1.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.
2.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.
3.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.
4.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.
5.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.
6.Survey on pharmacovigilance functions and operational models in 66 tertiary medical institutions in China
Xuelin SUN ; Dongfang QIAN ; Wenjing ZHAO ; Chunting WANG ; Xin HU ; Yatong ZHANG
China Pharmacy 2025;36(21):2711-2717
OBJECTIVE To provide practical basis and policy recommendations for improving the pharmacovigilance (PV) system construction in medical institutions across China. METHODS A questionnaire survey was conducted using a mixed sampling strategy of “online random sampling+offline supplementary sampling” to distribute questionnaires among pharmaceutical professionals in tertiary medical institutions nationwide. The questionnaire covered aspects such as the construction of PV systems, job position settings, information system support, operational practices, and multi-stakeholder collaboration. The data were analyzed using descriptive methods and SPSS 20.0 statistical software. RESULTS A total of 70 valid questionnaires were collected from 66 medical institutions, primarily Class A tertiary hospitals. The survey found that 90.00% had designated PV personnel and 74.29% routinely conducted PV activities. However, there were notable disparities in resource allocation and information system capacity, with less than 50% of the institutions conducting post-marketing drug re-evaluation. PV activities were primarily focused on the collection and reporting of adverse drug reactions, with limited capabilities in signal detection and risk assessment. CONCLUSIONS Among the surveyed tertiary hospitals, PV systems have begun to take shape. However, challenges persist in terms of system establishment, resource allocation, risk assessment, and inter-organizational coordination. Policy efforts should focus on strengthening regulatory frameworks, improving information sharing mechanisms, enhancing professional training, and strengthening collaboration between hospitals and market authorization holders to ensure the effective implementation of PV in medical institutions.
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.Preliminary exploration of differentiating and treating multiple system atrophy from the perspective of the eight extraordinary meridians
Di ZHAO ; Zhigang CHEN ; Nannan LI ; Lu CHEN ; Yao WANG ; Jing XUE ; Xinning ZHANG ; Chengru JIA ; Xuan XU ; Kaige ZHANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(3):392-397
Multiple system atrophy (MSA) is a rare neurodegenerative disease with complex clinical manifestations, presenting substantial challenges in clinical diagnosis and treatment. Its symptoms and the eight extraordinary meridians are potentially correlated; therefore, this article explores the association between MSA symptom clusters and the eight extraordinary meridians based on their circulation and physiological functions, as well as their treatment strategies. The progression from deficiency to damage in the eight extraordinary meridians aligns with the core pathogenesis of MSA, which is characterized by "the continuous accumulation of impacts from the vital qi deficiency leading to eventual damage". Liver and kidney deficiency and the emptiness of the eight extraordinary meridians are required for the onset of MSA; the stagnation of qi deficiency and the gradual damage to the eight extraordinary meridians are the key stages in the prolonged progression of MSA. The disease often begins with the involvement of the yin and yang qiao mai, governor vessel, thoroughfare vessel, and conception vessel before progressing to multiple meridian involvements, ultimately affecting all eight extraordinary meridians simultaneously. The treatment approach emphasizes that "the direct method may be used for joining battle, but indirect method will be needed in order to secure victory" and focuses on "eliminate pathogenic factors and reinforce healthy qi". Distinguishing the extraordinary meridians and focusing on the primary symptoms are pivotal to improving efficacy. Clinical treatment is aimed at the target, and tailored treatment based on careful clinical observation ensures precision in targeting the disease using the eight extraordinary meridians as the framework and core symptoms as the specific focus. Additionally, combining acupuncture, daoyin therapy, and other method may help prolong survival. This article classifies clinical manifestations based on the theory of the eight extraordinary meridians and explores treatment.
9.Current status of anticoccidial drug resistance in China
Yidan BAI ; Wenting LI ; Wanxin LUO ; Yuxin YU ; Dongfang LI ; Junlong ZHAO ; Lan HE
Chinese Journal of Schistosomiasis Control 2025;37(2):217-222
Avian coccidiosis, an acute parasitic disease that mainly harms chicks, is widely prevalent across the world, which poses a serious threat to poultry industry. Because of the single prophylactic formulations, veterinary clinical treatment of coccidiosis mainly relies on chemically synthesized agents, polyether ionophores and Chinese herbal medicines. The introduction of novel anticoccidial drugs is slow for a long period of time, and there is an increasing problem of anticoccidial drug resistance following long-term use, which has become an urgent problem to be solved in poultry industry. This review summarizes the levels of anticoccidial drug resistance across China from 2018 to 2023, and analyzes the resistance to various anticoccidial agents in coccidia. It is indicated that the overall prevalence of anticoccidial drug resistance is high in coccidia, and development of novel anticoccidial agents and products with reduced antibiotics use and alternatives of antibiotics is of an urgent need.
10.Ultrasound-guided percutaneous catheterization and drainage combined with polidocanol sclerosis therapy in treatment of thyroid cysts
Anyang LIU ; Yizhou BAI ; Qi QIN ; Xuewei WANG ; Peiliang ZHAO ; Jinyi TIAN ; Dongfang HUO ; Bin LUO
Chinese Journal of General Surgery 2025;40(10):802-805
Objective:To investigate the therapeutic effectiveness of ultrasound-guided percutaneous catheterization for continuous negative pressure drainage combined with polidocanol in treating large thyroid cysts.Method:Clinical data of 38 patients with large thyroid cysts who were treated consecutively with catheter drainage combined with polidocanol sclerotherapy by the same doctor at Beijing Tsinghua Changgung Hospital from Jan 2021 to May 2024 were retrospectively analyzed. The effectiveness and safety were statistically evaluated, and the relationship between drainage volume and cyst volume was analyzed.Results:Among the 38 patients with thyroid cysts who completed the treatment, the median follow-up was 9 months (range: 3-24 months). The effectiveness rate was 92% (35/38), of which 32 cases (84%) met the cure standard. The maximum diameter of the cysts before treatment was (4.8±1.0) cm, and the maximum diameter of the residual nodules after treatment was (1.5±1.1) cm, the difference was statistically significant ( t=17.389, P<0.01). The amount of drainage exudate is related to the volume of the cyst and the maximum diameter before treatment ( t=-3.149, P=0.003; t=-3.057, P<0.005). 19% of patients showed transient low fever after the injection of polidocanol, with no other complications. Conclusion:For large thyroid cysts, ultrasound-guided percutaneous catheterization for continuous negative pressure drainage combined with polidocanol sclerotherapy is a safe and effective method.


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