A kit for predicting the prognosis of a patient with biliary tract cancer who has undergone an intervention

Abstract

The application belongs to the field of medicine and biotechnology, and specifically discloses a kit for predicting the prognosis of a cholangiocarcinoma patient after interventional therapy, which comprises reagents and / or devices for detecting and / or counting the interventional therapy scheme of the cholangiocarcinoma patient, the number of anti-tumor treatment times, the T stage, the tumor diameter and the tumor differentiation degree. The kit can predict the survival probability of the cholangiocarcinoma patient 6 months, 1 year and 2 years after the interventional therapy, can facilitate the clinician to accurately evaluate the prognosis of the patient, can formulate an individual follow-up scheme according to the survival period, can shorten the time interval of each follow-up or review if the prognosis is poor, and can adjust the interventional therapy scheme according to the change of the disease condition; and if the prognosis is good, the follow-up or review time interval can be appropriately prolonged, so as to reduce the economic and psychological burden of the patient.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical biotechnology, specifically relating to a kit for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma. Background Technology

[0002] Cholangiocarcinoma (CC) is a malignant tumor originating from the epithelial tissue of the bile ducts. It occurs in the extrahepatic bile ducts from the confluence of the left and right hepatic ducts to the distal end of the common bile duct, accounting for 75% of malignant biliary tumors. In recent years, the incidence of cholangiocarcinoma in my country has been rising year by year, with more than 6 new cases per 100,000 people annually, and it is more common in middle-aged and elderly people over 50 years old. Cholangiocarcinoma has an insidious onset. In the early stages, due to the special morphology of the tumor and the small size of most masses, patients often have no obvious clinical symptoms. When the mass continues to grow and obstructs the bile duct, obstructive jaundice symptoms such as yellowing of the skin and sclera, generalized itching, dark tea-colored urine, and clay-colored stools may appear. At this time, the tumor has often progressed to the middle or late stage.

[0003] Common treatments for cholangiocarcinoma include surgery, radiotherapy, systemic therapy, and interventional therapy. Currently, the only cure for cholangiocarcinoma is radical surgical resection. However, most patients are diagnosed at an advanced stage, often with vascular or surrounding organ invasion, making radical surgery difficult. Because cholangiocarcinoma is mostly poorly vascularized and has a unique anatomical location, radiotherapy and chemotherapy are less effective, and treatment-related side effects severely impact patients' quality of life. Interventional therapies include drainage therapy, 125 I-particle chain implantation therapy and transarterial chemotherapy (TAI) are used. Drainage therapy includes percutaneous transhepatic biliary drainage (PTCD) and biliary stent implantation. In recent years, interventional therapy has become one of the important treatment methods for cholangiocarcinoma due to its advantages such as minimally invasiveness, repeatability, diversity of treatment methods, and high safety.

[0004] Patients with cholangiocarcinoma have a poor prognosis, with a 5-year survival rate of less than 30%. Their survival is influenced by a variety of factors. Previous studies have suggested that liver function classification, tumor stage, and treatment methods all affect prognosis, but most studies were conducted after surgery. While research on prognostic factors for interventional treatment of cholangiocarcinoma has been reported, the research content is relatively limited, either focusing on tumor size or analyzing only clinical data, and it is difficult to assess the exact survival time of each patient. Therefore, it is essential to conduct in-depth research on the prognostic factors after interventional treatment of cholangiocarcinoma to guide clinicians in developing appropriate interventional treatment plans and improving survival rates. Summary of the Invention

[0005] In view of the problems and shortcomings of the existing technology, the purpose of this invention is to provide a kit for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma.

[0006] To achieve the objectives of this invention, the technical solution adopted is as follows:

[0007] The first aspect of this invention provides a kit for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma. The kit includes reagents and / or equipment for detecting and / or statistically analyzing interventional treatment protocols, number of antitumor treatments, T stage, tumor diameter, and tumor differentiation degree in cholangiocarcinoma patients. The interventional treatment protocols include drainage therapy, drainage therapy +... 125 Three treatment options are I-particle chain implantation therapy, drainage therapy + arterial infusion chemotherapy; the number of anti-tumor treatments refers to the number of times the interventional therapy is performed. 125 The number of treatments for I-particle chain implantation therapy or arterial infusion chemotherapy is categorized into three levels: 0, 1, and ≥2 treatments. The T stage is categorized into four levels: T1, T2, T3, and T4. The tumor diameter is categorized into three levels: <17mm, ≥17mm and <33mm, and ≥33mm. The tumor differentiation is categorized into three levels: poorly differentiated, moderately differentiated, and well differentiated.

[0008] According to the above-described kit, preferably, the kit further includes a readable carrier on which the contents of Formulas I to VI are recorded:

[0009] PI = 0 × Interventional treatment plan a + 1.457 × Interventional treatment plan b + 1.097 × Interventional treatment plan c + 0 × Number of anti-tumor treatments a + 76 - 1.131 × Number of anti-tumor treatments b - 1.486 × Number of anti-tumor treatments c + 0 × T1 stage + 0.328 × T2 stage + 1.802 × T3 stage + 1.969 × T4 stage + 0 × Tumor diameter a + 1.413 × Tumor diameter b + 1.555 × Tumor diameter c + 0 × Tumor differentiation degree a + 65 - 0.688 × Tumor differentiation degree b - 1.277 × Tumor differentiation degree c; Formula I

[0010] In Formula I, interventional treatment plan a is drainage treatment, and interventional treatment plan b is drainage treatment + 125 I. Particle chain implantation therapy, interventional treatment plan c: drainage therapy + arterial perfusion chemotherapy; For any bile duct cancer patient, when using Equation 1 to calculate PI, the interventional treatment plan is selected from any one of interventional treatment plans a, b, and c, and the interventional treatment plan selected by the bile duct cancer patient is valued as 1, while the other two interventional treatment plans are valued as 0 (for example, if the interventional treatment plan selected by the bile duct cancer patient is interventional treatment plan b, then the value of interventional treatment plan b in Equation 1 is 1, and the values ​​of interventional treatment plan a and interventional treatment plan c are both 0).

[0011] The number of antitumor treatments, 'a', refers to 0 treatments; 'b' refers to 1 treatment; and 'c' refers to ≥2 treatments. For any bile duct cancer patient, when calculating PI using Equation 1, the number of antitumor treatments is selected from any one of a, b, or c. The selected number of antitumor treatments for the bile duct cancer patient is set to 1, while the other two are set to 0 (e.g., the bile duct cancer patient selects 1 treatment). 125 For I-particle chain implantation therapy, the value of the number of anti-tumor treatments b in Equation 1 is 1, and the values ​​of the number of anti-tumor treatments a and c are both 0.

[0012] For any bile duct cancer patient, when using Equation 1 to calculate PI, the T stage of the bile duct cancer patient is selected from any one of T1, T2, T3, and T4 stages, and the actual T stage of the bile duct cancer patient is set to 1, while the values ​​of other T stages are 0 (for example, if the actual T stage of the bile duct cancer patient is T2, then the value of T2 stage in Equation 1 is 1, and the values ​​of T1, T2, T3, and T4 stages are all 0).

[0013] Tumor diameter a refers to a tumor diameter < 17 mm, tumor diameter b refers to a tumor diameter greater than or equal to 17 mm and less than 33 mm, and tumor diameter c refers to a tumor diameter ≥ 33 mm. For any bile duct cancer patient, when using Equation 1 to calculate PI, the tumor diameter of the bile duct cancer patient is selected from any one of a, b, and c, and the actual tumor diameter of the bile duct cancer patient is taken as 1, while the other two tumor diameters are taken as 0 (for example, if the actual tumor diameter of the bile duct cancer patient is < 17 mm, then the tumor diameter a in Equation 1 is taken as 1, and the tumor diameter b and tumor diameter c are both taken as 0).

[0014] Differentiation degree a is low differentiation, differentiation degree b is moderate differentiation, and differentiation degree c is high differentiation. For any bile duct cancer patient, when using Equation 1 to calculate PI, the differentiation degree of the bile duct cancer patient is selected from any one of low differentiation, moderate differentiation, and high differentiation, and the actual differentiation degree of the bile duct cancer patient is taken as 1, while the other two differentiation degrees are taken as 0 (for example, if the actual differentiation degree of the bile duct cancer patient is moderate differentiation, then the differentiation degree b in Equation 1 is taken as 1, and the differentiation degree a and differentiation degree c are both taken as 0).

[0015] P = PI - 1.467; Equation II

[0016] In Equation II, PI represents the score obtained from Equation I, and P represents the linear prediction value;

[0017] P6 = S0(6) expP Formula III

[0018] In Equation III, S0(6) represents the average survival probability of bile duct cancer patients after interventional treatment for 6 months, P6 represents the survival probability of bile duct cancer patients after interventional treatment for 6 months, and P represents the linear prediction value calculated according to Equation II.

[0019] P 12 =S0(12) expP Formula IV

[0020] In Formula IV, S0(12) represents the average survival probability of cholangiocarcinoma patients 12 months after interventional therapy, and P 12 P represents the 12-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II.

[0021] P 24 =S0(24) expP ; Equation V

[0022] In formula V, S0(24) represents the average survival probability of bile duct cancer patients after interventional therapy at 24 months, and P 24 P represents the 24-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II.

[0023] Point=(PI)×100 / 1.969; Formula VI

[0024] In Equation VI, Point represents the total risk score, PI represents the score calculated by Equation I, and 100 / 1.969 represents the score corresponding to each unit of risk coefficient, where the maximum risk coefficient of 1.969 is defined as 100 points.

[0025] Based on the aforementioned kit for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma, preferably, the drainage treatment includes PTCD (percutaneous transhepatic biliary drainage) and biliary stent implantation.

[0026] According to the above-mentioned kit for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma, preferably, the readable carrier is the kit instruction manual; the contents of Formulas I, II, III, IV, V, and VI are printed on a card.

[0027] According to the above-mentioned kit for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma, preferably, the readable carrier is a computer-readable carrier.

[0028] A second aspect of the present invention provides a product for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma, the product comprising a carrier and a survival probability nomogram disposed on the carrier; the carrier being a card and / or a computer;

[0029] The survival probability nomogram consists of ten rows, with the first row being a risk score scale. The risk score ranges from 0 to 100, and the scale is divided into equal parts.

[0030] The second line represents the patient's interventional treatment plan, which includes drainage therapy and drainage therapy plus... 125 I-particle chain implantation therapy, drainage therapy + arterial infusion chemotherapy; drainage therapy is represented as 0, drainage therapy + 125 I-particle chain implantation therapy is represented as 1, drainage therapy + arterial perfusion chemotherapy is represented as 2, and each interventional treatment plan corresponds to a corresponding risk score in the first row;

[0031] The third row represents the patient's T stage, which includes four levels: T1, T2, T3, and T4. T1 is represented by 1, T2 by 2, T3 by 3, and T4 by 4. Each of the T1, T2, T3, and T4 stages corresponds to a risk score in the first row.

[0032] The fourth row represents the number of anti-tumor treatments a patient has received. The number of anti-tumor treatments is divided into three levels: 0, 1, and ≥2. 0 anti-tumor treatments is represented as 0; 1 anti-tumor treatment is represented as 1; and ≥2 anti-tumor treatments are represented as 2. 0, 1, and ≥2 anti-tumor treatments each correspond to a risk score in the first row.

[0033] The fifth row represents the patient's tumor diameter, which is divided into three grades: tumor diameter <17mm, tumor diameter ≥17mm and <33mm, and tumor diameter ≥33mm. Tumor diameter <17mm is represented as 1; tumor diameter ≥17mm and <33mm is represented as 2; and tumor diameter ≥33mm is represented as 3. Each tumor diameter grade corresponds to a risk score in the first row.

[0034] The sixth row represents the degree of tumor differentiation in the patient. Tumor differentiation degree includes poor differentiation, moderate differentiation, and high differentiation. Poor differentiation is represented by 1; moderate differentiation is represented by 2; and high differentiation is represented by 3. Each degree of tumor differentiation corresponds to a corresponding risk score in the first row.

[0035] The seventh row represents the total risk score scale, which ranges from 0 to 350. The scale is divided into equal parts. The total risk score is obtained by adding the risk scores of the five indicators in the second to sixth rows corresponding to the first row.

[0036] The eighth row represents the 6-month survival probability P6 of patients with bile duct cancer after interventional treatment. The survival probability ranges from 0.1 to 0.9. The scale is not equally divided. The scale distribution is obtained by exponentially transforming the linear prediction value according to Equation III described in the first aspect above.

[0037] The ninth row represents the 12-month survival probability (P) of patients with bile duct cancer after interventional treatment. 12 The scale has a survival probability range of 0.1 to 0.9, and the scale is not equally divided. The scale distribution is obtained by exponentially transforming the linear prediction value according to Equation IV described in the first aspect above.

[0038] The tenth row represents the 24-month survival probability (P) of patients with bile duct cancer after interventional treatment. 24 The scale has a survival probability range of 0.1 to 0.6, and the scale is not equally divided. The scale distribution is obtained by exponentially transforming the linear prediction value according to the formula V described in the first aspect above.

[0039] Based on the aforementioned product for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma, preferably, in the second row of the survival probability nomogram, drainage treatment is represented as 0, and the corresponding risk score on the first row of the score scale is 0; drainage treatment + 125 I-particle chain implantation therapy is represented as 1, with a corresponding risk score of 74 on the first row of the score scale; drainage therapy + arterial perfusion chemotherapy is represented as 2, with a corresponding risk score of 56 on the first row of the score scale.

[0040] The third row of the survival probability nomogram shows that period T1 is represented by 1, with a corresponding risk score of 0 on the first row score scale; period T2 is represented by 2, with a corresponding risk score of 17 on the first row score scale; period T3 is represented by 3, with a corresponding risk score of 91 on the first row score scale; and period T4 is represented by 4, with a corresponding risk score of 100 on the first row score scale.

[0041] In the fourth row of the survival probability nomogram, 0 anti-tumor treatments are represented as 0, with a corresponding risk score of 76 on the first row score scale; 1 anti-tumor treatment is represented as 1, with a corresponding risk score of 18 on the first row score scale; and ≥2 anti-tumor treatments are represented as 2, with a corresponding risk score of 0 on the first row score scale.

[0042] In the fifth row of the survival probability nomogram, a tumor diameter less than 17mm is represented as 1, with a corresponding risk score of 0 on the first row score scale; a tumor diameter greater than or equal to 17mm and less than 33mm is represented as 2, with a corresponding risk score of 72 on the first row score scale; and a tumor diameter ≥33mm is represented as 3, with a corresponding risk score of 79 on the first row score scale.

[0043] The sixth row of the survival probability nomogram is divided into three categories: low differentiation (1) corresponds to a risk score of 65 on the first row score scale; medium differentiation (2) corresponds to a risk score of 30 on the first row score scale; and high differentiation (3) corresponds to a risk score of 0 on the first row score scale.

[0044] A third aspect of the present invention provides a predictive system for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma, the predictive system comprising a variable input module, an analysis module, and an output module;

[0045] The variable input module includes five variable input sub-modules, namely, the interventional treatment plan input sub-module, the T-staging input sub-module, the number of anti-tumor treatments input sub-module, the tumor diameter input sub-module, and the tumor differentiation degree input sub-module;

[0046] The analysis module can establish a survival probability nodal plot based on the variables input by the variable input module and calculate the total risk score. The total risk score is the sum of the risk scores for interventional treatment plan, T stage, number of anti-tumor treatments, tumor diameter, and tumor differentiation degree. The survival prediction value for interventional treatment of bile duct cancer patients is calculated based on the total risk score.

[0047] The output module is used to output the predicted survival value for interventional treatment of patients with cholangiocarcinoma;

[0048] The interventional treatment plan includes drainage therapy, drainage therapy + 125 I-particle chain implantation therapy, drainage therapy + arterial infusion chemotherapy, the risk score corresponding to drainage therapy is 0, drainage therapy + 125 The risk score for I-particle chain implantation therapy is 74, and the risk score for drainage therapy + arterial perfusion chemotherapy is 56.

[0049] The T-phase includes four levels: T1, T2, T3, and T4. The risk score for T1 is 0, the risk score for T2 is 17, the risk score for T3 is 91, and the risk score for T4 is 100.

[0050] The number of anti-tumor treatment sessions refers to the number of sessions conducted during the interventional treatment plan. 125 The number of treatments for I-particle chain implantation therapy or arterial infusion chemotherapy is defined as follows: number of anti-tumor treatments includes 0 treatments, 1 treatment, and ≥2 treatments. Among these, 0 treatments correspond to a risk score of 76; 1 treatment corresponds to a risk score of 18; and ≥2 treatments correspond to a risk score of 0.

[0051] Tumor diameter is categorized into three levels: tumor diameter less than 17 mm, tumor diameter greater than or equal to 17 mm and less than 33 mm, and tumor diameter ≥ 33 mm. Among these, the risk score is 0 for tumor diameter less than 17 mm, 72 for tumor diameter greater than or equal to 17 mm and less than 33 mm, and 79 for tumor diameter ≥ 33 mm.

[0052] Tumor differentiation is categorized as poor, moderate, and high; the risk score for poor differentiation is 65; the risk score for moderate differentiation is 30; and the risk score for high differentiation is 0.

[0053] According to the above prediction system, preferably, the analysis module is capable of performing the following calculations: Equations I to VI:

[0054] PI = 0 × Interventional treatment plan a + 1.457 × Interventional treatment plan b + 1.097 × Interventional treatment plan c + 0 × Number of anti-tumor treatments a + 76 - 1.131 × Number of anti-tumor treatments b - 1.486 × Number of anti-tumor treatments c + 0 × T1 stage + 0.328 × T2 stage + 1.802 × T3 stage + 1.969 × T4 stage + 0 × Tumor diameter a + 1.413 × Tumor diameter b + 1.555 × Tumor diameter c + 0 × Tumor differentiation degree a + 65 - 0.688 × Tumor differentiation degree b - 1.277 × Tumor differentiation degree c; Formula I

[0055] In Formula I, interventional treatment plan a is drainage treatment, and interventional treatment plan b is drainage treatment + 125 I. Particle chain implantation therapy, interventional treatment plan c: drainage therapy + arterial perfusion chemotherapy; For any bile duct cancer patient, when using Equation 1 to calculate PI, the interventional treatment plan is selected from any one of interventional treatment plans a, b, and c, and the interventional treatment plan selected by the bile duct cancer patient is valued as 1, while the other two interventional treatment plans are valued as 0 (for example, if the interventional treatment plan selected by the bile duct cancer patient is interventional treatment plan b, then the value of interventional treatment plan b in Equation 1 is 1, and the values ​​of interventional treatment plan a and interventional treatment plan c are both 0).

[0056] The number of antitumor treatments, 'a', refers to 0 treatments; 'b' refers to 1 treatment; and 'c' refers to ≥2 treatments. For any bile duct cancer patient, when calculating PI using Equation 1, the number of antitumor treatments is selected from any one of a, b, or c. The selected number of antitumor treatments for the bile duct cancer patient is set to 1, while the other two are set to 0 (e.g., the bile duct cancer patient selects 1 treatment). 125 For I-particle chain implantation therapy, the value of the number of anti-tumor treatments b in Equation 1 is 1, and the values ​​of the number of anti-tumor treatments a and c are both 0.

[0057] For any bile duct cancer patient, when using Equation 1 to calculate PI, the T stage of the bile duct cancer patient is selected from any one of T1, T2, T3, and T4, and the actual T stage of the bile duct cancer patient is set to 1, while the values ​​of other T stages are 0 (for example, if the actual T stage of the bile duct cancer patient is T2, then the value of T2 stage in Equation 1 is 1, and the values ​​of T1, T2, T3, and T4 stages are all 0).

[0058] Tumor diameter a refers to a tumor diameter < 17 mm, tumor diameter b refers to a tumor diameter greater than or equal to 17 mm and less than 33 mm, and tumor diameter c refers to a tumor diameter ≥ 33 mm. For any bile duct cancer patient, when using Equation 1 to calculate PI, the tumor diameter of the bile duct cancer patient is selected from any one of a, b, and c, and the actual tumor diameter of the bile duct cancer patient is taken as 1, while the other two tumor diameters are taken as 0 (for example, if the actual tumor diameter of the bile duct cancer patient is < 17 mm, then the tumor diameter a in Equation 1 is taken as 1, and the tumor diameter b and tumor diameter c are both taken as 0).

[0059] Differentiation degree a is low differentiation, differentiation degree b is moderate differentiation, and differentiation degree c is high differentiation. For any bile duct cancer patient, when using Equation 1 to calculate PI, the differentiation degree of the bile duct cancer patient is selected from any one of low differentiation, moderate differentiation, and high differentiation, and the actual differentiation degree of the bile duct cancer patient is taken as 1, while the other two differentiation degrees are taken as 0 (for example, if the actual differentiation degree of the bile duct cancer patient is moderate differentiation, then the differentiation degree b in Equation 1 is taken as 1, and the differentiation degree a and differentiation degree c are both taken as 0).

[0060] P = PI - 1.467; Equation II

[0061] In Equation II, PI represents the score obtained from Equation I, and P represents the linear prediction value;

[0062] P6 = S0(6) expP Formula III

[0063] In Equation III, S0(6) represents the average survival probability of bile duct cancer patients after interventional treatment for 6 months, P6 represents the survival probability of bile duct cancer patients after interventional treatment for 6 months, and P represents the linear prediction value calculated according to Equation II.

[0064] P 12 =S0(12) expP Formula IV

[0065] In Formula IV, S0(12) represents the average survival probability of cholangiocarcinoma patients 12 months after interventional therapy, and P 12P represents the 12-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II.

[0066] P 24 =S0(24) expP ; Equation V

[0067] In formula V, S0(24) represents the average survival probability of bile duct cancer patients after interventional therapy at 24 months, and P 24 P represents the 24-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II.

[0068] Point=(PI)×100 / 1.969; Formula VI

[0069] In Equation VI, Point represents the total risk score, PI represents the score calculated by Equation I, and 100 / 1.969 represents the score corresponding to each unit of risk coefficient, where the maximum risk coefficient of 1.969 is defined as 100 points.

[0070] According to the above prediction system, preferably, the method for establishing a survival probability nomogram based on the variables input by the variable input module is to use the RMS package in R language to visualize the nomogram of the Cox regression model.

[0071] According to the above prediction system, preferably, the variable input module and the analysis module are connected by wired and / or wireless means; the analysis module and the output module are connected by wired and / or wireless means.

[0072] According to the above prediction system, preferably, the output module is a display, printer, or audio output device.

[0073] According to the above prediction system, preferably, the analysis module is a computer host, a central processing unit, or a network server.

[0074] The T staging described in this invention is determined based on CT images, and the degree of tumor differentiation is determined based on pathological results.

[0075] Compared with the prior art, the positive and beneficial effects achieved by the present invention are as follows:

[0076] (1) This application, through the study of clinical data of patients with bile duct cancer undergoing interventional treatment and their survival after interventional treatment, first discovered that the interventional treatment plan, number of anti-tumor treatments, T stage, tumor diameter, and tumor differentiation degree selected during interventional treatment of bile duct cancer patients are independent prognostic factors affecting the OS of bile duct cancer patients after interventional treatment, and can be used to predict the prognosis of bile duct cancer patients undergoing interventional treatment.

[0077] (2) Based on the independent prognostic factors of interventional treatment for bile duct cancer patients screened out in this invention, a nomogram prediction model was established to predict the 6-month, 1-year, and 2-year survival rates of bile duct cancer patients after interventional treatment. The nomogram prediction model showed good predictive ability in both the modeling and validation populations. In terms of calibration, the prediction results of the nomogram model established in this invention maintained a high degree of consistency with the actual results. In terms of discrimination, the AUC of the ROC curves of the nomogram model established in this invention for predicting the 6-month, 1-year, and 2-year survival probabilities of bile duct cancer patients after interventional treatment were 0.926, 0.921, and 0.975, respectively, and the C-index was 0.832. Both the AUC value and the C-index were greater than 0.8, indicating that the nomogram prediction model constructed in this invention had good calibration and the difference between its predicted survival probability and the actual probability was small.

[0078] (3) The nomogram prediction model constructed in this invention can predict the survival probability of bile duct cancer patients at 6 months, 1 year and 2 years after interventional treatment based on the interventional treatment plan selected, number of glucose antitumor treatments, T stage, tumor diameter and tumor differentiation degree. This can help clinicians accurately assess the patient's prognosis and formulate individualized follow-up plans based on the survival period. If the predicted prognosis is poor, the time interval between each follow-up or re-examination should be shortened and the interventional treatment plan should be adjusted according to the changes in the condition. If the predicted prognosis is good, the time interval between follow-up or re-examination can be appropriately extended to reduce the patient's economic and psychological burden. Attached Figure Description

[0079] Figure 1 This invention provides a nomogram model for predicting the survival probability of patients undergoing interventional treatment for cholangiocarcinoma.

[0080] Figure 2 Calibration curves were generated for the 6-month, 1-year, and 2-year survival rates of patients with cholangiocarcinoma undergoing interventional treatment in the modeling and validation groups; where A represents the modeling group and B represents the validation group.

[0081] Figure 3 ROC curves for 6-month, 1-year, and 2-year survival rates of patients with cholangiocarcinoma treated with interventional therapy in the modeling and validation groups; A represents the modeling group, and B represents the validation group.

[0082] Figure 4 The DCA curve is the nomogram model for predicting the survival probability of patients undergoing interventional treatment for cholangiocarcinoma according to this invention; where A represents 6 months, B represents 1 year, and C represents 2 years. Detailed Implementation

[0083] Example 1: Sample Collection and Statistics

[0084] 1. Sample collection and sample processing

[0085] (1) A total of 259 patients with bile duct cancer who underwent interventional treatment at the First Affiliated Hospital of Zhengzhou University from January 2014 to June 2021 were included.

[0086] Inclusion criteria: 1) Patients with cholangiocarcinoma confirmed by biliary biopsy; 2) Age > 18 years; 3) Liver function Child-Pugh A or B; 4) Pre-treatment CT scan showing measurable lesions; 5) Patients who cannot undergo surgical resection or refuse surgical treatment; 6) Interventional therapy as the first treatment method.

[0087] Exclusion criteria: 1) Child-Pugh C liver function; 2) Received any treatment other than targeted immunotherapy (targeted immunotherapy refers to targeted drugs and / or immunotherapy, which is an adjuvant anti-tumor treatment measure after interventional treatment) before or after interventional treatment; 3) Incomplete imaging data before interventional treatment; 4) Concurrent malignant tumors; 5) Concurrent severe dysfunction of vital organs such as heart, liver, and kidney; 6) Severe coagulation dysfunction; 7) Incomplete clinical or follow-up data.

[0088] (2) Collect clinical data that may affect the prognosis of patients with cholangiocarcinoma, including demographic data: gender, age, etc.; laboratory indicators: complete blood count, liver function, coagulation function, CA19-9, CEA, etc.; oncological characteristics: tumor diameter, pathological morphology classification, tumor location, degree of tumor differentiation, TNM stage, etc.; treatment-related data: interventional treatment plan, number of anti-tumor treatments, targeted immunotherapy, etc.

[0089] Liver function was assessed and graded based on five indicators: hepatic encephalopathy, degree of ascites, total bilirubin, albumin, and prolonged prothrombin time. The scoring criteria are shown in Table 1.

[0090] Table 1 Child-Pugh scoring criteria for liver function

[0091]

[0092] Note: 5-6 points is Grade A, 7-9 points is Grade B, and 10-15 points is Grade C.

[0093] (3) Interventional treatment plan:

[0094] 1) PTCD (Percutaneous Transhepatic Biliary Drainage)

[0095] Preoperatively, the bile duct requiring puncture and drainage is assessed based on imaging examinations. If puncture of the left bile duct is required, the upper abdomen, slightly to the left or right of the xiphoid process, can be selected as the puncture point. Taking the puncture of the right hepatic bile duct as an example: The patient lies supine on the DSA examination table, the right hypochondrium is disinfected and draped with a fenestrated drape, and the 7th-9th intercostal space along the right midaxillary line is selected as the puncture point. After local anesthesia with 2% lidocaine, a 21G puncture needle is used to puncture the intrahepatic bile duct under fluoroscopy. After confirmation by contrast imaging, the PTC three-piece set is exchanged. Contrast imaging clarifies the location and degree of obstruction. A 0.035-inch hydrophilic guidewire is introduced and a 5F KMP catheter is inserted. With the cooperation of the catheter and guidewire, the bile duct is opened to the obstructed segment into the duodenum. Contrast imaging through the KMP catheter further clarifies the location and extent of the stenosis. Replace the water-film stiffened guidewire, remove the KMP catheter, and insert a 9F sheath along the guidewire to a position above the biliary obstruction segment. Fix the guidewire, withdraw the sheath, and introduce an 8.5F or 10.2F external or internal / external biliary drainage tube, with the distal end looped in the duodenum. Connect a drainage bag as needed, and closely monitor bile drainage postoperatively.

[0096] 2) Biliary stent implantation

[0097] Based on imaging examinations and intraoperative angiography, an appropriate stent size is selected. For the lower and middle segments of the common bile duct and Bismuth type I stenosis, a single stent can be used; for Bismuth type II and higher stenosis, a double stent can be used. Using a PTCD (percutaneous transluminal coagulation) approach, a stiffened guidewire is introduced into the stent delivery system, and the stent is released across the stenosis. Generally, both ends of the stent should extend 1-2 cm beyond the upper and lower edges of the stenosis. In cases of lower common bile duct stenosis, the stent should not penetrate more than 1 cm into the duodenum. Follow-up angiography confirms stent placement and expansion. An internal and external biliary drainage tube is left in place for 3-5 days. The drainage tube can be removed after follow-up angiography confirms stent patency.

[0098] 3) Drainage therapy + 125 I-particle chain implantation therapy

[0099] The required particle quantity is calculated preoperatively using a treatment planning system (TPS). 125 I particles are sequentially inserted into the side-hole particle channel. The particle implantation length = [length of bile duct stenosis (mm) + 40mm / 4.5] × 2. The portion of the lumen without particles is sealed by shaping the proximal lumen using a heated needle. Based on PTCD, the particle drainage tube is advanced into the bile duct along a stiffened guidewire, ensuring that the particle chain completely covers the lesion area of ​​the bile duct. The tip of the drainage tube is looped in the duodenum and bandaged for fixation.

[0100] 4) Drainage therapy + arterial infusion chemotherapy

[0101] The patient was placed supine on the DSA examination table, routinely receiving oxygen and ECG monitoring. Both groin areas were disinfected and draped. After local anesthesia with 2% lidocaine, the right femoral artery was successfully punctured using a modified Seldinger technique, a 5F sheath was inserted, and a 0.035-inch guidewire and a 5F RH catheter were introduced. Peritoneal angiography was performed with the guidewire and catheter in place, and the catheter was left in the hepatic artery. Chemotherapy drugs, including gemcitabine and cisplatin, were continuously infused via a micro-infusion pump through the catheter. The chemotherapy cycle was one month, with a total of five treatments administered. During chemotherapy, hepatoprotective, acid-suppressing, and antiemetic treatments were administered to reduce related adverse reactions. The patient's blood count and coagulation function were closely monitored to prevent complications such as bone marrow suppression.

[0102] (4) Follow-up:

[0103] One month after interventional treatment, and every three months thereafter, patients were followed up by telephone, outpatient visits, or inpatient check-ups to record their overall survival (OS) and survival status. OS was defined as the time from the first interventional treatment to the patient's death or the end of follow-up. For patients receiving anti-tumor therapy, the time was calculated from the first anti-tumor treatment date; for patients not receiving anti-tumor therapy, the time was calculated from the first biliary drainage date. The follow-up endpoint was patient death or the study endpoint (February 20, 2022).

[0104] (5) Sample grouping

[0105] 70% (181 cases) of patients were randomly assigned to the modeling group, and the remaining 30% (78 cases) were assigned to the validation group.

[0106] 2. Statistical methods

[0107] Statistical description: Quantitative data are first tested for normality. Data that conform to a normal distribution are expressed as mean ± standard deviation (x ± s), while data that do not conform to a normal distribution are expressed as median (first percentile - third percentile). Qualitative data are expressed as frequency (percentage).

[0108] Statistical analysis: Statistical analysis was performed on the baseline data of the modeling and validation groups. Quantitative data were analyzed using the two independent samples t-test or Wilcoxon signed-rank test, while qualitative data were analyzed using the chi-square test. Univariate Cox proportional hazards regression analysis was performed on all baseline data. Variables initially identified as influencing prognosis (P < 0.05) were included in multivariate analysis. Variables with P < 0.2 were ultimately selected from the multivariate analysis and considered as prognostic variables affecting the survival of patients with cholangiocarcinoma. A nomogram model was established based on the independent risk factors identified above.

[0109] Validation of the predictive model: The accuracy of the nomogram was evaluated using the C-index, calibration curve, and area under the curve (AUC) of the receiver operating characteristic (ROC). The clinical effectiveness of the predictive model was assessed using decision curve analysis (DCA).

[0110] Statistical description, statistical analysis, and Cox regression analysis were performed using SPSS 21.0, and the prediction model was established and validated using R language.

[0111] Example 2: Screening of independent factors associated with survival after interventional therapy in patients with cholangiocarcinoma

[0112] (1) Factors that may be associated with survival after interventional treatment of cholangiocarcinoma using univariate Cox regression analysis:

[0113] In the modeling group, SPSS 21.0 statistical software was used to perform univariate Cox regression analysis on clinical factors that may be related to the survival of patients with cholangiocarcinoma after interventional treatment, to evaluate the predictive value of clinical factors on the survival of patients with cholangiocarcinoma after interventional treatment.

[0114] Univariate Cox regression analysis revealed that the risk factors associated with overall survival (OS) after interventional therapy in patients with cholangiocarcinoma (p < 0.05) were: white blood cell count, CA19-9, interventional therapy regimen, number of antitumor therapies, T stage, distant metastasis, tumor diameter, and tumor differentiation degree (p < 0.05) (see Table 2 for the results of univariate Cox regression analysis).

[0115] Table 2 Univariate Cox regression analysis of overall survival after interventional treatment in patients with cholangiocarcinoma

[0116]

[0117]

[0118]

[0119] (2) Independent factors that may be associated with survival after interventional treatment in patients with cholangiocarcinoma were analyzed using multivariate Cox regression:

[0120] Risk factors that showed statistically significant differences (P < 0.05) in the univariate Cox regression were included in the multivariate Cox regression analysis. The factors that affected the survival of patients with bile duct cancer after interventional treatment (P < 0.2) were: interventional treatment regimen, number of anti-tumor treatments, T stage, tumor diameter, and tumor differentiation degree (see Table 3 for results).

[0121] Table 3 Multivariate Cox regression analysis of survival-related risk factors in patients with bile duct cancer after interventional therapy.

[0122]

[0123] Example 3: Establishment of a survival prediction model for patients with cholangiocarcinoma after interventional therapy

[0124] Based on the results of multivariate Cox regression analysis, risk function expressions for each of the five independent factors screened as being related to the survival of patients with cholangiocarcinoma after interventional treatment were established. The risk function expressions for each factor are as follows:

[0125] PI = 0 × Interventional treatment plan a + 1.457 × Interventional treatment plan b + 1.097 × Interventional treatment plan c + 0 × Number of anti-tumor treatments a + 76 - 1.131 × Number of anti-tumor treatments b - 1.486 × Number of anti-tumor treatments c + 0 × T1 stage + 0.328 × T2 stage + 1.802 × T3 stage + 1.969 × T4 stage + 0 × Tumor diameter a + 1.413 × Tumor diameter b + 1.555 × Tumor diameter c + 0 × Differentiation degree a + 65 - 0.688 × Differentiation degree b - 1.277 × Differentiation degree c; Formula I

[0126] In Formula I, interventional treatment plan a is drainage treatment, and interventional treatment plan b is drainage treatment + 125 I. Particle chain implantation therapy, interventional treatment plan c: drainage therapy + arterial perfusion chemotherapy; For any bile duct cancer patient, when using Equation 1 to calculate PI, the interventional treatment plan is selected from any one of interventional treatment plans a, b, and c, and the interventional treatment plan selected by the bile duct cancer patient is valued as 1, while the other two interventional treatment plans are valued as 0 (for example, if the interventional treatment plan selected by the bile duct cancer patient is interventional treatment plan b, then the value of interventional treatment plan b in Equation 1 is 1, and the values ​​of interventional treatment plan a and interventional treatment plan c are both 0).

[0127] The number of anti-tumor treatment sessions refers to the number of sessions conducted during the interventional treatment plan. 125The number of treatments for PI (pill chain implantation therapy or arterial infusion chemotherapy) is defined as follows: PI number a refers to 0 treatments, PI number b refers to 1 treatment, and PI number c refers to ≥2 treatments. For any bile duct cancer patient, when calculating PI using Equation 1, the number of anti-tumor treatments is selected from any one of PI numbers a, b, or c. The selected anti-tumor treatment number for the bile duct cancer patient is set to 1, while the other two are set to 0 (e.g., the bile duct cancer patient selects 1 treatment). 125 In the case of I-particle chain implantation therapy, the value of the number of anti-tumor treatments b in Equation 1 is 1, and the values ​​of the number of anti-tumor treatments a and c are both 0.

[0128] For any bile duct cancer patient, when using Equation 1 to calculate PI, the T stage of the bile duct cancer patient is selected from any one of T1, T2, T3, and T4, and the actual T stage of the bile duct cancer patient is set to 1, while the values ​​of other T stages are 0 (for example, if the actual T stage of the bile duct cancer patient is T2, then the value of T2 stage in Equation 1 is 1, and the values ​​of T1, T2, T3, and T4 stages are all 0).

[0129] Tumor diameter a refers to a tumor diameter < 17 mm, tumor diameter b refers to a tumor diameter greater than or equal to 17 mm and less than 33 mm, and tumor diameter c refers to a tumor diameter ≥ 33 mm. For any bile duct cancer patient, when using Equation 1 to calculate PI, the tumor diameter of the bile duct cancer patient is selected from any one of a, b, and c, and the actual tumor diameter of the bile duct cancer patient is taken as 1, while the other two tumor diameters are taken as 0 (for example, if the actual tumor diameter of the bile duct cancer patient is < 17 mm, then the tumor diameter a in Equation 1 is taken as 1, and the tumor diameter b and tumor diameter c are both taken as 0).

[0130] Differentiation degree a represents poor differentiation, differentiation degree b represents moderate differentiation, and differentiation degree c represents high differentiation. For any bile duct cancer patient, when calculating the PI using Equation 1, the patient's differentiation degree is selected from any one of poor, moderate, or high differentiation, and the patient's actual differentiation degree is set to 1, while the other two differentiation degrees are set to 0 (for example, if the patient's actual differentiation degree is moderate, then differentiation degree b in Equation 1 is set to 1, and differentiation degree a and differentiation degree c are both set to 0). Based on the established risk function expressions for each factor, a survival probability expression for bile duct cancer patients after interventional treatment is established, as follows:

[0131] P = PI - 1.467; Equation II

[0132] In Equation II, PI represents the score obtained from Equation I, P represents the linear prediction value, and 1.467 is the base constant. The base constant 1.467 = 1.457 × (mean covariance of interventional treatment regimen b = 0.265) + 1.097 × (mean covariance of interventional treatment regimen c = 0.320) - 1.131 × (mean covariance of antitumor treatment number b = 0.254) - 1.486 × (mean covariance of antitumor treatment number c = 0.326) + 0.328 × (T2 stage covariance mean = 0.309) + 1.802 × (T3 stage covariance mean = 0.298) + 1.969 × (T4 stage covariance mean = 0.199) + 1.413 × (tumor diameter b covariance mean = 0.448) + 1.555 × (tumor diameter c covariance mean = 0.276) - 0.688 × (differentiation degree b covariance mean = 0.376) - 1.277 × (differentiation degree c covariance mean = 0.260).

[0133] P6 = S0(6) expP Formula III

[0134] In Equation III, S0(6) represents the average survival probability of bile duct cancer patients 6 months after interventional treatment, P6 represents the survival probability of bile duct cancer patients 6 months after interventional treatment, and P represents the linear prediction value calculated according to Equation II.

[0135] P 12 =S0(12) expP Formula IV

[0136] In Formula IV, S0(12) represents the average survival probability of cholangiocarcinoma patients 12 months after interventional therapy, and P 12 P represents the 12-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II.

[0137] P 24 =S0(24) expP ; Equation V

[0138] In formula V, S0(24) represents the average survival probability of bile duct cancer patients after interventional therapy at 24 months, and P 24 P represents the 24-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II.

[0139] Point=(PI)×100 / 1.969; Formula VI

[0140] In Equation VI, Point represents the total risk score, PI represents the score calculated by Equation I, and 100 / 1.969 represents the score corresponding to each unit of risk coefficient, where the maximum risk coefficient of 1.969 is defined as 100 points.

[0141] The value of Point is calculated by substituting PI into equation VI, and can be compared with the values ​​of P6 and P obtained by substituting PI into equations II to V. 12 P 24 In practical applications, knowing the total risk score allows us to obtain the corresponding values ​​for P6 and P. 12 P 24 The values ​​are more convenient. Specifically, S0(6) = 0.492, S0(12) = 0.210, S0(24) = 0.022.

[0142] The total risk score is obtained by transforming Equation I through Equation VI; the linear prediction value is obtained by transforming Equation I through Equation II; the 6-month survival probability can be calculated by transforming Equation I through Equation III; the 12-month survival probability can be calculated by transforming Equation I through Equation IV; and the 24-month survival probability can be calculated by transforming Equation I through Equation V.

[0143] The RMS package in R language is used to convert Equations I, II, III, IV, V, and VI established by Cox regression analysis into visual nomograms, resulting in the following: Figure 1 The nomogram shown is a predictive model for the survival probability of bile duct cancer patients after interventional treatment. The nomogram is printed on cards or edited on a computer.

[0144] The survival probability nomogram consists of ten rows, with the first row being a risk score scale. The risk score ranges from 0 to 100, and the scale is divided into equal parts.

[0145] The second line represents the patient's interventional treatment plan, which includes drainage therapy and drainage therapy plus... 125 I-particle chain implantation therapy, drainage therapy + arterial infusion chemotherapy; drainage therapy is represented as 0, drainage therapy + 125 I-particle chain implantation therapy is represented as 1, drainage therapy + arterial infusion chemotherapy is represented as 2, and each interventional treatment plan corresponds to a corresponding risk score in the first row; the third row represents the patient's T stage, which includes four levels: T1, T2, T3, and T4. T1 is represented as 1, T2 as 2, T3 as 3, and T4 as 4. T1, T2, T3, and T4 each correspond to a corresponding risk score in the first row;

[0146] The fourth row represents the number of anti-tumor treatments a patient has received. The number of anti-tumor treatments is divided into three levels: 0, 1, and ≥2. 0 anti-tumor treatments is represented as 0; 1 anti-tumor treatment is represented as 1; and ≥2 anti-tumor treatments are represented as 2. 0, 1, and ≥2 anti-tumor treatments each correspond to a risk score in the first row.

[0147] The fifth row represents the patient's tumor diameter, which is divided into three grades: tumor diameter <17mm, tumor diameter ≥17mm and <33mm, and tumor diameter ≥33mm. Tumor diameter <17mm is represented as 1; tumor diameter ≥17mm and <33mm is represented as 2; and tumor diameter ≥33mm is represented as 3. Each tumor diameter grade corresponds to a risk score in the first row.

[0148] The sixth row represents the degree of tumor differentiation in the patient. Tumor differentiation degree includes poor differentiation, moderate differentiation, and high differentiation. Poor differentiation is represented by 1; moderate differentiation is represented by 2; and high differentiation is represented by 3. Each degree of tumor differentiation corresponds to a corresponding risk score in the first row.

[0149] The seventh row represents the total risk score scale, which ranges from 0 to 350. The scale is divided into equal parts. The total risk score is obtained by adding the risk scores of the five indicators in the second to sixth rows corresponding to the first row.

[0150] The eighth row represents the 6-month survival probability P6 of patients with bile duct cancer after interventional treatment. The survival probability ranges from 0.1 to 0.9. The scale is not equally divided. The scale distribution is obtained by exponentially transforming the linear predictive value according to Equation III.

[0151] The ninth row represents the 12-month survival probability (P) of patients with bile duct cancer after interventional treatment. 12 The scale has a survival probability range of 0.1 to 0.9, and the scale is not equally divided. The scale distribution is obtained by exponentially transforming the linear prediction value according to Equation IV.

[0152] The tenth row represents the 24-month survival probability (P) of patients with bile duct cancer after interventional treatment. 24 The scale has a survival probability range of 0.1 to 0.6, and the scale is not equally divided. The scale distribution is obtained by exponentially transforming the linear prediction value according to formula V.

[0153] In the survival probability nomogram, the interventional treatment plan, the number of anti-tumor treatments, the T stage, the tumor diameter, and the degree of tumor differentiation correspond to different risk score ranges (see Table 4 for details). The total risk score is the sum of the risk scores for the interventional treatment plan, the number of anti-tumor treatments, the T stage, the tumor diameter, and the degree of tumor differentiation.

[0154] Table 4. Risk scores of independent prognostic factors affecting survival after interventional therapy in patients with cholangiocarcinoma.

[0155]

[0156] A vertical line is drawn at the position of the total risk score. The intersection of this vertical line and the 6-month survival probability line represents the 6-month survival probability of patients with bile duct cancer after interventional treatment. The same method can be used to obtain the 1-year and 2-year survival rates. Different total risk scores correspond to different 6-month, 1-year, and 2-year survival probabilities.

[0157] For example, if a patient with cholangiocarcinoma has an interventional treatment plan of biliary drainage + arterial infusion chemotherapy (56 points), ≥2 sessions of anti-tumor therapy (0 points), T stage of T2 (17 points), tumor diameter of 28.6 mm (72 points), and tumor differentiation grade of moderate (30 points), then his / her total score is 175 points, and the corresponding 6-month, 1-year, and 2-year survival rates are 74%, 23%, and 0%, respectively.

[0158] Example 4: Validation of a nomogram model for predicting survival probability after interventional therapy in patients with cholangiocarcinoma

[0159] The accuracy and effectiveness of the nomogram model for predicting the survival probability of bile duct cancer patients after interventional treatment, constructed in this invention, were evaluated using calibration curves, ROC curves, and DCA analysis.

[0160] The calibration curve between the predicted survival probability and the actual survival probability of the nomogram model for predicting the survival probability of patients with cholangiocarcinoma after interventional treatment, constructed in this invention, is shown below. Figure 2 As shown. By Figure 2 It can be seen that the calibration curves for the 6-month and 1-year survival probabilities of the modeling group are basically in line with the ideal curve, but the calibration curve for the 2-year survival probability is not plotted, which may be related to the small number of cases with a survival time of more than 2 years included. The calibration curve for the 1-year survival probability of the validation group overlaps with the ideal curve, and the calibration curves for the 6-month and 2-year survival probabilities are basically in line with the ideal curve. This indicates that the nomogram model has a high consistency between the predicted short-term survival rate and the actual survival rate of patients with cholangiocarcinoma.

[0161] The AUC curve of the nomogram model constructed in this invention for predicting the survival probability of bile duct cancer patients after interventional treatment is shown in the figure. Figure 3 As shown. By Figure 3The results show that the C-index was 0.832 in the modeling group and 0.848 in the validation group. Furthermore, the ROC curves for the modeling group indicate that the AUC at 6 months was 0.926 (95% CI: 0.888-0.963), at 1 year it was 0.921 (95% CI: 0.877-0.964), and at 2 years it was 0.975 (95% CI: 0.957-0.993). In the validation group, the AUCs at 6 months, 1 year, and 2 years were 0.957 (95% CI: 0.919-0.991), 0.918 (95% CI: 0.858-0.978), and 0.855 (95% CI: 0.748-0.962), respectively. Both the AUC values ​​and the C-index are greater than 0.8, indicating that the predictive model has good discrimination and high accuracy.

[0162] The DCA curve of the nomogram model constructed in this invention for predicting the survival probability of bile duct cancer patients after interventional treatment is shown in the figure. Figure 4 As shown. By Figure 4 As can be seen from the plotted DCA curves, there are two extreme curves. The horizontal curve represents all patients with cholangiocarcinoma who do not receive interventional treatment, with a net benefit of 0; the sloping curve represents all patients who receive interventional treatment, with a net benefit represented by a negative-sloping line. In the modeling group, the DCA curves at 6 months and 1 year (dashed lines) are both higher than the extreme curves, indicating that the net benefit is higher within this range, and the predictive model has good clinical effectiveness. However, the DCA curve at 2 years is closer to the extreme curves, indicating that the predictive model has a lower net benefit at 2 years.

[0163] Example 5: A predictive system for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma

[0164] A predictive system for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma includes a variable input module, an analysis module, and an output module; the variable input module and the analysis module are connected via wired and / or wireless means; the analysis module and the output module are connected via wired and / or wireless means; the output module is a display, printer, or audio output device; the analysis module is a computer host, central processing unit, or network server.

[0165] The variable input module includes five variable input sub-modules: an interventional treatment plan input sub-module, a T-staging input sub-module, an anti-tumor treatment frequency input sub-module, a tumor diameter input sub-module, and a tumor differentiation degree input sub-module. The analysis module can establish a survival probability nomogram based on the variables input from the variable input modules and calculate a total risk score. The total risk score is the sum of the risk scores for the interventional treatment plan, T-staging, number of anti-tumor treatments, tumor diameter, and tumor differentiation degree. Based on the total risk score, the module calculates the predicted survival value for interventional treatment of cholangiocarcinoma patients. The output module outputs the predicted survival value for interventional treatment of cholangiocarcinoma patients.

[0166] The analysis module is capable of performing the following calculations: Equations I to VI

[0167] PI = 0 × Interventional treatment plan a + 1.457 × Interventional treatment plan b + 1.097 × Interventional treatment plan c + 0 × Number of anti-tumor treatments a + 76 - 1.131 × Number of anti-tumor treatments b - 1.486 × Number of anti-tumor treatments c + 0 × T1 stage + 0.328 × T2 stage + 1.802 × T3 stage + 1.969 × T4 stage + 0 × Tumor diameter a + 1.413 × Tumor diameter b + 1.555 × Tumor diameter c + 0 × Tumor differentiation degree a + 65 - 0.688 × Tumor differentiation degree b - 1.277 × Tumor differentiation degree c; Formula I

[0168] In Formula I, interventional treatment plan a is drainage treatment, and interventional treatment plan b is drainage treatment + 125 I. Particle chain implantation therapy, interventional treatment plan c: drainage therapy + arterial perfusion chemotherapy; For any bile duct cancer patient, when using Equation 1 to calculate PI, the interventional treatment plan is selected from any one of interventional treatment plans a, b, and c, and the interventional treatment plan selected by the bile duct cancer patient is valued as 1, while the other two interventional treatment plans are valued as 0 (for example, if the interventional treatment plan selected by the bile duct cancer patient is interventional treatment plan b, then the value of interventional treatment plan b in Equation 1 is 1, and the values ​​of interventional treatment plan a and interventional treatment plan c are both 0).

[0169] The number of antitumor treatments, 'a', refers to 0 treatments; 'b' refers to 1 treatment; and 'c' refers to ≥2 treatments. For any bile duct cancer patient, when calculating PI using Equation 1, the number of antitumor treatments is selected from any one of a, b, or c. The selected number of antitumor treatments for the bile duct cancer patient is set to 1, while the other two are set to 0 (e.g., the bile duct cancer patient selects 1 treatment). 125In the case of I-particle chain implantation therapy, the value of the number of anti-tumor treatments b in Equation 1 is 1, and the values ​​of the number of anti-tumor treatments a and c are both 0.

[0170] For any bile duct cancer patient, when using Equation 1 to calculate PI, the T stage of the bile duct cancer patient is selected from any one of T1, T2, T3, and T4, and the actual T stage of the bile duct cancer patient is set to 1, while the values ​​of other T stages are 0 (for example, if the actual T stage of the bile duct cancer patient is T2, then the value of T2 stage in Equation 1 is 1, and the values ​​of T1, T2, T3, and T4 stages are all 0).

[0171] Tumor diameter a refers to a tumor diameter < 17 mm, tumor diameter b refers to a tumor diameter greater than or equal to 17 mm and less than 33 mm, and tumor diameter c refers to a tumor diameter ≥ 33 mm. For any bile duct cancer patient, when using Equation 1 to calculate PI, the tumor diameter of the bile duct cancer patient is selected from any one of a, b, and c, and the actual tumor diameter of the bile duct cancer patient is taken as 1, while the other two tumor diameters are taken as 0 (for example, if the actual tumor diameter of the bile duct cancer patient is < 17 mm, then the tumor diameter a in Equation 1 is taken as 1, and the tumor diameter b and tumor diameter c are both taken as 0).

[0172] Differentiation degree a is low differentiation, differentiation degree b is moderate differentiation, and differentiation degree c is high differentiation. For any bile duct cancer patient, when using Equation 1 to calculate PI, the differentiation degree of the bile duct cancer patient is selected from any one of low differentiation, moderate differentiation, and high differentiation, and the actual differentiation degree of the bile duct cancer patient is taken as 1, while the other two differentiation degrees are taken as 0 (for example, if the actual differentiation degree of the bile duct cancer patient is moderate differentiation, then the differentiation degree b in Equation 1 is taken as 1, and the differentiation degree a and differentiation degree c are both taken as 0).

[0173] P = PI - 1.467; Equation II

[0174] In Equation II, PI represents the score obtained from Equation I, and P represents the linear prediction value;

[0175] P6 = S0(6) expP Formula III

[0176] In Equation III, S0(6) represents the average survival probability of bile duct cancer patients after interventional treatment for 6 months, P6 represents the survival probability of bile duct cancer patients after interventional treatment for 6 months, and P represents the linear prediction value calculated according to Equation II.

[0177] P 12 =S0(12) expP Formula IV

[0178] In Formula IV, S0(12) represents the average survival probability of cholangiocarcinoma patients 12 months after interventional therapy, and P 12 P represents the 12-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II.

[0179] P 24 =S0(24) expP ; Equation V

[0180] In formula V, S0(24) represents the average survival probability of bile duct cancer patients after interventional therapy at 24 months, and P 24 P represents the 24-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II.

[0181] Point=(PI)×100 / 1.969; Formula VI

[0182] In Equation VI, Point represents the total risk score, PI represents the score calculated by Equation I, and 100 / 1.969 represents the score corresponding to each unit of risk coefficient, where the maximum risk coefficient of 1.969 is defined as 100 points.

[0183] The interventional treatment plan includes drainage therapy, drainage therapy + 125 I-particle chain implantation therapy, drainage therapy + arterial infusion chemotherapy, the risk score corresponding to drainage therapy is 0, drainage therapy + 125 The risk score for I-particle chain implantation therapy is 74, and the risk score for drainage therapy + arterial perfusion chemotherapy is 56.

[0184] The T-phase includes four levels: T1, T2, T3, and T4. The risk score for T1 is 0, the risk score for T2 is 17, the risk score for T3 is 91, and the risk score for T4 is 100.

[0185] The number of anti-tumor treatment sessions refers to the number of sessions conducted during the interventional treatment plan. 125 The number of treatments for I-particle chain implantation therapy or arterial infusion chemotherapy is defined as follows: number of anti-tumor treatments includes 0 treatments, 1 treatment, and ≥2 treatments. Among these, 0 treatments correspond to a risk score of 76; 1 treatment corresponds to a risk score of 18; and ≥2 treatments correspond to a risk score of 0.

[0186] Tumor diameter is categorized into three levels: tumor diameter less than 17 mm, tumor diameter greater than or equal to 17 mm and less than 33 mm, and tumor diameter ≥ 33 mm. Among these, the risk score is 0 for tumor diameter less than 17 mm, 72 for tumor diameter greater than or equal to 17 mm and less than 33 mm, and 79 for tumor diameter ≥ 33 mm.

[0187] Tumor differentiation is categorized as poor, moderate, and high; the risk score for poor differentiation is 65; the risk score for moderate differentiation is 30; and the risk score for high differentiation is 0.

[0188] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A kit for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma, characterized in that, This includes reagents and / or equipment for detecting and / or statistically analyzing interventional treatment protocols, number of antitumor treatments, T stage, tumor diameter, and tumor differentiation degree in patients with cholangiocarcinoma; wherein the interventional treatment protocols include drainage therapy, drainage therapy + 125 Three treatment options are I-particle chain implantation therapy, drainage therapy + arterial infusion chemotherapy; the number of anti-tumor treatments refers to the number of times the interventional therapy is performed. 125 The number of treatments for I-particle chain implantation therapy or arterial infusion chemotherapy is categorized into three levels: 0, 1, and ≥2 treatments. The T stage is categorized into four levels: T1, T2, T3, and T4. The tumor diameter is categorized into three levels: <17mm, ≥17mm and <33mm, and ≥33mm. The tumor differentiation is categorized into three levels: poorly differentiated, moderately differentiated, and well-differentiated. The kit also includes a readable carrier containing the contents of Formulas I to VI: PI = 0 × Interventional treatment plan a + 1.457 × Interventional treatment plan b + 1.097 × Interventional treatment plan c + 0 × Number of anti-tumor treatments a + 76 - 1.131 × Number of anti-tumor treatments b - 1.486 × Number of anti-tumor treatments c + 0 × T1 stage + 0.328 × T2 stage + 1.802 × T3 stage + 1.969 × T4 stage + 0 × Tumor diameter a + 1.413 × Tumor diameter b + 1.555 × Tumor diameter c + 0 × Tumor differentiation degree a + 65 - 0.688 × Tumor differentiation degree b - 1.277 × Tumor differentiation degree c; Formula I In Formula I, interventional treatment plan a is drainage treatment, and interventional treatment plan b is drainage treatment + 125 I. Particle chain implantation therapy, interventional treatment plan c. Drainage therapy + arterial perfusion chemotherapy; For any bile duct cancer patient, when using the above formula 1 to calculate PI, the interventional treatment plan is selected from any one of the interventional treatment plans a, b, and c, and the interventional treatment plan selected by the bile duct cancer patient is taken as 1, and the other two interventional treatment plans are taken as 0. The number of anti-tumor treatments 'a' refers to 0 treatments, 'b' refers to 1 treatment, and 'c' refers to ≥2 treatments. For any bile duct cancer patient, when calculating PI using Equation 1, the number of anti-tumor treatments is selected from any one of 'a', 'b', and 'c', with the selected number of anti-tumor treatments for the bile duct cancer patient being 1, and the other two numbers being 0. For any bile duct cancer patient, when using Equation 1 to calculate PI, the T stage of the bile duct cancer patient is selected from any one of T1, T2, T3 and T4 stages, and the actual T stage of the bile duct cancer patient is taken as 1, and the value of other T stages is taken as 0. Tumor diameter a refers to a tumor diameter <17mm, tumor diameter b refers to a tumor diameter greater than or equal to 17mm and less than 33mm, and tumor diameter c refers to a tumor diameter ≥33mm. For any bile duct cancer patient, when using Equation 1 to calculate PI, the tumor diameter of the bile duct cancer patient is selected from any one of a, b, and c, and the actual tumor diameter of the bile duct cancer patient is taken as 1, while the other two tumor diameters are taken as 0. Differentiation degree a is low differentiation, differentiation degree b is moderate differentiation, and differentiation degree c is high differentiation. For any bile duct cancer patient, when using Equation 1 to calculate PI, the differentiation degree of the bile duct cancer patient is selected from any one of low differentiation, moderate differentiation, and high differentiation, and the actual differentiation degree of the bile duct cancer patient is taken as 1, while the other two differentiation degrees are taken as 0. P = PI - 1.467; Equation II In Equation II, PI represents the score obtained from Equation I, and P represents the linear prediction value; P6=S0(6) expP Formula III In Equation III, S0(6) represents the average survival probability of bile duct cancer patients after interventional treatment for 6 months, P6 represents the survival probability of bile duct cancer patients after interventional treatment for 6 months, and P represents the linear prediction value calculated according to Equation II. P 12 =S0(12) expP Formula IV In Formula IV, S0(12) represents the average survival probability of cholangiocarcinoma patients 12 months after interventional therapy, and P 12 P represents the 12-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II. P 24 =S0(24) expP ; Equation V In formula V, S0(24) represents the average survival probability of bile duct cancer patients after interventional therapy at 24 months, and P 24 P represents the 24-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II. Point=(PI)×100 / 1.969; Formula VI In Equation VI, Point represents the total risk score, PI represents the score calculated by Equation I, and 100 / 1.969 represents the score corresponding to each unit of risk coefficient, where the maximum risk coefficient of 1.969 is defined as 100 points.

2. The kit for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma according to claim 1, characterized in that, The drainage treatment includes PTCD and biliary stent implantation.

3. The kit for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma according to claim 2, characterized in that, The readable medium is the kit instruction manual; the contents of Formulas I, II, III, IV, V, and VI are printed on the card.

4. A product for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma, characterized in that, The product includes a carrier and a survival probability nomogram disposed on the carrier; the carrier is a card and / or a computer. The survival probability nomogram consists of ten rows, with the first row being a risk score scale. The risk score ranges from 0 to 100, and the scale is divided into equal parts. The second line represents the patient's interventional treatment plan, which includes drainage therapy and drainage therapy plus... 125 Three treatment options are I-particle chain implantation therapy, drainage therapy + arterial infusion chemotherapy; drainage therapy is represented as 0, drainage therapy + 125 I-particle chain implantation therapy is represented as 1, drainage therapy + arterial perfusion chemotherapy is represented as 2, and each interventional treatment plan corresponds to a corresponding risk score in the first row; The third row represents the patient's T stage, which includes four levels: T1, T2, T3, and T4. T1 is represented by 1, T2 by 2, T3 by 3, and T4 by 4. Each of the T1, T2, T3, and T4 stages corresponds to a risk score in the first row. The fourth row represents the number of anti-tumor treatments a patient has received. The number of anti-tumor treatments is divided into three levels: 0, 1, and ≥2. 0 anti-tumor treatments are represented as 0; 1 anti-tumor treatment is represented as 1; and ≥2 anti-tumor treatments are represented as 2. 0, 1, and ≥2 anti-tumor treatments each correspond to a risk score in the first row. The fifth row represents the patient's tumor diameter, which is divided into three grades: tumor diameter <17mm, tumor diameter ≥17mm and <33mm, and tumor diameter ≥33mm. Tumor diameter <17mm is represented as 1; tumor diameter ≥17mm and <33mm is represented as 2; and tumor diameter ≥33mm is represented as 3. Each tumor diameter grade corresponds to a risk score in the first row. The sixth row represents the degree of tumor differentiation in the patient. Tumor differentiation degree includes poor differentiation, moderate differentiation, and high differentiation, with poor differentiation represented by 1; moderate differentiation represented by 2; and high differentiation represented by 3. Each degree of tumor differentiation corresponds to a risk score in the first row. The seventh row represents the total risk score scale, which ranges from 0 to 350. The scale is divided into equal parts. The total risk score is obtained by adding the risk scores of the five indicators in the second to sixth rows corresponding to the first row. The eighth row represents the scale of the 6-month survival probability P6 of patients with bile duct cancer after interventional treatment. The survival probability ranges from 0.1 to 0.

9. The scale is not equally divided. The scale distribution is obtained by exponentially transforming the linear prediction value according to Formula III in claim 2. The ninth row represents the 12-month survival probability (P) of patients with bile duct cancer after interventional treatment. 12 The scale has a survival probability range of 0.1 to 0.9, and the scale is not equally divided. The scale distribution is obtained by exponentially transforming the linear prediction value according to formula IV in claim 2. The tenth row represents the 24-month survival probability (P) of patients with bile duct cancer after interventional treatment. 24 The scale has a survival probability range of 0.1 to 0.6, and the scale is not equally divided. The scale distribution is obtained by exponentially transforming the linear prediction value according to formula V in claim 2.

5. The product for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma according to claim 4, characterized in that, In the second row of the survival probability nomogram, drainage treatment is represented as 0, and the corresponding risk score on the first row of the score scale is 0; drainage treatment + 125 I-particle chain implantation therapy is represented as 1, with a corresponding risk score of 74 on the first row of the score scale; drainage therapy + arterial perfusion chemotherapy is represented as 2, with a corresponding risk score of 56 on the first row of the score scale. The third row of the survival probability nomogram shows that period T1 is represented by 1, with a corresponding risk score of 0 on the first row score scale; period T2 is represented by 2, with a corresponding risk score of 17 on the first row score scale; period T3 is represented by 3, with a corresponding risk score of 91 on the first row score scale; and period T4 is represented by 4, with a corresponding risk score of 100 on the first row score scale. In the fourth row of the survival probability nomogram, 0 anti-tumor treatments are represented as 0, with a corresponding risk score of 76 on the first row score scale; 1 anti-tumor treatment is represented as 1, with a corresponding risk score of 18 on the first row score scale; and ≥2 anti-tumor treatments are represented as 2, with a corresponding risk score of 0 on the first row score scale. In the fifth row of the survival probability nomogram, a tumor diameter less than 17mm is represented as 1, with a corresponding risk score of 0 on the first row score scale; a tumor diameter greater than or equal to 17mm and less than 33mm is represented as 2, with a corresponding risk score of 72 on the first row score scale; and a tumor diameter ≥33mm is represented as 3, with a corresponding risk score of 79 on the first row score scale. In the sixth row of the survival probability nomogram, poor differentiation is represented as 1, with a corresponding risk score of 65 on the first row score scale. Medium differentiation is represented by 2, with a corresponding risk score of 30 on the first row of the score scale; high differentiation is represented by 3, with a corresponding risk score of 0 on the first row of the score scale.

6. A predictive system for predicting the prognosis of patients undergoing interventional treatment for cholangiocarcinoma, the predictive system comprising a variable input module, an analysis module, and an output module; The variable input module includes five variable input sub-modules, namely, the interventional treatment plan input sub-module, the T-staging input sub-module, the number of anti-tumor treatments input sub-module, the tumor diameter input sub-module, and the tumor differentiation degree input sub-module; The analysis module can establish a survival probability nodal plot based on the variables input by the variable input module and calculate the total risk score. The total risk score is the sum of the risk scores for interventional treatment plan, T stage, number of anti-tumor treatments, tumor diameter, and tumor differentiation degree. The survival prediction value for interventional treatment of bile duct cancer patients is calculated based on the total risk score. The output module is used to output the predicted survival value for interventional treatment of patients with cholangiocarcinoma; in, The interventional treatment plan includes drainage therapy, drainage therapy + 125 Three treatment options are available: I-particle chain implantation therapy, drainage therapy + arterial infusion chemotherapy, with drainage therapy having a risk score of 0. 125 The risk score for I-particle chain implantation therapy is 74, and the risk score for drainage therapy + arterial perfusion chemotherapy is 56. The T-phase includes four levels: T1, T2, T3, and T4. The risk score for T1 is 0, the risk score for T2 is 17, the risk score for T3 is 91, and the risk score for T4 is 100. The number of anti-tumor treatment sessions refers to the number of sessions conducted during the interventional treatment plan. 125 The number of treatments for I-particle chain implantation therapy or arterial infusion chemotherapy is defined as follows: number of anti-tumor treatments includes 0 treatments, 1 treatment, and ≥2 treatments. Among these, 0 treatments correspond to a risk score of 76; 1 treatment corresponds to a risk score of 18; and ≥2 treatments correspond to a risk score of 0. Tumor diameter is categorized into three levels: tumor diameter less than 17 mm, tumor diameter greater than or equal to 17 mm and less than 33 mm, and tumor diameter ≥ 33 mm. Among these, the risk score is 0 for tumor diameter less than 17 mm, 72 for tumor diameter greater than or equal to 17 mm and less than 33 mm, and 79 for tumor diameter ≥ 33 mm. Tumor differentiation is categorized as poor, moderate, and high; the risk score for poor differentiation is 65; the risk score for moderate differentiation is 30; and the risk score for high differentiation is 0.

7. The prediction system according to claim 6, characterized in that, The analysis module is capable of performing the following calculations: Equations I to VI PI = 0 × Interventional treatment plan a + 1.457 × Interventional treatment plan b + 1.097 × Interventional treatment plan c + 0 × Number of anti-tumor treatments a + 76 - 1.131 × Number of anti-tumor treatments b - 1.486 × Number of anti-tumor treatments c + 0 × T1 stage + 0.328 × T2 stage + 1.802 × T3 stage + 1.969 × T4 stage + 0 × Tumor diameter a + 1.413 × Tumor diameter b + 1.555 × Tumor diameter c + 0 × Tumor differentiation degree a + 65 - 0.688 × Tumor differentiation degree b - 1.277 × Tumor differentiation degree c; Formula I In Formula I, interventional treatment plan a is drainage treatment, and interventional treatment plan b is drainage treatment + 125 I. Particle chain implantation therapy, interventional treatment plan c. Drainage therapy + arterial perfusion chemotherapy; For any bile duct cancer patient, when using the above formula 1 to calculate PI, the interventional treatment plan is selected from any one of the interventional treatment plans a, b, and c, and the interventional treatment plan selected by the bile duct cancer patient is taken as 1, and the other two interventional treatment plans are taken as 0. The number of anti-tumor treatments 'a' refers to 0 treatments, 'b' refers to 1 treatment, and 'c' refers to ≥2 treatments. For any bile duct cancer patient, when calculating PI using Equation 1, the number of anti-tumor treatments is selected from any one of 'a', 'b', and 'c', with the selected number of anti-tumor treatments for the bile duct cancer patient being 1, and the other two numbers being 0. For any bile duct cancer patient, when using Equation 1 to calculate PI, the T stage of the bile duct cancer patient is selected from any one of T1, T2, T3, and T4, and the actual T stage of the bile duct cancer patient is set to 1, while the value of other T stages is 0. Tumor diameter a refers to a tumor diameter <17mm, tumor diameter b refers to a tumor diameter greater than or equal to 17mm and less than 33mm, and tumor diameter c refers to a tumor diameter ≥33mm. For any bile duct cancer patient, when using Equation 1 to calculate PI, the tumor diameter of the bile duct cancer patient is selected from any one of a, b, and c, and the actual tumor diameter of the bile duct cancer patient is taken as 1, while the other two tumor diameters are taken as 0. Differentiation degree a is low differentiation, differentiation degree b is moderate differentiation, and differentiation degree c is high differentiation. For any bile duct cancer patient, when using Equation 1 to calculate PI, the differentiation degree of the bile duct cancer patient is selected from any one of low differentiation, moderate differentiation, and high differentiation, and the actual differentiation degree of the bile duct cancer patient is taken as 1, while the other two differentiation degrees are taken as 0. P = PI - 1.467; Equation II In Equation II, PI represents the score obtained from Equation I, and P represents the linear prediction value; P6=S0(6) expP Formula III In Equation III, S0(6) represents the average survival probability of bile duct cancer patients after interventional treatment for 6 months, P6 represents the survival probability of bile duct cancer patients after interventional treatment for 6 months, and P represents the linear prediction value calculated according to Equation II. P 12 =S0(12) expP Formula IV In Formula IV, S0(12) represents the average survival probability of cholangiocarcinoma patients 12 months after interventional therapy, and P 12 P represents the 12-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II. P 24 =S0(24) expP ; Equation V In formula V, S0(24) represents the average survival probability of bile duct cancer patients after interventional therapy at 24 months, and P 24 P represents the 24-month survival probability of patients with bile duct cancer after interventional treatment, and P represents the linear prediction value calculated according to Equation II. Point=(PI)×100 / 1.969; Formula VI In Equation VI, Point represents the total risk score, PI represents the score calculated by Equation I, and 100 / 1.969 represents the score corresponding to each unit of risk coefficient, where the maximum risk coefficient of 1.969 is defined as 100 points.

8. The prediction system according to claim 6 or 7, characterized in that, The method for establishing a nomogram of stent restenosis probability based on the variables input by the variable input module is to use the RMS package in R language to visualize the nomogram of the Logistic regression model.

9. The prediction system according to claim 6 or 7, characterized in that, The variable input module and the analysis module are connected via wired and / or wireless means; the analysis module and the output module are connected via wired and / or wireless means; the output module is a display, printer, or audio output device; the analysis module is a computer host, central processing unit, or network server.

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