A universal processing method, device and equipment compatible with AERS data and FAERS data

Through a general processing method that is compatible with AERS and FAERS data, the use of MedDRA and WHODrug dictionary for automatic search and storage of information is solved, and the problem of the inability to compatible with AERS data and cumbersome operations in the existing technology is solved, the accuracy and reliability of the data are achieved, and the operation process is simplified.

CN119739707AInactive Publication Date: 2025-04-01BEIJING INSIGHT NETWORK CO LTD
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Patent Information

Application Number
CN202510245154.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-03-04
Publication Date
2025-04-01
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The existing FAERS data standardization technology is not compatible with AERS data, and due to the large amount of WHODrug drug information data, the operation is cumbersome, and the FDA's multiple modifications to the data fields and the existence of delete files after 2012q4 are not taken into account, which affects the reliability and accuracy of the data mining results.

Method used

It provides a general processing method that is compatible with AERS data and FAERS data. By reading the to-processed data files from the FAERS system, converting them to FAERS data format, and then converting them to JSON data format. Information is automatically searched and stored based on the MedDRA dictionary and WHODrug dictionary, and finally the processed data is stored in the target database and a data index is established.

Benefits of technology

It realizes standardized processing that is compatible with AERS and FAERS data, simplifies the operation process, ensures the accuracy and reliability of the data, and facilitates subsequent data cleaning, query, processing and statistical analysis.

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Abstract

The present invention discloses a general processing method, device and equipment compatible with AERS data and FAERS data, and relates to the technical field of data processing. The method is to first uniformly convert the data file to be processed read from the FAERS system into a first data file in the FAERS data format, and then convert the file into a second data file in the JSON data format, and then obtain the MedDRA term code and its level and drug information based on the MedDRA dictionary and the WHODrug dictionary respectively and store them in new fields, and finally store the second data file containing the new field in the target database, and establish a data index, so that in the data standardization process, not only can it be compatible with AERS data, but also can automatically search and store information with the help of the dictionary, solve the problem of cumbersome operation caused by the large amount of WHODrug drug information data, and can facilitate users to perform subsequent data cleaning, query, processing and statistical analysis, etc., which is convenient for practical application and promotion.
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Description

Technical Field

[0001] The present invention belongs to the field of data processing technology, and in particular relates to a general processing method, device and equipment compatible with AERS data and FAERS data. Background Art

[0002] In recent years, with the frequent occurrence of adverse drug reaction (ADR) events, the problem has increasingly evolved into a serious public health problem that needs to be solved. Research on the potential adverse reactions of currently marketed drugs mainly relies on the adverse drug reaction data in the spontaneous reporting systems of various organizations. The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is a typical public spontaneous reporting system (SRS). The FAERS database contains information on all ADR events and medication error events collected by the FDA, and is mainly used for post-market safety monitoring of drugs and biological products.

[0003] Since the reporter of the spontaneous reporting system can be a professional such as a doctor, pharmacist or nurse, or a non-professional such as a patient, a patient's family member or a lawyer, the data has problems such as multiple sources and inadequate format. Therefore, it is very important to standardize the data of the spontaneous reporting system to solve the problems of inaccurate, unreliable and no reference value of the mined adverse drug reaction signals.

[0004] In response to the above problems, the existing patent "CN117116503A, a FAERS data standardization method" proposes a FAERS data standardization method, which includes the following steps: A. Obtain the FAERS data set and integrate the data set; B. Fill missing values ​​and remove duplicates on the integrated DEMO table; C. Remove duplicates from the remaining tables in the FAERS data set; D. Standardize the REAC table; E. Standardize the drug names in the DRUG table; F. Generate a 2×2 contingency table of adverse drug reactions. Although this solution solves the problems of data duplication, data omission and non-standard drug names in the FAERS data set, improves the proportion of standardized drug names, makes the values ​​in the generated 2×2 contingency table of adverse drug reactions more accurate, and improves the accuracy of subsequent mining of adverse drug reaction signals, the FDA migrated the AERS (Adverse Events Reporting System) to the FAERS system in 2012q4, resulting in certain differences in the data between the two systems. Therefore, the aforementioned existing technology is not compatible with AERS data, and there is a problem of cumbersome operation due to the large amount of drug information data in WHODrug (World Health Organization Drug Dictionary, the most important dictionary for drug coding). In addition, the FDA has made multiple modifications to the data fields provided after 2012q4. The most important thing is that it began to provide delete files after 2019q1 (which can be translated into Chinese as deletion indication files, that is, if a certain adverse reaction report is deleted for some reason, a deletion indication will be provided in this file). The aforementioned existing technology did not take this into account when mining adverse drug reaction data, which will lead to the situation where data is invalid without knowing it, affecting the reliability and accuracy of subsequent data mining results. Summary of the invention

[0005] The purpose of the present invention is to provide a general processing method, device, computer equipment, computer-readable storage medium and computer program product that are compatible with AERS data and FAERS data, so as to solve the problems that the existing FAERS data standardization technology is incompatible with AERS data and has cumbersome operations due to the large amount of WHODrug drug information data.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions: First, a general processing method compatible with AERS data and FAERS data is provided, including: Reading a data file to be processed from the FAERS system, wherein the data format of the data file to be processed is an AERS data format or a FAERS data format; Convert the data files to be processed into a first data file in a FAERS data format, and then convert the first data file into a second data file in a JSON data format; extracting the adverse reaction name from the second data file, then searching in the MedDRA dictionary for at least one MedDRA term code that matches the adverse reaction name, and finally storing the at least one MedDRA term code and the level of each MedDRA term code in the at least one MedDRA term code in the newly added adverse reaction information field in the second data file; Extracting the drug name from the second data file, then searching for drug information corresponding to the drug name in the WHODrug dictionary, and finally storing the drug information in a newly added drug information field in the second data file; The second data file is stored in the target database, and a data index is established.

[0007] Based on the above invention content, a new data standardization scheme that can process AERS data and FAERS data compatibly is provided, that is, the data files to be processed read from the FAERS system are first uniformly converted into a first data file in the FAERS data format, and then the file is converted into a second data file in the JSON data format, and then the MedDRA term code and its level and drug information are obtained based on the MedDRA dictionary and the WHODrug dictionary respectively and stored in new fields, and finally the second data file containing the new field is stored in the target database, and a data index is established, so that in the data standardization process, not only can it be compatible with AERS data, but also the information can be automatically searched and stored with the help of the dictionary, which solves the problem of cumbersome operation caused by the large amount of WHODrug drug information data, and can facilitate users to perform subsequent data cleaning, query, processing and statistical analysis, etc., which is convenient for practical application and promotion.

[0008] In a possible design, the data file to be processed is read from the FAERS system, including: According to the data file address specified in the configuration file, the specified data file is found in the FAERS system; Automatically identify the file type of the designated data file. If the file type is an ascii file type, use the csv.DictReader reader to read the designated data file from the FAERS system as the data file to be processed. If the file type is an xml file type, use the xml.etree.ElementTree reader to read the designated data file from the FAERS system as the data file to be processed. The data format of the data file to be processed is an AERS data format or a FAERS data format.

[0009] In a possible design, the data files to be processed are uniformly converted into first data files in FAERS data format, including: According to the file name of the data file to be processed, if it is determined that the data file to be processed is in the AERS data format, based on the FAERS and AERS field mapping files, the data file to be processed is uniformly converted into a first data file in the FAERS data format; if it is determined that the data file to be processed is in the FAERS data format, the data file to be processed is directly used as the first data file.

[0010] In one possible design, after storing the second data file in the target database, the method further includes: Determine whether there are delete files corresponding to each adverse drug reaction report in the target database in the FAERS system; If it is determined that there is a delete file corresponding to a certain adverse drug reaction report in the target database in the FAERS system, then the certain adverse drug reaction report is marked as logically deleted; Grouping all adverse drug reaction reports in the target database that are not marked as logically deleted based on the case unique identifier CASEID to obtain adverse drug reaction report groups of different patients, wherein the adverse drug reaction report group contains at least one adverse drug reaction report that is not marked as logically deleted; For each patient, the adverse drug reaction report with the largest version number in the corresponding adverse drug reaction report group will be used as the corresponding latest data.

[0011] In a possible design, after determining the latest data of each patient, the method further includes: For each patient, drug information and adverse reaction information are extracted from the corresponding latest data, and then Cartesian product processing is performed on the drug information and the adverse reaction information to obtain at least one drug and adverse reaction pair, and finally the at least one drug and adverse reaction pair is stored in a newly added information field in the corresponding latest data.

[0012] In a possible design, after determining the latest data of each patient, the method further includes: For each patient, the integrity of the corresponding latest data is verified, and if the verification result indicates failure, a corresponding data incomplete prompt message is output.

[0013] In a second aspect, a general processing device compatible with AERS data and FAERS data is provided, including a data file reading unit, a file format conversion unit, an adverse reaction matching unit, a drug information search unit and a data file storage unit; The data file reading unit is used to read the data file to be processed from the FAERS system, wherein the data format of the data file to be processed is the AERS data format or the FAERS data format; The file format conversion unit is communicatively connected to the data file reading unit, and is used to uniformly convert the data files to be processed into a first data file in a FAERS data format, and then convert the first data file into a second data file in a JSON data format; The adverse reaction matching unit is communicatively connected to the file format conversion unit, and is used to extract the adverse reaction name from the second data file, then search for at least one MedDRA term code matching the adverse reaction name in the MedDRA dictionary, and finally store the at least one MedDRA term code and the level of each MedDRA term code in the at least one MedDRA term code in the newly added adverse reaction information field in the second data file; The drug information search unit is communicatively connected to the file format conversion unit, and is used to extract the drug name from the second data file, then search for drug information corresponding to the drug name in the WHODrug dictionary, and finally store the drug information in a newly added drug information field in the second data file; The data file storage unit is respectively communicatively connected to the adverse reaction matching unit and the drug information search unit, and is used to store the second data file in a target database and establish a data index.

[0014] In a third aspect, the present invention provides a computer device comprising a memory, a processor and a transceiver which are communicatively connected in sequence, wherein the memory is used to store a computer program, the transceiver is used to send and receive messages, and the processor is used to read the computer program and execute the general processing method as described in the first aspect or any possible design of the first aspect.

[0015] In a fourth aspect, the present invention provides a computer-readable storage medium having instructions stored thereon. When the instructions are run on a computer, the general processing method as described in the first aspect or any possible design of the first aspect is executed.

[0016] In a fifth aspect, the present invention provides a computer program product, comprising a computer program or instructions, which, when executed by a computer, implement the general processing method as described in the first aspect or any possible design of the first aspect.

[0017] Beneficial effects of the above scheme: (1) The present invention creatively provides a new data standardization scheme that can process AERS data and FAERS data compatibly, that is, firstly convert the data file to be processed read from the FAERS system into a first data file in the FAERS data format, and then convert the file into a second data file in the JSON data format, and then obtain the MedDRA term code and its level and drug information based on the MedDRA dictionary and the WHODrug dictionary respectively and store them in new fields, and finally store the second data file containing the new field in the target database, and establish a data index. In this way, in the process of data standardization, not only can it be compatible with AERS data, but it can also automatically search and store information with the help of the dictionary, solving the problem of cumbersome operation caused by the large amount of WHODrug drug information data, and facilitating users to perform subsequent data cleaning, query, processing and statistical analysis, etc., which is convenient for practical application and promotion; (2) It can avoid situations where data becomes invalid without being noticed, ensure the reliability and accuracy of subsequent data mining results, and facilitate query and analysis by generating drug-adverse reaction pairs. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0019] Figure 1A schematic flow chart of a general processing method for compatible AERS data and FAERS data provided in an embodiment of the present application.

[0020] Figure 2 A schematic diagram of a flow chart of reading a data file to be processed in a general processing method provided in an embodiment of the present application.

[0021] Figure 3 A schematic diagram of a process for processing based on a delete file in a general processing method provided in an embodiment of the present application.

[0022] Figure 4 A schematic diagram of the structure of a general processing device compatible with AERS data and FAERS data provided in an embodiment of the present application.

[0023] Figure 5 A schematic diagram of the structure of a computer device provided in an embodiment of the present application. DETAILED DESCRIPTION

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the present invention will be briefly introduced below in combination with the drawings and the description of the embodiments or the prior art. Obviously, the following description of the structures of the drawings is only some embodiments of the present invention. For ordinary technicians in this field, other embodiments can be obtained based on these embodiments without creative work. It should be noted that the description of these embodiments is used to help understand the present invention, but does not constitute a limitation of the present invention.

[0025] It should be understood that although the terms first and second, etc. may be used herein to describe various objects, these objects should not be limited by these terms. These terms are only used to distinguish one object from another object. For example, a first object can be referred to as a second object, and similarly, a second object can be referred to as a first object without departing from the scope of the exemplary embodiments of the present invention.

[0026] It should be understood that the term "and / or" that may appear in this document is merely a description of the association relationship between associated objects, indicating that there may be three relationships. For example, A and / or B can indicate three situations: A exists alone, B exists alone, or A and B exist at the same time. For another example, A, B and / or C can indicate the existence of any one of A, B and C or any combination of them. The term " / and" that may appear in this document describes another type of association object relationship, indicating that there may be two relationships. For example, A / and B can indicate two situations: A exists alone or A and B exist at the same time. In addition, the character " / " that may appear in this document generally indicates that the previous and next associated objects are in an "or" relationship.

[0027] Example like Figures 1-2 As shown, the general processing method provided in the first aspect of this embodiment and compatible with AERS data and FAERS data can be, but is not limited to, executed by a computer device with certain computing resources, such as a cloud server, a personal computer (PC, which refers to a multi-purpose computer with a size, price and performance suitable for personal use; desktops, laptops, small laptops, tablets and ultrabooks are all personal computers), smart phones, personal digital assistants (PDA) or wearable devices. Figure 1 As shown, the general processing method may include but is not limited to the following steps S1 to S5.

[0028] S1. Reading a data file to be processed from the FAERS system, wherein the data format of the data file to be processed is the AERS data format or the FAERS data format.

[0029] In step S1, the data file to be processed is the data processing object, which is specifically used to record the ADR events and medication error events reported by professionals such as doctors, pharmacists or nurses or non-professionals such as patients, patients' families or lawyers (these files generally contain the following four elements: identifiable patients, identifiable reporters, suspected drugs and adverse reactions, etc.). Since FDA migrated AERS to FAERS system in 2012q4, there will be early reporting files in AERS data format in the FAERS system. Specifically, Figure 2 As shown, the data file to be processed is read from the FAERS system, including but not limited to the following steps S11 to S12.

[0030] S11. According to the data file address specified in the configuration file, the specified data file is found in the FAERS system.

[0031] In the step S11, the configuration file is pre-configured by the user and is mainly used to indicate the storage location of the data file to be processed in the FAERS system for access and reading.

[0032] S12. Automatically identify the file type of the designated data file. If the file type is an ascii file type, use the csv.DictReader reader to read the designated data file from the FAERS system as the data file to be processed. If the file type is an xml file type, use the xml.etree.ElementTree reader to read the designated data file from the FAERS system as the data file to be processed. The data format of the data file to be processed is the AERS data format or the FAERS data format.

[0033] In step S12, the ascii file type and the xml file type are both existing common file types, and they can be automatically identified by existing technical means. In addition, the ascii file type is specifically but not limited to a TXT file type or a CSV (Comma-Separated Values) file type; the csv.DictReader reader and the xml.etree.ElementTree reader are both existing readers.

[0034] S2. Convert the data files to be processed into a first data file in FAERS data format, and then convert the first data file into a second data file in JSON data format.

[0035] In the step S2, specifically, the data file to be processed is uniformly converted into a first data file in FAERS data format, including but not limited to: according to the file name of the data file to be processed, if it is determined that the data file to be processed is in AERS data format, then based on the FAERS and AERS field mapping file, the data file to be processed is uniformly converted into a first data file in FAERS data format, and if it is determined that the data file to be processed is in FAERS data format, then the data file to be processed is directly used as the first data file. Since the file name is named based on the file path during the reading process, and in this file path, for AERS data format, it will start with the string "aers" (for example, the file name is "D:\Materials\09FDA&EMA\02fears data\ascii\aers_ascii_2009q3\ascii\INDI09Q3.TXT"), and for FAERS data format, it will start with the string "fears" (for example, the file name is "D:\Materials\09FDA&EMA\02fears data\ascii\faers_ascii_2014q2\ascii\DEMO14Q2.txt"), so the data format of the data file to be processed can be distinguished according to the file name. The FAERS and AERS field mapping file is provided by the FDA, which reflects the field mapping relationship between AERS data and FAERS data, so based on this field mapping relationship, the data format conversion from AERS data format to FAERS data format can be routinely performed. In addition, JSON (JavaScript Object Notation) is designed based on a subset of ECMAScript, and it is an open standard file format and data exchange format. It is easy for humans to read and write, and at the same time, it is also easy for machines to parse and generate. Therefore, the data format conversion from FAERS data format to JSON format can also be routinely completed for subsequent new field addition and data storage.

[0036] S3. Extract the adverse reaction name from the second data file, then find at least one MedDRA term code that matches the adverse reaction name in the MedDRA dictionary, and finally store the at least one MedDRA term code and the level where each MedDRA term code in the at least one MedDRA term code is located into the new adverse reaction information field in the second data file.

[0037] In step S3, since adverse reaction is one of the four elements of adverse drug reaction report, the adverse reaction name can be routinely extracted from the second data file. The MedDRA (Medical Dictionary for Regulatory Activities) is a standard terminology set created by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which is mainly used by pharmaceutical management departments and biopharmaceutical companies in various stages of clinical research before and after the launch of new drugs. Its main purpose is to provide a standardized terminology set to ensure consistency and comparability between different regions. Therefore, at least one MedDRA term code matching the adverse reaction name can be routinely found (due to the characteristics of MedDRA, multiple matches may be found). The newly added adverse reaction information field refers to a field that is added after the conversion to obtain JSON format data and is used to store adverse reaction information, so that after storing the at least one MedDRA term code and the level of each MedDRA term code, the original data content is not affected. In addition, the MedDRA dictionary needs to be routinely acquired asynchronously in advance; and the storage purpose of the aforementioned newly added adverse reaction information is to provide redundancy for subsequent data mining and reduce the performance overhead caused by association.

[0038] S4. Extract the drug name from the second data file, then search for drug information corresponding to the drug name in the WHO Drug dictionary, and finally store the drug information in a newly added drug information field in the second data file.

[0039] In step S4, since the suspected drug is one of the four elements of the adverse drug reaction report, the drug name can be routinely extracted from the second data file. Since the WHO Drug dictionary is an international classification reference dictionary for pharmaceutical product information, it is developed and collected by the World Health Organization Drug Monitoring Team (WHO PIDM, The WHO Programme for International Drug Monitoring) and updated and maintained by the Uppsala Monitoring Center, the drug information corresponding to the drug name can be routinely found, for example, specifically including MPID (Medicinal Product Identification, drug unique identification), PhpID (PH value) and ATC (Anatomical Therapeutic Chemical, Anatomical Therapeutic and Chemical Classification System) information, etc. The newly added drug information field refers to a field that is added after the conversion to JSON format data and is used to store drug information, so that after the drug information is stored, the original data content is not affected. In addition, the WHO Drug dictionary also needs to be routinely acquired asynchronously in advance.

[0040] S5. Store the second data file in the target database and create a data index.

[0041] In step S5, the target database and the specific storage location can be specified by the user. For example, the target database is specified as the ES database (the full name of which is ElsticSearch, a distributed search and analysis engine at the core of the Elastic Stack), which can be understood as a document database and can store json information itself and can also do batch storage. In addition, the purpose of establishing the data index is to facilitate the search for the second data file, and the specific establishment process is a prior art means.

[0042] Therefore, based on the general processing method described in the aforementioned steps S1 to S5, a new data standardization scheme that can be compatible with processing AERS data and FAERS data is provided, that is, the data files to be processed read from the FAERS system are first uniformly converted into a first data file in the FAERS data format, and then the file is converted into a second data file in the JSON data format, and then the MedDRA term code and its level and drug information are obtained based on the MedDRA dictionary and the WHODrug dictionary respectively and stored in the new field, and finally the second data file containing the new field is stored in the target database, and a data index is established. In this way, in the process of data standardization, not only can it be compatible with AERS data, but it can also use the dictionary to automatically search and store information, solve the problem of cumbersome operations caused by the large amount of WHODrug drug information data, and can facilitate users to perform subsequent data cleaning, query, processing and statistical analysis, etc., which is convenient for practical application and promotion.

[0043] Based on the technical solution of the first aspect, this embodiment further provides a possible design of how to perform data standardization based on the delete file, that is, after storing the second data file in the target database, Figure 3 As shown, the method also includes but is not limited to the following steps S61 to S64.

[0044] S61. Determine whether there are delete files corresponding to each adverse drug reaction report in the target database in the FAERS system.

[0045] In step S61, since the second data file is derived from the data file to be processed, and the data file to be processed is an information file for recording ADR events and medication error events reported by professionals such as doctors, pharmacists or nurses or non-professionals such as patients, patients' families or lawyers, there will be multiple adverse drug reaction reports in the target database (the data file to be processed and the adverse drug reaction report can be a one-to-one relationship or a one-to-many relationship). In addition, the specific judgment method can be but is not limited to the method of searching and parsing the delete file.

[0046] S62. If it is determined that there is a delete file corresponding to a certain adverse drug reaction report in the target database in the FAERS system, the certain adverse drug reaction report is marked as logically deleted.

[0047] S63. Group all adverse drug reaction reports in the target database that are not marked as logically deleted based on the case unique identifier CASEID to obtain adverse drug reaction report groups of different patients, wherein the adverse drug reaction report group contains at least one adverse drug reaction report that is not marked as logically deleted.

[0048] In step S63, since the identifiable patient is one of the four elements of the adverse drug reaction report, the unique case identifier CASEID in the adverse drug reaction report can be understood as the identifier of the same patient, thereby achieving the aforementioned grouping purpose, that is, when the CASEID is consistent, the adverse drug reaction reports with the CASEID and different primary keys primaryid can be divided into the same adverse drug reaction report group.

[0049] S64. For each patient, the adverse drug reaction report with the largest version number in the corresponding adverse drug reaction report group shall be used as the corresponding latest data.

[0050] In step S64, the version number may be determined by the specific information of the caseversion field in the adverse drug reaction report (ie, a patient's report may be updated, and this field is used to indicate the version number of the report).

[0051] After step S64, in order to facilitate subsequent data mining and analysis, preferably, after determining the latest data of each patient, the method further includes but is not limited to: extracting drug information and adverse reaction information from the corresponding latest data for each patient, then performing Cartesian product processing on the drug information and the adverse reaction information to obtain at least one drug and adverse reaction pair, and finally storing the at least one drug and adverse reaction pair in the newly added information field in the corresponding latest data. The aforementioned Cartesian product processing refers to processing based on two sets (i.e., drug information and adverse reaction information) to obtain a set of all possible combinations (i.e., at least one drug and adverse reaction pair); for example, if the drug information has drug A and drug B, and the adverse reaction information has adverse reaction 1 and adverse reaction 2, the following four drug and adverse reaction pairs can be processed: drug A and adverse reaction 1, drug B and adverse reaction 1, drug A and adverse reaction 2, and drug B and adverse reaction 2.

[0052] After step S64, in order to ensure the integrity of the latest data, preferably, after determining the latest data of each patient, the method further includes but is not limited to: verifying the integrity of the corresponding latest data for each patient, and if the verification result indicates failure, outputting a corresponding data incomplete prompt message. The specific methods of the aforementioned data integrity verification include but are not limited to: verifying whether the four elements of the report are met, and verifying whether the report corresponding to the CASEID exists (i.e., it has not been marked for deletion by the delete file), etc. In addition, if the verification result indicates failure, the adverse drug reaction report with another version number in the adverse drug reaction report group that is only lower than the version number corresponding to the current latest data can also be used as the latest data to ensure that subsequent data mining and analysis can be effectively performed based on the patient's latest data.

[0053] Therefore, based on the above-mentioned possible design one, it is possible to avoid the situation where data invalidation occurs without knowing it, ensure the reliability and accuracy of subsequent data mining results, and facilitate query and analysis by generating drug and adverse reaction pairs.

[0054] like Figure 4 As shown, the second aspect of this embodiment provides a virtual device for implementing the first aspect or any possible design of the general processing method described in the first aspect, including a data file reading unit, a file format conversion unit, an adverse reaction matching unit, a drug information search unit and a data file storage unit; The data file reading unit is used to read the data file to be processed from the FAERS system, wherein the data format of the data file to be processed is the AERS data format or the FAERS data format; The file format conversion unit is communicatively connected to the data file reading unit, and is used to uniformly convert the data files to be processed into a first data file in a FAERS data format, and then convert the first data file into a second data file in a JSON data format; The adverse reaction matching unit is communicatively connected to the file format conversion unit, and is used to extract the adverse reaction name from the second data file, then search for at least one MedDRA term code matching the adverse reaction name in the MedDRA dictionary, and finally store the at least one MedDRA term code and the level of each MedDRA term code in the at least one MedDRA term code in the newly added adverse reaction information field in the second data file; The drug information search unit is communicatively connected to the file format conversion unit, and is used to extract the drug name from the second data file, then search for drug information corresponding to the drug name in the WHODrug dictionary, and finally store the drug information in a newly added drug information field in the second data file; The data file storage unit is respectively communicatively connected to the adverse reaction matching unit and the drug information search unit, and is used to store the second data file in a target database and establish a data index.

[0055] The working process, working details and technical effects of the aforementioned device provided in the second aspect of this embodiment can be referred to the first aspect or any possible design of the general processing method described in the first aspect, and will not be repeated here.

[0056] like Figure 5 As shown, the third aspect of this embodiment provides a computer device for executing the general processing method described in the first aspect or any possible design in the first aspect, including a memory, a processor and a transceiver that are sequentially connected in communication, wherein the memory is used to store a computer program, the transceiver is used to send and receive messages, and the processor is used to read the computer program, and execute the general processing method described in the first aspect or any possible design in the first aspect. For example, the memory may include, but is not limited to, a random access memory (Random-Access Memory, RAM), a read-only memory (Read-Only Memory, ROM), a flash memory (Flash Memory), a first-input first output (FIFO) and / or a first-input last output (FILO) memory, etc.; the processor may include, but is not limited to, a microprocessor of the STM32F105 series. In addition, the computer device may also include, but is not limited to, a power module, a display screen and other necessary components.

[0057] The working process, working details and technical effects of the aforementioned computer device provided in the third aspect of this embodiment can be referred to the first aspect or any possible design of the general processing method described in the first aspect, and will not be repeated here.

[0058] The fourth aspect of this embodiment provides a computer-readable storage medium storing instructions including the general processing method described in the first aspect or any possible design in the first aspect, that is, the computer-readable storage medium stores instructions, and when the instructions are run on a computer, the general processing method described in the first aspect or any possible design in the first aspect is executed. Wherein, the computer-readable storage medium refers to a carrier for storing data, which may include but is not limited to computer-readable storage media such as floppy disks, optical disks, hard disks, flash memories, USB flash drives and / or memory sticks, and the computer may be a general-purpose computer, a special-purpose computer, a computer network or other programmable devices.

[0059] The working process, working details and technical effects of the aforementioned computer-readable storage medium provided in the fourth aspect of this embodiment can be referred to the general processing method described in the first aspect or any possible design in the first aspect, and will not be repeated here.

[0060] A fifth aspect of this embodiment provides a computer program product, including a computer program or instructions, wherein the computer program or instructions, when executed by a computer, implements the general processing method as described in the first aspect or any possible design in the first aspect. The computer may be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device.

[0061] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the protection scope of the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A general processing method compatible with AERS data and FAERS data, characterized in that: include: Reading a data file to be processed from the FAERS system, wherein the data format of the data file to be processed is an AERS data format or a FAERS data format; Convert the data files to be processed into a first data file in a FAERS data format, and then convert the first data file into a second data file in a JSON data format; extracting the adverse reaction name from the second data file, then searching in the MedDRA dictionary for at least one MedDRA term code that matches the adverse reaction name, and finally storing the at least one MedDRA term code and the level of each MedDRA term code in the at least one MedDRA term code in the newly added adverse reaction information field in the second data file; Extracting the drug name from the second data file, then searching for drug information corresponding to the drug name in the WHODrug dictionary, and finally storing the drug information in a newly added drug information field in the second data file; The second data file is stored in the target database, and a data index is established.

2. The general processing method according to claim 1, characterized in that: Read the data files to be processed from the FAERS system, including: According to the data file address specified in the configuration file, the specified data file is found in the FAERS system; Automatically identify the file type of the designated data file. If the file type is an ascii file type, use the csv.DictReader reader to read the designated data file from the FAERS system as the data file to be processed. If the file type is an xml file type, use the xml.etree.ElementTree reader to read the designated data file from the FAERS system as the data file to be processed. The data format of the data file to be processed is an AERS data format or a FAERS data format.

3. The general processing method according to claim 1, characterized in that: The data files to be processed are uniformly converted into first data files in FAERS data format, including: According to the file name of the data file to be processed, if it is determined that the data file to be processed is in the AERS data format, based on the FAERS and AERS field mapping files, the data file to be processed is uniformly converted into a first data file in the FAERS data format; if it is determined that the data file to be processed is in the FAERS data format, the data file to be processed is directly used as the first data file.

4. The general processing method according to claim 1, characterized in that: After storing the second data file in the target database, the method further includes: Determine whether there are delete files corresponding to each adverse drug reaction report in the target database in the FAERS system; If it is determined that there is a delete file corresponding to a certain adverse drug reaction report in the target database in the FAERS system, then the certain adverse drug reaction report is marked as logically deleted; Grouping all adverse drug reaction reports in the target database that are not marked as logically deleted based on the case unique identifier CASEID to obtain adverse drug reaction report groups of different patients, wherein the adverse drug reaction report group contains at least one adverse drug reaction report that is not marked as logically deleted; For each patient, the adverse drug reaction report with the largest version number in the corresponding adverse drug reaction report group will be used as the corresponding latest data.

5. The general processing method according to claim 4, characterized in that: After determining the latest data of each patient, the method further includes: For each patient, drug information and adverse reaction information are extracted from the corresponding latest data, and then Cartesian product processing is performed on the drug information and the adverse reaction information to obtain at least one drug and adverse reaction pair, and finally the at least one drug and adverse reaction pair is stored in a newly added information field in the corresponding latest data.

6. The general processing method according to claim 4, characterized in that: After determining the latest data of each patient, the method further includes: For each patient, the integrity of the corresponding latest data is verified, and if the verification result indicates failure, a corresponding data incomplete prompt message is output.

7. A universal processing device compatible with AERS data and FAERS data, characterized in that: It includes a data file reading unit, a file format conversion unit, an adverse reaction matching unit, a drug information search unit and a data file storage unit; The data file reading unit is used to read the data file to be processed from the FAERS system, wherein the data format of the data file to be processed is the AERS data format or the FAERS data format; The file format conversion unit is communicatively connected to the data file reading unit, and is used to uniformly convert the data files to be processed into a first data file in a FAERS data format, and then convert the first data file into a second data file in a JSON data format; The adverse reaction matching unit is communicatively connected to the file format conversion unit, and is used to extract the adverse reaction name from the second data file, then search in the MedDRA dictionary for at least one MedDRA term code that matches the adverse reaction name, and finally store the at least one MedDRA term code and the level of each MedDRA term code in the at least one MedDRA term code in the newly added adverse reaction information field in the second data file; The drug information search unit is communicatively connected to the file format conversion unit, and is used to extract the drug name from the second data file, then search for drug information corresponding to the drug name in the WHODrug dictionary, and finally store the drug information in a newly added drug information field in the second data file; The data file storage unit is respectively communicatively connected to the adverse reaction matching unit and the drug information search unit, and is used to store the second data file in a target database and establish a data index.

8. A computer device, characterized in that: It comprises a memory, a processor and a transceiver which are communicatively connected in sequence, wherein the memory is used to store a computer program, the transceiver is used to send and receive messages, and the processor is used to read the computer program and execute the general processing method as described in any one of claims 1 to 6.

9. A computer-readable storage medium, characterized in that The computer-readable storage medium stores instructions, and when the instructions are executed on the computer, the general processing method as described in any one of claims 1 to 6 is executed.

10. A computer program product comprising a computer program or instructions, characterized in that When the computer program or the instruction is executed by a computer, the general processing method according to any one of claims 1 to 6 is implemented.

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