1.Exploring on Quality Evaluation Methods of Clinical Case Reports in Traditional Chinese Medicine Based on China Clinical Cases Library of Traditional Chinese Medicine
Kaige ZHANG ; Feng ZHANG ; Bo ZHOU ; Haimin CHEN ; Yong ZHU ; Changcheng HOU ; Liangzhen YOU ; Weijun HUANG ; Jie YANG ; Guoshuang ZHU ; Shukun GONG ; Jianwen HE ; Yang YE ; Yuqiu AN ; Chunquan SUN ; Qingjie YUAN ; Buman LI ; Xingzhong FENG ; Kegang CAO ; Hongcai SHANG ; Jihua GUO ; Xiaoxiao ZHANG ; Zhining TIAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):271-276
As the core vehicle for preserving and transmitting traditional Chinese medicine(TCM) academic thought and clinical experience, the establishment of a robust quality evaluation system for TCM clinical case reports is a crucial component in the current standardization and modernization of TCM. Based on the practical experience of constructing the China Clinical Cases Library of Traditional Chinese Medicine by the China Association of Chinese Medicine, this study conducted a comprehensive analysis of critical challenges, including insufficient authenticity and unfocused evaluation criteria. It proposed a three-dimensional evaluation framework grounded in the structure-process-outcome logic, encompassing three dimensions of authenticity and standardization, characteristics and advantages, application and translational impact. This framework integrated 12 key evaluation indicators in a systematic manner. The model preserved the academic characteristics of TCM syndrome differentiation and treatment, while aligning with modern scientific research standards, achieving a balance between individualized TCM experience and standardized evaluation. Concurrently, this study provided theoretical foundations and methodological guidance for evaluating the quality of TCM clinical cases, contributing significantly to the inheritance of TCM knowledge, evidence-based practice, and the reform of talent evaluation mechanisms.
2.Smart traditional Chinese medicine empowers the whole chain of “prevention–screening–diagnosis–treatment–management” for major chronic diseases in primary healthcare: Research on cardiovascular–cerebrovascular diseases and tumors
Xiaoyu ZHANG ; Jianlin WEI ; Yuqi LIANG ; Liangzhen YOU ; Mei ZHANG ; Hongcai SHANG
Science of Traditional Chinese Medicine 2026;4(2):132-139
Driven by policy initiatives promoting the integration of digital-intelligent technologies with primary healthcare and the digital transformation of traditional Chinese medicine (TCM), Smart TCM has emerged as a pivotal strategy for enhancing primary healthcare services for major chronic diseases. This paper reviews the current status, challenges, and feasible pathways of Smart TCM in community-level management of cardiovascular–cerebrovascular diseases and tumors, which represent major chronic disease burdens. Our findings indicate that Smart TCM demonstrates emerging potential in primary healthcare for chronic diseases across the entire continuum of “prevention-screening-diagnosis-treatment-management.” However, several significant challenges persist, including data silos and security vulnerabilities, limited applicability of existing models to real-world clinical needs, and insufficient digital literacy among primary healthcare physicians and elderly patients. To address these constraints, this paper proposes a multidimensional strategy encompassing the development of secure and interoperable regional data platforms, lightweight intelligent devices and support services aligned with primary care capacity, unified technical and data standards with corresponding quality control systems, adaptive and dynamically updated artificial intelligent models, interdisciplinary workforce training and patient education programs, and enhanced policy and health insurance support. Overall, Smart TCM shows great promise for improving the efficiency of primary healthcare delivery and establishing innovative TCM-based chronic disease management paradigms.
3.Analysis of Clinical and Phenomics Characteristics of Patients with Phlegm-Stasis Binding Syndrome and Its Accompanied Patterns in Stable Angina Pectoris of Coronary Heart Disease
Chongchai LI ; Han LI ; Zheng LI ; Zeng LI ; Yushi ZHOU ; Yuhan AO ; Shuang XU ; Xue WANG ; Yaoyao SUN ; Dongning WU ; Hongcai SHANG ; Mingxue ZHANG
Journal of Traditional Chinese Medicine 2026;67(14):1514-1522
ObjectiveTo explore the clinical and phenomics characteristics of patients with phlegm-stasis binding syndrome and its accompanied patterns in stable angina pectoris (SAP) of coronary heart disease (CHD). MethodsA multicenter cross-sectional study design was adopted. A total of 300 patients with SAP of CHD were enrolled and classified into 120 cases of phlegm-stasis binding syndrome, 125 cases of qi deficiency-accompanied syndrome, 38 cases of qi stagnation-accompanied syndrome, and 17 cases of toxin accumulation-accompanied syndrome according to traditional Chinese medicine (TCM) patterns. Data of patients with different TCM patterns were collected, including general condition, TCM symptoms, blood lipids, coagulation function, immune indicators, and serum metabolomics. Metabolic pathway enrichment analysis was used to compare differences in phenomics characteristics among groups. Metabolites with variable importance in projection (VIP) ≥1 and fold change (FC) ≥2 were considered as representative differential metabolites. ResultsPatients in each TCM pattern type were most commonly in the 60-75 years age group, with a relatively high proportion of males. Regarding TCM symptoms, patients with phlegm-stasis binding syndrome most commonly presented with wiry-choppy or wiry-slippery pulse, chest pain, and chest tightness; in patients with qi deficiency-accompanied syndrome, fatigue, chest pain, and weak pulse were most common; in patients with qi stagnation-accompanied sydnrome, wiry-choppy or wiry-slippery pulse, chest pain, and symptoms that increase or decrease with emotional changes, belching, or flatulence were most common; in patients with toxin accumulation-accompanied syndrome, bitter taste in the mouth, chest tightness, irritability, restlessness or manic delirium, and dry and hard stools or foul-smelling diarrhea were most common. Comparisons among the different TCM patterns showed statistically significant differences in coagulation parameters (P<0.05), whereas no statistically significant difference was found in blood lipid levels and immune indicators (P>0.05).Metabolomics analysis suggested that disorders of glycerophosphate metabolism and valine, leucine, and isoleucine metabolism are characteristic features of phlegm-stasis binding syndrome and its accompanied patterns. The representative differential metabolites between phlegm-stasis binding syndrome and qi deficiency-accompanied syndrome were 7,8-dihydrobiopterin (FC = 3.58) and oxypurinol (FC = 124.50). Those between phlegm-stasis binding syndrome and qi stagnation-accompanied syndrome were cytidine 5′-diphosphocholine (FC = 2.62) and D-mannosamine (FC = 2.99). Those between phlegm-stasis binding syndrome and toxin accumulation-accompanied syndrome were anserine (FC = 7.83) and canrenone (FC = 8.94). ConclusionThere are certain differences in the clinical characteristics and phenomics characteristics among patients with SAP due to CHD exhibiting phlegm-stasis binding syndrome and its accompanied patterns. The phenomics characteristics mainly involve biological alterations such as lipid metabolism disorders, amino acid metabolism abnormalities, and multiple immune indicators activation, which may provide a reference for precise differentiation and treatment of SAP of CHD in TCM clinical practice.
4.Analysis of Clinical and Phenomics Characteristics of Patients with Phlegm-Stasis Binding Syndrome and Its Accompanied Patterns in Stable Angina Pectoris of Coronary Heart Disease
Chongchai LI ; Han LI ; Zheng LI ; Zeng LI ; Yushi ZHOU ; Yuhan AO ; Shuang XU ; Xue WANG ; Yaoyao SUN ; Dongning WU ; Hongcai SHANG ; Mingxue ZHANG
Journal of Traditional Chinese Medicine 2026;67(14):1514-1522
ObjectiveTo explore the clinical and phenomics characteristics of patients with phlegm-stasis binding syndrome and its accompanied patterns in stable angina pectoris (SAP) of coronary heart disease (CHD). MethodsA multicenter cross-sectional study design was adopted. A total of 300 patients with SAP of CHD were enrolled and classified into 120 cases of phlegm-stasis binding syndrome, 125 cases of qi deficiency-accompanied syndrome, 38 cases of qi stagnation-accompanied syndrome, and 17 cases of toxin accumulation-accompanied syndrome according to traditional Chinese medicine (TCM) patterns. Data of patients with different TCM patterns were collected, including general condition, TCM symptoms, blood lipids, coagulation function, immune indicators, and serum metabolomics. Metabolic pathway enrichment analysis was used to compare differences in phenomics characteristics among groups. Metabolites with variable importance in projection (VIP) ≥1 and fold change (FC) ≥2 were considered as representative differential metabolites. ResultsPatients in each TCM pattern type were most commonly in the 60-75 years age group, with a relatively high proportion of males. Regarding TCM symptoms, patients with phlegm-stasis binding syndrome most commonly presented with wiry-choppy or wiry-slippery pulse, chest pain, and chest tightness; in patients with qi deficiency-accompanied syndrome, fatigue, chest pain, and weak pulse were most common; in patients with qi stagnation-accompanied sydnrome, wiry-choppy or wiry-slippery pulse, chest pain, and symptoms that increase or decrease with emotional changes, belching, or flatulence were most common; in patients with toxin accumulation-accompanied syndrome, bitter taste in the mouth, chest tightness, irritability, restlessness or manic delirium, and dry and hard stools or foul-smelling diarrhea were most common. Comparisons among the different TCM patterns showed statistically significant differences in coagulation parameters (P<0.05), whereas no statistically significant difference was found in blood lipid levels and immune indicators (P>0.05).Metabolomics analysis suggested that disorders of glycerophosphate metabolism and valine, leucine, and isoleucine metabolism are characteristic features of phlegm-stasis binding syndrome and its accompanied patterns. The representative differential metabolites between phlegm-stasis binding syndrome and qi deficiency-accompanied syndrome were 7,8-dihydrobiopterin (FC = 3.58) and oxypurinol (FC = 124.50). Those between phlegm-stasis binding syndrome and qi stagnation-accompanied syndrome were cytidine 5′-diphosphocholine (FC = 2.62) and D-mannosamine (FC = 2.99). Those between phlegm-stasis binding syndrome and toxin accumulation-accompanied syndrome were anserine (FC = 7.83) and canrenone (FC = 8.94). ConclusionThere are certain differences in the clinical characteristics and phenomics characteristics among patients with SAP due to CHD exhibiting phlegm-stasis binding syndrome and its accompanied patterns. The phenomics characteristics mainly involve biological alterations such as lipid metabolism disorders, amino acid metabolism abnormalities, and multiple immune indicators activation, which may provide a reference for precise differentiation and treatment of SAP of CHD in TCM clinical practice.
5.Construction and Verification of Prediction Model of Qi Deficiency and Blood Stasis Syndrome in Chronic Heart Failure
Tong JIANG ; Xiaodan FAN ; Shijia WANG ; Fengxia LIN ; Zhicong ZENG ; Liangzhen YOU ; Hongcai SHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):154-163
ObjectiveTo construct and validate a clinical prediction model for Qi deficiency and blood stasis syndrome in chronic heart failure (CHF),aiming to assist clinical diagnosis and provide tools and methods for individualized treatment of CHF. MethodsThe clinical data of patients with chronic heart failure treated at Dongzhimen Hospital of Beijing University of Chinese Medicine from January 2022 to January 2024 were retrospectively collected. The patients were randomly divided into a training group and a validation group with a ratio of 7∶3. First, the least absolute shrinkage and selection operator (LASSO) regression analysis was used to preliminarily screen the predictive factors affecting the diagnosis of Qi deficiency and blood stasis syndrome in CHF. Subsequently, the Logistic regression method was applied to conduct a more in-depth and detailed analysis of these factors. Variables with P<0.05 in the results of the multi-factor Logistic regression were carefully selected and included. Based on the regression coefficients obtained from this analysis, a model was constructed, and a nomogram was accurately drawn. Using R software,the receiver operating characteristic (ROC) curve,calibration curve,and decision curve analysis (DCA) were precisely drawn. These analyses were used to comprehensively evaluate the model from three crucial aspects: discrimination,calibration,and clinical applicability. Additionally, the accuracy,specificity,sensitivity,positive predictive value,and negative predictive value of the model were meticulously calculated to conduct a more all-round and comprehensive assessment. ResultsIn total, 168 cases were successfully obtained in the training group, and 71 cases were included in the validation group. After a thorough comparison, it was found that there were no statistically significant differences in the baseline data between the two groups. After being rigorously screened by the LASSO-multivariate logistic regression method, dark red tongue,smoking history,cardiac troponin I,and N-terminal pro-B-type natriuretic peptide (NT-ProBNP) were identified as the influencing factors for diagnosing patients with the Qi deficiency and blood stasis syndrome in CHF. The constructed model demonstrated an area under the curve (AUC) of 0.812 in the training group and 0.719 in the validation group. The calibration curve showed that the predicted curve of the model was close to the actual observed curve. DCA indicated that the model could provide substantial clinical benefits for patients at the decision thresholds ranging from 0.2 to 0.9. ConclusionThe clinical prediction model for Qi deficiency and blood stasis syndrome in chronic heart failure constructed in this study shows good performance. It has certain application value in clinical practice, which may contribute to the improvement of the diagnosis and treatment of CHF patients with this syndrome.
6.Textual Research on the Origin and Evolution of Olfactory Diagnosis in Traditional Chinese Medicine
Zijian XU ; Qian FU ; Yin JIANG ; Xiaoyu ZHANG ; Rui ZHONG ; Zhouyou WU ; Hongcai SHANG ; Mei ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(10):2790-2799
Olfactory diagnosis refers to the method of diagnosing diseases by smelling the odor emitted from the patient's body,secretions and excreta,and the odor of the sick room.It is one of the important diagnostic methods under the guidance of traditional Chinese medicine(TCM)theory,and is included in the"inquiry and olfaction"of TCM.In recent years,there has been rapid development in medical-engineering integration,artificial intelligence,big data,and other interdisciplinary fields.This has been promoting the TCM gradually to develop towards accurate,efficient and personalized medical treatment,which has opened a new era of"Smart TCM".In this paper,the ancient literature related to olfactory diagnosis was systematically reviewed,the developmental characteristics of olfactory diagnosis theories in various periods was sorted out,and the different views of TCM specialists on the odors emitted by the human body in physiological and pathological states was summarized.The paper is to explore the origin of TCM olfactory diagnosis and its periodization,clarify the diagnosis of abnormal odors,corresponding to the nature,etiology and prognosis of the disease,and clarify the development of TCM olfactory diagnosis.It provides a theoretical source and literature basis for promoting the research of"smart olfactory diagnosis of TCM"and facilitating the development of objectivity,standardization and intelligence of olfactory diagnosis in TCM.
7.Textual Research on the Origin and Evolution of Olfactory Diagnosis in Traditional Chinese Medicine
Zijian XU ; Qian FU ; Yin JIANG ; Xiaoyu ZHANG ; Rui ZHONG ; Zhouyou WU ; Hongcai SHANG ; Mei ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(10):2790-2799
Olfactory diagnosis refers to the method of diagnosing diseases by smelling the odor emitted from the patient's body,secretions and excreta,and the odor of the sick room.It is one of the important diagnostic methods under the guidance of traditional Chinese medicine(TCM)theory,and is included in the"inquiry and olfaction"of TCM.In recent years,there has been rapid development in medical-engineering integration,artificial intelligence,big data,and other interdisciplinary fields.This has been promoting the TCM gradually to develop towards accurate,efficient and personalized medical treatment,which has opened a new era of"Smart TCM".In this paper,the ancient literature related to olfactory diagnosis was systematically reviewed,the developmental characteristics of olfactory diagnosis theories in various periods was sorted out,and the different views of TCM specialists on the odors emitted by the human body in physiological and pathological states was summarized.The paper is to explore the origin of TCM olfactory diagnosis and its periodization,clarify the diagnosis of abnormal odors,corresponding to the nature,etiology and prognosis of the disease,and clarify the development of TCM olfactory diagnosis.It provides a theoretical source and literature basis for promoting the research of"smart olfactory diagnosis of TCM"and facilitating the development of objectivity,standardization and intelligence of olfactory diagnosis in TCM.
8.A Framework of Screening lndicators for Characteristic External Treatment Techniques with Miao Medicine Based on the Mixed Methods Research
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(3):668-673
Efficient screening constitutes a prerequisite for the research,development,generalization and application of characteristic external treatment techniques with Miao medicine featured by miscellaneous content as well as the coexistence of essence and dross,while the bottleneck lies in the absence of a screening indicators.Based on own features and current development status of characteristic external treatment techniques with Miao medicine,this study proposed a"three-stage"design thought involving qualitative exploration,tool research and development,and quantitative research in exploratory sequential design under the framework of mixed methods research.The present study systematically integrated qualitative and quantitative research methods as well as data to compensate for the shortcomings of single research paradigm-sourced data that was insufficient to comprehensively address various difficulties in the establishment of a screening indicators.It is expected to provide ideas and methodological references for establishing a screening indicators for characteristic external treatment techniques with Miao medicine.
9.Evidence map on the treatment of heart failure with Yiqifumai injec-tion
Shichao LYU ; Yunjiao WANG ; Yiming ZUO ; Hongcai SHANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(2):222-231
AIM:To display the distribution of evi-dence in the field of Yiqifumai injection treatment for heart failure.METHODS:To retrieve relevant da-tabases such as CBM,CNKI,Wanfang,VIP,Co-chrane Library,PubMed,Embase,and Web of Sci-ence,and search for the China Clinical Trial Regis-try,ClinicalTrials.gov and collect clinical studies,sys-tematic evaluations,and guideline studies on the treatment of heart failure with Yiqifumai injection.The evidence map research method use a table to display the proportion of literature,sample size,co-morbidities,and quality evaluations of systematic evaluations.Use a pie chart to display the propor-tion distribution of research types,a line chart to describe publication trends,and a bubble chart to display the distribution of evidence.RESULTS:The overall number of articles on the treatment of heart failure with Yiqifumai injection is in a steady development stage.Clinical studies are mainly small sample,single center,short-term randomized controlled trials,with a sample size of 60-100 cases and an intervention duration of mostly 14 days.The underlying disease is mainly coronary heart dis-ease.Clinical research evidence tends to support the therapeutic effect of Yiqifumai injection com-bined with conventional Western medicine in im-proving heart failure patients'heart function and quality of life.However,there are also issues such as low overall quality of research,unreasonable clinical trial design,small sample size,incomplete selection of outcome indicators,low international recognition of certain outcome indicators,and lack of reporting on long-term outcomes The overall quality of randomized controlled trials andsystem-atic evaluation methodology is low.CONCLUSION:In the future,more large sample,multicenter clini-cal randomized controlled trials should be conduct-ed to obtain higher-level evidence-based medicine evidence to fully demonstrate the advantages of traditional Chinese medicine treatment,and pro-mote the common development of traditional Chi-nese medicine cardiology and evidence-based med-icine.
10.Evidence map on the treatment of heart failure with Yiqifumai injec-tion
Shichao LYU ; Yunjiao WANG ; Yiming ZUO ; Hongcai SHANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(2):222-231
AIM:To display the distribution of evi-dence in the field of Yiqifumai injection treatment for heart failure.METHODS:To retrieve relevant da-tabases such as CBM,CNKI,Wanfang,VIP,Co-chrane Library,PubMed,Embase,and Web of Sci-ence,and search for the China Clinical Trial Regis-try,ClinicalTrials.gov and collect clinical studies,sys-tematic evaluations,and guideline studies on the treatment of heart failure with Yiqifumai injection.The evidence map research method use a table to display the proportion of literature,sample size,co-morbidities,and quality evaluations of systematic evaluations.Use a pie chart to display the propor-tion distribution of research types,a line chart to describe publication trends,and a bubble chart to display the distribution of evidence.RESULTS:The overall number of articles on the treatment of heart failure with Yiqifumai injection is in a steady development stage.Clinical studies are mainly small sample,single center,short-term randomized controlled trials,with a sample size of 60-100 cases and an intervention duration of mostly 14 days.The underlying disease is mainly coronary heart dis-ease.Clinical research evidence tends to support the therapeutic effect of Yiqifumai injection com-bined with conventional Western medicine in im-proving heart failure patients'heart function and quality of life.However,there are also issues such as low overall quality of research,unreasonable clinical trial design,small sample size,incomplete selection of outcome indicators,low international recognition of certain outcome indicators,and lack of reporting on long-term outcomes The overall quality of randomized controlled trials andsystem-atic evaluation methodology is low.CONCLUSION:In the future,more large sample,multicenter clini-cal randomized controlled trials should be conduct-ed to obtain higher-level evidence-based medicine evidence to fully demonstrate the advantages of traditional Chinese medicine treatment,and pro-mote the common development of traditional Chi-nese medicine cardiology and evidence-based med-icine.

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