CN113317879B - Kit for predicting TIPS postoperative stent restenosis of liver cirrhosis patient - Google Patents
Kit for predicting TIPS postoperative stent restenosis of liver cirrhosis patient Download PDFInfo
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Abstract
The invention belongs to the field of medical biotechnology, and particularly discloses a kit for predicting stent restenosis after TIPS (Chronic hepatitis A Virus) operation of a cirrhosis patient. The kit can predict the probability of stent restenosis of the cirrhosis patient in 1 year after the TIPS operation according to the existence of spleen resection history and diabetes of the cirrhosis patient in the TIPS operation treatment, the portal vein puncture position in the TIPS operation and the stent position after the TIPS operation, and is helpful for a clinician to formulate an individualized postoperative review or follow-up scheme according to the probability of the expected stent restenosis.
Description
Technical Field
The invention belongs to the technical field of medical biology, and particularly relates to a kit for predicting TIPS (TIPS) postoperative stent restenosis of a cirrhosis patient.
Background
Cirrhosis is the most common and leading cause of portal hypertension, and patients with cirrhosis almost inevitably develop portal hypertension. Portal hypertension can cause a series of serious clinical symptoms, such as esophageal and gastric venous rupture bleeding (EGVB), refractory pleural effusion and the like, wherein the fatality rate can reach 20% 6 weeks after EGVB occurs. If no effective measures for preventing re-bleeding are taken after the first EGVB treatment, the re-bleeding rate can reach 60 percent within 1 year, and the fatality rate is about 33 percent. The principle of Transjugular Intrahepatic Portosystemic Shunt (TIPS) is to establish a shunt between the intrahepatic hepatic vein and the portal vein and its main branches, so that part of the portal blood flow is shunted into the inferior vena cava, thereby reducing portal vein pressure and relieving the symptoms caused by portal hypertension. Compared with the traditional surgical shunt operation, the TIPS has the advantages of small wound, quick recovery, obvious curative effect, higher safety and the like. After 30 years of exploration and continuous development, the TIPS technology is nearly mature at present, is widely applied to treating hepatic cirrhosis, Bujia syndrome, hepatic sinus obstruction syndrome and portal hypertension such as fundus esophageal variceal hemorrhage, refractory ascites and the like caused by various reasons, and obtains remarkable clinical curative effect.
However, the restenosis or occlusion of the stent after the TIPS operation always influences the middle-term and long-term curative effect of the TIPS, restricts the development of the TIPS, and is one of the main complications after the TIPS operation. Research reports that the 1-year restenosis rate of the TIPS postoperative stent can reach 12.8-53.8%, the TIPS stent restenosis can cause stent dysfunction, so that the pressure of a portal vein system is increased again, and the symptoms such as esophageal and gastric variceal bleeding and ascites are mainly recurred, the life quality of a patient is seriously affected, the life safety of the patient is harmed, and the economic burden of families and society is increased. Therefore, it is important to explore the influencing factors of the TIPS stent restenosis and how to reduce the incidence of the TIPS stent restenosis and improve the prognosis of patients.
At present, the research on high-risk factors of the restenosis of the shunt after the TIPS operation is less, and a clinical prediction model of a patient with the restenosis of a bracket after the TIPS operation is lacked. Therefore, the research aims to explore the risk factors of the bracket restenosis after the hepatitis B cirrhosis patients receive the Transjugular Intrahepatic Portosystemic Shunt (TIPS), establish a nomogram prediction model of the bracket restenosis risk after the TIPS operation of the hepatitis B cirrhosis patients, screen and identify the high risk patients in early stage, provide basis for taking intervention measures in early clinical stage, carrying out effective treatment and improve the patient prognosis.
As a graph calculation model, the nomogram can conveniently integrate risk factors of disease occurrence and development to generate the survival rate or disease occurrence rate of a specific individual. Currently, the value of nomograms in the diagnosis and prognosis of various diseases, adverse events is gaining increasing acceptance. However, at present, a prognosis prediction line chart model of the stent restenosis after TIPS operation of a cirrhosis patient is not established at home and abroad.
Disclosure of Invention
In view of the problems and disadvantages of the prior art, the present invention aims to provide a kit for predicting TIPS postoperative stent restenosis in patients with liver cirrhosis.
In order to realize the purpose of the invention, the technical scheme adopted by the invention is as follows:
the invention provides application of reagents and/or instruments for detecting position morphology of a TIPS stent, a portal vein puncture position, a history of splenectomy and diabetes in preparation of products for predicting stent restenosis after TIPS operation of patients with cirrhosis.
In a second aspect, the invention provides a kit for predicting post-TIPS stent restenosis in a cirrhosis patient, the kit comprising reagents and/or instruments for detecting TIPS stent position morphology, portal puncture location, history of splenectomy, diabetes.
According to the kit for predicting the TIPS postoperative stent restenosis of the cirrhosis patients, the kit preferably further comprises a readable carrier, wherein the readable carrier records the contents of the following formulas I to VI,
PI ═ 1.907 × TIPS scaffold position morphology +1.507 × portal venipuncture location +1.534 × history of splenectomy +1.412 × diabetes; formula I
In formula I, the values of the position and the shape of the TIPS stent are as follows: the position form of the TIPS bracket is good, and the value is 0; the position form of the TIPS bracket is poor, and the value is 1;
the value of the portal puncture position is as follows: the portal vein puncture position is positioned on the left branch, and the value is 0; the portal vein puncture position is positioned on the right branch and takes the value of 1;
taking the spleen resection history: no history of splenectomy, and the value is 0; 1, the spleen resection history is obtained;
values for diabetes: no diabetes, value is 0; diabetes mellitus exists, and the value is 1;
p ═ PI-4.292; formula II
In formula II, PI represents the score obtained in formula I, and P represents the linear predictive value;
P’＝1/(1+e-p) (ii) a Formula III
In the formula III, P' represents the probability of restenosis of the stent of a cirrhosis patient in 1 year after TIPS operation, and P represents a linear predicted value obtained by calculation according to the formula II;
point ═ (PI) × 100/1.907; formula IV
In formula IV, Point represents the total risk score, and PI represents the score calculated by formula I; 100/1.907 indicates that the maximum risk factor of 1.907 is defined as 100 points, with a corresponding score per unit risk factor.
The kit for predicting the restenosis of the TIPS postoperative stent of the cirrhosis patient is preferably provided, wherein the readable carrier is a kit instruction; the contents of formula I, formula II, formula III, formula IV are printed on the card.
The kit for predicting the restenosis of the TIPS postoperative stent of the cirrhosis patient is preferably characterized in that the readable carrier is a computer readable carrier.
In a third aspect, the invention provides a product for predicting stent restenosis after TIPS surgery in a cirrhosis patient, the product comprising a carrier and a stent restenosis probability nomogram arranged on the carrier; the carrier is a card and/or a computer;
the support restenosis probability nomogram comprises seven straight lines which are sequentially arranged from top to bottom and are parallel to each other, each straight line represents a scale, and scales are marked on the scale;
the scale value of the 1 st scale is 0-100, the scale value 0 is at the extreme point of the leftmost end, the scale value 100 is at the extreme point of the rightmost end, and the scale of the scale is divided equally;
the scale value of the 2 nd scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 74;
the scale value of the 3 rd scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 80;
the scale value of the 4 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 79;
the scale value of the 5 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 100;
the scale value of the 6 th scale is 0-400, the scale value 0 is at the extreme point of the leftmost end, the scale value 400 is at the extreme point of the rightmost end, and the scales of the scale are divided equally;
the scale value of the 7 th scale is 0.1-0.9, the scale value is 0.1 at the extreme point of the leftmost end, the scale value is 0.9 at the extreme point of the rightmost end, the scale unit of the scale is 0.1, and the scale distribution on the scale is obtained by converting the linear predicted value according to the formula III;
wherein the 1 st scale represents a scale with a score corresponding to the scale on the 2 nd to 5 th scales; the 2 nd scale represents diabetes mellitus as described in the kit of the second aspect, the scale value corresponding to the 2 nd scale for non-diabetes mellitus is 0, and the scale value corresponding to the 2 nd scale for diabetes mellitus is 1; the 3 rd scale represents the spleen resection history in the kit according to the second aspect, the scale value corresponding to the 3 rd scale without spleen resection history is 0, and the scale value corresponding to the 3 rd scale with spleen resection history is 1; the 4 th scale represents the portal vein puncturing position in the kit according to the second aspect, the scale value of the portal vein puncturing position on the left branch on the 4 th scale is 0, and the scale value of the portal vein puncturing position on the right branch on the 4 th scale is 1; the 5 th scale represents the position form of the TIPS scaffold in the kit of the second aspect, the good position form of the TIPS scaffold corresponds to a scale value of 0 on the 4 th scale, and the bad position form of the TIPS scaffold corresponds to a scale value of 1 on the 4 th scale; scale 6 represents the total risk score; the 7 th scale represents the probability of stent restenosis occurring 1 year after TIPS treatment in patients with cirrhosis.
The invention provides a prediction system for predicting the restenosis of a TIPS postoperative stent of a cirrhosis patient, which comprises a variable input module, an analysis module and an output module;
the variable input module comprises four variable input submodules, wherein the four variable input submodules are respectively a TIPS bracket position and shape input submodule, a portal puncture position input submodule, a spleen excision history input submodule and a diabetes input submodule;
the analysis module can establish a stent restenosis probability nomogram and calculate a total risk score based on the variables input by the variable input module, wherein the total risk score is the accumulated sum of the TIPS stent position form, the portal vein puncture position, the spleen resection history and the risk score of diabetes; calculating a predicted value of the probability of restenosis of the TIPS postoperative stent of the liver cirrhosis patient according to the total risk score;
the output module is used for outputting the predicted value of the restenosis probability of the TIPS postoperative stent of the liver cirrhosis patient;
wherein, the position form of the TIPS bracket is good, and the corresponding risk score is 0; the position form of the TIPS bracket is bad, and the corresponding risk score is 100;
the portal vein puncture position is positioned on the left branch, and the corresponding risk score is 0; the portal vein puncture position is positioned on the right branch, and the corresponding risk score is 79;
no history of splenectomy, corresponding risk score of 0; there was a history of splenectomy, with a corresponding risk score of 80; no diabetes, corresponding risk score of 0; with diabetes, the corresponding risk score is 74.
According to the above prediction system, preferably, the analysis module is capable of performing the following calculations of formulas I to IV:
PI ═ 1.907 × TIPS scaffold position morphology +1.507 × portal venipuncture location +1.534 × history of splenectomy +1.412 × diabetes; formula I
In formula I, the values of the position and the shape of the TIPS stent are as follows: the position form of the TIPS bracket is good, and the value is 0; the position form of the TIPS bracket is poor, and the value is 1;
the value of the portal puncture position is as follows: the portal vein puncture position is positioned on the left branch, and the value is 0; the portal vein puncture position is positioned on the right branch and takes the value of 1;
taking the spleen resection history: no history of splenectomy, the value is 0; 1, the spleen resection history is obtained;
values for diabetes: no diabetes, value is 0; diabetes mellitus exists, and the value is 1;
p ═ PI-4.292; formula II
In formula II, PI represents the score obtained in formula I, and P represents the linear predictive value;
P’＝1/(1+e-p) (ii) a Formula III
In the formula III, P' represents the probability of restenosis of the stent of a cirrhosis patient in 1 year after TIPS operation, and P represents a linear predicted value obtained by calculation according to the formula II;
point ═ (PI) × 100/1.907; formula IV
In formula IV, Point represents the total risk score, and PI represents the score calculated by formula I; 100/1.907 indicates that the maximum risk factor of 1.907 is defined as 100 points, with a corresponding score per unit risk factor.
According to the prediction system, preferably, the method for establishing the stent restenosis probability nomogram based on the variables input by the variable input module is to use an R language RMS operation package to complete nomogram visualization of a Logistic regression model.
According to the prediction system, the variable input module and the analysis module are preferably connected in a wired mode and/or a wireless mode; the analysis module and the output module are connected in a wired mode and/or a wireless mode.
According to the above prediction system, preferably, the output module is a display, a printer or an audio output device.
According to the prediction system, preferably, the analysis module is a computer host, a central processing unit or a network server.
The position form of the TIPS bracket refers to the position of the hepatic vein end of the TIPS bracket after TIPS operation of a liver cirrhosis patient and the included angle between the far end and the portal vein branch, and the position form of the TIPS bracket is diagnosed by enhancing the imaging examination such as CT/MRI and the like. The TIPS stent position should be well established to meet the following criteria: (1) the proximal end of the stent extends to the inferior vena cava without excessively entering the inferior vena cava and the right atrium (the clinical practice guideline of the transjugular intrahepatic portosystemic shunt of the portal vein in China (2019 edition) [ J ] China medical journal, 2019(45): 3534-; (2) the far ends of the stents are all in compliance with the shape of the portal vein and are basically parallel to the wall of the portal vein (the included angle between the tail ends of the stents and the tangent line of the wall of the portal vein is less than or equal to 20 degrees) (see figure 1). In fig. 1, the stent extends proximally to the inferior vena cava (shown by an arrow) and is well-positioned; the far end of the bracket conforms to the shape of the portal vein, the included angle between the far end of the bracket and the portal vein is 15.3 degrees, and the position and the shape are good. Failure to meet the above criteria is poor bracket positioning (see A, B, C in FIG. 2). The stent shown in fig. 2 a does not extend proximally into the inferior vena cava, is susceptible to "capping" (arrow shown), and is poorly positioned; the combined stent shown in B in fig. 2 has an included angle of 49.0 degrees with the portal vein, and has a poor position and shape, while the combined stent shown in C in fig. 2 has a poor position and shape when the proximal end of the combined stent excessively enters the inferior vena cava (shown by an arrow), and the distal end of the combined stent conforms to the shape of the portal vein, and has an included angle of 80.5 degrees with the portal vein, and has a poor position and shape.
The portal vein puncture position refers to a portal vein puncture position of a liver cirrhosis patient during a TIPS operation, the portal vein puncture position is determined by a puncture position during an actual TIPS operation, a first-stage branch of a hepatic portal vein comprises a left branch and a right branch, most of the portal vein puncture positions are punctured to the left branch or the right branch of the portal vein during the actual TIPS operation, and the portal vein trunk puncture position is rarely punctured directly. The splenectomy history refers to whether a splenectomy history exists before TIPS (surgical treatment) of a liver cirrhosis patient, and the splenectomy history can be obtained through medical record inquiry, preoperative CT (computed tomography) and other image data; the diabetes refers to whether the liver cirrhosis patient suffers from diabetes during TIPS operation treatment, and the diabetes is detected or judged through medical record inquiry and fasting blood sugar and glycosylated hemoglobin.
Compared with the prior art, the invention has the following positive beneficial effects:
(1) according to the method, through researching clinical data of the liver cirrhosis patient subjected to TIPS operation treatment during TIPS operation treatment and the condition of restenosis of the TIPS stent, whether splenectomy history and diabetes exist during the TIPS operation treatment of the liver cirrhosis patient, and portal vein puncture position and position form of the TIPS stent during the TIPS operation are independent prognostic factors influencing the restenosis of the TIPS stent of the liver cirrhosis patient for the first time, and the method can be used for predicting the probability of restenosis of the TIPS stent of the liver cirrhosis patient after the TIPS operation.
(2) According to the screened independent prognosis factors of the restenosis of the TIPS postoperative stent of the cirrhosis patient, the nomogram prediction model capable of predicting the restenosis of the TIPS postoperative stent of the cirrhosis patient for 1 year is established, and the nomogram prediction model shows good prediction capability in modeling population and verification population; in the aspect of calibration degree, the predicted result and the actual result of the histogram model built by the invention keep higher consistency; in the aspect of distinction, the area under the ROC curve of the established histogram model for predicting the restenosis of the TIPS postoperative stent of the liver cirrhosis patient is 0.817 (modeling group). Therefore, the stent restenosis nomogram prediction model constructed by the invention has good calibration degree, and the probability of predicting the restenosis of the stent after the TIPS operation of the hepatitis B cirrhosis patient is higher in consistency with the actual probability.
(3) The nomogram prediction model constructed by the invention can predict the probability of 1-year stent restenosis after TIPS operation of the cirrhosis patient according to whether the spleen resection history, diabetes and the portal vein puncture position during the TIPS operation and the stent position after the TIPS operation exist during the TIPS operation treatment of the cirrhosis patient, so that a clinician can accurately evaluate the probability of 1-year stent restenosis after the TIPS operation of the patient, and can formulate an individualized postoperative review or follow-up scheme according to the probability of the expected stent restenosis, if the probability of the expected stent restenosis is higher, the interval of each review or follow-up of the patient is shortened, and the treatment scheme is adjusted according to the change of the disease condition; if the probability of stent restenosis is expected to be low, the review or follow-up interval can be properly prolonged to reduce the economic and psychological burden of the patient.
Drawings
FIG. 1 is a schematic illustration of a TIPS stent in a well-defined position;
FIG. 2 is a schematic view of a TIPS stent in a poorly positioned configuration;
FIG. 3 is an alignment chart prediction model for predicting TIPS postoperative stent restenosis in patients with liver cirrhosis according to the present invention;
FIG. 4 is an ROC curve of a TIPS postoperative stent restenosis probability nomogram model for predicting stent restenosis of a liver cirrhosis patient according to the present invention, wherein A is a modeling group, and B is a verification group;
FIG. 5 is a calibration graph of the probability of restenosis predicted by the probability histogram model of stent restenosis after TIPS for patients with liver cirrhosis according to the present invention and the actual probability of stent restenosis for patients, wherein A is a modeling group and B is a verification group.
Detailed Description
Example 1: sample collection and sample processing
(1) A total of 355 patients with hepatitis b cirrhosis who received TIPS treatment at the first affiliated hospital of zhengzhou university from 2012 month 1 to 2020 month 1 were enrolled. Inclusion criteria were: 1) clinically, patients with hepatitis B cirrhosis are definitely diagnosed; 2) combined with portal hypertension; 3) receiving TIPS surgical treatment; 4) the TIPS stent is a single viaorr stent or a bare stent combined fluent stent. Exclusion criteria: 1) cirrhosis caused by other viral hepatitis, autoimmunity, alcoholic and other reasons; 2) patients with malignant tumors of liver and other parts are merged; 3) merging portal vein spongiform changes; 4) combined with other severe systemic diseases (organ failure, severe infection, cardiovascular and cerebrovascular diseases, etc.); 5) follow-up visit for less than 1 year or incomplete disease data.
(2) Demographic data (sex, age, presence or absence of diabetes combined, presence or absence of history of splenectomy, etc.), laboratory indices (leukocytes, hemoglobin, platelets, serum sodium, International Normalized Ratio (INR), blood creatinine, blood urea, albumin, bilirubin, etc.), TIPS intraoperative indices (portal puncture location, TIPS stent type and combination, TIPS stent position morphology, etc.), and follow-up data (time to stent restenosis, etc.) were collected for each patient. The position form of the TIPS bracket and the portal puncture position (belonging to a branch) are obtained by two radiologists with more than 10 years of working experience according to corresponding imaging images; the TIPS procedure was performed by two interventionalists with more than 10 years of work experience.
(3) TIPS procedure: indirect portal angiography: a patient is in a supine position, a disinfection drape is laid in the inguinal regions on both sides, 2% lidocaine local anesthesia is successfully punctured into the right femoral artery by adopting an improved Seldinger puncture method, a 5F arterial sheath is placed, a hydrophilic membrane guide wire and a coil pipe are introduced, a cannula is matched to the superior mesenteric artery, positive lateral high-pressure radiography is carried out, and the portal vein and the main branch position and the blood flow direction of the portal vein are displayed. Internal jugular vein puncture and hepatic vein intubation: the patient is in a supine position with the head biased to the left. The conventional disinfection drape is used in the operation area, and after local anesthesia of 2% lidocaine, the right internal jugular vein is successfully punctured by using an 18G puncture needle. Introducing hydrophilic membrane guide wire and straight side hole catheter to lower cavity vein radiography. And (3) introducing a hunter head catheter in an exchange manner, matching with a water film guide wire, and carrying out super-selection on the liver vein, and carrying out contrast verification. Portal vein puncture: introducing RUPS-100 puncture kit along the hardened guide wire, selecting puncture position according to indirect portal vein radiography and hepatic vein radiography conditions, adjusting puncture angle, puncturing portal vein, pumping back portal vein blood, injecting contrast medium under fluoroscopy to confirm successful puncture, introducing hydrophilic membrane guide wire and straight head hole-measuring catheter, performing portal vein far-end radiography, displaying portal vein main trunk and branch conditions, and measuring portal vein main trunk pressure. Varicose vein embolism: according to the portal vein contrast result, the degree of varicosity and the clinical symptoms of a patient, whether varicose vein embolism is performed or not is selected, and the embolism material is a spring ring. Stent implantation shunt: introducing the balloon catheter, and performing balloon dilatation on the shunt. And after the saccule is expanded, the introduction of the stent delivery device is exchanged, and after the accurate positioning, the Viatorr stent is released. When the combined stent is implanted, the bare stent is released firstly, and then the covered stent is sent to release. After the stent is released successfully, the straight-head side hole catheter is introduced to the far end of the portal vein for radiography, the positions of the stent, the blood flow direction and the like are determined, and the pressure of the main trunk of the portal vein is measured.
(4) Follow-up: the follow-up time is 1 year, the follow-up endpoint is that the stent is restenosis within 1 year after the TIPS operation, and the follow-up mode is as follows: follow-up visits are carried out according to the inpatient medical record, the inpatient or outpatient examination and examination result and the condition of the reexamination and radiography of the patient at each reexamination.
(5) 70% (249 cases) of patients were randomly divided into building blocks, and the remaining 30% (106 cases) were classified as verification groups.
Example 2: independent factor screening related to restenosis of TIPS postoperative stent of liver cirrhosis patient
(1) Independent factors that may be associated with restenosis after TIPS surgery in patients with cirrhosis were analyzed using one-way Logistic regression:
in the modeling module, SPSS 21.0 statistical software is used for carrying out single-factor Logistic regression analysis on clinical factors possibly related to restenosis of a TIPS postoperative stent of a liver cirrhosis patient, and the prediction value of the clinical factors on the prediction of the restenosis of the TIPS postoperative stent of the liver cirrhosis patient is evaluated.
Through single-factor Logistic regression analysis, the risk factors related to restenosis of the TIPS postoperative stent are as follows: age, diabetes, portal thrombosis, history of splenectomy, platelet count, INR, portal puncture location and stent site morphology (p < 0.05), factors unrelated to restenosis after TIPS surgery stents were: gender, leukocytes, hemoglobin, serum sodium, creatinine, urea, albumin, bilirubin, CTP score, CTP fractionation, MELD score, stent type, and combination (p > 0.05) (see Table 1 for single factor Logistic regression analysis).
TABLE 1 TIPS postoperative Stent restenosis Single factor Logistic regression analysis for cirrhosis patients
(2) Independent factors that may be associated with post-TIPS surgery in patients with cirrhosis were analyzed using multifactorial Logistic regression:
the risk factors with significant statistical difference (P is less than 0.05) in the single-factor Logistic regression are included in the multi-factor Logistic regression analysis, and the independent risk factors of the bracket restenosis after the TIPS operation of the liver cirrhosis patient are obtained as follows: diabetes, history of splenectomy, portal venipuncture location, stent site morphology (results see table 2).
TABLE 2 Multi-factor Logistic regression analysis of TIPS postoperative stent restenosis in patients with liver cirrhosis
Example 3: establishment of model for predicting stent restenosis after TIPS (Chronic hepatitis A Virus) operation of cirrhosis patients
Independent factors related to the restenosis of the TIPS postoperative stent of the cirrhosis patients, which are obtained by multi-factor Logistic regression analysis, are assigned, and the assignment conditions are shown in Table 3.
TABLE 3 assignment of independent prognostic factors associated with TIPS postoperative Stent restenosis in patients with cirrhosis
| Variables of | Assignment of value |
| TIPS stent position morphology | Good is 0 and bad is 1 |
| Portal vein puncture site | Left branch is 0, right branch is 1 |
| History of spleen excision | None is equal to 0 and there is equal to 1 |
| Diabetes mellitus | None is equal to 0 and there is equal to 1 |
Establishing a risk function expression of each factor according to a multi-factor Logistic regression analysis result and beta values of 4 screened independent factors related to TIPS postoperative stent restenosis of a liver cirrhosis patient, wherein the risk function expression of each factor is as follows:
PI ═ 1.907 × TIPS scaffold position morphology +1.507 × portal venipuncture location +1.534 × history of splenectomy +1.412 × diabetes; formula I
In formula I, the values of the position and the shape of the TIPS stent are as follows: the position form of the TIPS bracket is good, and the value is 0; the position form of the TIPS bracket is poor, and the value is 1;
the value of the portal puncture position is as follows: the portal vein puncture position is positioned on the left branch, and the value is 0; the portal vein puncture position is positioned on the right branch and takes the value of 1;
taking the spleen resection history: no history of splenectomy, and the value is 0; 1, the spleen resection history is obtained;
values for diabetes: no diabetes, value is 0; diabetes mellitus exists, and the value is 1.
P ═ PI-4.292; formula II
In formula II, PI represents the score obtained from formula I, P represents the linear predictive value, -4.292 is the intercept in the multi-factor Logistic regression analysis.
P’＝1/(1+e-p) (ii) a Formula III
In the formula III, P' represents the probability of restenosis of the stent of a cirrhosis patient in 1 year after TIPS operation, and P represents a linear predicted value obtained by calculation according to the formula II;
point ═ (PI) × 100/1.907; formula IV
In formula IV, Point represents the total risk score, and PI represents the score calculated by formula I; 100/1.907 indicates that the maximum risk factor of 1.907 is defined as 100 points, with a corresponding score per unit risk factor.
The numerical value of Point is calculated by substituting the PI into the formula IV and can correspond to the numerical value of P 'obtained by substituting the PI into the formulas II to III, and the numerical value of P' can be obtained by knowing the total risk score in practical application, so that the method is more convenient.
Obtaining a total risk score by converting a formula I through a formula IV; converting the formula I through a formula II to obtain a linear predicted value; the probability of stent restenosis of patients with cirrhosis in 1 year after TIPS surgery can be calculated by the transformation of formula I and formula III.
The formulas I, II, III and IV established by Logistic regression analysis are converted into visual nomograms (shown in figure 3) by using an R language RMS calculation packet, and the nomograms are printed on a card or edited on a computer.
The specific commands for converting the R language RMS operation packet into the visual nomogram are as follows:
# Call required calculation Package
library(rms)
setwd ("C: \ \ Users \ \ tenov \ \ Desktop \ \ data analysis result")
non_tumor<-read.table("input.txt",header＝T,sep＝"\t")
non _ tumor $ diabetes < -factor (non _ tumor $ diabetes, labels ═ c ("none", "present"))
non _ tumor $ spleen resection history < -factor (non _ tumor $ spleen resection history, labels ═ c ("none", "present"))
non _ tumor $ portal vein puncture position < -factor (non _ tumor $ portal vein puncture position, labels ═ c ("right branch", "left branch"))
non _ tumor $ TIPS scaffold position morphology-factor (non _ tumor $ TIPS scaffold position morphology, labels ═ c ("poor", "good"))
ddist<-datadist(non_tumor)
options(datadist＝"ddist")
mylo < -lrm (whether stent restenosis-diabetes + history of splenectomy + portal puncture location + TIPS stent position morphology, data non _ tumor, x T, y T)
mynom < -nomogram (mylog, fun ═ plogis, fun.at ═ c (0.0001,0.1,0.2,0.3,0.4,0.5,0.6,0.7,0.8,0.9,0.9999), lp ═ F, funlabel ═ stent restenosis probability ")
plot(mynom)
The probability nomogram forecasting model of the stent restenosis after TIPS operation of the liver cirrhosis patient can be obtained through the steps shown in figure 3.
The stent restenosis probability nomogram comprises seven straight lines which are sequentially arranged from top to bottom and are parallel to each other, each straight line represents a scale, and scales are marked on the scale;
the scale value of the 1 st scale is 0-100, the scale value 0 is at the extreme point of the leftmost end, the scale value 100 is at the extreme point of the rightmost end, and the scales of the scale are divided equally;
the scale value of the 2 nd scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 74;
the scale value of the 3 rd scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 80;
the scale value of the 4 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 79;
the scale value of the 5 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 100;
the scale value of the 6 th scale is 0-400, the scale value 0 is at the extreme point of the leftmost end, the scale value 400 is at the extreme point of the rightmost end, and the scales of the scale are divided equally;
the scale value of the 7 th scale is 0.1-0.9, the scale value is 0.1 at the extreme point of the leftmost end, the scale value is 0.9 at the extreme point of the rightmost end, the scale unit of the scale is 0.1, and the scale distribution on the scale is obtained by converting the linear predicted value according to the formula III;
wherein the 1 st scale represents a scale with a score corresponding to the scale on the 2 nd to 5 th scales; the 2 nd scale represents diabetes, the scale value corresponding to the 2 nd scale without diabetes is 0, and the scale value corresponding to the 2 nd scale with diabetes is 1; the 3 rd scale represents spleen resection history, the scale value corresponding to the 3 rd scale without spleen resection history is 0, and the scale value corresponding to the 3 rd scale with spleen resection history is 1; the 4 th scale represents the portal vein puncture position, the scale value of the portal vein puncture position on the 4 th scale on the left branch is 0, and the scale value of the portal vein puncture position on the 4 th scale on the right branch is 1; the 5 th scale represents the position form of the TIPS bracket, the scale value corresponding to the good position form of the TIPS bracket on the 4 th scale is 0, and the scale value corresponding to the bad position form of the TIPS bracket on the 4 th scale is 1; scale 6 represents the total risk score; the 7 th scale represents the probability of stent restenosis occurring 1 year after TIPS treatment in patients with cirrhosis.
The TIPS stent position morphology, portal venipuncture position, spleen resection history and diabetes in the stent restenosis probability nomogram correspond to different risk score ranges respectively (see table 4 specifically), and the total risk score is the sum of the TIPS stent position morphology, portal venipuncture position, spleen resection history and risk score of diabetes.
TABLE 4 Risk score of independent prognostic factors associated with TIPS postoperative stent restenosis in patients with cirrhosis
And drawing a vertical line at the position of the total risk score, wherein the intersection point of the vertical line and the stent restenosis probability line is the probability of the patient suffering from stent restenosis within 1 year after TIPS operation.
For example, if a cirrhosis patient has a poorly formed stent position (100 points), the portal puncture position is the right branch (79 points), there is no history of splenectomy (0 points), there is no history of diabetes (0 points), then his/her total score is 179 points, and the corresponding probability of restenosis occurring in the stent 1 year after TIPS surgery is 29.4%.
Example 4: nomogram model verification for predicting probability of stent restenosis after TIPS (Chronic hepatitis A Virus) operation of liver cirrhosis patient
The discrimination and calibration degree of the nomogram model for predicting the probability of the TIPS postoperative stent restenosis of the cirrhosis patients are evaluated by applying R language (4.0.3 version) in a modeling group and a verification group.
The C-index (C-index) and the Receiver Operating Curve (ROC) are indexes of discrimination test, and the larger the numerical value is, the smaller the difference between the predicted value and the actual value of the model is. The calibration graph is used to evaluate the calibration degree of the model, and the closer the curve is to 45 degrees represents the higher the consistency of the predicted result and the actual result.
ROC graphs of the modeling and validation sets were plotted and the results are shown in fig. 4. As can be seen from FIG. 5, the AUC of the ROC curve of the stent restenosis probability nomogram model in the modeling group is 0.817, the AUC of the ROC curve of the stent restenosis probability nomogram model in the verification group is 0.804, and the AUC of the ROC curves of the modeling group and the verification group are both greater than 0.75, so that the prediction model has good discrimination and stronger discrimination of whether the stent has restenosis after TIPS (TIPS) operation for patients with hepatitis B cirrhosis.
And (3) verifying the calibration degree: the bootstrap method is adopted, sampling is repeated for 1000 times, and a calibration curve between the predicted stent restenosis probability and the actual stent restenosis probability of the TIPS postoperative stent restenosis probability forecasting model for the liver cirrhosis patient established by the invention is verified, and the result is shown in FIG. 4. As can be seen from fig. 4, the calibration curve in the building block and the verification block is fitted to the ideal condition, and the curve is approximately 45 °; and the P values of the Hosmer-Lemeshow test of the stent restenosis probability prediction model in the establishing module and the verification group are both greater than 0.05, and the difference has no statistical significance. The results show that the calibration degree of the prediction model for predicting the probability of restenosis of the TIPS postoperative stent of the hepatitis B cirrhosis patient constructed by the invention is good, and the probability of restenosis of the TIPS postoperative stent of the hepatitis B cirrhosis patient predicted to occur is higher in consistency with the actual probability.
Example 5: prediction system for predicting restenosis of TIPS postoperative stent of liver cirrhosis patient
For the convenience of clinical use, a prediction system for predicting restenosis of a TIPS postoperative stent of a liver cirrhosis patient is also provided, and the prediction system comprises: the device comprises a variable input module, an analysis module and an output module; the variable input module is connected with the analysis module in a wired mode and/or a wireless mode; the analysis module is connected with the output module in a wired mode and/or a wireless mode; the output module is a display, a printer or an audio output device; the analysis module is a computer host, a central processing unit or a network server.
The variable input module comprises four variable input submodules, and the four variable input submodules are a TIPS bracket position and form input submodule, a portal vein puncture position input submodule, a spleen resection history input submodule and a diabetes input submodule respectively.
The analysis module can establish a stent restenosis probability alignment chart based on the variables input by the variable input module and calculate a total risk score, wherein the total risk score is the sum of the TIPS stent position form, the portal puncture position, the spleen resection history and the risk score of diabetes; calculating a predicted value of the probability of restenosis of the TIPS postoperative stent of the liver cirrhosis patient according to the total risk score; the output module is used for outputting the predicted value of the probability of the restenosis of the TIPS postoperative stent of the liver cirrhosis patient.
Wherein, the analysis module can carry out the following operations of formula I to formula IV:
PI ═ 1.907 × TIPS scaffold position morphology +1.507 × portal venipuncture location +1.534 × history of splenectomy +1.412 × diabetes; formula I
In formula I, the values of the position and the shape of the TIPS stent are as follows: the position form of the TIPS bracket is good, and the value is 0; the position form of the TIPS bracket is poor, and the value is 1;
the value of the portal puncture position is as follows: the portal vein puncture position is positioned on the left branch and takes the value of 0; the portal vein puncture position is positioned on the right branch and takes the value of 1;
taking the spleen resection history: no history of splenectomy, and the value is 0; 1, the spleen resection history is obtained;
values for diabetes: no diabetes, value is 0; diabetes mellitus, value 1;
p ═ PI-4.292; formula II
In formula II, PI represents the score obtained in formula I, and P represents the linear predictive value;
P’＝1/(1+e-p) (ii) a Formula III
In the formula III, P' represents the probability of restenosis of the stent of a cirrhosis patient in 1 year after TIPS operation, and P represents a linear predicted value obtained by calculation according to the formula II;
point ═ (PI) × 100/1.907; formula IV
In formula IV, Point represents the total risk score, and PI represents the score calculated by formula I; 100/1.907 indicates that the maximum risk factor of 1.907 is defined as 100 points, with a corresponding score per unit risk factor.
Wherein, the position form of the TIPS bracket is good, and the corresponding risk score is 0; the position form of the TIPS bracket is bad, and the corresponding risk score is 100;
the portal vein puncture position is positioned on the left branch, and the corresponding risk score is 0; the portal vein puncture position is positioned on the right branch, and the corresponding risk score is 79;
no history of splenectomy, corresponding risk score of 0; there was a history of splenectomy, with a corresponding risk score of 80;
no diabetes, corresponding risk score of 0; with diabetes, the corresponding risk score is 74.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
Claims (8)
1. A kit for predicting stent restenosis after TIPS surgery of a cirrhosis patient is characterized by comprising reagents and/or instruments for detecting position morphology of the TIPS stent, a portal venipuncture position, a history of spleen resection and diabetes; the kit also comprises a readable carrier, wherein the readable carrier is recorded with the contents of the following formulas I to VI,
PI ═ 1.907 × TIPS scaffold position morphology +1.507 × portal venipuncture location +1.534 × history of splenectomy +1.412 × diabetes; formula I
In formula I, the values of the position and the shape of the TIPS stent are as follows: the position form of the TIPS bracket is good, and the value is 0; the position form of the TIPS bracket is bad, and the value is 1;
the value of the portal puncture position is as follows: the portal vein puncture position is positioned on the left branch, and the value is 0; the portal vein puncture position is positioned on the right branch and takes the value of 1;
taking the spleen resection history: no history of splenectomy, and the value is 0; 1, the spleen resection history is obtained;
values for diabetes: no diabetes, value is 0; diabetes mellitus exists, and the value is 1;
p ═ PI-4.292; formula II
In formula II, PI represents the score obtained in formula I, and P represents the linear predictive value;
P’＝1/(1+e-p) (ii) a Formula III
In the formula III, P' represents the probability of restenosis of the stent of a cirrhosis patient in 1 year after TIPS operation, and P represents a linear predicted value obtained by calculation according to the formula II;
point ═ (PI) × 100/1.907; formula IV
In formula IV, Point represents the total risk score, and PI represents the score calculated by formula I; 100/1.907 indicates that the maximum risk factor of 1.907 is defined as 100 points, with a corresponding score per unit risk factor.
2. The kit for predicting TIPS postoperative stent restenosis in a cirrhosis patient of claim 1, wherein the readable carrier is kit instructions; the contents of formula I, formula II, formula III, formula IV are printed on the card.
3. A product for predicting stent restenosis after TIPS surgery in a cirrhosis patient, the product comprising a support and a stent restenosis probability nomogram disposed on the support; the carrier is a card and/or a computer;
the support restenosis probability nomogram comprises seven straight lines which are sequentially arranged from top to bottom and are parallel to each other, each straight line represents a scale, and scales are marked on the scale;
the scale value of the 1 st scale is 0-100, the scale value 0 is at the extreme point of the leftmost end, the scale value 100 is at the extreme point of the rightmost end, and the scale of the scale is divided equally;
the scale value of the 2 nd scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 74;
the scale value of the 3 rd scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 80;
the scale value of the 4 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 79;
the scale value of the 5 th scale is 0-1, the scale value 0 is at the extreme point of the leftmost end, and the scale value 1 is at the extreme point of the rightmost end; the score of the first scale corresponding to the scale value 0 is 0, and the score of the first scale corresponding to the scale value 1 is 100;
the scale value of the 6 th scale is 0-400, the scale value 0 is at the extreme point of the leftmost end, the scale value 400 is at the extreme point of the rightmost end, and the scales of the scale are divided equally;
the 7 th scale has a scale value of 0.1-0.9, a scale value of 0.1 is at the leftmost end point, a scale value of 0.9 is at the rightmost end point, the scale unit of the scale is 0.1, and the scale distribution on the scale is obtained by converting the linear prediction value according to the formula III in claim 1;
wherein the 1 st scale represents a scale with a score corresponding to the scale on the 2 nd to 5 th scales; the 2 nd scale represents diabetes as described in the kit of any of claims 1-2, no diabetes corresponding to a scale value of 0 on the 2 nd scale and diabetes corresponding to a scale value of 1 on the 2 nd scale; the 3 rd scale represents a history of splenectomy as described in any of the kits of claims 1-2, no history of splenectomy corresponding to a scale value of 0 on the 3 rd scale and a history of splenectomy corresponding to a scale value of 1 on the 3 rd scale; the 4 th scale represents the portal vein puncturing position of the kit according to any one of claims 1 to 2, wherein the portal vein puncturing position on the left branch corresponds to a scale value of 0 on the 4 th scale and the portal vein puncturing position on the right branch corresponds to a scale value of 1 on the 4 th scale; the 5 th scale represents the TIPS scaffold positional configuration as described in the kit of any of claims 1-2, good TIPS scaffold positional configuration corresponding to a scale value of 0 on the 4 th scale and poor TIPS scaffold positional configuration corresponding to a scale value of 1 on the 4 th scale; the 6 th scale represents the total risk score, which is calculated according to formula IV in claim 1; the 7 th scale represents the probability of stent restenosis occurring 1 year after TIPS treatment in patients with cirrhosis.
4. A prediction system for predicting post-TIPS stent restenosis in a cirrhosis patient, the prediction system comprising: the device comprises a variable input module, an analysis module and an output module;
the variable input module comprises four variable input submodules, wherein the four variable input submodules are respectively a TIPS bracket position and form input submodule, a portal vein puncture position input submodule, a spleen resection history input submodule and a diabetes input submodule;
the analysis module can establish a stent restenosis probability nomogram and calculate a total risk score based on the variables input by the variable input module, wherein the total risk score is the accumulated sum of the TIPS stent position form, the portal vein puncture position, the spleen resection history and the risk score of diabetes; calculating a predicted value of the probability of restenosis of the TIPS postoperative stent of the liver cirrhosis patient according to the total risk score;
the output module is used for outputting the predicted value of the restenosis probability of the TIPS postoperative stent of the liver cirrhosis patient;
wherein, the position form of the TIPS bracket is good, and the corresponding risk score is 0; the position form of the TIPS bracket is bad, and the corresponding risk score is 100;
the portal vein puncture position is positioned on the left branch, and the corresponding risk score is 0; the portal vein puncture position is positioned on the right branch, and the corresponding risk score is 79;
no history of splenectomy, corresponding risk score of 0; there was a history of splenectomy, with a corresponding risk score of 80;
no diabetes, corresponding risk score 0; with diabetes, the corresponding risk score is 74.
5. The prediction system of claim 4, wherein the analysis module is capable of performing the following operations from formula I to formula IV:
PI ═ 1.907 × TIPS scaffold position morphology +1.507 × portal venipuncture location +1.534 × history of splenectomy +1.412 × diabetes; formula I
In formula I, the values of the position and the shape of the TIPS stent are as follows: the position form of the TIPS bracket is good, and the value is 0; the position form of the TIPS bracket is poor, and the value is 1;
the value of the portal puncture position is as follows: the portal vein puncture position is positioned on the left branch, and the value is 0; the portal vein puncture position is positioned on the right branch and takes the value of 1;
taking the spleen resection history: no history of splenectomy, and the value is 0; 1, the spleen resection history is obtained;
values for diabetes: no diabetes, value is 0; diabetes mellitus exists, and the value is 1;
p ═ PI-4.292; formula II
In formula II, PI represents the score obtained in formula I, and P represents the linear predictive value;
P’＝1/(1+e-p) (ii) a Formula III
In the formula III, P' represents the probability of restenosis of the stent of a cirrhosis patient in 1 year after TIPS operation, and P represents a linear predicted value obtained by calculation according to the formula II;
point ═ (PI) × 100/1.907; formula IV
In formula IV, Point represents the total risk score, and PI represents the score calculated by formula I; 100/1.907 indicates that the maximum risk factor of 1.907 is defined as 100 points, with a corresponding score per unit risk factor.
6. The prediction system of claim 4 or 5, wherein the method for establishing a stent restenosis probability nomogram based on the variables input by the variable input module is to perform nomogram visualization of Logistic regression model using R language RMS computation package.
7. The prediction system according to claim 4 or 5, wherein the variable input module and the analysis module are connected by a wire and/or a wireless way; the analysis module and the output module are connected in a wired mode and/or a wireless mode.
8. The prediction system of claim 4 or 5, wherein the output module is a display, a printer, or an audio output device; the analysis module is a computer host, a central processing unit or a network server.
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