With the wide application of real world research in the field of traditional Chinese medicine (TCM), it is particularly important to fully understand the concept of TCM real world data and its characteristics, and the quality control of TCM real world data has also become a focus of research attention.In this paper, the key features of real world data in TCM and the currently faced data quality problems are sorted out in detail, and existing quality assessment dimensions, models and informative assessment tools are comprehensively reviewed, and the practical application effects and shortcomings of such tools are further explored.Based on the above analyses, the future development direction of real world data quality assessment methods for TCM is proposed.The aim of this paper is to put forward constructive suggestions to facilitate the establishment of a more comprehensive real world data quality assessment and control system for TCM, so as to improve the accuracy and reliability of TCM research and to ensure the scientificity and standardisation of TCM therapeutic methods.

In order to facilitate clinicians to make faster choices from many clinical guidelines, this paper evaluates the quality of clinical guidelines on Chinese medicine interventions for coronary heart disease using AGREE II and RIGHT reporting standards, and summarises their diagnostic and therapeutic opinions.It also assesses the role played by real world studies in the guidelines for TCM intervention in coronary heart disease and evaluates the quality of real world studies on TCM intervention in coronary heart disease.The results show that of the 10 guidelines included, 8 are evaluated as grade B and 2 as grade C.After summarizing the diagnostic and therapeutic opinions it is found that coronary heart disease is classified into different types of evidence in different guidelines, and the classification criteria have not yet been unified, among which the probabilities of cardioblood stasis and obstruction, qi and yin deficiency, cardio-kidney and yang deficiency, qi and blood stasis and qi and blood stasis are higher, and all of them are recommended in 5 or more guidelines.The recommended GRADE levels for herbal medicines are B, C and D.The former studies on which these guidelines were based were randomized controlled trials, systematic reviews, or expert consensus, and there were no real world studies as the source of evidence, and the evidence-based evidence of the characteristics of TCM was insufficiently reflected.Therefore, this study proposes the following recommendations for the development of guidelines on coronary heart disease in TCM.In the future, emphasis should be placed on constructing guideline evaluation tools that are consistent with the characteristics of TCM, standardising the process of guideline or consensus development, carrying out high-level, high-quality prospective studies, and considering controlling for the effects of bias, confounders, uncertainties, limitations and other influences on the quality of real world studies, in order to obtain high-quality real world research evidence with better quality, higher level of evidence, and more precise and reliable efficacy, focusing on the application of high-quality real world evidence, and also focusing on the promotion of its application, in order to better improve the clinical outcomes of patients with coronary heart disease, enhance clinical efficacy, and promote the long term development of Chinese medicine.

Tic disorder is a neurodevelopmental disorder disease that originates in childhood, and more recognized pathogenesis is the dysfunction of the dopaminergic basal ganglion circuit, which is related to a variety of neurochemical and neurotransmitter abnormalities.The drugs currently used for the treatment of tic disorder mainly aim at modulating neurotransmitter imbalances.This article summarizes the recent basic experimental and clinical research on how Chinese and western medicines regulate neurotransmitters in the treatment of tic disorder, and reviews the research status and progress of the treatment, so as to further reveal the pathogenesis of tic disorder and provide a theoretical basis for the clinical application of western medicine in the treatment of tic disorder.The results suggest that the treatment of tic disorder may be related to a decrease in the amount of excitatory neurotransmitters as a whole, as well as an increase in the amount of inhibitory neurotransmitters.However, due to the clinical dispensation of routine cerebrospinal fluid (CSF) and the invasive nature of lumbar puncture, CSF is rarely obtained for neurotransmitter content in children with tic disorder, and the proportion of neurotransmitters across the blood-brain barrier is not clear.It is expected that future studies can further establish a model of the exposure-effect relationship between Chinese and western medicines on plasma, especially cerebrospinal fluid neurotransmitter levels in children with tic disorder, and realize the precise administration of aripiprazole by adjusting the neurotransmitter levels under the guidance of the model.

Based on the Clinical-Research-Disease Management Integration Platform of Jiangsu Hospital of Traditional Chinese Medicine, this article investigates the risk factors for the progression of patients with chronic kidney disease (CKD) stages 3-5 and the protective effects of traditional Chinese medicine (TCM).A total of 186 patients with CKD stages 3-5 attending the hospital from Mar 1, 2020 to Oct 30, 2023 were collected and grouped according to progression of their renal function, and the risk factors for the progression of the patients' renal function, as well as the effects of traditional Chinese medicine on their renal function, were assessed by logistic regression.Among 186 patients the average estimated glomerular filtration rate (eGFR) reduction rate was about 15.22% and the average eGFR slope was -3.44 mL·(min·1.73 m²）^-1 in the group with progressive renal function, and the average eGFR reduction rate was about 1.02% and the average eGFR slope was 1.33 mL·(min·1.73 m²）^-1 in the group with stable renal function.Logistic regression analysis using whether renal function progressed as the dependent variable and clinical indicators as independent variables showed that combined hypertension, uric acid >420 μmol·L^-1, and albumin <34 g·L^-1 were the risk factors for renal function progression in CKD patients, and age >65 years and taking TCM were the protective factors.Patients were grouped based on the duration of TCM usage.Survival analysis indicated that both the intermittent and continuous TCM usage groups had a higher rate of stable kidney function and higher eGFR compared to the group that did not use TCM.The results demonstrate that in CKD patients with concurrent hypertension, the higher uric acid levels and the lower albumin levels, the higher the risk of kidney function progression.TCM treatment and patients aged 65 and above tend to stabilize kidney function.Continuous and long-term intermittent use of TCM can delay the progression of kidney function deterioration in CKD patients and postpone the need for renal replacement therapy.

Through a systematic review of the origin and 40 years of development of Traditional Chinese Medicine(TCM) big data knowledge engineering, we clariffy the major events and research achievements in each stage of the research, expound the ideas and methods of real world TCM clinical study based on medical records, emphasize the importance of transforming from data driven mode to data and knowledge driven mode to promote the innovation of the real world TCM clinical study model, and argue that the basis of model transformation and innovation is to reconstruct the knowledge attributes of TCM clinical case data base, make tacit knowledge explicit, realize full expression of knowledge, and build a TCM clinical case knowledge base.Taking case data knowledge, knowledge coding and knowledge mapping as examples, we highlight the key technologies and core links of TCM big data knowledge engineering, and fully confirm that big data knowledge engineering is the only way for real world TCM clinical study.Under the guidance of the national high-quality development strategy of TCM, with the goal of cultivating new quality productivity and forming a new business form of clinical research of TCM with new development concepts, we will build a big data knowledge engineering technology platform and a warehouse of TCM clinical knowledge, provide a technical platform and knowledge resources for carrying out large-scale model research in the field of TCM, and promote the clinical intelligence and high-quality development of TCM.

The famous classical formulas(FCF) is a widely used prescription with definite curative effect and obvious characteristics and advantages recorded in ancient Chinese medicine books, which were accumulated with extensive human experience in clinical practice and were mostly presented in case form.By analyzing the development of FCF cases in inheritance, it was found that there were problems such as excessive emphasis on individual experience summarization, lack of systematic sorting, inappropriate matching of the current research model, lack of high-quality evidence, and insufficient exploration of tacit knowledge, which limited the inheritance and development of FCF.In the framework of real world study, the team proposed combining big data technology with the inheritance of FCF through the cognitive hierarchy model of the human brain, "data-information-knowledge-wisdom, " that is, structuring data, information, evaluating case records, uncovering tacit knowledge, and presenting knowledge maps, ultimately realizing the reconstruction of classical prescription case records and the transformation of assisted decision-making.

Scientific problem identification in real-world research is the cornerstone for conducting in-depth studies that result in high-quality real world evidence.This study, taking the descriptive statistical analysis of real-world actual diagnostic and treatment data of the persistent vegetative state (PVS) at the Vegetative Wake-up Promotion Centre of Xi'an Traditional Chinese Medicine Encephalopathy Hospital Affiliated to Shaanxi University of Traditional Chinese Medicine as an example, comprehensively collected demographic information of PVS patients including Chinese and western medical doctors, their disease conditions, speciality examinations, laboratory examinations, scale examinations, information on Chinese medicine evidence and identification and type indicators and treatment indicators.The results found that the combination of Chinese and Western medicines such as acupuncture and moxibustion became one of the optional and effective treatments for PVS, but there were problems such as unclear treatment effects under complex interventions and inconsistency in the way evidence was classified.The analysis demonstrated the scientific problem discovery process of combining PVS clinical healthcare practice with the TCM clinical real world study.It also lays a foundation for further summarising the efficacy and diagnostic and treatment experience of Chinese medicine in promoting awakening of PVS, predicting the prognosis and likelihood of awakening of PVS patients, and improving the rate of promoting awakening of patients in persistent vegetative state.

When composite endpoints are used as efficacy indicators in clinical efficacy evaluation, the same weight is usually assigned to each indicator for overall evaluation.In fact, different indicators are often of different importances for patients, and a simple comprehensive analysis cannot reflect the important concept of "patient-centered".To address these issues, this article introduces an efficacy evaluation method based on patient preference analysis of composite endpoints.By integrating multidimensional indicators (such as clinical efficacy indicators, patient-reported outcomes) while considering each patient preference, this method ranks different indicators, assigns varying importances, and compares efficacies of interventions.It is concluded that this method is suitable for the evaluation of complex intervention in traditional Chinese medicine and is compatible with the holistic view and individual treatment, which can reflect the clinical reality and the real diagnosis and treatment environment, and embody the real value of treatment to patients.It is suggested that in the future, the traditional Chinese medicine researchers should apply this method in efficacy evaluation scenarios with multiple composite indicators, patient-reported outcomes and real world.

With the rapid advancement of medical informatization, clinical diagnostic and treatment data are becoming extensively available, providing a solid foundation for real world study.This study focuses on prescription compatibility patterns of constipation patients who have received traditional Chinese medicine (TCM) treatment at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine over a 4-year period.Analyzing TCM prescription data from 16,416 constipation patients, the study aims to identify distinctive prescription patterns unique to the hospital.The identified core prescription is validated through randomized double-blind placebo-controlled trials and network pharmacology analysis.Clinical research demonstrates an overall effective rate of 77.78% for the core prescription, significantly surpassing the placebo group (33.33%).Network pharmacology analysis indicates that the core prescription may modulate biological pathways, including calcium ion signaling, MAPK signaling, cholinergic synapses, and GABAergic synapses.The results suggest that knowledge discovery techniques based on clinical data can uncover novel constipation treatments (Houpo, Laifuzi, Roucongrong, and Dafupi) that represent the hospital's characteristics and differ from commonly used traditional formulations.This study explores a research paradigm for summarizing clinical experience and provides a pathway for clinical knowledge discovery based on big data.

With the continuous advancement in the research of developmental language disorders in children, numerous studies have revealed the high prevalence and complexity of these disorders in the pediatric population.This study, based on a neuroscientific perspective, delves into the synergistic application of acupuncture therapy and whole-brain language therapy models in the treatment of childhood language disorders.With acupuncture, specific acupoints are precisely targeted to regulate the flow of qi and blood, achieve yin-yang balance within the body, and fundamentally promote the recovery of children's language functions.Concurrently, the whole-brain language therapy model focuses on activating multiple functional regions of the brain through systematic functional training aimed at strengthening the connectivity and coordination of neural networks, thereby significantly enhancing children's language expression abilities.This model includes key response training, cultivation of social pragmatic skills, and assessment and reinforcement of auditory comprehension abilities, comprehensively improving children's language skills and social interaction capabilities.The study found that combining acupuncture therapy with the whole-brain language therapy model allows for personalized and dynamic treatment adjustments based on the specific characteristics and developmental stages of children's language disorders.This innovative treatment strategy not only significantly improves therapeutic efficiency but also injects positive momentum into the overall development of children, providing a comprehensive, systematic, and effective new pathway for the treatment of childhood language disorders.

This article studies the impact of treatment frequency of the Tiaojing Cuyun acupuncture (acupuncture for regulating menstruation and promoting pregnancy) in the treatment of premature ovarian insufficiency (POI) based on real-world evidence.Using a prospective cohort study design, 100 POI patients were categorized into strong exposure and weak exposure groups based on different levels of acupuncture stimulation, with a primary outcome event of a 10 IU/L decrease in follicle stimulating hormone (FSH).Demographic and clinical characteristics of the cases were analyzed, and serum hormone levels before and after treatment, Kupperman scale scores, peak systolic velocity (PSV), and resistance index (RI） were compared with a logistic regression model to determine the optimal threshold of acupuncture stimulation exposure.The results indicated that the total acupuncture treatment duration of 6 weeks was the most sensitive dividing point, with 6 weeks or longer being considered as the high-exposure group.There were 73 cases in the high-exposure group and 27 cases in the low-exposure group.Before and after treatment, the FSH levels decreased in both groups, while the levels of estradiol (E2) and anti-Müllerian hormone (AMH) significantly increased (P<0.05).The Kupperman scores and RI decreased while PSV increased in both groups.Furthermore, the strong exposure group showed superior efficacy compared to the weak exposure group.Logistic regression analysis indicated that age, age at menarche, and the number of acupuncture treatments were correlated with efficacy (P<0.05).The "Tiaojing Cuyun" acupuncture technique can effectively improve premature ovarian insufficiency, and the efficacy is even better with a total acupuncture treatment duration of 6 weeks or longer.

Irritable bowel syndrome with predominant diarrhea (IBS-D), characterized by chronic and recurrent diarrhea and abdominal pain associated with defecation, is a common subtype of irritable bowel syndrome (IBS) in China, which seriously affects the quality of patient life.Previous investigation showed that Xingpi capsule is effective in the treatment of IBS but lacks clinical research evidence to provide reference for rational drug use.This study adopted a patient-centered prospective design, and systematically collected and analyzed population characteristics, disease improvement after taking Xingpi capsule in a real clinical diagnosis and treatment environment, as well as patient satisfaction and other information.The aim is to provide realworld evidence for rational drug use by clinicians and to provide reference for the design of clinical research elements for validation study of Xingpi capsule for IBS-D treatment in the absence of clinical evidence.This study observed and analyzed 28 symptom scores, major symptom group scores, gastrointestinal symptom rating scale(GSRS) scores and adverse events of 326 patients treated with Xipi capsule from Oct 2021 to Oct 2022.The results were as follows.Patients with IBS-D were more female than male (about 1.35 times), the proportion of young patients was relatively high (52.76%), and 90.80% of the patients were treated with Xingpi capsule alone.On the first day of treatment, the total symptom score, the major symptom cluster score and the insomnia symptom score were significantly improved (P<0.001), the GSRS score was significantly improved on the third day (P<0.001).Among the 326 patients, 99.08% were satisfied with the therapeutic effect of Xingpi capsule, and 6 (1.84%) had adverse events, including 1 case of nausea, 2 cases of stomach discomfort, 1 case of constipation, 1 case of dry mouth, and 1 case of upper abdominal discomfort.All six patients experienced discomfort within three days of taking the capsule, and discomfort disappeared after two to three days of continuing taking the pill.After 14 days of observation, Xingpi capsule could be used to treat young, middle-aged and elderly IBS-D; and clinical single drug effect was good.It could improve gastrointestinal symptoms such as diarrhea, abdominal pain, esophageal reflux and abnormal stool in patients with IBS-D, and treat the main symptoms of IBS-D within 2 days, with good safety and high patient satisfaction.

Myelosuppression is one of the most common adverse reactions of chemotherapy, which leads to dose reduction, delays, or even interruptions of the treatment.This study adopted a prospective cohort design to collect data from chemotherapynaive patients with solid tumors.Patients were divided into two groups based on whether they continuously used Qi-invigorating and blood-nourishing traditional Chinese medicine (TCM) formulas for at least four cycles during the chemotherapy.The incidence rates of myelosuppression were compared between the two groups.Results showed that the incidence rates of grade 3~ 4 neutropenia, grade 2 or higher thrombocytopenia, and grade 2 or higher anemia were significantly lower in the exposure group compared to the non-exposure group, with all differences being statistically significant (P<0.001, P=0.002, P=0.007, respectively).The study demonstrated that the concurrent use of TCM formulas and patent medicines based on the principles of Qi-invigorating and blood-nourishing during chemotherapy can significantly reduce the incidence of myelosuppression.Qiinvigorating and blood-nourishing therapy can be used as a preventive measure for chemotherapy-induced myelosuppression in solid tumors, applied simultaneously with chemotherapy as a preventive strategy based on syndrome differentiation.

By searching domestic and international databases, with shetong zhuyu decoction as the theme, and according to the "five principles" of quality markers of traditional Chinese medicines, a comprehensive predictive analysis of potential markers for the quality evaluation of shetong zhuyu decoction was carried out, and it was found that hydroxy safflower yellow pigment A, amygdalin, ferulic acid, ligustilide, ligustilide, ligusticum lactone A, ligustilide I, chlorogenic acid, Gentianoside, strychnoside, isoeuropteroside, qiangwuol, inosine, quercetin, kaempferol, benzoic acid, glycyrrhizic acid, glycyrrhizin, glycyrrhizin, and so on can be used as the quality markers of shetong zhuyu decoction, which in turn can provide important support for the subsequent quality control, medicinal efficacy evaluation, modernization research, and internationalization development of this formula.

The high prevalence of hypertension and its wide range of complications have made it a significant risk factor for cardiovascular disease mortality.Zhengan xifeng decoction (ZXD) is a classic traditional Chinese medicine prescription used in the clinical treatment of hypertension.However, there is a lack of systematic analysis of its composition rules and biological effects.In order to further explore the clinical application characteristics of ZXD in the treatment of hypertension, this study established a dataset based on the electronic medical records of hypertension patients from the Affiliated Hospital of Shandong University of Traditional Chinese Medicine from 2011 to 2019.Apriori algorithm was used to quantify the compatibility strength of the Chinese medicines in ZXD, while convolutional neural networks were employed to quantify the dosage characteristics.Topological feature analysis of protein interactions was used to examine biological characteristics.The outcome was then input into k-nearest neighbors, support vector machines, gradient boosting decision trees, Bayesian networks, and logistic regression models to evaluate the efficacy of each model, reflecting the composition rules and mechanisms of action of ZXD from multiple dimensions.The results showed that the k-nearest neighbors algorithm performed the best among the five models (AUC=93.5%), identifying 87 effective combinations, validating the mechanisms by which ZXD regulates cytokines, reduces inflammation, and corrects metabolic disorders.External testing indicated that this research could be extrapolated to other diseases.This study demonstrates that the model effectively integrates convolutional neural network data and network topology data, incorporating dosage information and biological characteristics into the exploration of Chinese medicine combinations.It complements traditional association rule models and has good general applicability and extrapolation capability, providing an interdisciplinary research approach for mining multimodal Chinese medicine datasets.

Evidence generated from real world data can be used to support drug development，therefoere the real world study of traditional Chinese medicine (TCM) has ushered in a good opportunity for development.However it faces new ethical risks and challenges.The article analyzes the common ethical issues involved in real world study, such as population selection, study duration, implementation scenarios, personnel, and research data.It outlines the choice and elements of informed consent models and further explores the challenges and solutions that TCM real world study may encounter in human experience, data governance, and research design.The analysis demonstrates that domestic regulations related to real world study are becoming more refined and aligned with international standards.Researchers need to dynamically learn relevant requirements, scientifically design clinical studies, and implement ethical requirements to ultimately form reliable, trustworthy, and usable real-world evidence.

As health economics methods have been widely adopted for developing clinical guidelines and adjusting health policies in the word, the advantages of acupuncture—being simple, convenient, effective, and affordable—urgently need scientific validations through health economics evaluation methods.This paper reviews published health economics articles on acupuncture and summarizes the progress and characteristics of current evaluations in this field.It also analyzes the reasons for low homogeneity and limited number of studies in acupuncture health economics evaluations.These reasons include the scarcity of long-term follow-up data from randomized controlled trials (RCTs) and real-world data in acupuncture clinical research, limited assessments of quality of life, and significant cost differences across countries and regions.The paper suggests further efforts to improve the development of acupuncture health economics guidelines, standardize research methods, and strengthen construction and training in related disciplines.By exploring the cost-effectiveness of acupuncture, its attractiveness and acceptance in the global health field can be enhanced, so as to provide strong support for the international promotion of acupuncture and its integration into mainstream medical systems.

Since Kaplan et al.first proposed the concept of RWS in 1993, China has become a hot spot in the real world research of traditional Chinese medicine.How to effectively collect value data (RWD) related to patients, and how to make correct, efficient, and accurate statistics, induction, organization, and analysis of the data, making it evidence of use value, potential benefits, and potential risks (RWE) have become important research topics.Japan's "configuration (home) medicine (box)" and its comprehensive, three-dimensional, and multi-level "ledger" information accumulation model formed under various conditions have made real records, data statistics, information induction, observation and analysis, and objective judgments on the usage history, functional testing, and effect verification of more than 100 ancient classic Chinese herbal medicines for more than 300 years.They have completed the transformation of data accumulation into evidence and into real-world research results, providing strong support for the secondary development, improvement, and enhancement of Chinese herbal medicines.Under the theoretical framework of "value medicine", ancient classic Chinese herbal medicines have been used to "prevent diseases before they occur and prevent recurrence after they occur".The value cognition of "treating diseases before they occur" has been constructed as a quantitative means.Given the current situation of limited research in this field, it is recommended to strengthen the exploration of the background and historical evolution of Japan's real-world research on "configuration (home) medicine (box)", analyze its mode characteristics and unique value, summarize its enlightening and reference value, and provide reference for improving the quality and efficiency of real-world research.