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.Effect of Wei's Huoxue Tongluo Formula(韦氏活血通络方)on Visual Function and Fundus Blood Flow in Treating Atrophic-Stage Non-Arteritic Anterior Ischemic Optic Neuropathy with Qi Deficiency and Blood Stasis
Yan WANG ; Linlin CAO ; Meiling HAO ; Xiaoding SHUI ; Simin SONG ; Kun DING ; Rilong ZHOU ; Yu LUO ; Yize HUANG ; Xiaoyu LIANG ; Liang LIAO
Journal of Traditional Chinese Medicine 2026;67(10):1062-1070
ObjectiveTo evaluate the efficacy and possible mechanism of Wei's Huoxue Tongluo Formula (韦氏活血通络方,WHTF) in treating atrophic-stage non-arteritic anterior ischemic optic neuropathy (NAION) with qi deficiency and blood stasis. MethodsA total of 82 atrophic-stage NAION patients with qi deficiency and blood stasis were randomly divided into a treatment group and a control group, with 41 cases in each group. The treatment group was given oral administration of WHTF twice a day plus acupoint injection of distilled water 2 ml at Taiyang (EX-HN5) once daily, while the control group received injection of compound anisodine injection 2 ml at Taiyang (EX-HN5) once daily and oral administration of WHTF placebo twice a day. Both groups received treatment for a course of 14 days. The best-corrected visual acuity (BCVA), optic disc perfusion density (PD), flux index (FI), macular superficial PD, vascular density (VD), and traditional Chinese medicine (TCM) syndrome scores were compared between groups before treatment and on day 7 and day 14 of treatment. Additionally, mean defect (MD) and mean sensitivity (MS) of visual fields were measured before treatment and on day 14, along with safety evaluation. ResultsAfter treatment, both groups showed significant improvement in BCVA, visual field MD and MS, and TCM syndrome scores (P<0.05 or P<0.01). On day 14 of treatment, the TCM syndrome score in the treatment group was significantly lower than that in the control group (P<0.05). There was no significant improvement in optic disc PD and FI, and macular superficial PD and VD after treatment in either group (P>0.05) except that on day 7 the macular superficial foveal PD in the control group was significantly better than that in the treatment group (P<0.05). During the treatment period, no serious adverse events occurred in either group. ConclusionWHTF can improve the visual function indicators including visual acuity and visual field, as well as TCM syndrome scores in atrophic-stage NAION patients with qi deficiency and blood stasis. It shows clinical safety, although it does not appear to have a significant effect on optic disc or macular blood flow.
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.From Cure to Control: Construction and Application of “Green Therapy” System for Tumors in the Elderly
Cancer Research on Prevention and Treatment 2026;53(7):509-515
Elderly patients with tumors face unique challenges due to age-related decline in organ function, multiple comorbidities, and poor tolerance to treatment, often limiting the applicability of the traditional “maximum tolerated therapy” approach in this population. This article aims to explore the “green therapy” system tailored for tumors in elderly patients. Proposed by Professor Hu Kaiwen in 2003, this system replaces “cure” with “control,” integrating modern minimally invasive techniques with holistic regulation from Traditional Chinese Medicine to form a treatment strategy that balances local and systemic approaches. This paper systematically elucidates the construction and application of this system in tumors in elderly patients, highlighting its core value of achieving long-term peaceful coexistence between patients and tumors through low-damage methods, thereby offering a new treatment option aligned with the physiological characteristics of this population.
6.Qishen Liuwei Prescription Combined with Conventional Antihypertensive Therapy in Intervention of Senile Primary Hypertension Complicated with Frailty: A Randomized Controlled Trial
Hanxi CHAN ; Yanran HUI ; Lijun HUANG ; Linbo YU ; Huali XIAO ; Kun ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(18):162-170
ObjectiveTo evaluate the clinical efficacy and safety of the Qishen Liuwei presoription for senile hypertension complicated with frailty (of Qi deficiency and blood stasis pattern, or deficiency of both spleen and kidney pattern). MethodsA single-center, randomized controlled clinical trial design was employed in this study. Sixty-four eligible patients, treated at the Cardiology Outpatient Clinic of Dongfang Hospital, Beijing University of Chinese Medicine between June 2024 and February 2025, were randomly allocated into an observation group or a control group, with 32 patients in each group. Both groups received standard conventional antihypertensive therapy, while the observation group additionally received the Qishen Liuwei Formula (one dose per day, in separate servings in the morning and evening). For both groups, a treatment course consisted of 4 weeks, followed by a 2-month follow-up period. Then, the primary indicator (Fried frailty phenotype scores), along with secondary indicators including traditional Chinese medicine (TCM) syndrome scores and changes in blood pressure were observed before and after treatment. ResultsRegarding Fried frailty phenotype scores, the observation group exhibited significantly improved grip strength, 4.57 m walk time, the duration of weekly walks, ''effort required for any activity'', and ''inability to walk forward'' after treatment, while only the latter two indicators were significantly improved in the control group (P<0.05). Compared with the control group, the observation group demonstrated significantly superior improvement in the duration of weekly walks, ''effort required for any activity'', and frailty (P<0.05). For total TCM syndrome scores, both groups displayed significantly decreased total TCM syndrome scores (P<0.05) after treatment, and the decrease was more significant in the observation group (P<0.05). Regarding office blood pressure, both groups showed significantly decreased diastolic blood pressure and mean arterial pressure after treatment, while the observation group also showed significantly decreased systolic blood pressure (P<0.05). During treatment, one case of facial rash occurred in the observation group, representing an adverse reaction rate of 3.13% (1/32). The rash resolved one week after discontinuation of medication. No adverse reactions occurred in the control group during treatment. No statistically significant difference was observed in the incidence of adverse reactions between the two groups. ConclusionFor senile hypertension complicated with frailty, the Qishen Liuwei presoription effectively improves physical activity, muscle strength, frailty-related symptoms, and TCM syndrome remission. When combined with Western medicine, the Formula contributes to stable blood pressure control and demonstrates a favorable clinical safety profile, indicating its clinical application potential.
7.Screening of Anti-breast Cancer Active Ingredients in Famous Classical Formula Yanghetang
Sijia SU ; Xinyu ZHAO ; Jingna ZHOU ; Junfeng GAO ; Xu TANG ; Binyu WEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):21-30
ObjectiveBased on ultra performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS/MS), the combination of serum pharmacochemistry, response profile of absorbed components in serum, network pharmacology and drug-likeness prediction was used to screen the potential active ingredients of Yanghetang against breast cancer. MethodsUPLC-Q-TOF-MS/MS was used to identify the main components in different solvent extracts of Yanghetang, and serum pharmacochemistry was applied to analyze the absorbed components from the serum of female SD rats after 0.5, 1, 2 h of administration. Combined with the response characteristic values of serum drug components obtained from UNIFI 1.8.2, the absorbed prototype components and metabolites were screened to get the absorbed components of Yanghetang with a significant patterns of elimination and growth. Network pharmacology was applied to construct a drug-component-pathway-target-disease network, and molecular docking was performed between absorbed components and key targets of breast cancer, and the drug similarity was analyzed by SwissADME. ResultsForty-two compounds were identified in Yanghetang samples extracted with different solvents, of which 16 compounds were common to the three different extraction solvents(methanol, 50% methanol and water). The results of drug-containing serum analysis showed that there were 16 absorbed components in serum, including 5 prototypes and 11 metabolites. Network pharmacology results showed that Yanghetang against breast cancer involved 15 key targets such as proto-oncogene tyrosine-protein kinase Src(SRC), epidermal growth factor receptor(EGFR) and phosphoinositide 3 kinase catalytic alpha polypeptide(PIK3CA). Molecular docking results showed that 16 potential active ingredients were well combined with the predicted targets. Combined with drug likenesses, 12 compounds in the absorbed components of Yanghetang were considered to have potential for anti-breast cancer activity, mainly including α-pinene and γ-eudesmol and their metabolites, of which one was from Ephedrae Herba, one was from Rehmanniae Radix, and eight were from Cinnamomi Cortex. ConclusionThe chemical components of Yanghetang mainly include polysaccharides, monoterpene glycosides and coumarins, and its prototype components mainly undergo oxidation, hydrolysis and acetylation after entering the blood. Its anti-breast cancer mechanism may be related to the regulation of signaling pathways such as the mitogen-activated protein kinase(MAPK) and phosphatidylinositol 3-kinase/protein kinase B(PI3K/Akt). The results of this study can lay a foundation for further exploration of Yanghetang in the treatment of breast cancer.
8.Construction of a Diagnostic Model for Traditional Chinese Medicine Syndromes of Chronic Cough Based on the Voting Ensemble Machine Learning Algorithm
Yichen BAI ; Suyang QIN ; Chongyun ZHOU ; Liqing SHI ; Kun JI ; Chuchu ZHANG ; Panfei LI ; Tangming CUI ; Haiyan LI
Journal of Traditional Chinese Medicine 2025;66(11):1119-1127
ObjectiveTo explore the construction of a machine learning model for the diagnosis of traditional Chinese medicine (TCM) syndromes in chronic cough and the optimization of this model using the Voting ensemble algorithm. MethodsA retrospective analysis was conducted using clinical data from 921 patients with chronic cough treated at the Respiratory Department of Dongfang Hospital, Beijing University of Chinese Medicine. After standardized processing, 84 clinical features were extracted to determine TCM syndrome types. A specialized dataset for TCM syndrome diagnosis in chronic cough was formed by selecting syndrome types with more than 50 cases. The synthetic minority over-sampling technique (SMOTE) was employed to balance the dataset. Four base models, logistic regression (LR), decision tree (dt), multilayer perceptron (MLP), and Bagging, were constructed and integrated using a hard voting strategy to form a Voting ensemble model. Model performance was evaluated using accuracy, recall, precision, F1-score, receiver operating characteristic (ROC) curve, area under the curve (AUC), and confusion matrix. ResultsAmong the 921 cases, six syndrome types had over 50 cases each, phlegm-heat obstructing the lung (294 cases), wind pathogen latent in the lung (103 cases), cold-phlegm obstructing the lung (102 cases), damp-heat stagnating in the lung (64 cases), lung yang deficiency (54 cases), and phlegm-damp obstructing the lung (53 cases), yielding a total of 670 cases in the specialized dataset. High-frequency symptoms among these patients included cough, expectoration, odor-induced cough, throat itchiness, itch-induced cough, and cough triggered by cold wind. Among the four base models, the MLP model showed the best diagnostic performance (test accuracy: 0.9104; AUC: 0.9828). Compared with the base models, the Voting ensemble model achieved superior performance with an accuracy of 0.9289 on the training set and 0.9253 on the test set, showing a minimal overfitting gap of 0.0036. It also achieved the highest AUC (0.9836) in the test set, outperforming all base models. The model exhi-bited especially strong diagnostic performance for damp-heat stagnating in the lung (AUC: 0.9984) and wind pathogen latent in the lung (AUC: 0.9970). ConclusionThe Voting ensemble algorithm effectively integrates the strengths of multiple machine learning models, resulting in an optimized diagnostic model for TCM syndromes in chronic cough with high accuracy and enhanced generalization ability.
9.Deep Forest Ensemble Model:a Novel Strategy for Complex Medical Image Data
Yi ZHOU ; Fang SHAO ; Dongfang YOU
Chinese Journal of Health Statistics 2025;42(4):510-515
Objective To compare the predictive performance of the deep forest ensemble model,deep forest,and random forest in medical classification.Methods This study proposed a deep forest ensemble model that integrated Sobol-MDA(Sobol-mean decrease accuracy)with the cascading structure of deep forest and feature extraction capabilities of random forest.The model was applied to both simulation and real medical data analysis.The simulation experiments covered scenarios such as unbalanced outcome variables,nonlinear relationships,noise variables,multicollinearity,and interactions.The real data analysis was conducted on parotid MRI data to compare the performance of the models in terms of area under curve(AUC)and other metrics.Results In both the simulation and real data analysis,the deep forest ensemble model demonstrated superiority,especially in complex interaction scenarios,where its predictive performance significantly outperformed deep forest and random forest models.Conclusion Deep forest ensemble model shows significant advantages in addressing complex medical classification tasks.Its predictive performance outperforms traditional models.
10.Efficacy and safety of PD-1 inhibitors combined with chemotherapy for the treatment of local recurrence at the primary tumor site of ESCC following definitive chemoradiotherapy or radiotherapy
Yuxi SHI ; Hui LI ; Lei ZHOU ; Yiyu GUO ; Dongfang GE ; Xinyu XU ; Chenguang BAI ; Zhi ZHANG ; Guoren ZHOU ; Jinjun YE
Chinese Journal of Oncology 2025;47(5):418-425
Objective:Exploring the efficacy and safety of the combination of programmed cell death protein 1 (PD-1) inhibitors with chemotherapy for the treatment of local recurrence at the primary tumor site of esophageal squamous cell carcinoma (ESCC) following definitive chemoradiotherapy.Methods:Seventy-six patients with local recurrence at the primary tumor site of ESCC following definitive chemoradiotherapy, who were treated at the Cancer Hospital Affiliated with Nanjing Medical University from January 2019 to January 2024. All patients received treatment with a PD-1 inhibitor combined with chemotherapy, and the short-term efficacy, long-term efficacy, and adverse reactions were observed. Univariate and multivariate Cox regression models were employed to identify the factors influencing overall survival (OS) and after-recurrence survival (ARS).Results:Among the 76 patients, 7 achieved partial response, 35 had stable disease, and 34 experienced progressive disease. The objective response rate was 9.2% (7/76), and the disease control rate was 55.3% (42/76). With a median follow-up time of 23.1 months, 33 out of 76 patients died. The median survival time was 38.5 months (95% CI: 29.6-47.3 months); the 1-year, 2-year, and 3-year OS were 94.5%, 66.6%, and 51.7%, respectively. The median ARS was 14.7 months (95% CI: 10.4-19.1 months); the 6-month, 12-month, and 24-month ARS were 85.8%, 59.6%, and 25.7%, respectively. Univariate analysis showed that the initial radiation dose, the Eastern Cooperative Oncology Group (ECOG) performance status of patients after recurrence, the recurrence-free interval (RFI), and the approach to chemotherapy treatment following local esophageal recurrence were factors affecting OS and ARS ( P<0.05). Multivariate analysis showed that initial radiotherapy dose ( HR=0.268, 95% CI: 0.100-0.720), the ECOG performance status after recurrence ( HR=4.106, 95% CI: 1.228-13.728), and RFI ( HR=0.248, 95% CI: 0.106-0.582) were independent prognostic factors for OS. Additionally, the initial radiation dose ( HR=0.289, 95% CI: 0.098-0.853) and the ECOG performance status after recurrence ( HR=5.143,95% CI:1.404-18.838) were independent prognostic factors for ARS. The incidence of treatment-related adverse-reactions was 85.5% (65/76). Grade 3 or higher treatment-related adverse reactions primarily included anemia in 4 cases, leukopenia in 8 cases, neutropenia in 9 cases, thrombocytopenia in 2 cases, liver function abnormalities in 4 cases, and elevated troponin T in 2 cases. There were no cases of treatment-related mortality. Conclusions:The combination of PD-1 inhibitors with chemotherapy is safe and effective for local recurrence at the primary tumor site of ESCC following definitive chemoradiotherapy and can provide survival benefits for patients. This approach can be considered as a therapeutic option for local recurrence at the primary tumor site of ESCC following definitive chemoradiotherapy.

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