Method and system for evaluating treatment effect of femoral shaft fracture in clinical test

Abstract

The invention provides a method and a system for evaluating a femoral shaft fracture treatment effect in a clinical test. The method comprises the following steps: S1, acquiring historical data of a to-be-tested sample drug clinically used by a subject, and taking the historical data as a test group; s2, presetting evaluation parameters; s3, presetting a mapping relation between the historical data and the evaluation parameters; s4, establishing a ray joint evaluation model according to the scoring parameters in the S2 and the mapping relation in the S3; s5, acquiring historical data of a to-be-tested sample drug which is not clinically used by the subject, and taking the historical data as a control group; s6, inputting the historical data of the test group and the historical data of the control group into the ray joint evaluation model at the same time; and S7, calculating the result in the step S6, and judging the optimal effect results of the test group and the control group. According to the method, evaluation of effectiveness, safety and economy can be given to sample experiment drugs.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical treatment effect evaluation, and particularly relates to a method and system for evaluating treatment effect of femoral shaft fracture in clinical trials. BACKGROUND

[0002] Femoral shaft fracture refers to the fracture of the part of femur below the lesser trochanter to the above femoral condyle, which is one of the most common adult fractures in clinic, accounting for about 6% of all body fractures. The fracture is usually caused by high-energy injury. 30% of patients are accompanied by multiple fractures, extensive soft tissue and organ damage, etc. These injuries can cause a large amount of bleeding and even shock. Femur is one of the main weight-bearing bones of lower limbs, so the fracture often does not heal, and improper treatment can cause lower limb deformity and dysfunction. According to relevant reports, the nonunion accounts for about 6%-10% of all body fractures. In a survey of traumatic fractures in 1998, femoral fracture ranked second among all limb fractures, and femoral shaft fracture accounted for nearly half of femoral fractures. With the development of traffic and construction industries in recent years, the incidence of femoral shaft fractures caused by traffic and construction injuries is increasing year by year, and the medical and social pressure is becoming more and more prominent.

[0003] However, the drugs for treating such diseases usually have some adverse reactions. For example, in January-June 2017, the national adverse drug reaction monitoring system data showed that there were 7 adverse reaction reports of Henggu Bone Injury Healing Agent. Among them, 1 male accounted for 14.3%, and 6 females accounted for 85.7%. The oldest was 67 years old and the youngest was 29 years old. Through the relevance evaluation of the city evaluation in the 7 reports, 3 reports (42.8%) were "very likely", and 4 reports (57.2%) were "possible". The severity of the reports was all general, and the description recorded dry mouth and slight dizziness. In the first half of 2018, there were 31 adverse reaction reports of Henggu Bone Injury Healing Agent. Among them, 16 cases of adverse reactions recorded in the instructions accounted for 51.6%; 1 case of serious adverse reaction accounted for 3.2%; 15 cases of new general adverse reactions accounted for 48.4%; 2 cases of new serious adverse reactions accounted for 6.4%; there was no group adverse reaction event, and there was no death case. The two new serious adverse reaction reports were from medical institutions, and the two cases caused other important medical events, and the adverse reactions were skin rash. After stopping the drug, the patients were given corresponding treatment and their conditions improved. However, whether such drugs have effectiveness, safety and economy in clinical experiments needs to be considered.

[0004] Therefore, it is necessary to study a method and system for evaluating the treatment effect of femoral shaft fracture in clinical trials to overcome the shortcomings of the prior art and solve or alleviate one or more of the above problems. SUMMARY

[0005] Therefore, the application provides a method and system for evaluating the treatment effect of femoral shaft fracture in clinical trials, which can evaluate the effectiveness, safety and economy of the results of sample experiments.

[0006] In one aspect, the application provides a method for evaluating the treatment effect of femoral shaft fracture in clinical trials, which comprises the following steps:

[0007] S1: obtaining the historical data of subjects using the sample drug in clinical trials as a test group;

[0008] S2: presetting the evaluation parameters;

[0009] S3: presetting the mapping relationship between the historical data and the evaluation parameters;

[0010] S4: establishing a radiological joint evaluation model according to the evaluation parameters in S2 and the mapping relationship in S3;

[0011] S5: obtaining the historical data of subjects not using the sample drug in clinical trials as a control group;

[0012] S6: inputting the historical data of the test group and the historical data of the control group into the radiological joint evaluation model;

[0013] S7: calculating the results in S6 to determine the superior efficacy results of the test group and the control group.

[0014] According to any possible implementation of the above-mentioned aspect, further provided is an implementation, wherein the historical data in S1 is the radiological detection result of femoral shaft fracture.

[0015] According to any possible implementation of the above-mentioned aspect, further provided is an implementation, wherein the evaluation parameters in S2 include the radiological direction, the fracture line parameters and the callus parameters.

[0016] According to any possible implementation of the above-mentioned aspect, further provided is an implementation, wherein the radiological direction includes the front, rear, left and right of the femoral shaft to be detected.

[0017] According to any possible implementation of the above-mentioned aspect, further provided is an implementation, wherein the fracture line parameters include first fracture line parameters and second fracture line parameters, the first fracture line parameters correspond to the presence of fracture line, and the second fracture line parameters correspond to the absence of fracture line.

[0018] According to any possible implementation of the above-mentioned aspect, further provided is an implementation, wherein the callus parameters include first callus parameters and second callus parameters, the first callus parameters correspond to the absence of callus formation, and the second callus parameters correspond to the visible callus formation.

[0019] According to the aspect and any possible implementation manner above, further provided is an implementation manner, and the mapping relationship in S3 is specifically:

[0020] The first fracture line parameter and the first callus parameter exist simultaneously, and a first evaluation parameter is preset;

[0021] The first fracture line parameter and the second callus parameter exist simultaneously, and a second evaluation parameter is preset;

[0022] The second fracture line parameter and the second callus parameter exist simultaneously, and a third evaluation parameter is preset;

[0023] The corresponding result of the first evaluation parameter is 1 point, the corresponding result of the second evaluation parameter is 2 points, and the corresponding result of the third evaluation parameter is 3 points.

[0024] According to the aspect and any possible implementation manner above, further provided is an implementation manner, and S6 is specifically:

[0025] S61: The historical data of the test group and the historical data of the control group are simultaneously obtained through the mapping relationship in S3 to calculate four groups of evaluation parameters of the front, the back, the left and the right of the femoral shaft to be detected;

[0026] S62: The four groups of evaluation parameters corresponding to each data in the historical data of the test group and the historical data of the control group are summed to obtain evaluation data of the test group and the control group;

[0027] S63: The evaluation data of the test group and the control group are simultaneously input into a radiographic joint evaluation model for calculation.

[0028] According to the aspect and any possible implementation manner above, further provided is an implementation manner, and the calculation method in S7 is specifically: a change value of the evaluation data is calculated, variance analysis is used for comparison between the test group and the control group, a confidence interval of the difference value of the two groups of evaluation data is calculated, and if the lower limit of the 95% confidence interval of the difference value is greater than the superior efficacy boundary value 1, it is indicated that the test group is superior to the control group.

[0029] According to the aspect and any possible implementation manner above, further provided is an evaluation system for a treatment effect of femoral shaft fracture in a clinical trial, the evaluation system comprising an input end, a processing end, a storage end and an output end, the input end being connected to the storage end and the output end through the processing end, and the processing end executing the evaluation method.

[0030] Compared with the prior art, the present application can obtain the following technical effects:

[0031] The present application can test the treatment effect, effectiveness, safety and economy of the drug for treating femoral shaft fracture through a randomized, double-blind, placebo parallel control multi-center clinical trial.

[0032] Of course, implementing any product of the present application does not necessarily need to achieve all the technical effects described above at the same time. BRIEF DESCRIPTION OF DRAWINGS

[0033] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiments will be briefly introduced as follows. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor on the basis of these drawings.

[0034] Figure 1 is a flowchart of the evaluation method provided by an embodiment of the present application. DETAILED DESCRIPTION

[0035] In order to better understand the technical solutions of the present application, the embodiments of the present application will be described in detail below with reference to the drawings.

[0036] It should be clear that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments obtained by those skilled in the art on the basis of the embodiments in the present application without creative labor are within the scope of protection of the present application.

[0037] The terms used in the embodiments of the present application are only for the purpose of describing the specific embodiments, and are not intended to limit the present application. The singular forms "a", "said" and "the" used in the embodiments of the present application and the appended claims are also intended to include the plural forms, unless the context clearly indicates otherwise.

[0038] The present application provides an evaluation method for the treatment effect of femoral shaft fracture in clinical trials, the evaluation method comprising the following steps:

[0039] S1: obtaining the historical data of the subjects using the test sample drug in clinical practice and taking it as a test group;

[0040] S2: presetting evaluation parameters;

[0041] S3: presetting the mapping relationship between the historical data and the evaluation parameters;

[0042] S4: establishing a joint evaluation model of X-rays according to the scoring parameters in S2 and the mapping relationship in S3;

[0043] S5: obtaining the historical data of the subjects not using the test sample drug in clinical practice and taking it as a control group;

[0044] S6: inputting the historical data of the test group and the historical data of the control group into the radiographic joint evaluation model simultaneously;

[0045] S7: calculating the result in S6 to determine the efficacy result of the test group and the control group.

[0046] The historical data in S1 is the radiographic detection result of femoral shaft fracture.

[0047] The evaluation parameters in S2 include radiographic direction, fracture line parameter and callus parameter.

[0048] The radiographic direction includes the front, back, left and right of the femoral shaft to be detected.

[0049] The fracture line parameter includes first fracture line parameter and second fracture line parameter, the first fracture line parameter corresponds to the presence of fracture line, and the second fracture line parameter corresponds to the absence of fracture line.

[0050] The callus parameter includes first callus parameter and second callus parameter, the first callus parameter corresponds to no callus formation, and the second callus parameter corresponds to visible callus formation.

[0051] The mapping relationship in S3 is specifically:

[0052] The first fracture line parameter and the first callus parameter exist simultaneously, and a first evaluation parameter is preset;

[0053] The first fracture line parameter and the second callus parameter exist simultaneously, and a second evaluation parameter is preset;

[0054] The second fracture line parameter and the second callus parameter exist simultaneously, and a third evaluation parameter is preset;

[0055] The first evaluation parameter corresponds to a result of 1 point, the second evaluation parameter corresponds to a result of 2 points, and the third evaluation parameter corresponds to a result of 3 points.

[0056] S6 is specifically:

[0057] S61: obtaining four groups of evaluation parameters of the front, back, left and right of the femoral shaft to be detected by the mapping relationship in S3 through the historical data of the test group and the historical data of the control group simultaneously;

[0058] S62: summing up the four groups of evaluation parameters corresponding to each data in the historical data of the test group and the historical data of the control group to obtain the evaluation data of the test group and the control group;

[0059] S63: inputting the evaluation data of the test group and the control group into the radiographic joint evaluation model simultaneously for calculation.

[0060] The calculation method in S7 is specifically: calculating the change value of evaluation data, comparing the test group and the control group by variance analysis, and calculating the confidence interval of the difference value of the evaluation data of the two groups, if the lower limit of the 95% confidence interval of the difference value is greater than the superior efficiency boundary value 1, it indicates that the test group is superior to the control group.

[0061] Wherein, the change value = visit point - baseline;

[0062] The confidence interval calculation formula is as follows:

[0063]

[0064] The variance analysis method is specifically as follows:

[0065] Total variation:

[0066]

[0067] Between-group variation:

[0068]

[0069] Within-group variation:

[0070]

[0071] Wherein, in the formula is the mean of the test group, is the mean of the control group, is the combined variance estimate of the two groups, n1 is the number of observation cases in the test group, n2 is the number of observation cases in the control group, is the variance of the test group, is the variance of the control group, X1 is the observation value of the test group, X2 is the observation value of the control group, X ij is the observation value, is the total variance, N is the total number of observation cases, n i is the number of observation cases corresponding to each group, is the mean corresponding to each group, k is the number of groups, is the variance corresponding to each group.

[0072] The application provides an evaluation system for the treatment effect of femoral shaft fracture in clinical trials, which comprises an input end, a processing end, a storage end and an output end, the input end is connected to the storage end and the output end through the processing end, and the processing end executes the evaluation method.

[0073] Example 1:

[0074] The application provides the following comparative cases to prove the feasibility of the application:

[0075] 1. Test group

[0076] The data results of the patients treated in the Beijing Jishuitan Hospital Orthopedics Department from 2023 to 2024 are as follows:

[0077]

[0078] The evaluation scores of each group are as follows:

[0079]

[0080]

[0081] The change value calculation results are as follows:

[0082] The mean change value of the test group is 7

[0083] 2. Control group

[0084] The data results of the patients treated in the Beijing Jishuitan Hospital Orthopedics Department from 2023 to 2024 are as follows:

[0085]

[0086]

[0087] The evaluation scores of each group are as follows:

[0088]

[0089]

[0090] The change value calculation results are as follows:

[0091] The mean change value of the control group is 3.9

[0092] The variance analysis is used to compare the test group and the control group, and the confidence interval of the difference value of the evaluation data of the two groups is calculated. The comparison result of the lower limit of the 95% confidence interval of the difference value and the superior efficiency boundary value 1 is as follows: the mean difference is 3.1, the confidence interval is 1.89-4.31, and the lower limit 1.89 is greater than the superior efficiency boundary value 1. The result shows that the test group is superior to the control group.

[0093] The above describes a method and system for evaluating the treatment effect of femoral shaft fracture in clinical trials. The above examples are used to help understand the method and its core idea; at the same time, for those skilled in the art, according to the idea of the present application, the specific implementation and application range will be changed, and the above description should not be understood as a limitation of the present application.

[0094] Certain terms are used in the specification and claims to refer to specific components. Those skilled in the art will understand that hardware manufacturers may use different names to refer to the same component. This specification and claims do not distinguish components based on differences in name, but rather on differences in function. The terms "comprising" and "including" used throughout the specification and claims are open-ended and should be interpreted as "comprising / including but not limited to". "Approximately" means that within an acceptable margin of error, those skilled in the art can solve the technical problem and substantially achieve the technical effect within a certain margin of error. The following descriptions in the specification are preferred embodiments for carrying out this application; however, these descriptions are for the purpose of illustrating the general principles of this application and are not intended to limit the scope of this application. The scope of protection of this application shall be determined by the appended claims.

[0095] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a product or system comprising a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a product or system. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the product or system that includes said element.

[0096] It should be understood that the term "and / or" used in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this article generally indicates that the preceding and following related objects have an "or" relationship.

[0097] The foregoing description illustrates and describes several preferred embodiments of this application. However, as previously stated, it should be understood that this application is not limited to the forms disclosed herein and should not be construed as excluding other embodiments. It can be used in various other combinations, modifications, and environments, and can be altered within the scope of the application concept described herein through the foregoing teachings or techniques or knowledge in related fields. Any modifications and variations made by those skilled in the art that do not depart from the spirit and scope of this application should be within the protection scope of the appended claims.

Claims

1. A method for evaluating the effectiveness of treatment of a femoral shaft fracture in a clinical trial, characterized by, The evaluation method comprises the following steps: S1: obtaining the history data of the subjects using the test sample drug in clinical practice as a test group; S2: presetting evaluation parameters; S3: presetting the mapping relationship between the history data and the evaluation parameters; S4: establishing a joint evaluation model according to the scoring parameters in S2 and the mapping relationship in S3; S5: obtaining the history data of the subjects not using the test sample drug in clinical practice as a control group; S6: inputting the history data of the test group and the history data of the control group into the joint evaluation model at the same time; S7: calculating the results in S6 to determine the superior efficiency results of the test group and the control group.

2. The evaluation method according to claim 1, characterized by The history data in S1 is the radiological detection result of femoral shaft fracture.

3. The evaluation method according to claim 1, characterized by, The evaluation parameters in S2 include the ray direction, the fracture line parameters and the callus parameters.

4. The evaluation method according to claim 3, characterized by The ray direction includes the front, back, left and right of the femoral shaft to be detected.

5. The evaluation method according to claim 4, characterized by The fracture line parameters include the first fracture line parameter and the second fracture line parameter, the first fracture line parameter corresponds to the presence of a fracture line, and the second fracture line parameter corresponds to the absence of a fracture line.

6. The evaluation method according to claim 5, characterized by The callus parameters include the first callus parameter and the second callus parameter, the first callus parameter corresponds to the absence of callus formation, and the second callus parameter corresponds to the presence of callus formation.

7. The evaluation method according to claim 6, characterized by The mapping relationship in S3 is as follows: The first fracture line parameter and the first callus parameter exist at the same time, and the first evaluation parameter is preset; The first fracture line parameter and the second callus parameter exist at the same time, and the second evaluation parameter is preset; The second fracture line parameter and the second callus parameter exist at the same time, and the third evaluation parameter is preset; The first evaluation parameter corresponds to a result of 1 point, the second evaluation parameter corresponds to a result of 2 points, and the third evaluation parameter corresponds to a result of 3 points.

8. The evaluation method according to claim 7, characterized by S6 is specifically as follows: S61: obtaining four groups of evaluation parameters of the front, back, left and right of the femoral shaft to be detected by the mapping relationship in S3 at the same time through the history data of the test group and the history data of the control group; S62: summing up the four groups of evaluation parameters corresponding to each data in the history data of the test group and the history data of the control group to obtain the evaluation data of the test group and the control group; S63: inputting the evaluation data of the test group and the control group into the joint evaluation model at the same time for calculation.

9. The evaluation method according to claim 8, characterized by, The calculation method in S7 is specifically as follows: calculating the change value of the evaluation data, comparing the test group and the control group by variance analysis, and calculating the confidence interval of the difference value of the two groups of evaluation data at the same time, if the lower limit of the 95% confidence interval of the difference value is greater than the superior efficiency boundary value 1, it means that the test group is superior to the control group.

10. An evaluation system for the treatment effect of a femoral shaft fracture in a clinical trial, characterized by, The evaluation system comprises an input end, a processing end, a storage end and an output end, the input end is connected to the storage end and the output end at the same time through the processing end, and the processing end executes the evaluation method according to any one of claims 1-9.

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