Method for evaluating efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning

Abstract

This invention discloses a method for evaluating the efficacy of cell therapy combined with hydrogen-oxygen negative ions in reproductive system conditioning, belonging to the field of biomedical technology. Subjects are randomly divided into a combined treatment group, a cell therapy-only group, and a hydrogen-oxygen negative ion-only group. Data on blood sex hormones, semen quality, penile hemodynamics, and oxidative stress markers are collected before, during, and after treatment. The synergistic gain of the combined therapy is quantified through a comprehensive enhancement index, an additional gain index, and a penalty factor correction. Inter-group difference curves are constructed, and the duration of advantage onset, duration of advantage, and area of ​​advantage are extracted, and a weighted fusion is used to output the combined advantage coefficient. This invention overcomes the shortcomings of traditional single-dimensional assessments, comprehensively covers multiple aspects of the reproductive system, and for the first time introduces a efficacy stability penalty mechanism, objectively quantifying the additional clinical value and advantageous characteristics of the combined therapy, providing a standardized assessment tool for individualized treatment decisions.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and more specifically, to a method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in the treatment of reproductive system disorders. Background Technology

[0002] With the development of regenerative medicine and physical therapy, cell therapy and hydrogen-oxygen negative ion therapy have gradually become emerging research directions in the field of male reproductive system conditioning. Cell therapy can fundamentally improve the physiological function of the reproductive system by repairing damaged reproductive tissue through targeted differentiation, regulating the function of testicular interstitial cells, and improving the local microenvironment. Hydrogen-oxygen negative ions, with their strong antioxidant properties, can eliminate excess reactive oxygen free radicals in the body, reduce oxidative stress damage, improve blood circulation in the corpora cavernosa and testicular tissues, and exert anti-inflammatory and immunomodulatory effects. Preliminary clinical explorations suggest that the combined use of the two may produce a synergistic effect and has better therapeutic potential than single therapy, but a standardized system for objectively quantifying their efficacy is still lacking.

[0003] Currently, the methods for evaluating the effectiveness of treatments for male reproductive dysfunction still have the following shortcomings: The assessment dimensions are too narrow. Most studies focus only on a few indicators such as semen quality parameters or blood sex hormone levels, failing to comprehensively cover the core pathophysiological aspects of reproductive function, such as endocrine regulation, sperm production, hemodynamics, and oxidative stress balance, and thus failing to reflect the overall benefit of treatment. The lack of specific evaluation mechanisms for combination therapies means that existing methods mostly follow the evaluation framework of monotherapy, without considering the synergistic effect between cell therapy and hydrogen-oxygen negative ions, making it impossible to quantify the additional benefits of combination therapy relative to two monotherapy, and making it difficult to clarify the clinical value of combination therapy. The lack of quantitative consideration of efficacy stability and the failure of existing assessments to take into account the degree of efficacy dispersion among different subjects make it impossible to reflect the clinical universality and reliability of the therapy, which may lead to bias in the assessment results.

[0004] To this end, a method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in the treatment of reproductive system disorders has been introduced. Summary of the Invention

[0005] In order to overcome the above-mentioned defects of the prior art, embodiments of the present invention provide a method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in the treatment of reproductive system disorders.

[0006] To achieve the above objectives, the present invention provides the following technical solution: Methods for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning include: Step S1: Male subjects with reproductive dysfunction were randomly assigned to the combined treatment group, the cell therapy single group, and the hydrogen-oxygen negative ion single group; Step S2: The intervention was carried out on each group of subjects according to the preset plan. The combined treatment group received both cell therapy and hydrogen-oxygen negative ion inhalation. The cell therapy group received only the same cell therapy as the combined treatment group. The hydrogen-oxygen negative ion group received only the same hydrogen-oxygen negative ion inhalation as the combined treatment group. Step S3: Before treatment, at each preset intermediate time point after the start of treatment, and after the end of treatment, collect assessment index data for each subject. The assessment index data includes blood sex hormone levels, semen quality parameters, penile hemodynamic parameters, and oxidative stress markers. Step S4: Based on the evaluation index data of the combined treatment group, the single cell therapy group, and the single hydrogen-oxygen negative ion group at each time point, use the pre-edited evaluation algorithm to calculate the additional gain index of the combined therapy relative to the two single therapies, simultaneously establish the inter-group difference curve, extract the efficacy correlation parameters from the curve, and output the combined advantage coefficient.

[0007] Specifically, blood sex hormone levels include serum total testosterone, serum free testosterone, luteinizing hormone, and follicle-stimulating hormone; Semen quality parameters include progressive motility sperm rate, sperm concentration, semen volume, and total sperm motility; Penile hemodynamic parameters include peak systolic velocity, end-diastolic velocity, resistance index, and cavernous artery diameter; Oxidative stress markers include oxidative damage markers and antioxidant capacity markers; Oxidative damage markers include serum malondialdehyde and serum 8-hydroxydeoxyguanosine; Antioxidant capacity markers include serum superoxide dismutase and serum total antioxidant capacity.

[0008] Specifically, S4-1: In the single group of cell therapy, for each assessment indicator data of the subject, the assessment indicator data before and after treatment are used as the reference benchmark and treatment result, respectively. The original improvement rate of each assessment indicator data is calculated. Based on the original improvement rate of each group corresponding to blood sex hormone level, semen quality parameters, penile hemodynamic parameters and oxidative stress markers, the comprehensive improvement index of each group in the single group of cell therapy is output as the cell therapy index set. The comprehensive improvement index includes the comprehensive blood sex hormone improvement index, the comprehensive semen quality improvement index, the comprehensive penile blood flow improvement index, and the comprehensive oxidative stress improvement index.

[0009] Specifically, the calculation logic of the comprehensive improvement index; After classifying each evaluation indicator data into positive and negative indicators, the original improvement rate of different types of indicators is output using the calculation logic of the corresponding type. For each subject, the original improvement rate of each group under each type of indicator is combined with a preset weight set, and the weighted fusion process is performed to output the improvement index of each type of indicator for the subject. For each subject in the single group of cell therapy, the arithmetic mean of the improvement index of the same type of indicator was taken as the comprehensive improvement index.

[0010] Specifically, S4-2: Similar to step S4-1, calculate the original improvement rate of each assessment indicator data for the subject under the single group of hydrogen and oxygen negative ions, using the assessment indicator data before and after treatment as the reference benchmark and treatment result, and output the comprehensive improvement index of each assessment indicator under the single group of hydrogen and oxygen negative ions as the hydrogen and oxygen negative ion index set. S4-3: Similar to step S4-1, calculate the original improvement rate of each assessment indicator data for the subjects in the combined treatment group, using the assessment indicator data before and after treatment as the reference benchmark and treatment result, and output the comprehensive improvement index of each assessment indicator data in the combined treatment group as the combined treatment index set.

[0011] Specifically, S4-4: Based on the cell therapy index set, the hydrogen and oxygen negative ion index set, and the combination therapy index set, calculate the additional gain index of combination therapy relative to two groups of single therapies. In the calculation process, a penalty factor quantified by the difference in the degree of efficacy of each subject under different therapies is introduced.

[0012] Specifically, the calculation logic of the extra gain exponent; S4-4-1: The combined treatment group, the cell therapy single group, and the hydrogen-oxygen negative ion single group are identified by the group identifier G, where G=C / H / U, G=C represents the combined treatment group, G=H represents the cell therapy single group, and G=U represents the hydrogen-oxygen negative ion single group; For the combination therapy group and the cell therapy group alone, the comprehensive improvement index of each group in the combination therapy index set and the cell therapy index set is extracted, and the ratio of the comprehensive improvement indices of the same type is calculated to obtain the single-type comprehensive gain ratio. The combined gain ratios of each group for the combination therapy group and the single cell therapy group are weighted and fused together with a preset set of benefit weights to obtain the additional gain index of the combination therapy group relative to the single cell therapy group. S4-4-2: Similarly to step S4-4-1, for the combined treatment group and the hydrogen-oxygen negative ion single group, extract the comprehensive improvement index of each group in the combined treatment index set and the hydrogen-oxygen negative ion index set, and calculate the ratio of the comprehensive improvement index of the same type to obtain the single-type comprehensive gain ratio. The combined gain ratio of each group for the combined treatment group and the single hydrogen-oxygen negative ion group is calculated and then weighted and fused with a preset set of benefit weights to obtain the additional gain index of the combined treatment group relative to the single hydrogen-oxygen negative ion group.

[0013] Specifically, the calculation logic of the penalty factor; The standard deviations of the improvement indices of each type of indicator for different subjects in the combined treatment group and the single cell therapy group were calculated respectively; the coefficients of variation of each type of indicator in the combined treatment group and the single cell therapy group were calculated based on the standard deviations; the difference between 1 and the coefficients of variation in the combined treatment group and the single cell therapy group was calculated as a penalty factor. The combined enhancement index of each group in the combined therapy index set and the cell therapy index set is multiplied by the corresponding output penalty factor for correction.

[0014] Specifically, the logic for constructing the inter-group difference curve; Preset intermediate time points after the start of treatment ;in This represents the end time of treatment, where m is the time point number. Obtain the corresponding indicators at time points for the combined treatment group, the cell therapy group alone, and the hydrogen and oxygen negative ion group. The overall improvement index; For each treatment group, the difference between the two groups was calculated at each time point; That is, the difference between the combination therapy group and the cell therapy single group. ; The difference between the combined treatment group and the single hydrogen-oxygen negative ion group ; With time as the horizontal axis, and Plot a curve with the vertical axis as the ordinate, which will serve as the difference curve between groups.

[0015] Specifically, Logic for calculating the joint advantage coefficient; Starting along the time axis, examine the inter-group difference curves point by point, identify the first time point that meets the preset conditions, and record it as the advantage start time point; calculate the time difference between the advantage start time point and the pre-treatment time point, and output the duration required for the efficacy advantage of the combined treatment; Starting from the point of advantage initiation, the duration for which the combination therapy group met the preset conditions was recorded as the duration of advantage. For each treatment time point, it is determined whether the preset conditions are met, and the time points that meet the preset conditions are represented by the number e; the consecutive time points marked as e are divided into independent dominant intervals; for each consecutive dominant interval, the area is calculated using the trapezoidal method, and the dominant area is obtained by summing them up. After weighted fusion processing of the duration required for therapeutic advantage, duration of advantage, and area of ​​advantage for each type of indicator, the combined advantage coefficient is output.

[0016] The technical effects and advantages of this invention are as follows: This invention introduces a specific evaluation mechanism for cell therapy combined with hydrogen and oxygen negative ions. By calculating the additional gain index of the combined therapy relative to two single therapies, and incorporating a penalty factor to correct for the dispersion of efficacy among different subjects, it quantifies the synergistic effect and clinical universality of the combined treatment. Simultaneously, by constructing inter-group difference curves, it extracts parameters such as the time point of advantage onset, duration of advantage, and area of ​​advantage, ultimately outputting a combined advantage coefficient. This coefficient comprehensively reflects the speed at which the combined therapy begins to show efficacy, the duration of advantage maintenance, and the cumulative benefit throughout the treatment cycle compared to single therapies. This method can clarify the clinical value-added potential of combined therapies, providing a quantitative basis for optimizing individualized treatment plans and treatment decisions. This invention overcomes the shortcomings of traditional assessment methods that focus only on single dimensions such as semen quality or sex hormones. It integrates four major categories of core indicators: blood sex hormone levels, semen quality parameters, penile hemodynamic parameters, and oxidative stress markers. Through positive / negative indicator classification, weighted fusion, and comprehensive improvement index calculation, it achieves multi-dimensional quantitative comparison of combined therapies, single cell therapies, and single hydrogen-oxygen negative ion therapies. It can comprehensively cover key pathophysiological aspects of the reproductive system, such as endocrine regulation, spermatogenesis, blood perfusion, and redox balance, providing a basis for clinical judgment of overall efficacy. Attached Figure Description

[0017] Figure 1 This is a flowchart of the efficacy evaluation method for cell therapy combined with hydrogen and oxygen negative ions in the reproductive system conditioning of this invention. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] like Figure 1 As shown, the efficacy evaluation method for cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning is as follows: Step S1: Male subjects with reproductive dysfunction who meet the inclusion criteria are randomly assigned to the combined treatment group, the cell therapy single group, and the hydrogen-oxygen negative ion single group; For example, 90 male patients with impaired reproductive function who met the inclusion and exclusion criteria were selected and randomly divided into group A (30 cases), group B (30 cases), and group C (30 cases) after obtaining informed consent. The baseline characteristics (age, body mass index, disease duration, etc.) of all patients were not statistically different and were comparable. Random number sequences were generated using the PROCPLAN procedure in SAS software. These sequences were placed in sealed, opaque envelopes with sequential numbers. Patients opened the envelopes in the order of enrollment to determine their group. None of the three groups of patients were informed of their specific group, i.e., a single-blind procedure was implemented. However, the therapists performing the procedure were aware of the groupings, while the data collection and statistical analysis personnel remained blind.

[0020] Step S2: The intervention was carried out on each group of subjects according to the preset plan. The combined treatment group received both cell therapy and hydrogen-oxygen negative ion inhalation. The cell therapy group received only the same cell therapy as the combined treatment group. The hydrogen-oxygen negative ion group received only the same hydrogen-oxygen negative ion inhalation as the combined treatment group. Step S3: Before treatment, at each preset intermediate time point after the start of treatment, and after the end of treatment, collect assessment index data for each subject. The assessment index data includes blood sex hormone levels, semen quality parameters, penile hemodynamic parameters, and oxidative stress markers. Blood sex hormone levels include serum total testosterone, serum free testosterone, luteinizing hormone, and follicle-stimulating hormone; Semen quality parameters include progressive motility sperm rate, sperm concentration, semen volume, and total sperm motility; Penile hemodynamic parameters include peak systolic velocity, end-diastolic velocity, resistance index, and cavernous artery diameter; Oxidative stress markers include oxidative damage markers and antioxidant capacity markers; Oxidative damage markers include serum malondialdehyde and serum 8-hydroxydeoxyguanosine; Antioxidant capacity markers include serum superoxide dismutase and serum total antioxidant capacity; Step S4: Based on the evaluation index data of the combined treatment group, the single cell therapy group, and the single hydrogen-oxygen negative ion group at each time point, use the pre-edited evaluation algorithm to calculate the additional gain index of the combined therapy relative to the two single therapies, simultaneously establish the efficacy trend curve of each group, extract the efficacy correlation parameters from the curve, and output the combined advantage coefficient. S4-1: In the single group of cell therapy, for each assessment index data of the subject, the assessment index data before and after treatment are used as the reference benchmark and treatment result, respectively. The original improvement rate of each assessment index data is calculated. Based on the original improvement rate of each group corresponding to blood sex hormone level, semen quality parameters, penile hemodynamic parameters and oxidative stress markers, the comprehensive improvement index of each group in the single group of cell therapy is output as the cell therapy index set. The comprehensive improvement index includes the comprehensive blood sex hormone improvement index, the comprehensive semen quality improvement index, the comprehensive penile blood flow improvement index, and the comprehensive oxidative stress improvement index; Specifically: After classifying each evaluation indicator data into positive and negative indicators, the original improvement rate of different types of indicators is output using the calculation logic of the corresponding type. Additional notes, for example, include the following positive indicators among the above evaluation metrics: Total testosterone, serum free testosterone, luteinizing hormone, follicle-stimulating hormone; Forward motility of sperm, sperm concentration, semen volume, and total sperm motility; Peak systolic velocity, resistance index, and cavernous artery diameter; Serum superoxide dismutase and serum total antioxidant capacity.

[0021] The original improvement rate of the positive indicator is obtained through the formula. The calculations were performed to obtain the result. in This represents the original improvement rate of the j-th indicator for the i-th subject in a single group of cell therapy. This represents the value of the j-th indicator for the i-th subject at the end of treatment in a single group of cell therapy. This represents the baseline value of the j-th indicator for the i-th subject in a single cell therapy group before treatment.

[0022] Negative indicators include: End-diastolic flow rate, serum malondialdehyde, and serum 8-hydroxydeoxyguanosine; The original improvement rate of the negative indicator is obtained through the formula. .

[0023] For each subject, the original improvement rate of each group under each type of indicator is combined with a preset weight set, and the weighted fusion process is performed to output the improvement index of each type of indicator for the subject. That is, using formulas The improvement index is obtained through calculation. ; This represents the improvement index of the i-th subject in the k-th dimension; k: dimension number (1=blood sex hormones, 2=semen quality, 3=penile blood flow, 4=oxidative stress). This indicates the number of indicators contained in the k-th dimension; Let be the weight of the j-th indicator in the k-th dimension; and the sum of the weights of each indicator in each dimension is one, and the weights are preset using the clinical expert consensus weighting method. Let be the original improvement rate of the j-th indicator for the i-th subject.

[0024] For each subject in a single group of cell therapy, the arithmetic mean of the improvement index of the same type of indicator was taken as the comprehensive improvement index. S4-2: Similar to step S4-1, calculate the original improvement rate of each assessment indicator data for the subject under the single group of hydrogen and oxygen negative ions, using the assessment indicator data before and after treatment as the reference benchmark and treatment result, and output the comprehensive improvement index of each assessment indicator under the single group of hydrogen and oxygen negative ions as the hydrogen and oxygen negative ion index set. S4-3: Similarly to step S4-1, calculate the original improvement rate of each assessment indicator data for the subjects in the combined treatment group, using the assessment indicator data before and after treatment as the reference benchmark and treatment result, and output the comprehensive improvement index of each assessment indicator data in the combined treatment group as the combined treatment index set. S4-4: Based on the cell therapy index set, the hydrogen and oxygen negative ion index set, and the combination therapy index set, calculate the additional gain index of combination therapy relative to two groups of single therapies. In the calculation process, a penalty factor quantified by the difference in the degree of efficacy of each subject under different therapies is introduced. Specifically: S4-4-1: The combined treatment group, the cell therapy single group, and the hydrogen-oxygen negative ion single group are identified by the group identifier G, where G=C / H / U, G=C represents the combined treatment group, G=H represents the cell therapy single group, and G=U represents the hydrogen-oxygen negative ion single group; The greater the dispersion of efficacy among subjects under different treatments, the greater the individual differences of the treatment and the worse the stability of clinical benefits. Therefore, it is necessary to penalize the comprehensive improvement index and use the dispersion coefficient method to quantify the intensity of the penalty. Calculate the standard deviation of the improvement index of each type of indicator for different subjects in the combined treatment group and the cell therapy single group respectively; Standard deviation ; The number of valid participants in group G; i is the participant number; The coefficients of variation for each type of index were calculated based on the standard deviation for the combined treatment group and the single cell therapy group. The difference between 1 and the coefficient of variation is calculated for the combined treatment group and the cell therapy single group, and used as a penalty factor; Additional note: If the difference is less than the preset reference discrete parameter, then the preset boundary value will be used.

[0025] The combined enhancement index of each group in the combined therapy index set and the cell therapy index set is multiplied by the corresponding output penalty factor for correction; For the combination therapy group and the cell therapy group alone, the comprehensive improvement index of each group in the combination therapy index set and the cell therapy index set is extracted, and the ratio of the comprehensive improvement indices of the same type is calculated to obtain the single-type comprehensive gain ratio. Additional explanation: In the ratio calculation process, the comprehensive improvement index of the combined treatment index is used. For molecular and cell therapy index sets, the corresponding comprehensive enhancement index Using the denominator, a ratio is calculated. A ratio greater than 1 indicates that the combination therapy is superior to the corresponding single therapy in this dimension. The larger the value, the more significant the advantage. The closer to 1, the more comparable the efficacy of the combination therapy to the corresponding single therapy. A ratio less than 1 indicates that the combination therapy is inferior to the corresponding single therapy in this dimension.

[0026] The combined gain ratios of each group for the combination therapy group and the single cell therapy group are weighted and fused together with a preset set of benefit weights to obtain the additional gain index of the combination therapy group relative to the single cell therapy group. That is, the additional gain index of the combined treatment group relative to the single cell therapy group through the formula. Calculated; in , , as well as These represent the combined gain ratios for each group in the combination therapy group and the cell therapy-only group, respectively. , , as well as Let be a pre-defined set of benefit weights, and let them sum to one.

[0027] S4-4-2: Similarly to step S4-4-1, for the combined treatment group and the hydrogen-oxygen negative ion single group, extract the comprehensive improvement index of each group in the combined treatment index set and the hydrogen-oxygen negative ion index set, and calculate the ratio of the comprehensive improvement index of the same type to obtain the single-type comprehensive gain ratio. As a supplementary explanation, similarly, S4-4-1 needs to be corrected using a penalty factor.

[0028] The combined gain ratio of each group for the combined treatment group and the single hydrogen-oxygen negative ion group is calculated and then weighted and fused with a preset benefit weight set to obtain the additional gain index of the combined treatment group relative to the single hydrogen-oxygen negative ion group. That is, the additional gain index of the combined treatment group relative to the single hydrogen and oxygen negative ion group through the formula. Calculated; in , , as well as These represent the calculated single-type comprehensive gain ratios for the combined treatment group and the single-group treatment with hydrogen and oxygen negative ions, respectively. , , as well as Let be a pre-defined set of benefit weights, and let them sum to one.

[0029] S4-5: Set the preset intermediate time points after the start of treatment ;in This represents the end time of treatment, where m is the time point number. Obtain the corresponding indicators at time points for the combined treatment group, the cell therapy group alone, and the hydrogen and oxygen negative ion group. The overall improvement index; For each treatment group, the difference between the two groups was calculated at each time point; That is, the difference between the combination therapy group and the cell therapy single group. ; Differences between various types of indicators ; and These represent the overall improvement index of each group within the combined treatment group. The comprehensive improvement index of each group under the single group of cell therapy.

[0030] The difference between the combined treatment group and the single hydrogen-oxygen negative ion group ; Differences between various types of indicators ; This represents the comprehensive improvement index of various indicators under a single group of hydrogen and oxygen negative ions.

[0031] With time as the horizontal axis, and Plot a curve with the vertical axis as the ordinate, to represent the difference curve between groups; Starting along the time axis, examine the inter-group difference curves point by point, identify the first time point that meets the preset conditions, and record it as the advantage initiation time point; Preset conditions: and All values ​​greater than 0 indicate that the overall improvement index of each group in the combined group is higher than that of the cell group and the hydrogen-oxygen group.

[0032] The time difference between the start time of the advantage and the time before treatment is calculated, and the duration required for the efficacy advantage of the combined treatment is output. Starting from the point of advantage initiation, the duration for which the combination therapy group met the preset conditions was recorded as the duration of advantage. The proportion of time during which combination therapy maintains a significant advantage relative to the total treatment time reflects the stability and persistence of the advantages of combination therapy.

[0033] For each treatment time point, determine whether the preset conditions are met, and represent the time points that meet the preset conditions with the number e; Divide the consecutive time points marked as e into independent dominant intervals; For example, interval 1: ; Interval 2: (The intermediate intervals are not advantageous points and are divided separately).

[0034] For each consecutive dominant interval, the area is calculated using the trapezoidal method, and the dominant areas are summed to obtain the dominant area. That is, for two adjacent effective dominant points, the area of ​​this segment is: ; The average of the two differences at the same time point is taken as the average dominance magnitude at that point, and the area of ​​the interval is calculated using the trapezoidal method, while also taking into account the dominance strength of the joint group over the two individual groups. The area of ​​all valid intervals is summed to obtain the dominant area.

[0035] It represents the cumulative total benefit of the combination therapy relative to the two individual groups over the entire treatment period, taking into account both the intensity and duration of the advantage; the higher the value, the more significant the overall advantage.

[0036] After weighted fusion processing of the duration required for efficacy advantage, duration of advantage, and area of ​​advantage for each type of indicator, the combined advantage coefficient is output. After normalizing the duration of therapeutic advantage, duration of advantage, and area of ​​advantage for each type of indicator, they were labeled as follows: , , ; The formula for calculating the dominance coefficient of a single-type indicator is: Single-type dominance coefficient ;in , as well as These are preset weighting coefficients, and their sum is one; The single-dimensional joint advantage coefficients of various types of indicators are weighted and fused using a predefined set of benefit weights to obtain the final joint advantage coefficient.

[0037] The above formulas are all dimensionless calculations. Dimensionless calculations can be performed using various methods such as standardization, which will not be elaborated here. The formulas are derived from software simulations based on a large amount of collected data, and the preset parameters in the formulas can be set by those skilled in the art according to the actual situation.

[0038] The above embodiments can be implemented, in whole or in part, by software, hardware, firmware, or any other combination thereof. When implemented using software, the above embodiments can be implemented, in whole or in part, as a computer program product. The computer program product includes one or more computer instructions or computer programs. When the computer instructions or computer programs are loaded or executed on a computer, all or part of the processes or functions described in the embodiments of this application are generated. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. The computer instructions can be stored in a computer-readable storage medium or transmitted from one computer-readable storage medium to another. For example, the computer instructions can be transmitted from one website, computer, server, or data center to another website, computer, server, or data center via wired or wireless (e.g., infrared, wireless, microwave, etc.) means. The computer-readable storage medium can be any available medium that a computer can access or a data storage device such as a server or data center that includes one or more sets of available media. The available medium can be a magnetic medium (e.g., floppy disk, ATA hard disk, magnetic tape), an optical medium (e.g., DVD), or a semiconductor medium. The semiconductor medium can be a solid-state ATA hard disk.

[0039] It should be understood that in the various embodiments of this application, the order of the above-mentioned processes does not imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of this application.

[0040] Those skilled in the art will recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0041] In the several embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative; for instance, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection between apparatuses or units may be electrical, mechanical, or other forms.

[0042] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0043] In addition, the functional units in the various embodiments of this application can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit.

[0044] If the aforementioned functions are implemented as software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, or a portion of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable ATA hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0045] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in the treatment of reproductive system disorders, characterized in that, include: Step S1: Male subjects with reproductive dysfunction were randomly assigned to the combined treatment group, the cell therapy single group, and the hydrogen-oxygen negative ion single group; Step S2: The intervention was carried out on each group of subjects according to the preset plan. The combined treatment group received both cell therapy and hydrogen-oxygen negative ion inhalation. The cell therapy group received only the same cell therapy as the combined treatment group. The hydrogen-oxygen negative ion group received only the same hydrogen-oxygen negative ion inhalation as the combined treatment group. Step S3: Before treatment, at each preset intermediate time point after the start of treatment, and after the end of treatment, collect assessment index data for each subject. The assessment index data includes blood sex hormone levels, semen quality parameters, penile hemodynamic parameters, and oxidative stress markers. Step S4: Based on the evaluation index data of the combined treatment group, the single cell therapy group, and the single hydrogen-oxygen negative ion group at each time point, use the pre-edited evaluation algorithm to calculate the additional gain index of the combined therapy relative to the two single therapies, simultaneously establish the inter-group difference curve, extract the efficacy correlation parameters from the curve, and output the combined advantage coefficient.

2. The method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning according to claim 1, characterized in that: Blood sex hormone levels include serum total testosterone, serum free testosterone, luteinizing hormone, and follicle-stimulating hormone; Semen quality parameters include progressive motility sperm rate, sperm concentration, semen volume, and total sperm motility; Penile hemodynamic parameters include peak systolic velocity, end-diastolic velocity, resistance index, and cavernous artery diameter; Oxidative stress markers include oxidative damage markers and antioxidant capacity markers; Oxidative damage markers include serum malondialdehyde and serum 8-hydroxydeoxyguanosine; Antioxidant capacity markers include serum superoxide dismutase and serum total antioxidant capacity.

3. The method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning according to claim 2, characterized in that: S4-1: In the single group of cell therapy, for each assessment index data of the subject, the assessment index data before and after treatment are used as the reference benchmark and treatment result, respectively. The original improvement rate of each assessment index data is calculated. Based on the original improvement rate of each group corresponding to blood sex hormone level, semen quality parameters, penile hemodynamic parameters and oxidative stress markers, the comprehensive improvement index of each group in the single group of cell therapy is output as the cell therapy index set. The comprehensive improvement index includes the comprehensive blood sex hormone improvement index, the comprehensive semen quality improvement index, the comprehensive penile blood flow improvement index, and the comprehensive oxidative stress improvement index.

4. The method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning according to claim 3, characterized in that: The calculation logic of the comprehensive improvement index; After classifying each evaluation indicator data into positive and negative indicators, the original improvement rate of different types of indicators is output using the calculation logic of the corresponding type. For each subject, the original improvement rate of each group under each type of indicator is combined with a preset set of weights, and the weighted fusion process is performed to output the improvement index of each type of indicator for the subject. For each subject in the single group of cell therapy, the arithmetic mean of the improvement index of the same type of indicator was taken as the comprehensive improvement index.

5. The method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning according to claim 3, characterized in that: S4-2: Similar to step S4-1, calculate the original improvement rate of each assessment indicator data for the subject under the single group of hydrogen and oxygen negative ions, using the assessment indicator data before and after treatment as the reference benchmark and treatment result, and output the comprehensive improvement index of each assessment indicator under the single group of hydrogen and oxygen negative ions as the hydrogen and oxygen negative ion index set. S4-3: Similar to step S4-1, calculate the original improvement rate of each assessment indicator data for the subjects in the combined treatment group, using the assessment indicator data before and after treatment as the reference benchmark and treatment result, and output the comprehensive improvement index of each assessment indicator data in the combined treatment group as the combined treatment index set.

6. The method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning according to claim 5, characterized in that: S4-4: Based on the cell therapy index set, the hydrogen and oxygen negative ion index set, and the combination therapy index set, calculate the additional gain index of combination therapy relative to two groups of single therapies. In the calculation process, a penalty factor quantified by the difference in the degree of efficacy of each subject under different therapies is introduced.

7. The method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning according to claim 6, characterized in that: The calculation logic of the additional gain exponent; S4-4-1: The combined treatment group, the cell therapy single group, and the hydrogen-oxygen negative ion single group are identified by the group identifier G, where G=C / H / U, G=C represents the combined treatment group, G=H represents the cell therapy single group, and G=U represents the hydrogen-oxygen negative ion single group; For the combination therapy group and the cell therapy group alone, the comprehensive improvement index of each group in the combination therapy index set and the cell therapy index set is extracted, and the ratio of the comprehensive improvement indices of the same type is calculated to obtain the single-type comprehensive gain ratio. The combined gain ratios of each group for the combination therapy group and the single cell therapy group are weighted and fused together with a preset set of benefit weights to obtain the additional gain index of the combination therapy group relative to the single cell therapy group. S4-4-2: Similarly to step S4-4-1, for the combined treatment group and the hydrogen-oxygen negative ion single group, extract the comprehensive improvement index of each group in the combined treatment index set and the hydrogen-oxygen negative ion index set, and calculate the ratio of the comprehensive improvement index of the same type to obtain the single-type comprehensive gain ratio. The combined gain ratio of each group for the combined treatment group and the single hydrogen-oxygen negative ion group is calculated and then weighted and fused with a preset set of benefit weights to obtain the additional gain index of the combined treatment group relative to the single hydrogen-oxygen negative ion group.

8. The method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning according to claim 7, characterized in that: The calculation logic of the penalty factor; The standard deviations of the improvement indices of each type of indicator for different subjects in the combined treatment group and the single cell therapy group were calculated respectively; the coefficients of variation of each type of indicator in the combined treatment group and the single cell therapy group were calculated based on the standard deviations; the difference between 1 and the coefficients of variation in the combined treatment group and the single cell therapy group was calculated as a penalty factor. The combined enhancement index of each group in the combined therapy index set and the cell therapy index set is multiplied by the corresponding output penalty factor for correction.

9. The method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning according to claim 7, characterized in that: Logic for constructing between-group difference curves; Preset intermediate time points after the start of treatment ;in This represents the end time of treatment, where m is the time point number. Obtain the corresponding indicators at time points for the combined treatment group, the cell therapy group alone, and the hydrogen and oxygen negative ion group. The overall improvement index; For each treatment group, the difference between the two groups was calculated at each time point; That is, the difference between the combination therapy group and the cell therapy single group. ; The difference between the combined treatment group and the single hydrogen-oxygen negative ion group ; With time as the horizontal axis, and Plot a curve with the vertical axis as the ordinate, which will serve as the difference curve between groups.

10. The method for evaluating the efficacy of cell therapy combined with hydrogen and oxygen negative ions in reproductive system conditioning according to claim 9, characterized in that: Logic for calculating the joint advantage coefficient; Starting along the time axis, examine the inter-group difference curves point by point, identify the first time point that meets the preset conditions, and record it as the advantage initiation time point; The time difference between the start time of the advantage and the time before treatment is calculated, and the duration required for the efficacy advantage of the combined treatment is output. Starting from the point of advantage initiation, the duration for which the combination therapy group met the preset conditions was recorded as the duration of advantage. For each treatment time point, it is determined whether the preset conditions are met, and the time points that meet the preset conditions are represented by the number e; the consecutive time points marked as e are divided into independent dominant intervals; for each consecutive dominant interval, the area is calculated using the trapezoidal method, and the dominant area is obtained by summing them up. After weighted fusion processing of the duration required for therapeutic advantage, duration of advantage, and area of ​​advantage for each type of indicator, the combined advantage coefficient is output.

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