalent to designing a method for calculating radiation absorbed dose by nuclide based on the decay characteristics of 225Ac drugs, effectively solving the problem of inaccurate dose assessment caused by the complexity of its decay chain. Specifically, when calculating the first radiation absorbed dose, the 225Ac decay process is decomposed into three independent parts: 225 Ac itself, and its first-generation decay products ( 221 Fr or217 At), and second-generation decay products (At), and second-generation decay products (At), 213 Bior 213 Each component (Po) is integrally calculated based on the total drug activity, corresponding contribution factor, activity function value at t=0, and biological metabolic decay time coefficient, thereby accurately quantifying the dose to the tumor lesion area. This method of segmented radionuclide and multi-index modeling fully considers... 225 Ac and its many decay products (such as Ac and its multiple decay products) 221 Fr、 217 At、 213 Bihe 213 Each of the Po's independent physical decay and biological metabolic characteristics avoids the errors that may be caused by traditional single index models. Therefore, this embodiment can effectively improve the accuracy and reliability of radiation absorbed dose assessment, providing a more solid data foundation for the clinical efficacy assessment of radiopharmaceuticals. This can more accurately guide drug development iteration and clinical application, and reduce unnecessary clinical trial risks.

[0046] In some preferred embodiments, when there are multiple drugs to be evaluated and the types of drugs to be evaluated are the same, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators; When there are multiple drugs to be evaluated and different types of drugs to be evaluated, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators, This represents the biological response factors corresponding to the tumor lesion area. This represents the biological response factors corresponding to the organs at risk. These represent the model parameters of the LQ model corresponding to the tumor lesion region. The parameters represent the LQ model parameters corresponding to the organs at risk, and X represents the fractionated dose value of external X-ray radiotherapy under the same radiation biological effects. The logarithmic factor representing the survival curve of cells within the tumor lesion region in response to high linear metastatic radiation. The logarithmic factor representing the survival curve of cells in a high-linear-transfer-energy radiation response within a risk organ.

[0047] In some preferred embodiments, the components of the drug to be evaluated include 211 At or 212 When Pb is present, the formula for calculating the first absorbed radiation dose is as follows: ; in, Indicates the first absorbed radiation dose. Indicates the contributing factors corresponding to the tumor lesion area. Indicates the total drug activity. and They represent 211 At and 212 The specific value of the activity function of the tumor lesion region corresponding to Pb at time t=0. This represents the physical decay time coefficient of the drug being evaluated. and They represent 211 At and 212 The time coefficient of Pb's biological metabolic decay in the tumor lesion area; The formula for calculating the second absorbed radiation dose is as follows: ; in, Indicates the second absorbed radiation dose. This indicates the contribution factor corresponding to the risk organ. and They represent 211 At and 212 The specific value of the risk organ activity function corresponding to Pb at time t=0. and They represent 211 At and 212 The time factor of Pb's biological metabolic decay in organs at risk.

[0048] This embodiment , , , and All of these can be obtained by consulting relevant literature on in vitro cell radiation irradiation experiments.

[0049] In some preferred embodiments, when there are multiple drugs to be evaluated and the types of drugs to be evaluated are the same, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators; When there are multiple drugs to be evaluated and different types of drugs to be evaluated, the formula for calculating the efficacy evaluation index is as follows: ; in, Indicates performance evaluation indicators, This represents the biological response factors corresponding to the tumor lesion area. This represents the biological response factors corresponding to the organs at risk. These represent the model parameters of the LQ model corresponding to the tumor lesion region. The parameters represent the LQ model parameters corresponding to the organs at risk, and X represents the fractionated dose value of external X-ray radiotherapy under the same radiation biological effects. The logarithmic factor representing the survival curve of cells within the tumor lesion region in response to high linear metastatic radiation. The logarithmic factor representing the survival curve of cells in a high-linear-transfer-energy radiation response within a risk organ.

[0050] As can be seen from the above, the clinical efficacy evaluation method for radiopharmaceuticals provided in this application introduces the activity function of the tumor lesion area and the activity function of the risk organ, and calculates the first and second absorbed radiation doses respectively, and finally generates efficacy evaluation indicators. This method enables accurate evaluation of drug efficacy based on early investigator-initiated or Phase I and Phase II clinical data. In other words, this application can accurately evaluate drug performance without Phase III clinical trials. Therefore, this application can effectively reduce the waste of resources, shorten the new drug launch cycle, and avoid the shelving of promising drugs due to failure to pass Phase III clinical trials, thereby effectively improving the efficiency and success rate of drug development. In other words, this application provides scientific and economic decision support for the clinical application of radiopharmaceuticals.

[0051] Please refer to Figure 2 , Figure 2This application provides a schematic diagram of the structure of an electronic device according to an embodiment of the present application. The electronic device includes a processor 101 and a memory 102. The processor 101 and the memory 102 are interconnected and communicate with each other via a communication bus 103 and / or other forms of connection mechanisms (not shown). The memory 102 stores computer-readable instructions executable by the processor 101. When the electronic device is running, the processor 101 executes these computer-readable instructions to perform the method in any optional implementation of the above embodiments, thereby achieving the following function: Step S1: Obtaining the spatiotemporal distribution data and total drug activity of the drug to be evaluated based on imaging data; the imaging data includes SPECT imaging data of the drug to be evaluated collected in early investigator-initiated, Phase I or Phase II trials, PET imaging data corresponding to the drug to be evaluated, SPECT imaging data of diagnostic drugs with the same target and similar targeting ligands as the drug to be evaluated, and diagnostic drugs with the same target and similar targeting ligands as the drug to be evaluated. Step S2: Determine the activity function modeling method and the contribution factors corresponding to the tumor lesion area and the risk organ based on the composition and half-life of the drug to be evaluated; Step S3: Obtain the activity function of the tumor lesion area and the activity function of the risk organ based on the spatiotemporal distribution data using the activity function modeling method; The activity function of the tumor lesion area is a function of the ratio of the uptake activity of the tumor lesion area to the total drug activity over time, and the activity function of the risk organ is a function of the ratio of the uptake activity of the risk organ to the total drug activity over time; Step S4: Calculate the first absorbed radiation dose based on the activity function of the tumor lesion area, the total drug activity, and the contribution factors corresponding to the tumor lesion area; Step S5: Calculate the second absorbed radiation dose based on the activity function of the risk organ, the total drug activity, and the contribution factors corresponding to the risk organ; Step S6: Generate an efficacy evaluation index based on the ratio of the first absorbed radiation dose to the second absorbed radiation dose.

[0052] This application also provides a computer-readable storage medium storing a computer program thereon. When the computer program is executed by a processor, it performs the method in any optional implementation of the above embodiments to achieve the following functions: Step S1: Obtain the spatiotemporal distribution data and total drug activity of the drug to be evaluated based on imaging data; the imaging data includes any one or more of the following: SPECT imaging data of the drug to be evaluated collected in early investigator-initiated, Phase I or Phase II trials; PET imaging data of the drug to be evaluated; SPECT imaging data of a diagnostic drug with the same target and similar targeting ligand as the drug to be evaluated; and PET imaging data of a diagnostic drug with the same target and similar targeting ligand as the drug to be evaluated; Step S2: Determine the activity function modeling method and the corresponding tumor lesion area based on the composition and half-life of the drug to be evaluated. Step S3: Using the activity function modeling method, obtain the activity function of the tumor lesion area and the activity function of the risk organ based on the spatiotemporal distribution data; the activity function of the tumor lesion area is a function of the ratio of the uptake activity of the tumor lesion area to the total drug activity over time, and the activity function of the risk organ is a function of the ratio of the uptake activity of the risk organ to the total drug activity over time; Step S4: Calculate the first absorbed radiation dose based on the activity function of the tumor lesion area, the total drug activity, and the contribution factor corresponding to the tumor lesion area; Step S5: Calculate the second absorbed radiation dose based on the activity function of the risk organ, the total drug activity, and the contribution factor corresponding to the risk organ; Step S6: Generate an efficacy evaluation index based on the ratio of the first absorbed radiation dose to the second absorbed radiation dose. The computer-readable storage medium can be implemented by any type of volatile or non-volatile storage device or a combination thereof, such as Static Random Access Memory (SRAM), Electrically Erasable Programmable Read-Only Memory (EEPROM), Erasable Programmable Read Only Memory (EPROM), Programmable Red-Only Memory (PROM), Read-Only Memory (ROM), magnetic storage, flash memory, magnetic disk, or optical disk.

[0053] As can be seen from the above, the radiopharmaceutical clinical efficacy assessment method, electronic device, and storage medium provided in this application, by introducing the tumor lesion area activity function and the risk organ activity function, and calculating the first and second absorbed radiation doses respectively, and finally generating efficacy assessment indicators, achieves accurate assessment of drug efficacy based on early investigator-initiated or Phase I and Phase II clinical data. That is, this application can accurately assess drug performance without Phase III clinical trials. Therefore, this application can effectively reduce the waste of resources, shorten the new drug launch cycle, and avoid the shelving of promising drugs due to failure to pass Phase III clinical trials, thereby effectively improving the efficiency and success rate of drug development. In other words, this application is equivalent to providing scientific and economic decision support for the clinical application of radiopharmaceuticals.

[0054] In the embodiments provided in this application, it should be understood that relational terms such as first and second are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations.

[0055] The above are merely embodiments of this application and are not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A method for evaluating the clinical efficacy of radiopharmaceuticals, characterized in that, The method for evaluating the clinical efficacy of radiopharmaceuticals includes the following steps: S1. Obtain the spatiotemporal distribution data and total drug activity of the drug to be evaluated based on the imaging data; the imaging data includes any one or more of the following: SPECT imaging data of the drug to be evaluated collected in early investigator-initiated, Phase I or Phase II, PET imaging data of the drug to be evaluated, SPECT imaging data of a diagnostic drug with the same target and similar targeting ligand as the drug to be evaluated, and PET imaging data of a diagnostic drug with the same target and similar targeting ligand as the drug to be evaluated. S2. Determine the activity function modeling method, the contribution factor corresponding to the tumor lesion area, and the contribution factor corresponding to the risk organ based on the composition and half-life of the drug to be evaluated. S3. Using the activity function modeling method, obtain the tumor lesion region activity function and the risk organ activity function based on the spatiotemporal distribution data; the tumor lesion region activity function is a function of the ratio of the uptake activity of the tumor lesion region to the total drug activity over time, and the risk organ activity function is a function of the ratio of the uptake activity of the risk organ to the total drug activity over time. S4. Calculate the first absorbed radiation dose based on the activity function of the tumor lesion area, the total drug activity, and the contribution factor corresponding to the tumor lesion area. S5. Calculate the second absorbed radiation dose based on the risk organ activity function, the total drug activity, and the contribution factor corresponding to the risk organ; S6. Generate an effectiveness evaluation index based on the ratio of the first absorbed radiation dose to the second absorbed radiation dose.

2. The method for evaluating the clinical efficacy of radiopharmaceuticals according to claim 1, characterized in that, When there are multiple drugs to be evaluated and different types of drugs to be evaluated, step S6 includes: S61. For each of the drugs to be evaluated, obtain the biological response factors corresponding to the tumor lesion area and the biological response factors corresponding to the risk organ according to the type of the drug to be evaluated, and then use the ratio of the product of the first absorbed radiation dose and the biological response factor corresponding to the tumor lesion area to the product of the second absorbed radiation dose and the biological response factor corresponding to the risk organ as the efficacy evaluation index.

3. The method for evaluating the clinical efficacy of radiopharmaceuticals according to claim 2, characterized in that, The components of the drug to be evaluated include 177 Lu、 131 I, 90 Y or 161 At time Tb, the formula for calculating the first absorbed radiation dose is as follows: ； in, Indicates the first absorbed radiation dose. Indicates the contributing factors corresponding to the tumor lesion area. Indicates the total drug activity. This represents the specific value of the activity function of the tumor lesion region at time t=0. This represents the physical decay time coefficient of the drug being evaluated. This represents the time coefficient of the biological metabolic decay of the drug to be evaluated within the tumor lesion area; The formula for calculating the second absorbed radiation dose is as follows: ； in, Indicates the second absorbed radiation dose. This indicates the contribution factor corresponding to the risk organ. This represents the specific value of the risk organ activity function at time t=0. This represents the time coefficient of the biological metabolic decay of the drug to be evaluated in the organs at risk.

4. The method for evaluating the clinical efficacy of radiopharmaceuticals according to claim 3, characterized in that, When there are multiple drugs to be evaluated, and all of the drugs to be evaluated are of the same type, the formula for calculating the efficacy evaluation index is as follows: ； in, Indicates performance evaluation indicators, Indicates the physical half-life of the drug to be evaluated. and These represent the biological half-life of the drug under evaluation within the tumor lesion area and within the risk organ, respectively. When there are multiple drugs to be evaluated and different types of drugs to be evaluated, the formula for calculating the efficacy evaluation index is as follows: ； in, Indicates performance evaluation indicators, This represents the biological response factors corresponding to the tumor lesion area. This represents the biological response factors corresponding to the organs at risk. These represent the model parameters of the LQ model corresponding to the tumor lesion region. The parameters represent the LQ model parameters corresponding to the organs at risk, and X represents the fractionated dose value of external X-ray radiotherapy under the same radiation biological effects. This indicates the cell repair rate corresponding to the tumor lesion area. This indicates the cell repair rate corresponding to the organ at risk.

5. The method for evaluating the clinical efficacy of radiopharmaceuticals according to claim 2, characterized in that, The components of the drug to be evaluated include 225 When Ac, the formula for calculating the first absorbed radiation dose is as follows: ； in, Indicates the first absorbed radiation dose. Indicates the total drug activity. , and They represent 225 Ac、 221 Fr or 217 At and 213 Bior 213 Po corresponds to the contributing factor of the tumor lesion region. express 225 The specific value of the activity function of the tumor lesion region corresponding to Ac at time t=0. and They represent 221 Fr and 217 The specific value of the activity function of the tumor lesion region corresponding to At at time t=0. and They represent 213 Bihe 213 The specific value of the activity function of the tumor lesion region corresponding to Po at time t=0. express 225 The time coefficient of biological metabolic decay of Ac within the tumor lesion area. and They represent 221 Fr and 217 At is the time coefficient of biological metabolic decay within the tumor lesion area. and They represent 213 Bihe 213 Po is the time factor of biological metabolic decay in the tumor lesion area; The formula for calculating the second absorbed radiation dose is as follows: ； in, Indicates the second absorbed radiation dose. , and They represent 225 Ac、 221 Fr or 217 At and 213 Bior 213 Po corresponds to the risk organ contribution factor. express 225 The specific value of the risk organ activity function corresponding to Ac at time t=0. and They represent 221 Fr and 217 The specific value of the risk organ activity function corresponding to At at time t=0. and They represent 213 Bihe 213 The specific value of the risk organ activity function corresponding to Po at time t=0. express 225 Ac is the time factor for biological metabolic decay in organs at risk. and They represent 221 Fr and 217 At is the time factor for biological metabolic decay in organs at risk. and They represent 213 Bihe 213 Po is the time factor for biological metabolic decay in organs at risk.

6. The method for evaluating the clinical efficacy of radiopharmaceuticals according to claim 5, characterized in that, When there are multiple drugs to be evaluated, and all of the drugs to be evaluated are of the same type, the formula for calculating the efficacy evaluation index is as follows: ； in, Indicates performance evaluation indicators; When there are multiple drugs to be evaluated and different types of drugs to be evaluated, the formula for calculating the efficacy evaluation index is as follows: ； in, Indicates performance evaluation indicators, This represents the biological response factors corresponding to the tumor lesion area. This represents the biological response factors corresponding to the organs at risk. These represent the model parameters of the LQ model corresponding to the tumor lesion region. The parameters represent the LQ model parameters corresponding to the organs at risk, and X represents the fractionated dose value of external X-ray radiotherapy under the same radiation biological effects. The logarithmic factor representing the survival curve of cells within the tumor lesion region in response to high linear metastatic radiation. The logarithmic factor representing the survival curve of cells in a high-linear-transfer-energy radiation response within a risk organ.

7. The method for evaluating the clinical efficacy of radiopharmaceuticals according to claim 2, characterized in that, The components of the drug to be evaluated include 211 At or 212 When Pb is present, the formula for calculating the first absorbed radiation dose is as follows: ； in, Indicates the first absorbed radiation dose. Indicates the contributing factors corresponding to the tumor lesion area. Indicates the total drug activity. and They represent 211 At and 212 The specific value of the activity function of the tumor lesion region corresponding to Pb at time t=0. This represents the physical decay time coefficient of the drug being evaluated. and They represent 211 At and 212 The time coefficient of Pb's biological metabolic decay in the tumor lesion area; The formula for calculating the second absorbed radiation dose is as follows: ； in, Indicates the second absorbed radiation dose. This indicates the contribution factor corresponding to the risk organ. and They represent 211 At and 212 The specific value of the risk organ activity function corresponding to Pb at time t=0. and They represent 211 At and 212 The time factor of Pb's biological metabolic decay in organs at risk.

8. The method for evaluating the clinical efficacy of radiopharmaceuticals according to claim 7, characterized in that, When there are multiple drugs to be evaluated, and all of the drugs to be evaluated are of the same type, the formula for calculating the efficacy evaluation index is as follows: ； in, Indicates performance evaluation indicators; When there are multiple drugs to be evaluated and different types of drugs to be evaluated, the formula for calculating the efficacy evaluation index is as follows: ； in, Indicates performance evaluation indicators, This represents the biological response factors corresponding to the tumor lesion area. This represents the biological response factors corresponding to the organs at risk. These represent the model parameters of the LQ model corresponding to the tumor lesion region. The parameters represent the LQ model parameters corresponding to the organs at risk, and X represents the fractionated dose value of external X-ray radiotherapy under the same radiation biological effects. The logarithmic factor representing the survival curve of cells within the tumor lesion region in response to high linear metastatic radiation. The logarithmic factor representing the survival curve of cells in a high-linear-transfer-energy radiation response within a risk organ.

9. An electronic device, characterized in that, It includes a processor and a memory, the memory storing computer-readable instructions that, when executed by the processor, perform the steps of the method as described in any one of claims 1-8.

10. A computer-readable storage medium having a computer program stored thereon, characterized in that, When the computer program is executed by a processor, it performs the steps of the method as described in any one of claims 1-8.

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