1.Efficacy and safety of surgery-assisted transjugular intrahepatic portosystemic shunt in treatment of portal hypertension comorbid with complex portal vein thrombosis
Zhenhua FAN ; Chengbin DONG ; Qimei LI ; Yu ZHANG ; Yifan WU ; Dongfang LIU ; Guangzhong XU ; Dezhong WANG ; Jianfei CHEN ; Zhendong YUE ; Lei WANG
Journal of Clinical Hepatology 2026;42(3):586-592
ObjectiveTo investigate the feasibility, safety, and efficacy of surgery-assisted transjugular intrahepatic portosystemic shunt (SA-TIPS) in the treatment of portal hypertension comorbid with complex portal vein thrombosis, including cavernous transformation of the portal vein (CTPV). MethodsAn analysis was performed for the data of 36 patients with portal hypertension and complex portal vein thrombosis who underwent SA-TIPS in Beijing Shijitan Hospital, Capital Medical University, from November 2023 to January 2025, including general status, technical data of the surgical process (surgical success rate, puncture times, time of operation, the number of stents used, and the length of shunt), perioperative complications, and surgical recovery. The change in portal pressure gradient (PPG) after shunt was compared, and the rate of reaching the standard for PPG reduction was calculated, as well as stent patency rate within 1 week after surgery. The paired samples t-test was used for comparison of continuous data between two groups. ResultsAmong the 36 patients, 34 (94.4%) underwent SA-TIPS successfully. The incidence rate of perioperative complications was 16.7% (6/36), including 3 cases of thoraco-abdominal hemorrhage, 2 cases of intraoperative arrhythmia, and 1 case of incision infection. There was a significant reduction in PPG after SA-TIPS (t=19.85, P<0.01), and the patients achieving a ≥50% reduction in PPG accounted for 76.5% (26/34). Imaging reexamination within 1 week showed a shunt patency rate of 100%. ConclusionSA-TIPS has a high technical success rate, a favorable safety profile, and good efficacy in the treatment of portal hypertension comorbid with complex portal vein thrombosis (including CTPV), and therefore, it holds promise for clinical application.
2.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.
3.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions (T/CACM 1563.2-2024) were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine (TCM). This guideline was jointly developed with 23 authoritative medical and research institutions in China, under the lead of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM (including research and development, marketing, and application) and to establish a four-dimensional framework of "organizational structure, institutional system, information platform, and vigilance activities". Key components included the establishment of a TCM Safety Committee, the construction of nine core systems, the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B standards, alongside the risk monitoring, identification, assessment, and control during clinical trials and post-marketing phases. Therefore, this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations, the guideline compilation involved multiple rounds of expert interviews, systematic evidence integration, and broad consensus. This guideline was specified to be applicable to medical institutions at all levels, primarily addressing core issues, including the difficulty in adverse reaction identification, low reporting rates, and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous, ensuring alignment with current national laws and regulations, and was registered internationally. In the future, implementation will be promoted through standardized training, tiered dissemination, as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks, ensure patient medication safety, and promote the high-quality development of TCM.
4.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions (T/CACM 1563.2-2024) were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine (TCM). This guideline was jointly developed with 23 authoritative medical and research institutions in China, under the lead of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM (including research and development, marketing, and application) and to establish a four-dimensional framework of "organizational structure, institutional system, information platform, and vigilance activities". Key components included the establishment of a TCM Safety Committee, the construction of nine core systems, the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B standards, alongside the risk monitoring, identification, assessment, and control during clinical trials and post-marketing phases. Therefore, this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations, the guideline compilation involved multiple rounds of expert interviews, systematic evidence integration, and broad consensus. This guideline was specified to be applicable to medical institutions at all levels, primarily addressing core issues, including the difficulty in adverse reaction identification, low reporting rates, and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous, ensuring alignment with current national laws and regulations, and was registered internationally. In the future, implementation will be promoted through standardized training, tiered dissemination, as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks, ensure patient medication safety, and promote the high-quality development of TCM.
5.Revisiting Intelligent Syndrome Differentiation in Traditional Chinese Medicine under the Disease-Syndrome Combination Model:Perspectives from Disease "Ambiguity and Precision"
Xinlong LI ; Sulin WANG ; Dongning YAN ; Xinran ZHAO ; Genming ZHANG
Journal of Traditional Chinese Medicine 2026;67(7):705-709
The ambiguity of symptom information in traditional Chinese medicine (TCM) syndrome differentiation can be amplified in the direct reasoning process from symptoms to syndromes in the absence of constraints, which affects the accuracy and stability of intelligent syndrome differentiation. TCM disease concepts, while historically rational, are structurally ambiguous in both their connotation and extension, making it difficult to serve as stable prior knowledge in intelligent modeling. In contrast, modern medical diseases, based on objective testing and quantifiable indicators, have relatively clear boundaries and reproducible standards. This study proposes a disease-syndrome combination model, adopting modern medical diseases as structural prior variables to reconstruct the hierarchical relationships among disease, symptoms, and syndromes. By applying disease constraints, effective screening of information from the four examinations and compressing the reasoning space are achieved. Furthermore, by integrating artificial intelligence technologies, such as multimodal fusion and knowledge graphs, an intelligent syndrome differentiation model driven by both prior knowledge and clinical data is constructed, providing a feasible path to enhance the accuracy of syndrome differentiation and realize the intelligentization of TCM diagnosis and treatment.
6.Study on the mechanism of Huatan qushi huoxue formula in improving metabolic dysfunction-associated steatohepatitis by inhibiting macrophage pyroptosis
Yajie GUAN ; Qizhen ZHANG ; Junjiao XU ; Yijia SONG ; Dongfang SHANG ; Wenxia ZHAO ; Minghao LIU
China Pharmacy 2026;37(7):864-869
OBJECTIVE To focus on the classic NOD-like receptor protein 3 (NLRP3)/Caspase-1/gasdermin D (GSDMD) pyroptosis pathway and explore the mechanism by which Huatan qushi huoxue formula (HQHF) inhibits macrophage pyroptosis to ameliorate metabolic dysfunction-associated steatohepatitis (MASH). METHODS RAW264.7 cells were divided into 5 groups: Control group (10% blank serum), Model group [10% blank serum+5 μg/mL lipopolysaccharide (LPS)], HQHF-L group (2.5% drug-containing serum+7.5% blank serum+5 μg/mL LPS), HQHF-M group (5% drug-containing serum+5% blank serum+5 μg/mL LPS), and HQHF-H group (10% drug-containing serum+5 μg/mL LPS). After 24 h of routine culture post-administration, cells and supernatants were collected for assays. Cell morphology was observed via scanning electron microscopy and phase-contrast microscopy; localization and expression of gasdermin D-N (GSDMD-N) were observed by immunofluorescence. Interleukin-1β (IL-1β) and IL-18 contents in supernatants were detected by ELISA; mRNA and protein expressions of NLRP3, Caspase-1, and GSDMD were measured using real-time PCR and Western blot. RESULTS Compared with the Control group, the Model group showed typical pyroptotic morphology (cell membrane bulging and pore formation), increased aggregation and fluorescence intensity of GSDMD-N on the cell membrane ( P <0.05), significantly increased the contents of IL-1β and IL-18 in cell supernatants ( P <0.05), and significantly up-regulated mRNA and protein expressions of NLRP3, Caspase-1, and GSDMD in cells ( P <0.05). Compared with the Model group, the HQHF-L, HQHF-M and HQHF-H groups showed improved pyroptotic morphology, reduced membrane localization and significantly weakened fluorescence intensity of GSDMD-N ( P <0.05), significantly decreased the contents of IL-1β and IL-18 in cell supernatants ( P <0.05), and significantly down-regulated mRNA and protein expressions of NLRP3, Caspase-1, and GSDMD in cells ( P <0.05). CONCLUSIONS HQHF inhibits LPS-induced macrophage pyroptosis, and its mechanism of improving MASH may be associated with the suppression of the activation of the classical NLRP3/Caspase-1/GSDMD pyroptosis pathway.
7.Current Status of Traditional Chinese Medicine Diagnosis and Treatment of Inflammatory Bowel Disease and the Research on Mechanism
Junxiang LI ; Hong SHEN ; Tangyou MAO ; Lei ZHU ; Jiaqi ZHANG ; Zhibin WANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(1):103-110
In recent years, traditional Chinese medicine (TCM) has achieved significant progress in the treatment of inflammatory bowel disease (IBD). A comprehensive literature search was conducted covering the period from January 1, 2010, to December 30, 2024, across Chinese databases including China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP China Science and Technology Journal Database, and the Chinese Biomedical Literature Service System, as well as international databases such as PubMed, Web of Science, and Embase. The clinical applications and mechanistic studies of TCM in IBD were systematically reviewed. The current status of TCM research on the etiology and pathogenesis of IBD, innovative clinical practices, and multimodal therapeutic approaches, including Chinese herbal formulas, single herbs or active compounds, acupuncture, herbal retention enema, and acupoint application, were summarized, together with their synergistic effects when combined with western medical treatments. The development and application of Chinese patent medicines for IBD are undergoing a profound transition from efficacy validation to mechanistic exploration. Mechanistic studies on the effects of TCM in IBD mainly focus on regulating gut microbiota homeostasis, repairing the intestinal mucosal barrier, and modulating intestinal immune balance. Furthermore, future research directions for TCM-based IBD management are proposed, including the establishment of TCM diagnostic and treatment models, expanding integrated applications of external and internal TCM therapies, innovating personalized treatment strategies, and advancing drug development. These efforts aim to provide insights for the standardized and precision-oriented development of TCM in the diagnosis and treatment of IBD.
8.Clinical Advantages of Traditional Chinese Medicine in Treatment of Childhood Simple Obesity: Insights from Expert Consensus
Qi ZHANG ; Yingke LIU ; Xiaoxiao ZHANG ; Guichen NI ; Heyin XIAO ; Junhong WANG ; Liqun WU ; Zhanfeng YAN ; Kundi WANG ; Jiajia CHEN ; Hong ZHENG ; Xinying GAO ; Liya WEI ; Qiang HE ; Qian ZHAO ; Huimin SU ; Zhaolan LIU ; Dafeng LONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):238-245
Childhood simple obesity has become a significant public health issue in China. Modern medicine primarily relies on lifestyle interventions and often suffers from poor long-term compliance, while pharmacological options are limited and associated with potential adverse effects. Traditional Chinese Medicine (TCM) has a long history in the prevention and management of this condition, demonstrating eight distinct advantages, including systematic theoretical foundation, diversified therapeutic approaches, definite therapeutic efficacy, high safety profile, good patient compliance, comprehensive intervention strategies, emphasis on prevention, and stepwise treatment protocols. Additionally, TCM is characterized by six distinctive features: the use of natural medicinal substances, non-invasive external therapies, integration of medicinal dietetics, simple exercise regimens, precise syndrome differentiation, and diverse dosage forms. By combining internal and external treatments, TCM facilitates individualized regimen adjustment and holistic regulation, demonstrating remarkable effects in improving obesity-related metabolic indicators, regulating constitutional imbalance, and promoting healthy behaviors. However, challenges remain, such as inconsistent operational standards, insufficient high-quality clinical evidence, and a gap between basic research and clinical application. Future efforts should focus on accelerating the standardization of TCM diagnosis and treatment, conducting multicenter randomized controlled trials, and fostering interdisciplinary integration, so as to enhance the scientific validity and international recognition of TCM in the prevention and treatment of childhood obesity.
9.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.
10.Effects of Modified Guomin Decoction (加味过敏煎) on Traditional Chinese Medicine Syndromes and Quality of Life in Patients with Mild to Moderate Atopic Dermatitis of Heart Fire and Spleen Deficiency Pattern:A Randomized,Double-Blind,Placebo-Controlled Trial
Jing NIE ; Rui PANG ; Lingjiao QIAN ; Hua SU ; Yuanwen LI ; Xinyuan WANG ; Jingxiao WANG ; Yi YANG ; Yunong WANG ; Yue LI ; Panpan ZHANG
Journal of Traditional Chinese Medicine 2025;66(10):1031-1037
ObjectiveTo observe the clinical efficacy and safety of Modified Guomin Decoction (加味过敏煎, MGD) in patients with mild to moderate atopic dermatitis (AD) of the traditional Chinese medicine (TCM) pattern of heart fire and spleen deficiency, and to explore its possible mechanisms. MethodsIn this randomized, double-blind, placebo-controlled study, 72 patients with mild to moderate AD and the TCM pattern of heart fire and spleen deficiency were randomly divided into a treatment group and a control group, with 36 cases in each group. The treatment group received oral MGD granules combined with topical vitamin E emulsion, while the control group received oral placebo granules combined with topical vitamin E treatment. Both groups were treated twice daily for 4 weeks. Clinical efficacy, TCM syndrome scores, Visual Analogue Scale (VAS) for pruritus, Dermatology Life Quality Index (DLQI) scores, Scoring Atopic Dermatitis (SCORAD) and serum biomarkers, including interleukin-33 (IL-33), interleukin-1β (IL-1β), immunoglobulin E (IgE), and tumor necrosis factor-α (TNF-α) were compared before and after treatment. Safety indexes was also assessed. ResultsThe total clinical effective rates were 77.78% (28/36) in the treatment group and 38.89% (14/36) in the control group, with cure rates of 19.44% (7/36) and 2.78% (1/36), respectively. The treatment group showed significantly better clinical outcomes compared to the control group (P<0.05). The treatment group exhibited significant reductions in total TCM syndrome scores, including erythema, edema, papules, scaling, lichenification, pruritus, irritability, insomnia, abdominal distension, and fatigue scores, as well as reductions in VAS, DLQI, SCORAD, and serum IgE and IL-33 levels (P<0.05 or P<0.01). Compared to the control group, the treatment group had significantly better improvements in all indicators except for insomnia (P<0.05). No adverse events occurred in either group. ConclusionMGD is effective and safe in treating mild to moderate AD patients with heart fire and spleen deficiency pattern. It significantly alleviates pruritus, improves TCM syndromes and quality of life, and enhances clinical efficacy, possibly through modulation of immune responses.

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