1.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.
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.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.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.
5.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.
6.Association of menopausal time and menopausal age with nonalcoholic fatty liver disease: An analysis based on a restricted cubic spline model
Chenlu ZHAO ; Suping MA ; Dongfang SHANG ; Sutong LIU ; Xiaoyan LIU ; Yuanyuan ZHENG ; Wenxia ZHAO
Journal of Clinical Hepatology 2025;41(2):247-253
ObjectiveTo investigate the association of menopausal time and menopausal age with the risk of nonalcoholic fatty liver disease (NAFLD), and to provide a basis for the early prevention and treatment of NAFLD in clinical practice. MethodsRelated data were collected from 373 postmenopausal women who attended the outpatient service of Department of Spleen, Stomach, Liver and Gallbladder Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, from January 2017 to December 2021, including general information, menopausal age, menopausal time, and presence or absence of NAFLD. The chi-square test was used for comparison of categorical data; the independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between groups. A Logistic regression analysis was used to calculate the association intensity and 95% confidence interval (95%CI) of menopausal time and menopausal age for the risk of NAFLD, and the restricted cubic spline (RCS) method was used to investigate the dose-response relationship between menopausal time/age and the risk of NAFLD. ResultsCompared with the women with normal menopause or late menopause, the women with early menopause had a higher prevalence rate of NAFLD and a higher degree of steatosis and fibrosis (all P<0.05). After adjustment for the confounding factors such as age and age of menarche, the risk of NAFLD in women with a menopausal time of >3 years was 4.80 (95%CI: 1.93 — 11.95, P=0.001) times that in women with a menopausal time of ≤3 years, and the risk of NAFLD in women with early or late menopause was 8.14 times (95%CI: 1.77 — 37.58, P=0.007) and 0.09 times (95%CI: 0.03 — 0.32, P<0.001), respectively, that in those with a normal menopausal age. There is a dose-response relationship between menopausal time/age and the risk of NAFLD. Menopausal time is positively correlated with the association intensity of NAFLD, while menopausal age is negatively correlated with the association intensity of NAFLD. ConclusionThe longer the menopause time and the earlier the menopause age, the ligher the risk of NAFLD.
7.Effect of Roxadustat and rHuEPO on novel inflammatory immune indices in non-dialysis diabetic nephropathy anemia patients
Zhouxia XIANG ; Dan PENG ; Dongfang ZHAO ; Meng HE ; Shunian GUO ; Shu RONG
Clinical Medicine of China 2025;41(2):127-132
Objective:To investigate the effects of Roxadustat and recombinant human erythropoietin (rHuEPO) on novel inflammatory immune indices in anemic patients with non-dialysis type 2 diabetes mellitus combined with chronic kidney disease (CKD).Methods:A retrospective case-control study was performed in this study. Patients with non-dialysis type 2 diabetes mellitus combined with CKD admitted to Shanghai First People's Hospital from December 2015 to December 2023 were selected. Among those patients, 252 cases were treated with rHuEPO (rHuEPO group) and 103 cases were treated with Roxadustat (Roxadustat group). Both group had a course of treatment over three months. The baseline data and novel inflammatory immunity indices, systemic immuno-inflammation index (SII), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) were compared between the two groups of patients before and after 3 months of treatment.Results:The differences in gender, age, body mass index, systolic blood pressure, diastolic blood pressure, history of cardiovascular and cerebrovascular disease, history of hypertension, estimated glomerular filtration rate, and use of hypoglycemic, antihypertensive, and lipid-lowering medications were not statistically significant when compared between the two groups of patients (all P>0.05). Before treatment, the differences in NLR, PLR, SII, and LMR between the two groups were not statistically significant (all P>0.05); after 3 months of treatment, NLR, PLR, SII, and LMR were lower in both groups than before treatment [rHuEPO group: (2.3±0.8)% vs. (2.8±0.8)%, (83±33)% vs. (160±49)%, (2.3±0.8)% vs. (3.1±0.7)%, (476±227)% vs. (594±243)%, with t values of 9.25, 23. 20, 26.67, and 9.62, respectively, all P<0.001; Roxadustat group: (1.7±0.6)% versus (2.9±1.0)%, (72±30)% versus (162±47)%, (2.0±0.8)% versus (3.1±0.9)%, (408±151)% versus (605±267)%, with t values of 8. 38, 14.27, 8.62, and 5.97, respectively, all P<0.001], and NLR, PLR, and SII were lower in the Roxadustat group than in the rHuEPO group ( t=5.00, P<0.001, t=2.44, P=0.015, t=2.09, P=0.040). Conclusion:In patients with anemia in non-dialysis type 2 diabetes mellitus associated with CKD,Roxadustat had similar ability of reducing the level of novel inflammatory markers compared to rHuEPO.
8.Comparative Study on the Differences in Average Transaction Costs Per-referral of Patients in Different Models of Integrated Delivery Systems
Chunping HU ; Jinxin CUI ; Dongfang ZHU ; Qiuping ZHAO ; Pengfei WANG ; Jian WU ; Yadong NIU ; Yudong MIAO
Chinese Hospital Management 2025;(9):46-50,56
Objective To compare the differences in the average transaction costs per-referral patients under different models of Integrated Delivery Systems(IDS).Methods Using a typical case sampling method,it selected referred patients from three IDS models:the county medical alliance in D City(Qinghai Province),the urban medical consortium in J District(Zhengzhou City,Henan Province),and the health management coalition in N County(Shandong Province).Structured questionnaires collected demographics,average transaction costs per-referral and cost perceptions.t-tests and ANOVA assessed cost differences;generalized linear regression identified influencing factors.Results Among 915 patients,the average transaction costs per-referral were 1 035.05 yuan(county alliance),195.31 yuan(urban consortium),and 700.97 yuan(health management coalition),with statistically significant differences(P<0.05).The urban consortium exhibited lower time costs and specialized input costs.Key influencing factors included older age(county alliance),education level,employment status,and referral travel time(urban consortium),as well as urban-rural disparities(health management coalition).Patients'cost perceptions significantly differed across models(P<0.05).Conclusion The urban medical consortium demonstrated the lowest patient the average transaction costs,highlighting its institutional advantage in minimizing financial burdens.
9.Weighted random forest for estimating individualized treatment rules
Ziyu ZHAO ; Mengyi LU ; Fang SHAO ; Dongfang YOU ; Yang ZHAO
Chinese Journal of Epidemiology 2025;46(8):1431-1437
With the rapid development of personalized medicine, recommending the optimal treatment regimes among multiple options for individual patients has become a key topic in the study of individualized treatment rules. Existing methods often face challenges such as limited accuracy and robustness when handling multi-category treatment problems. This study proposes a weighted random forest method that formulates the treatment decision problem as a weighted classification task. By incorporating the expected loss differences among treatment outcomes, the method enhances its learning process and improves recommendation performance with the non-parametric nature and flexibility of random forests. The weighted random forest method is further applied to real-world hypertension intervention data to generate personalized antihypertensive treatment recommendations based on the patient's baseline characteristics, demonstrating its potential value in clinical practice. This research aims to provide a new approach for individualized treatment rules in multi-treatment settings and to support the development of data-driven clinical decision-making systems.
10.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.

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