An individualized phosphorus reduction computing system

Abstract

The application discloses an individualized phosphorus reduction calculation system, which has the following characteristics: a dietary phosphorus intake evaluation module for quantitatively evaluating dietary phosphorus intake in a period of time; a drug phosphorus binding evaluation module for evaluating the amount of phosphorus binding of drugs; a hemodialysis phosphorus removal evaluation module for obtaining the amount of dialysis phosphorus removal by analyzing the dialysis waste liquid of a maintenance hemodialysis patient; and a phosphorus load evaluation module for calculating the phosphorus load condition of the patient or formulating an individualized intervention scheme according to the phosphorus load zero requirement based on the output data of the dietary phosphorus intake evaluation module, the drug phosphorus binding evaluation module and the hemodialysis phosphorus removal evaluation module and the personal data of the patient. The application can guide hemodialysis patients to formulate individualized treatment schemes from the aspects of diet, phosphorus binding agent and dialysis according to the individual phosphorus load state and the target of phosphorus load zero, so that the phosphorus reduction effect of the hemodialysis patients is improved.

Description

Technical Field

[0001] This invention relates to the field of treatment of hyperphosphatemia, and more specifically to a personalized phosphorus reduction calculation system. Background Technology

[0002] Cardiovascular disease is the leading cause of death in chronic kidney disease (CKD), accounting for more than 50% of all deaths. Studies have shown that hyperphosphatemia can promote vascular calcification and cardiomyopathy, significantly increasing the risk of cardiovascular events and death in dialysis patients. Therefore, exploring the treatment of hyperphosphatemia is one of the most pressing issues and challenges in the field of nephrology today.

[0003] Healthy adults ingest an average of 1200 mg of phosphorus daily, with 800 mg excreted by the kidneys and 400 mg by the intestines, thus maintaining homeostasis in blood phosphorus levels. When chronic kidney disease progresses to uremia, the kidneys are unable to excrete phosphorus, and almost every patient develops hyperphosphatemia. Therefore, uremia patients must control hyperphosphatemia by restricting dietary phosphorus intake, using oral phosphate binders to reduce intestinal phosphorus absorption, and increasing dialysis phosphorus excretion. From the KDIGO guidelines in 2003 to the KDOQI guidelines in 2017, although international guidelines have repeatedly emphasized these three phosphorus-lowering methods, there are still no clear guidelines on dietary structure, phosphate binder dosage, dialysis dosage, and when combination therapy is necessary. Clinical application has been relatively indiscriminate, and the rate of hyperphosphatemia control needs improvement. International studies on dialysis prognosis and practice models show that over the past 10 years, the incidence of hyperphosphatemia in dialysis patients abroad has remained at 40%-50%, while in China it has reached 81%.

[0004] Our research group previously conducted a series of studies on nutritional assessment and phosphorus metabolism disorders in hemodialysis patients. We surveyed the current status of phosphorus intake in hemodialysis patients, analyzed the impact of residual renal function on serum phosphorus, and completed a randomized controlled clinical trial of low-protein diet for controlling serum phosphorus. Ultimately, the group found significant individual differences in phosphorus intake and dialysis clearance, a difference that is poorly understood by clinicians and a major factor contributing to the varying effects of phosphorus-lowering treatment. This aligns with recent findings in the leading American Journal of Kidney Diseases (AJKD), which points out that individual differences in phosphorus metabolism are a significant reason for inconsistent treatment outcomes. Therefore, to improve phosphorus-lowering effects, a thorough investigation of patients' phosphorus metabolism status is essential.

[0005] A patient's phosphorus metabolism status can be described by phosphorus load. For end-stage renal disease patients undergoing hemodialysis, phosphorus load (Δphosphorus) is the difference between dietary phosphorus intake and renal phosphorus excretion, dialysis phosphorus clearance, and phosphorus bound by phosphate binders over a period of time, assuming stable bone and tissue cell metabolism. That is, the body's phosphorus load (Δphosphorus, mg / week) = [Average daily dietary phosphorus intake (mg / day) - Phosphate binder bound phosphorus (mg / day)] × 7 × 65% (gastrointestinal absorption rate) - Dialysis phosphorus clearance (mg / week) - Residual renal function phosphorus clearance (mg / week). Although scholars both domestically and internationally have reported significant differences in phosphorus clearance from diet or dialysis among dialysis patients, there is a lack of research quantifying dietary phosphorus, dialysis phosphorus, and phosphate binder bound phosphorus for each individual, thus individual phosphorus load remains unknown. If individualized treatment plans could be developed for hemodialysis patients based on their individual phosphorus load status, aiming for zero phosphorus load, this could potentially improve the phosphorus-lowering effect in hemodialysis patients.

[0006] Currently, the KDIGO guidelines recommend the following treatments for hyperphosphatemia in maintenance hemodialysis patients: restricting dietary phosphorus intake, intensifying dialysis, and using phosphate binders. However, there are no clear guidelines on dietary structure, required phosphate binder dosages, necessary dialysis doses, or when combination therapy is needed.

[0007] Reduce dietary phosphorus intake: The guidelines recommend reducing the intake of foods high in phosphorus and avoiding liquids high in phosphorus such as cola and tea. They also suggest reducing the intake of fast food. However, the guidelines lack clear directions on how to implement these measures.

[0008] Phosphate binders should be used based on serum phosphorus, calcium, and PTH levels. If the patient has evidence of hypercalcemia or cardiovascular calcification, non-calcium-containing phosphate binders are recommended as the first choice. If the patient has low PTH, calcium-containing phosphate binders are not recommended. All phosphate binders should be started orally at the initial dose determined in the clinical trial, followed by weekly follow-up of serum phosphorus levels, with dosage adjustments made by 50% based on the patient's serum phosphorus level. However, recent studies have found that serum phosphorus levels are not an ideal indicator of phosphorus metabolism. A single serum phosphorus test result exhibits significant randomness and fluctuation in patients with kidney disease, especially those with end-stage renal disease, making it difficult to reflect the state of phosphorus metabolism. Therefore, relying on serum phosphorus levels to guide the use of phosphate-lowering drugs has drawbacks.

[0009] Increasing dialysis phosphorus removal: The guidelines recommend that prolonged nighttime dialysis and short-term daily dialysis can increase dialysis phosphorus removal. Using large-area high-flux dialysis membranes may increase dialysis phosphorus removal, but there is a lack of details on how to increase dialysis time or change dialysis mode.

[0010] While the KDIGO guidelines provide some guidance for phosphorus-lowering treatment in patients with hyperphosphatemia, they lack detailed classifications of diet and medication for different populations or individuals, and do not offer precise dosage guidelines, thus failing to guide clinical implementation. Assessing phosphorus clearance during hemodialysis is extremely difficult, influenced by numerous factors and impossible to observe directly. Previous studies have established different assessment methods for phosphorus clearance in hemodialysis patients, based on factors such as dialysis time, phosphate concentration in dialysis waste fluid after one hour, dialyzer phosphorus clearance rate, and serum phosphorus concentration, but these methods have yielded unsatisfactory results and have not been widely adopted in clinical practice. Patients with hyperphosphatemia exhibit high heterogeneity and individual variability, thus requiring more precise individualized treatment. This would allow clinicians to quantitatively adjust dietary and phosphorus-lowering drug interventions based on dialysis phosphorus clearance, reducing treatment costs and adverse reactions. Summary of the Invention

[0011] This invention was developed to solve the above-mentioned problems, and its purpose is to provide an individualized phosphorus reduction calculation system.

[0012] This invention provides a personalized phosphorus reduction calculation system, characterized by: a dietary phosphorus intake assessment module for quantitatively assessing dietary phosphorus intake over a period of time; a drug phosphorus binding assessment module for assessing the phosphorus binding amount of drugs; a hemodialysis phosphorus clearance assessment module for obtaining dialysis phosphorus clearance by analyzing dialysis waste fluid from maintenance hemodialysis patients; and a phosphorus load assessment module for calculating the patient's phosphorus load or developing an individualized intervention plan based on the output data from the dietary phosphorus intake assessment module, the drug phosphorus binding assessment module, the hemodialysis phosphorus clearance assessment module, and the patient's personal data.

[0013] The personalized phosphorus reduction calculation system provided by this invention may also have the following features: the assessment methods of the dietary phosphorus intake assessment module include the three-day food diary method, the 24-hour dietary review method, the food frequency questionnaire method, and the nPNA indirect calculation method.

[0014] The personalized phosphorus reduction calculation system provided by this invention may also have the following feature: the evaluation method of the drug phosphorus binding assessment module is the daily total phosphorus binding efficacy method.

[0015] The personalized phosphorus reduction calculation system provided by this invention may also have the following features: The hemodialysis phosphorus clearance assessment module collects and analyzes dialysis waste fluid from maintenance hemodialysis patients to obtain the relationship between hemodialysis phosphorus clearance and phosphate concentration in dialysis waste fluid, as well as the patient's clinical biochemical data, thus establishing an assessment model for hemodialysis phosphorus clearance. Based on this assessment model, a multivariate polynomial regression method based on Taylor's theorem is used to correct the phosphorus clearance rate coefficient, employing a quadratic function with indeterminate coefficients to improve the predictive efficacy of the hemodialysis phosphorus clearance assessment model. During the correction of the phosphorus clearance rate coefficient, age, dry weight, and C... 45 The coefficients were all fixed and included in a second-order multivariate polynomial regression analysis to obtain new coefficients for dialyzer phosphorus clearance rate, and an optimization model for phosphorus clearance in hemodialysis patients was established: Phosphorus clearance per dialysis session = 80.3 × C45 - 0.024 × age + 0.07 × dry weight + β × phosphorus clearance rate - 8.14. Where β = 6.231 × 10⁻⁶. -3 ×Phosphorus removal rate -1.886×10 -5 ×Phosphorus removal rate 2 -0.467, C 45 The concentration of phosphate in the dialysis waste fluid is 45 minutes after the start of dialysis.

[0016] The personalized phosphorus reduction calculation system provided by this invention may also have the following features: the phosphorus load assessment module calculates the phosphorus load of patients based on the three-day food diary method, the daily total binding efficacy of phosphorus binders, and the optimization model of phosphorus clearance in hemodialysis patients, or formulates an individualized intervention plan according to the requirement of zero phosphorus load.

[0017] The personalized phosphorus reduction calculation system provided by this invention may also have the following feature: the principle of the phosphorus load assessment module is as follows: Δphosphorus = dietary phosphorus × 65% (gastrointestinal absorption rate) - dialysis-removed phosphorus - phosphorus bound by phosphate binders - residual renal excretion of phosphorus. When Δphosphorus equals 0, the patient's phosphorus intake and clearance reach a balance, the phosphorus load status remains stable, and the blood phosphorus level remains relatively stable.

[0018] The personalized phosphorus reduction calculation system provided by this invention may also have the following feature: wherein the personalized intervention plan is any one or more of the following: personalized diet plan, personalized medication dosage, and personalized dialysis dosage.

[0019] The role and effect of invention

[0020] The personalized phosphorus reduction calculation system according to the present invention includes: a dietary phosphorus intake assessment module for quantitatively assessing dietary phosphorus intake over a period of time; a drug phosphorus binding assessment module for assessing the phosphorus binding amount of drugs; a hemodialysis phosphorus clearance assessment module for obtaining dialysis phosphorus clearance by analyzing dialysis waste fluid from maintenance hemodialysis patients; and a phosphorus load assessment module for calculating the patient's phosphorus load or developing an individualized intervention plan based on the output data of the dietary phosphorus intake assessment module, the drug phosphorus binding assessment module, the hemodialysis phosphorus clearance assessment module, and the patient's personal data.

[0021] Therefore, the personalized phosphorus reduction calculation system involved in this invention is the first multicenter clinical system to construct a phosphorus clearance assessment model for conventional hemodialysis and hemodiafiltration therapy. A phosphorus load assessment model and a personalized phosphorus reduction calculation system were established. It makes up for the deficiencies of the guidelines: (1) It can quantitatively assess phosphorus load and understand the causes of hyperphosphatemia in patients; (2) Based on the quantitatively assessed phosphorus load value, a plan for dietary phosphorus intake, dialysis phosphorus clearance, and drug phosphorus combination is formulated with the goal of zeroing phosphorus load. The above plan can also be used alone, in pairs, or in combination of three. 3D treatment is based on evidence; (3) It improves the phosphorus reduction rate and shortens the phosphorus reduction time. Ultimately, personalized and precise phosphorus reduction is achieved.

[0022] Furthermore, the phosphorus load assessment module of this invention opens up new avenues for the quantitative assessment of phosphorus load in maintenance hemodialysis patients. This invention proposes that "phosphorus load" is primarily influenced by dietary phosphorus intake, dialysis phosphorus clearance, drug phosphorus binding, and residual renal function phosphorus clearance, facilitating assessment by clinicians based on patient conditions. More importantly, the phosphorus load assessment module constructed in this invention overcomes the shortcomings of previous research models, which involved numerous influencing factors, complex calculations, and invasive procedures, achieving true clinical operability. Therefore, the phosphorus load assessment module constructed in this invention opens up new avenues for the quantitative assessment of phosphorus load in maintenance hemodialysis patients, providing possibilities for individualized phosphorus-lowering therapy.

[0023] Furthermore, the individualized treatment plan of this invention also proposes specific practical methods for the combined use of diet, medication, and dialysis, providing a guarantee for the implementation of the "3D" treatment principle proposed in the KDIGO guidelines. Therefore, the phosphorus load assessment model and individualized treatment method can provide a technical approach for phosphorus-lowering therapy in hemodialysis patients without residual renal function.

[0024] Finally, the phosphorus load assessment module constructed in this invention overcomes the shortcomings of previous research models, such as numerous influencing factors, complex calculations, and the need for invasive procedures, thus achieving true clinical operability. The phosphorus load assessment module opens up new avenues for quantitative assessment of phosphorus load in maintenance hemodialysis patients, providing possibilities for individualized phosphorus-lowering therapy. Through a multi-center, prospective clinical trial, the effectiveness and practical value of the individualized phosphorus-lowering calculation system provided by this invention are verified for the first time, providing convenience and new technical support for precise phosphorus-lowering therapy in clinical practice. A new pathway for clinical quantitative assessment of phosphorus metabolism and individualized phosphorus-lowering therapy is established, its economic advantages are evaluated, and new ideas are provided for stable control of serum phosphorus levels in clinical practice. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of a three-day food diary in an embodiment of the present invention;

[0026] Figure 2 This is a schematic diagram of the recipe calculation system in an embodiment of the present invention;

[0027] Figure 3 This is a diagram showing the dosage and binding efficiency of common phosphorus binders in the embodiments of the present invention;

[0028] Figure 4 The dialyzer and its parameters involved in the embodiments of the present invention;

[0029] Figure 5 The figures shown are Bland-Altman analysis results of the optimized model for phosphorus clearance in hemodialysis patients in the embodiments of the present invention for predicting phosphorus clearance in hemodialysis and hemodiafiltration therapy. Figure 5 (a) is hemodialysis treatment. Figure 5 (b) For hemodiafiltration treatment;

[0030] Figure 6 This is a diagram of the main interface of the individualized phosphorus reduction calculation system in an embodiment of the present invention;

[0031] Figure 7 In the embodiments of the present invention, the baseline serum phosphorus levels of the conventional treatment group and the individualized treatment group are consistent with the phosphorus load.

[0032] Figure 8 This describes the changes in serum phosphorus levels and target achievement rates of subjects in embodiments of the present invention.

[0033] Figure 9 The results of the subject dialysis adequacy and medication adherence assessment in the embodiments of the present invention;

[0034] Figure 10 This is a schematic diagram of the operation panel of the individualized phosphorus reduction calculation system software in an embodiment of the present invention;

[0035] Figure 11 This is a schematic diagram of the data input interface of the individualized phosphorus reduction calculation system in an embodiment of the present invention;

[0036] Figure 12 This is a schematic diagram of the phosphorus retention calculation results of the individualized phosphorus reduction calculation system in an embodiment of the present invention;

[0037] Figure 13 This is a schematic diagram of the drug calculation results of the individualized phosphorus reduction calculation system in an embodiment of the present invention;

[0038] Figure 14 This is a schematic diagram of the dietary calculation results of the individualized phosphorus reduction calculation system in an embodiment of the present invention. Detailed Implementation

[0039] To make the technical means, creative features, objectives and effects of the present invention easy to understand, the following embodiments, in conjunction with the accompanying drawings, provide a detailed description of an individualized phosphorus reduction calculation system of the present invention.

[0040] This embodiment provides a personalized phosphorus reduction calculation system.

[0041] To achieve precise phosphorus-lowering therapy aimed at zero phosphorus load, it is essential to clarify the specific amounts of phosphorus intake through diet, medication binding, and dialysis removal, thereby improving the efficiency and effectiveness of phosphorus reduction. Firstly, it is necessary to define the calculation methods for dietary phosphorus intake, medication binding, and dialysis removal.

[0042] The individualized phosphorus reduction calculation system in this embodiment includes a dietary phosphorus intake assessment module, a drug phosphorus binding assessment module, a hemodialysis phosphorus clearance assessment module, and a phosphorus load assessment module.

[0043] The dietary phosphorus intake assessment module is used to quantitatively assess dietary phosphorus intake over a period of time.

[0044] The assessment methods for the dietary phosphorus intake assessment module include the three-day food diary method, the 24-hour dietary review method, the food frequency questionnaire method, and the indirect calculation method of nPNA.

[0045] Figure 1 This is a schematic diagram of a three-day food diary in this embodiment.

[0046] Figure 2 This is a schematic diagram of the recipe calculation system in this embodiment.

[0047] In this embodiment, a three-day food diary method was used to calculate and assess the patient's dietary phosphorus intake over a certain period of time.

[0048] The drug phosphorus binding assessment module is used to assess the amount of phosphorus bound to a drug.

[0049] The phosphorus binding capacity of drugs is also easy to calculate. The phosphorus binding efficacy of commonly used phosphorus binders has been clearly reported. For example, each gram of calcium acetate can bind 41 mg of phosphorus, and each gram of sevelamer carbonate can bind 26.3 mg of phosphorus. The total daily phosphorus binding efficacy of phosphorus binders is often used to assess the therapeutic dose of phosphorus-lowering drugs. The residual renal function's phosphorus clearance is usually assessed by multiplying the patient's 24-hour urinary phosphorus level by the 24-hour urine volume.

[0050] Figure 3 This diagram shows the dosage and binding efficiency of common phosphorus binders in this embodiment.

[0051] The hemodialysis phosphorus clearance assessment module obtains the amount of phosphorus cleared during dialysis by analyzing the dialysis waste fluid of maintenance hemodialysis patients.

[0052] The hemodialysis phosphorus clearance assessment module collects and analyzes dialysis waste fluid from maintenance hemodialysis patients to determine the relationship between hemodialysis phosphorus clearance and phosphate concentration in the dialysis waste fluid, as well as the patients' clinical biochemical data, thus establishing an assessment model for hemodialysis phosphorus clearance in hemodialysis patients. Based on this model, a multivariate polynomial regression method based on Taylor's theorem is introduced from mathematical analysis to correct the coefficients of the phosphorus clearance rate. A quadratic function with indeterminate coefficients is used to improve the model's predictive efficacy.

[0053] In the process of correcting the phosphorus clearance coefficient, age, dry weight, and C... 45 The coefficients were all fixed and included in the second-order multivariate polynomial regression analysis to obtain new coefficients for dialyzer phosphorus clearance rate, and to establish an optimization model for phosphorus clearance in hemodialysis patients:

[0054] Phosphorus removal per dialysis session = 80.3 × C45 - 0.024 × age + 0.07 × dry weight + β × phosphorus clearance rate - 8.14.

[0055] In the formula, β = 6.231 × 10 -3 ×Phosphorus removal rate -1.886×10 -5 ×Phosphorus removal rate 2 -0.467, C 45 The concentration of phosphate in the dialysis waste fluid is 45 minutes after the start of dialysis.

[0056] This optimized model for phosphorus clearance during hemodialysis in hemodialysis patients can be used to evaluate various dialyzers.

[0057] Figure 4 This refers to the dialyzer and its parameters involved in this embodiment.

[0058] The phosphorus load assessment module calculates the patient's phosphorus load or develops an individualized intervention plan based on the output data from the dietary phosphorus intake assessment module, the drug phosphorus binding assessment module, the hemodialysis phosphorus clearance assessment module, and the patient's personal data.

[0059] In the phosphorus load assessment module, dietary phosphorus intake is assessed using a three-day food diary, with the average of the three days' dietary phosphorus intake taken as the average daily dietary phosphorus intake; phosphorus binding capacity is assessed using the total binding efficacy of the phosphorus binder, which is the product of the phosphorus binding efficacy of a single drug tablet and the number of tablets taken daily; dialysis phosphorus clearance is calculated based on the aforementioned optimized model for dialysis phosphorus clearance in hemodialysis patients; residual renal function phosphorus clearance can be calculated based on 24-hour urinary phosphorus levels and urinary phosphorus. Since most hemodialysis patients have completely lost residual renal function, this can be ignored in this case.

[0060] The corrected optimized model for phosphorus clearance in hemodialysis patients was validated on internal and external test datasets. The results showed that the corrected optimized model can stably and accurately predict phosphorus clearance in hemodialysis treatment using different dialyzers.

[0061] Figure 5 This figure shows the Bland-Altman analysis results of the optimized model for phosphorus clearance in hemodialysis patients in this embodiment, predicting phosphorus clearance during hemodialysis and hemodiafiltration therapy.

[0062] like Figure 5 As shown, Figure 5 (a) Bland-Altman analysis of the difference between the predicted and actual observations of the optimized model for hemodialysis treatment; the vertical axis is the difference, i.e., the predicted value of the optimized model minus the actual observation; the horizontal axis is the mean, i.e., the average of the actual observation and the predicted value of the model; (mean difference 0.15, standard deviation 1.85). Figure 5 (b) Bland-Altman analysis of the difference between the predicted and actual observations of the optimized model for hemodialysis filtration treatment; the vertical axis represents the difference, i.e., the predicted value of the optimized model minus the actual observation; the horizontal axis represents the mean, i.e., the average of the actual observation and the model prediction; (mean difference 0.12, standard deviation 2.20).

[0063] Figure 6 This is a diagram of the main interface of the individualized phosphorus reduction calculation system in this embodiment.

[0064] like Figure 6As shown, this personalized phosphorus reduction calculation system applies the aforementioned optimization model for phosphorus clearance in hemodialysis patients. After inputting the relevant parameters, it can calculate the patient's phosphorus load or formulate individualized intervention plans based on the phosphorus load zeroing requirement, facilitating clinical application. For example, by inputting the patient's age, dry weight, daily dietary phosphorus intake, weekly dialysis frequency and duration, phosphorus concentration in the dialysis waste fluid at 45 minutes, dialyzer phosphorus clearance rate, dialysate flow rate, and phosphate binder dosage into the calculation system, clicking "Calculate Weekly Phosphorus Retention" will yield the current weekly phosphorus load change for the patient. Similarly, inputting the required weekly phosphorus retention amount can also calculate the patient's daily phosphorus intake limit or phosphate binder / dialysis treatment dosage.

[0065] This embodiment uses a multicenter prospective randomized controlled trial to further verify the clinical guidance role of phosphorus load assessment software. The individualized phosphorus reduction calculation system in this embodiment is used to calculate the dosage of phosphate binders and dialysis dosage, and propose individualized phosphorus reduction treatment. Based on the treatment requirements of phosphorus load zeroing, individualized dietary plans, medication dosages or dialysis dosages are proposed.

[0066] Specifically, the principle of the phosphorus load assessment model for hemodialysis patients is expressed by the following formula:

[0067] △Phosphorus = Dietary phosphorus × 65% (gastrointestinal absorption rate) - Phosphorus removed by dialysis - Phosphorus bound by phosphate binders - Phosphorus excretion by residual kidney.

[0068] When Δphosphorus equals 0, the intake and elimination of phosphorus in hemodialysis patients reach a balance, the phosphorus load status remains stable, and the blood phosphorus level remains relatively stable.

[0069] Figure 7 The baseline serum phosphorus levels and phosphorus load of the conventional treatment group and the individualized treatment group in this embodiment are the same.

[0070] Figure 8 This shows the changes in blood phosphorus levels and target achievement rates of the subjects in this embodiment.

[0071] like Figures 7-8 As shown, this multicenter prospective randomized controlled clinical trial, by comparing conventional drug treatment, demonstrated that using a phosphorus load assessment model to achieve zero phosphorus load in maintenance hemodialysis patients can significantly reduce serum phosphorus levels, reduce phosphorus load, effectively improve the rate of achieving serum phosphorus targets, and to a certain extent achieve the goal of treating phosphorus load rather than simply serum phosphorus levels.

[0072] Therefore, individualized phosphorus-lowering therapy is significantly more effective than conventional treatment regimens in lowering phosphorus levels.

[0073] Figure 9 This represents the assessment results of dialysis adequacy and medication adherence in the subjects in this embodiment.

[0074] like Figure 9 As shown, medication adherence was monitored by the number of doses taken weekly as reported by the subjects. Good medication adherence was considered to be achieved when the dosage reached 80%-120% of the required dose. Dialysis adherence was monitored by the subjects' spKt / V ratio; a ratio >1.2 was considered good dialysis adherence. Personalized treatment demonstrated good safety and subject adherence, and the average cost of phosphorus-lowering therapy was significantly lower than that of conventional treatment.

[0075] The Personalized Phosphate-Lowering Calculation System for Hemodialysis Patients is a medical software designed to provide hemodialysis physicians with personalized nutritional guidance, dialysis adjustments, and phosphate-lowering drug administration for hyperphosphatemia. Currently, the treatment of hyperphosphatemia in hemodialysis patients lacks assessment of the patient's phosphorus balance, hindering personalized drug administration. Furthermore, treatment plans rely on individual physician experience, lacking standardized protocols, thus limiting the effectiveness of hyperphosphatemia treatment. This software calculates phosphorus intake based on the patient's food diary, phosphorus clearance based on the dialyzer's phosphorus removal efficiency, and phosphorus binding based on the type and quantity of phosphate-binding drugs used. Through mathematical formulas, it calculates the patient's weekly phosphorus retention, facilitating physicians' assessment of the dialysis patient's phosphorus balance. The software also allows setting phosphorus retention to 0 and calculating the amount of phosphorus the patient can ingest, the amount of phosphorus required for dialysis, or the amount of phosphorus required for drug binding, thus helping patients achieve phosphorus balance, reducing the incidence of hyperphosphatemia, standardizing clinical treatment of hyperphosphatemia, and achieving precision medicine.

[0076] The method of using the individualized phosphorus reduction calculation system in this embodiment is as follows:

[0077] Step S1, run the personalized phosphorus reduction calculation system software: double-click the phosphorus calculator.exe icon to run the software.

[0078] Figure 10 This is a schematic diagram of the operation panel of the individualized phosphorus reduction calculation system software in this embodiment.

[0079] Step S2: Input data into the personalized phosphorus reduction calculation system software.

[0080] Manually enter the patient's age, weight, dietary phosphorus intake, number of dialysis sessions per week, duration of each dialysis session, phosphorus concentration of the dialysate at 45 minutes, dialyzer phosphorus removal efficiency, dialysate flow rate, single-tablet dose and weekly count of oral calcium carbonate, single-tablet dose and weekly count of oral calcium acetate, single-tablet dose and weekly count of oral laminarum carbonate, and single-tablet dose and weekly count of oral lanthanum carbonate. If the dialysis time is greater than 4 hours, the 4-hour phosphorus concentration of the dialysate must be entered. If the dialysis time is less than or equal to 4 hours, the default value in this example is 0.

[0081] Figure 11This is a schematic diagram of the data input interface of the individualized phosphorus reduction calculation system in this embodiment.

[0082] Step S3, Phosphorus Retention Calculation: Click the "Weekly Phosphorus Retention Calculation" button, and the weekly phosphorus retention results will be displayed above.

[0083] Figure 12 This is a schematic diagram of the phosphorus retention calculation results of the individualized phosphorus reduction calculation system in this embodiment.

[0084] Step S4, Drug Calculation: Set the "Weekly Phosphorus Retention" data to 0. Assuming the patient is adding lanthanum carbonate to their existing medication, set the "Lanthanum Carbonate Single Tablet Dosage" data to 500mg. Click the "Weekly Lanthanum Carbonate Calculation" button, and the required lanthanum carbonate dosage for the patient will be displayed on the right.

[0085] Figure 13 This is a schematic diagram of the drug calculation results of the individualized phosphorus reduction calculation system in this embodiment.

[0086] Step S5, Dietary Calculation: Set the "Weekly Phosphorus Retention" data to 0, and click the "Daily Phosphorus Intake Calculation" button. The patient's daily phosphorus intake will be displayed in the upper right corner.

[0087] Figure 14 This is a schematic diagram of the dietary calculation results of the individualized phosphorus reduction calculation system in this embodiment.

[0088] In this embodiment, for a hemodialysis patient with hyperphosphatemia, the patient is 50 years old, weighs 50 kg, has a daily phosphorus intake of 900 mg, undergoes dialysis 3 times a week for 4 hours each time, has a dialysate phosphorus concentration of 0.2 mmol / L after 45 minutes, a dialyzer phosphorus removal efficiency of 139 ml / min, a dialysate flow rate of 500 ml / min, and is taking oral calcium carbonate 6 tablets daily (750 mg per tablet). These parameters are entered into the calculator software, and the weekly phosphorus retention is calculated to be 736 mg. Conversely, setting the phosphorus retention to 0 and the number of calcium carbonate tablets required for removal is calculated to be 63 tablets. Therefore, this software achieves individualized phosphorus-lowering treatment based on parameters that can be collected clinically from the patient.

[0089] The role and effect of the embodiments

[0090] The personalized phosphorus reduction calculation system described in this embodiment includes: a dietary phosphorus intake assessment module for quantitatively assessing dietary phosphorus intake over a period of time; a drug phosphorus binding assessment module for assessing the phosphorus binding amount of drugs; a hemodialysis phosphorus clearance assessment module for obtaining dialysis phosphorus clearance by analyzing dialysis waste fluid from maintenance hemodialysis patients; and a phosphorus load assessment module for calculating the patient's phosphorus load or developing an individualized intervention plan based on the output data from the dietary phosphorus intake assessment module, the drug phosphorus binding assessment module, the hemodialysis phosphorus clearance assessment module, and the patient's personal data.

[0091] Therefore, the individualized phosphorus reduction calculation system involved in this embodiment is the first multicenter clinical system to construct a phosphorus clearance assessment model for conventional hemodialysis and hemodiafiltration therapy. A phosphorus load assessment model and an individualized phosphorus reduction calculation system were established. It makes up for the deficiencies of the guidelines: (1) It can quantitatively assess phosphorus load and understand the causes of hyperphosphatemia in patients; (2) Based on the quantitatively assessed phosphorus load value, a plan for dietary phosphorus intake, dialysis phosphorus clearance, and drug phosphorus combination is formulated with the goal of zeroing phosphorus load. The above plan can also be used alone, in pairs, or in combination of three. 3D treatment is based on evidence; (3) It improves the phosphorus reduction rate and shortens the phosphorus reduction time. Ultimately, it achieves individualized and precise phosphorus reduction.

[0092] Furthermore, the phosphorus load assessment module in this embodiment opens up new avenues for the quantitative assessment of phosphorus load in maintenance hemodialysis patients. This embodiment proposes that "phosphorus load" is mainly affected by dietary phosphorus intake, dialysis phosphorus clearance, drug phosphorus binding, and residual renal function phosphorus clearance, facilitating assessment by clinicians based on patient conditions. More importantly, the phosphorus load assessment module constructed in this embodiment overcomes the shortcomings of previous research models, such as numerous influencing factors, complex calculations, and the need for invasive procedures, achieving true clinical operability. Therefore, the phosphorus load assessment module constructed in this embodiment opens up new avenues for the quantitative assessment of phosphorus load in maintenance hemodialysis patients, providing possibilities for individualized phosphorus-lowering therapy.

[0093] Furthermore, the individualized treatment plan in this embodiment also proposes specific practical methods for the combined use of diet, medication, and dialysis, providing a guarantee for the implementation of the "3D" treatment principle proposed in the KDIGO guidelines. Therefore, the phosphorus load assessment model and individualized treatment method can provide a technical approach for phosphorus-lowering therapy in hemodialysis patients without residual renal function.

[0094] Furthermore, the phosphorus load assessment module constructed in this embodiment overcomes the shortcomings of previous research models, such as numerous influencing factors, complex calculations, and the need for invasive procedures, thus achieving true clinical operability. The phosphorus load assessment module opens up new avenues for the quantitative assessment of phosphorus load in maintenance hemodialysis patients, providing possibilities for individualized phosphorus-lowering therapy. Through a multi-center, prospective clinical trial, the effectiveness and practical value of the individualized phosphorus-lowering calculation system provided in this embodiment are verified for the first time, providing convenience and new technical support for the clinical implementation of precision phosphorus-lowering therapy. A new pathway for the clinical quantitative assessment of phosphorus metabolism and individualized phosphorus-lowering therapy is established, its economic advantages are evaluated, and new ideas are provided for the stable control of serum phosphorus levels in clinical practice.

[0095] Finally, the personalized phosphorus-lowering treatment system software in this embodiment has several key features: 1. The interface is simple, requiring only the input of clinical parameters, most of which are the patient's own clinical data, with a few requiring clinical laboratory tests; 2. It can not only calculate phosphorus retention and understand the patient's phosphorus balance information, but also, in turn, personalize drug administration or develop dialysis and nutrition plans, achieving two goals at once.

[0096] The above embodiments are preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention.

Claims

1. A personalized phosphorus reduction calculation system, characterized in that, Calculate the patient's phosphorus load or develop an individualized intervention plan based on the phosphorus load zeroing requirement, including: The dietary phosphorus intake assessment module is used to quantitatively assess dietary phosphorus intake over a period of time. The drug phosphorus binding assessment module is used to assess the amount of phosphorus bound to a drug. The hemodialysis phosphorus clearance assessment module obtains the amount of phosphorus cleared during dialysis by analyzing the dialysis waste fluid of maintenance hemodialysis patients; The phosphorus load assessment module, based on the output data from the dietary phosphorus intake assessment module, the drug phosphorus binding assessment module, and the hemodialysis phosphorus clearance assessment module, as well as the patient's personal data, calculates the patient's phosphorus load or develops an individualized intervention plan according to the phosphorus load zeroing requirement. The hemodialysis phosphorus clearance assessment module collects and analyzes dialysis waste fluid from maintenance hemodialysis patients to determine the relationship between hemodialysis phosphorus clearance and phosphate concentration in dialysis waste fluid, as well as the patient's clinical biochemical data, thus establishing an assessment model for hemodialysis phosphorus clearance in hemodialysis patients. Based on the existing model for assessing phosphorus clearance in hemodialysis patients, the phosphorus clearance coefficient is corrected using a multivariate polynomial regression method based on Taylor's theorem. A quadratic function with indeterminate coefficients is then employed to improve the predictive efficacy of the model. In the process of correcting the phosphorus clearance coefficient, age, dry weight, and C... 45 The coefficients were all fixed and included in the second-order multivariate polynomial regression analysis to obtain new coefficients for dialyzer phosphorus clearance rate, and to establish an optimization model for phosphorus clearance in hemodialysis patients: Phosphorus removal per dialysis session = 80.3 × C45 - 0.024 × age + 0.07 × dry weight + β × phosphorus clearance rate - 8.14 In the formula, β = 6.231 × 10 -3 ×Phosphorus removal rate -1.886×10 -5 ×Phosphorus removal rate 2 -0.467, C 45 This refers to the phosphate concentration in the dialysis waste fluid 45 minutes after the start of dialysis. The phosphorus load assessment module calculates the patient's phosphorus load based on the three-day food diary method, the daily total binding efficacy of phosphate binders, and an optimized model for phosphorus clearance during hemodialysis, or develops individualized intervention plans based on the requirement of zero phosphorus load. The principle of the phosphorus load assessment module is as follows: △Phosphorus = Dietary phosphorus × 65% (gastrointestinal absorption rate) - Phosphorus removed by dialysis - Phosphorus bound by phosphate binders - Phosphorus excretion by residual kidney tissue. When Δphosphorus equals 0, the patient's phosphorus intake and clearance are in balance, the phosphorus load status remains stable, and the blood phosphorus level remains relatively stable.

2. The personalized phosphorus reduction calculation system according to claim 1, characterized in that: in, The assessment methods for the dietary phosphorus intake assessment module include the three-day food diary method, the 24-hour dietary review method, the food frequency questionnaire method, and the indirect calculation method of nPNA.

3. The personalized phosphorus reduction calculation system according to claim 1, characterized in that: in, The evaluation method for the drug phosphorus binding assessment module is the daily total phosphorus binding potency method.

4. The personalized phosphorus reduction calculation system according to claim 1, characterized in that: in, The individualized intervention plan is any one or more of the following: individualized diet plan, individualized medication dosage, and individualized dialysis dosage.

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