Intelligent intensive production method and system for clinical research of traditional chinese medicine, and electronic device

Abstract

This invention relates to the field of traditional Chinese medicine (TCM) technology, and more particularly to an intelligent and intensive production method, system, and electronic equipment for TCM clinical research. The invention aims to address the technical problems in existing TCM clinical research, such as low research efficiency, inconsistent data quality, insufficient scientific rigor of protocols, and imperfect regulatory feedback mechanisms, caused by the fragmented and isolated nature of each stage and the lack of an intelligent and intensive production method covering the entire process. The method includes: acquiring a target instruction for TCM clinical services input by a user; intelligently designing a protocol based on the target instruction to generate a complete TCM clinical research protocol; automatically acquiring TCM clinical data related to the target instruction based on the research protocol; classifying and statistically analyzing the clinical data and identifying relevant historical TCM clinical research protocols; performing a synthetic analysis of current clinical data and historical research protocols to determine TCM clinical evidence related to the target instruction; and executing and monitoring the TCM clinical research based on the acquired clinical data and evidence. This invention significantly improves the efficiency, scientific rigor, and data quality of TCM clinical research by constructing a fully automated and intelligent closed loop from instruction input to research execution, thus promoting the modernization of TCM research.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to an intelligent and intensive production method and system for clinical research in traditional Chinese medicine, as well as electronic equipment. Background Technology

[0002] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a method and system for intensive production of the entire process of clinical research in traditional Chinese medicine using information technology and artificial intelligence.

[0003] Traditional Chinese medicine (TCM) is a precious legacy accumulated by the Chinese nation over thousands of years in its struggle against disease; it is a treasure of the Chinese nation. In contemporary times, with the rapid development of modern science and technology, the research paradigm of TCM is also undergoing profound changes. The cross-disciplinary integration of cutting-edge technologies from biology, chemistry, and informatics with traditional TCM theories provides unprecedented tools and perspectives for systematically and deeply revealing the mechanisms of action of TCM at multiple levels, including molecular, cellular, tissue, and even systemic levels. For example, the application of technologies such as genomics, proteomics, and metabolomics is gradually elucidating the molecular basis of TCM in treating complex diseases. Simultaneously, to gain wider international recognition for its clinical research findings, the field of TCM is actively introducing and adhering to internationally accepted modern clinical trial design standards and methods, emphasizing the scientific rigor and standardization of research.

[0004] However, despite significant progress in the concepts and specific technologies applied in TCM clinical research, severe challenges and technical bottlenecks remain in the organization and management of the overall process. The core issue is that current related technologies and methods are generally highly fragmented and unsystematic, severely lacking an intensive production method that can integrate the entire clinical research process from protocol design, data collection, statistical analysis to results translation.

[0005] Traditional TCM clinical research models rely heavily on researchers' personal experience and manual processes, and their inherent shortcomings are becoming increasingly apparent. First, in the research protocol design stage, there is a strong reliance on the subjective judgment and past experience of field experts, lacking intelligent, model-based decision-making tools based on big data. This makes it difficult to fully guarantee the scientific rigor and efficiency of the protocol design. Second, in the data collection and management stage, clinical data acquisition still primarily relies on manual recording and decentralized, heterogeneous electronic systems, lacking automated and standardized data collection mechanisms. This not only leads to low work efficiency but, more seriously, results in inconsistent data quality, inconsistent formats, and widespread missing and erroneous values, posing significant obstacles to subsequent high-quality analysis. Third, at the data analysis level, existing technologies mostly employ traditional statistical methods, which are cumbersome and struggle to address the unique multidimensional, heterogeneous, and noisy characteristics of TCM clinical data, failing to fully extract the deeper information and evidence contained within the data.

[0006] Furthermore, the entire process of TCM clinical research is extremely complex, involving multiple stages from basic theoretical research, formula composition screening, pharmacodynamic evaluation, clinical trials to final clinical application feedback. It is an interdisciplinary and long-term systematic project. This complexity further exacerbates the data silo effect and poor information flow between different stages. The lack of effective real-time data tracking, auditing, and quantitative evaluation mechanisms during the research process makes it difficult to effectively guarantee the standardization and compliance of the research. Once violations or operational errors occur, they are difficult to detect and correct in a timely manner. At the same time, the valuable efficacy feedback data generated after the clinical application of research results has not formed an effective closed loop to systematically guide and optimize subsequent research designs, resulting in a disconnect between research and practice.

[0007] In summary, existing technologies in the field of TCM clinical research suffer from a series of problems, including independent processes, lack of systematic integration, low levels of intelligence, chaotic data management, and imperfect regulatory feedback mechanisms. These problems severely restrict the efficiency and quality of TCM research and hinder its modernization and internationalization. Therefore, a novel technological solution is urgently needed to address these shortcomings and achieve intelligent, automated, and intensive production throughout the entire TCM clinical research process. Summary of the Invention

[0008] This invention relates to the field of traditional Chinese medicine (TCM) technology, and more particularly to an intensive production method, system, and electronic equipment for the entire TCM clinical process. TCM, a precious legacy of the Chinese nation for thousands of years, has accumulated rich experience in clinical practice and research methods throughout history. With the rapid development of modern science and technology, interdisciplinary research methods from biology, chemistry, and informatics have been introduced into the field of TCM. For example, the application of advanced technologies such as genomics and proteomics provides new possibilities for deeply revealing the mechanisms of TCM in treating diseases from multiple levels and dimensions. Simultaneously, to align with the increasingly stringent clinical trial standards of the international medical community, TCM clinical research is gradually incorporating modern clinical trial design standards and methods. However, despite continuous technological advancements, the field of TCM clinical research still faces severe challenges. Related technologies and methods are fragmented and unsystematic, with a serious lack of an intensive production model that can cover the entire research process.

[0009] The current technological shortcomings are mainly reflected in the following aspects. First, research efficiency is low and scientific rigor is insufficient. Traditional research design largely relies on researchers' personal experience, lacking intelligent decision support based on big data and artificial intelligence, resulting in long design cycles and difficulty in ensuring scientific rigor. At the data level, the acquisition of clinical data relies heavily on manual recording or decentralized information systems, with insufficient automation and real-time performance, leading not only to low efficiency but also to inconsistent data quality, making subsequent structured storage and high-quality analysis difficult. Second, data mining and analysis capabilities are limited. Existing methods for classifying, statistically analyzing, and synthesizing TCM clinical data are relatively traditional, lacking efficient statistical models and advanced natural language processing technologies, making the analysis process cumbersome and time-consuming, and limiting the depth and reliability of the results, making it difficult to fully extract the potential value from massive and complex TCM data. Third, the integration and supervision mechanisms for the entire process are severely inadequate. Real-time data tracking, process auditing, and quantitative evaluation mechanisms are generally lacking during the research process, making it difficult to effectively detect and correct violations or operational errors in a timely manner. Meanwhile, efficacy feedback information from clinical applications has not been systematically collected and used for the optimization and re-evaluation of research protocols, failing to form an effective closed-loop improvement system. Finally, there is a general lack of an intensive and automated production paradigm. The various stages of TCM clinical research—including protocol design, data collection, statistical analysis, evidence synthesis, and process monitoring—are independent and poorly connected, failing to form an organic, end-to-end intensive production model. This directly leads to insufficient utilization of research resources, lengthy research cycles, and difficulty in effectively ensuring the quality and consistency of research results.

[0010] To address the shortcomings of the existing technologies, the present invention aims to provide a method, system, and electronic equipment for intensive production throughout the entire clinical process of traditional Chinese medicine (TCM) research. This invention aims to overcome the drawbacks of fragmented processes, low efficiency, lack of intelligent support, and systematic management in TCM clinical research, thereby achieving automated, intelligent, and intensive production throughout the entire research process and significantly improving the overall efficiency and quality of TCM clinical research.

[0011] To achieve the above objectives, this invention provides a method for intensive production of the entire TCM clinical process, which constructs an end-to-end automated research workflow. The method begins by acquiring the user's input target instruction for TCM clinical services. The system parses this instruction and initiates the entire research process. Subsequently, based on the target instruction and combined with historical research cases, the system intelligently designs a solution, automatically generating a scientific and complete TCM clinical research plan. Guided by this plan, the system automatically activates the data acquisition module to collect TCM clinical data related to the target instruction in real time and accurately. After acquiring the data, the system uses an advanced statistical analysis module to perform in-depth classification and statistics on this clinical data, and matches and identifies relevant historical TCM clinical research plans based on statistical features. Next, the system performs a comprehensive synthetic analysis of the current clinical data and the selected historical research plans, using the principles of evidence-based medicine to extract and identify TCM clinical evidence strongly correlated with the user's target instruction. Finally, supported by high-quality clinical data and strong clinical evidence, the system initiates and executes the TCM clinical research, while simultaneously providing real-time, intelligent monitoring and evaluation of the entire research process.

[0012] The technical solution provided by this invention integrates various previously isolated and inefficient aspects of traditional Chinese medicine clinical research into a highly efficient, collaborative, data-driven, and automated production process by constructing an integrated platform that combines intelligent solution design, automated data processing, evidence-based evidence generation, and refined process monitoring. This not only significantly shortens the research cycle and reduces reliance on human experience and potential human error, but also enhances the scientific rigor and reliability of research results through in-depth data mining and analysis, thereby providing strong technical support for promoting the modernization and internationalization of traditional Chinese medicine. Attached Figure Description

[0013] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0014] Figure 1This is a flowchart illustrating the integrated production method for the entire clinical process of traditional Chinese medicine provided in this embodiment of the invention. Figure 2 This is a schematic diagram of the integrated production system for the entire clinical process of traditional Chinese medicine provided in this embodiment of the invention; Figure 3 This is a schematic diagram of the physical structure of the electronic device provided in an embodiment of the present invention. Detailed Implementation

[0015] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0016] This invention provides a method for intensive production of traditional Chinese medicine throughout the entire clinical process, such as... Figure 1 The flowchart shown illustrates a method that aims to systematically integrate and intelligently upgrade various stages of TCM clinical research, forming a highly efficient, automated, and intensive production process. This method and its corresponding systems (such as...) Figure 2 (as shown) and electronic devices (such as) Figure 3 The specific implementation method (as shown) will be explained in detail through the following steps.

[0017] Step 1: Obtain the target instruction for TCM clinical services input by the user.

[0018] This step is the starting point of the entire automation process, from... Figure 2 The instruction acquisition module 201 executes. The target instruction is a structured information input by the user through the interactive interface provided by the system, which clarifies the specific needs or research commands for this TCM clinical service.

[0019] Definition and Purpose: The target instruction is the core basis for driving the execution of all subsequent automation modules, and its purpose is to accurately capture the user's research intent. For example, the user may input "evaluate the clinical efficacy and safety of a certain traditional Chinese medicine formula in treating type 2 diabetes mellitus with Qi and Yin deficiency syndrome".

[0020] Implementation: The system provides a user interface that allows users to input commands via text, form selection, or even natural language. Upon receiving the input, the command acquisition module 201 first parses and verifies it. For example, using Natural Language Processing (NLP) technologies, such as Named Entity Recognition (NER), it automatically extracts key parameters from the input text, such as "Research Topic (Traditional Chinese Medicine Formula A)," "Disease Type (Type 2 Diabetes)," "Traditional Chinese Medicine Syndrome (Qi and Yin Deficiency Syndrome)," and "Research Objective (Efficacy and Safety)." Subsequently, the system verifies the format and completeness of the command, ensuring all necessary parameters are provided. After successful verification, the command is converted into standardized, machine-readable structured data (such as JSON or XML format) and stored in system memory or a database, serving as the input source for all subsequent module calls. This automated process ensures the accuracy, consistency, and traceability of the commands, laying a solid foundation for the smooth operation of the entire process.

[0021] Step 2: Design intelligent solutions based on target instructions to generate TCM clinical research protocols.

[0022] After acquiring and parsing the target instruction, the system will activate. Figure 2 The solution generation module 202 in the middle executes an intelligent solution design process, which aims to overcome the shortcomings of traditional design methods that rely on human experience and are inefficient.

[0023] Definition and Purpose: Intelligent solution design refers to the process by which a system, utilizing built-in algorithms, rule bases, and knowledge bases, automatically analyzes target instructions and generates a rigorous, complete, and scientifically feasible clinical research protocol for traditional Chinese medicine. This protocol serves as a guiding document for subsequent data acquisition and clinical research implementation.

[0024] Implementation method: This step is broken down into a series of closely linked sub-steps, as follows: Determining the Research Design Type: The system first uses the target instruction and retrieves a built-in database of research cases in the field of traditional Chinese medicine clinical research. It then automatically analyzes and determines the optimal research design type. The database stores a large number of high-quality historical research examples and their metadata. The system uses a feature matching algorithm to compare the similarity between the current instruction and examples in the database (e.g., in terms of research objectives, intervention types, etc.), thereby recommending the most suitable design type, such as randomized controlled trials (RCTs), cohort studies, and case-control studies. These designs can be sorted by recommendation level for user selection or automatically determined by the system.

[0025] Sample size estimation: Based on the determined research design type, the system automatically retrieves the corresponding sample size estimation formula and relevant parameters from its statistical knowledge base. Parameters include the expected effect size, Type I error probability (α, i.e., the significance level), Type II error probability (β), or statistical power (1-β), etc. The system can automatically calculate the minimum sample size required for the study and supports users in performing sensitivity analysis by adjusting parameters, ensuring that the research design has sufficient statistical power and avoiding resource waste or unreliable conclusions due to insufficient or excessive sample size.

[0026] Identifying research subjects and setting up groupings: Based on the sample size estimation results, the system assists in formulating detailed inclusion and exclusion criteria to identify research subjects. For example, based on the target instruction of "type 2 diabetes" and "Qi and Yin deficiency syndrome," the system can extract relevant diagnostic criteria (such as the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China") and TCM syndrome diagnostic criteria from the knowledge base to form precise screening conditions. Subsequently, the system uses a randomization algorithm (such as stratified block randomization) to automatically assign the identified research subjects to the experimental group (receiving TCM herbal intervention) and the control group (receiving placebo or conventional therapy), ensuring the balance of baseline data between groups to minimize selection bias.

[0027] Developing Interventions: The system will specify every detail of the intervention. For the experimental group, the system will extract or generate detailed information about the Chinese herbal formula (herbs, dosage), processing methods, dosage form, administration method, frequency, and course of treatment from its formula knowledge base, ensuring the standardization and reproducibility of the intervention. The same detailed intervention plan will be defined for the control group.

[0028] Generating and Optimizing the Protocol Document: Finally, the protocol generation module 202 integrates all the above elements—including research background, objectives, design type, sample size, subject criteria, grouping method, specific interventions, observation indicators (such as blood glucose, glycated hemoglobin, and TCM syndrome scores), and statistical analysis plan—and automatically generates a complete and structured TCM clinical research protocol document using a preset template engine. After generation, the system will also perform an intelligent verification to check for logical contradictions or parameter inconsistencies between the various parts of the protocol and provide optimization suggestions to ensure the final quality of the protocol.

[0029] Step 3: Automated acquisition and management of TCM clinical data based on the research protocol

[0030] After the solution is generated, Figure 2 The data acquisition module 203 is activated and is responsible for the automated acquisition and management of data, aiming to solve the problems of low efficiency and difficulty in controlling the quality of traditional data collection.

[0031] Definition and Purpose: This step refers to the system automatically and in real time collecting relevant data from the clinical practice environment of traditional Chinese medicine according to the data requirements in the generated research plan, and then standardizing and storing the data in a structured manner.

[0032] Implementation method: Automated Data Acquisition and Real-time Monitoring: The system establishes a secure data transmission channel with hospital information systems (HIS), electronic medical record (EMR) systems, or wearable sensor devices through a pre-defined data interface (such as API). Based on the data items defined in the research protocol, the system automatically and accurately extracts the required TCM clinical data from these data sources, such as patient basic information, diagnostic records, laboratory test results, and prescription usage records. This process is performed in real time and continuously monitors data changes.

[0033] Early Warning Handling: The system incorporates an early warning mechanism during data acquisition. Researchers can pre-set safety thresholds for key data indicators (such as the incidence of serious adverse events or abnormal fluctuations in key efficacy indicators). While monitoring data in real time, the system continuously compares the collected data with these thresholds. If data exceeds the preset range, an early warning will be automatically triggered, notifying researchers via SMS, email, or system messages to intervene promptly and ensure research safety and data quality.

[0034] Structured Storage and Data Cleaning: The acquired raw data is fed into the data processing pipeline. First, the system standardizes and organizes the data according to preset classification and coding rules (such as using the International Classification of Diseases (ICD-10) coding and the Traditional Chinese Medicine terminology system), and stores it in a pre-built, structured data warehouse. Then, the system initiates data cleaning and auditing procedures, using data validation rules and machine learning algorithms (such as anomaly detection models) to automatically identify and correct errors, outliers, duplicate records, and missing values ​​in the data. For example, for missing values, the system can select methods such as mean / median imputation, regression imputation, or K-nearest neighbor imputation based on the data type and distribution to ensure that the data stored in the data warehouse is complete, accurate, and reliable, laying the foundation for subsequent high-quality statistical analysis. Simultaneously, the system employs data encryption and access control mechanisms to protect patient privacy and data security.

[0035] Step 4: Determine the historical research plan through statistical analysis.

[0036] Once the data is ready, Figure 2 The statistical analysis module 204 is launched to perform efficient automated statistical analysis, aiming to overcome the limitations of traditional analysis methods that are cumbersome and dependent on professional statisticians.

[0037] Definition and Purpose: This step refers to the system applying built-in statistical models and algorithms to automatically classify and statistically analyze the cleaned TCM clinical data, and using the statistical results to identify and match relevant historical research protocols.

[0038] Implementation method: Data classification and labeling: The system first automatically classifies and labels the data in the data warehouse according to preset rules. For example, based on the patient's diagnosis information, syndrome type, and intervention measures received, each data record is labeled accordingly, making it structured and easier for the model to process.

[0039] Targeted Statistical Code Generation: This is an innovative aspect of the invention. The system inputs labeled data into a pre-built statistical model. The core function of this model is to generate "targeted statistical code." Specifically, the system uses natural language processing technology to parse the initial user target instructions and the metadata of the data, and then matches them with a pre-defined "code rule base." This rule base stores a large number of parameterized code templates corresponding to different statistical analysis tasks (such as descriptive statistics, t-tests, chi-square tests, survival analysis, etc.). Upon successful matching, the system automatically generates directly executable statistical code (such as R or Python code) based on the corresponding template.

[0040] Performing Statistical Analysis and Protocol Matching: The system then uses the generated target statistical code to perform batch statistical analysis on the TCM clinical data, outputting detailed statistical reports. Based on these statistical analysis results (such as the distribution characteristics of key variables, the significance of differences between groups, etc.), the system queries its historical research protocol database and uses similarity matching algorithms (such as cosine similarity calculation based on vector space models) to filter and determine a list of historical TCM clinical research protocols that are most relevant to the current study in terms of data characteristics.

[0041] Step 5: Synthetic Analysis and Determination of Clinical Evidence in Traditional Chinese Medicine

[0042] After identifying relevant historical research Figure 2 The synthetic analysis module 205 in the middle will perform the synthesis and refinement of evidence, which is a key step in realizing evidence-based decision-making.

[0043] Definition and Purpose: Synthetic analysis refers to the comprehensive and systematic integration and analysis of current clinical data and selected high-quality historical research protocols using the principles and methods of evidence-based medicine, thereby generating higher-level and more reliable clinical evidence for traditional Chinese medicine.

[0044] Implementation method: Historical Research Quality Assessment and Grading: The system first employs the principles and methods of evidence-based medicine to rigorously assess the quality of the historical research protocols selected in the previous step. Assessment criteria can be based on internationally recognized tools, such as the Cochrane Risk of Bias Assessment Tool. The system automatically examines each study's design type, randomization method, blinding implementation, data integrity, etc., and provides a quantitative quality score. Based on this score, the system automatically categorizes historical research protocols into high-quality, medium-quality, and low-quality levels, allowing for different weightings in subsequent synthesis or the inclusion of only high-quality studies.

[0045] Intelligent synthesis of multi-source evidence: The system filters out all high-quality historical research evidence and combines it with data from current studies, using preset analytical techniques (such as meta-analysis) for intelligent synthesis. The system can automatically extract key effect indicators (such as efficacy rate, risk ratio (RR), odds ratio (OR), etc.) and their variation information from various studies.

[0046] The system calculates the pooled effect size and draws conclusions using statistical models (such as fixed-effects or random-effects models). Finally, based on these quantitative results, the system arrives at a comprehensive conclusion, such as, "Based on existing evidence, this traditional Chinese medicine formula can effectively reduce glycated hemoglobin levels in patients with type 2 diabetes," and stores and outputs this conclusion as high-level clinical evidence of traditional Chinese medicine in a structured manner.

[0047] Step Six: Conduct clinical research and comprehensive supervision of traditional Chinese medicine.

[0048] Supported by high-quality data and high-level evidence, the system entered the research execution and monitoring phase, by... Figure 2 The clinical research module 206 is responsible for this.

[0049] Definition and Purpose: This step refers to the system not only assisting in the execution of the research plan, but more importantly, conducting real-time, intelligent tracking, auditing, and evaluation of the entire research process to ensure the compliance, standardization, and high quality of the research, thus solving the problem of the lack of effective supervision in traditional research.

[0050] Implementation method: Real-time data tracking and auditing: The system provides intelligent oversight of the entire research process, covering all aspects such as protocol execution, data collection, and ethical compliance. Through deep integration with the data collection system, the system can track the generation and modification records of every data point in real time, forming an immutable audit log. Once violations (such as non-compliant data entry) or operational errors are detected, the system will immediately flag them and notify relevant personnel for correction.

[0051] Quantitative Assessment and Report Generation: The system utilizes a pre-established regulatory indicator system and assessment model to continuously quantitatively assess the research process. This indicator system may include key indicators such as protocol compliance, data integrity, and timeliness of adverse event reporting. The system periodically calculates the scores of these indicators and generates comprehensive regulatory reports based on the assessment model. These reports present the research progress and quality status in visual formats such as charts, providing decision support for research managers.

[0052] Clinical Application Feedback and Re-evaluation Optimization: The method of this invention also includes an important closed-loop feedback mechanism. After the results of clinical research are applied to actual clinical practice, the system can continuously collect real-world efficacy feedback data through an interface. Subsequently, the system uses big data analytics and data mining techniques (such as association rule mining and cluster analysis) to conduct in-depth analysis of this feedback data, assessing the effectiveness and safety of the therapy in the real world and identifying potential new indications or risk signals. Finally, the system feeds these analysis results back to researchers for continuous optimization and iteration of existing TCM clinical research protocols, forming a virtuous cycle of "research-application-feedback-optimization" to continuously improve the level of TCM clinical research.

[0053] System and Hardware Implementation

[0054] The method described in this invention is implemented through an integrated production system covering the entire clinical process of traditional Chinese medicine. For example... Figure 2 As shown, the system includes: an instruction acquisition module 201, a protocol generation module 202, a data acquisition module 203, a statistical analysis module 204, a synthetic analysis module 205, and a clinical research module 206. These modules work together to implement all the steps of the above method.

[0055] This system can run on an electronic device. For example... Figure 3 As shown, this electronic device is a typical computer hardware structure, including but not limited to: one or more processors 310, a memory 330, and a communication interface 320, all interconnected via a communication bus 340. The processor 310 is responsible for executing computer program instructions stored in the memory 330 to implement the various method steps described in this invention. The memory 330 may include read-only memory (ROM), random access memory (RAM), etc., for storing program code and data during processing. This invention can also be embodied as a computer-readable storage medium storing a computer program implementing the above methods, or a computer program product containing the program.

[0056] In summary, the above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A smart and intensive production method for clinical research in traditional Chinese medicine, characterized in that, The process includes the following steps: obtaining the target instructions for TCM clinical services input by the user; designing an intelligent solution based on the target instructions to generate a TCM clinical research plan; Based on the aforementioned TCM clinical research protocol, TCM clinical data related to the target instruction are automatically acquired; through statistical analysis, the TCM clinical data are classified and statistically analyzed to determine historical TCM clinical research protocols related to the TCM clinical data; the TCM clinical data and the historical TCM clinical research protocols are synthesized and analyzed to determine TCM clinical evidence related to the target instruction; and TCM clinical research is conducted based on the TCM clinical data and the TCM clinical evidence.

2. The intelligent and intensive production method for clinical research of traditional Chinese medicine according to claim 1, characterized in that, The intelligent scheme design based on the target instructions to generate a TCM clinical research plan includes: determining the research design type based on the target instructions and research cases in the field of TCM clinical research; determining the sample size estimation formula and parameters for TCM clinical research according to the research design type; determining the research subjects for TCM clinical research based on the sample size estimation formula and parameters, and setting up experimental and control groups based on the research subjects; formulating intervention measures, including the composition and usage of TCM prescriptions; and generating a TCM clinical research plan based on the experimental group, the control group, and the intervention measures.

3. The integrated production method for the entire clinical process of traditional Chinese medicine as described in claim 1, characterized in that, The automatic acquisition of TCM clinical data related to the target instruction based on the TCM clinical research protocol includes: real-time monitoring of the TCM clinical data related to the target instruction, and real-time acquisition of the TCM clinical data; comparing several data indicators in the TCM clinical data with pre-set indicator thresholds, and issuing an early warning if the data indicators exceed the indicator thresholds.

4. The integrated production method for the entire clinical process of traditional Chinese medicine as described in claim 1, characterized in that, The process of automatically acquiring TCM clinical data related to the target instruction based on the TCM clinical research protocol further includes: organizing the TCM clinical data according to preset classification and coding rules, and storing it in a pre-constructed structured data warehouse; cleaning and auditing the data in the data warehouse, correcting anomalies and errors in the data in the data warehouse, and ensuring the reliability of the data.

5. The integrated production method for the entire clinical process of traditional Chinese medicine as described in claim 1, characterized in that, The step of classifying and statistically analyzing the TCM clinical data includes: classifying and labeling the TCM clinical data; inputting the TCM clinical data into a pre-constructed statistical model to obtain a target statistical code output by the statistical model, wherein the target statistical code corresponds to the TCM clinical data; and performing statistical analysis on the TCM clinical data based on the target statistical code.

6. The integrated production method for the entire clinical process of traditional Chinese medicine as described in claim 1, characterized in that, The process of synthesizing and analyzing the TCM clinical data and the historical TCM clinical research protocols to determine the TCM clinical evidence relevant to the target instruction includes: using the principles and methods of evidence-based medicine to conduct a quality assessment of the historical TCM clinical research protocols; classifying the historical TCM clinical research protocols according to the assessment results; and using pre-defined analytical techniques to intelligently synthesize multiple high-quality TCM clinical research evidences, calculate the combined effect size and its confidence interval, and draw a comprehensive conclusion.

7. The integrated production method for the entire clinical process of traditional Chinese medicine as described in claim 1, characterized in that, The process of conducting TCM clinical research based on the TCM clinical data and TCM clinical evidence includes: real-time data tracking and auditing of the TCM clinical research process to identify and correct violations and operational errors; and quantitatively evaluating the TCM clinical research process through a pre-established regulatory indicator system and evaluation model, and generating an evaluation report.

8. A fully integrated production device for the entire clinical process of traditional Chinese medicine, characterized in that, The integrated production device for the entire TCM clinical process includes: an instruction acquisition module for acquiring target instructions for TCM clinical services input by a user; a scheme generation module for intelligent scheme design based on the target instructions to generate TCM clinical research schemes; a data acquisition module for automatically acquiring TCM clinical data related to the target instructions based on the TCM clinical research schemes; a statistical analysis module for classifying and statistically analyzing the TCM clinical data to determine historical TCM clinical research schemes related to the TCM clinical data; a synthetic analysis module for performing synthetic analysis on the TCM clinical data and the historical TCM clinical research schemes to determine TCM clinical evidence related to the target instructions; and a clinical research module for conducting TCM clinical research based on the TCM clinical data and the TCM clinical evidence.

9. A computer device, comprising: A memory, a processor, and a computer program stored in the memory and executable on the processor, characterized in that the processor executes the computer program to implement the steps of the integrated production method for the entire clinical process of traditional Chinese medicine as described in any one of claims 1-7.

10. A computer-readable storage medium having a computer program stored thereon, characterized in that, When the computer program is executed by the processor, it implements the steps of the integrated production method for the entire clinical process of traditional Chinese medicine as described in any one of claims 1-7.

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