1.Treatment Principles and Paradigm of Diabetic Microvascular Complications Responding Specifically to Traditional Chinese Medicine
Anzhu WANG ; Xing HANG ; Lili ZHANG ; Xiaorong ZHU ; Dantao PENG ; Ying FAN ; Min ZHANG ; Wenliang LYU ; Guoliang ZHANG ; Xiai WU ; Jia MI ; Jiaxing TIAN ; Wei ZHANG ; Han WANG ; Yuan XU ; .LI PINGPING ; Zhenyu WANG ; Ying ZHANG ; Dongmei SUN ; Yi HE ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):272-279
To explore the advantages of traditional Chinese medicine (TCM) and integrative TCM-Western medicine approaches in the treatment of diabetic microvascular complications (DMC), refine key pathophysiological insights and treatment principles, and promote academic innovation and strategic research planning in the prevention and treatment of DMC. The 38th session of the Expert Salon on Diseases Responding Specifically to Traditional Chinese Medicine, hosted by the China Association of Chinese Medicine, was held in Beijing, 2024. Experts in TCM, Western medicine, and interdisciplinary fields convened to conduct a systematic discussion on the pathogenesis, diagnostic and treatment challenges, and mechanism research related to DMC, ultimately forming a consensus on key directions. Four major research recommendations were proposed. The first is addressing clinical bottlenecks in the prevention and control of DMC by optimizing TCM-based evidence evaluation systems. The second is refining TCM core pathogenesis across DMC stages and establishing corresponding "disease-pattern-time" framework. The third is innovating mechanism research strategies to facilitate a shift from holistic regulation to targeted intervention in TCM. The fourth is advancing interdisciplinary collaboration to enhance the role of TCM in new drug development, research prioritization, and guideline formulation. TCM and integrative approaches offer distinct advantages in managing DMC. With a focus on the diseases responding specifically to TCM, strengthening evidence-based support and mechanism interpretation and promoting the integration of clinical care and research innovation will provide strong momentum for the modernization of TCM and the advancement of national health strategies.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
3.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
4.CEACAM6 Expression is Associated with Immune Infiltration and Poor Prognosis in Esophageal Squamous Cell Carcinoma
Jiahui LI ; Enwei XU ; Wei CUI ; Yuanyuan ZHAO ; Keqing KANG ; Peng BU ; Guohai ZHAO ; Yang ZHOU
Cancer Research on Prevention and Treatment 2026;53(3):194-202
Objective To investigate the expression of carcinoembryonic antigen-related cell adhesion molecule 6 (CEACAM6) in esophageal squamous cell carcinoma (ESCC) and analyze its correlation with immune cell infiltration and patient prognosis. Methods Three ESCC datasets (GSE161533, GSE26886, and GSE23400) from the GEO database were analyzed to identify differentially expressed genes. CEACAM6 was identified as a key gene through survival analysis. Its expression, prognostic value, and relationship with immune cell infiltration were further explored using databases, such as TIMER. Tissue samples were collected from 162 patients with ESCC. Immunohistochemistry was performed to detect the expression of CEACAM6, immune cell markers (CD4, CD8, CD20, and CD56), and immune checkpoint molecules (HHLA2 and CD40LG). Correlations between CEACAM6 expression and clinicopathological features, immune cell infiltration, and immune checkpoints were analyzed. Results Bioinformatic analysis and clinical sample validation confirmed that CEACAM6 expression was significantly upregulated in ESCC tissues compared with adjacent nontumor tissues (P<0.05). High CEACAM6 expression was closely associated with advanced clinical stage (AJCC Ⅲ-Ⅳ), high T stage (T3-T4), lymph node metastasis, nonulcerative type, and poor prognosis. Furthermore, CEACAM6 expression levels were positively correlated with the infiltration density of CD8+ T cells, CD4+ T cells, and CD20+ B cells within the tumor microenvironment and with the expression of the immune checkpoint molecules HHLA2 and CD40LG (all P<0.05). Conclusion CEACAM6 serves as an independent poor prognostic factor for ESCC. Its high expression is implicated in the modulation of the tumor immune microenvironment by correlating with specific immune cell infiltration and immune checkpoint molecules, suggesting its potential as a novel prognostic biomarker and immunotherapeutic target for ESCC.
5.Clinical and Mechanistic Study of Modified Sinisan in Treating Precancerous Lesions of Digestive System Based on "Inflammation-to-Cancer Transformation"
Xuhang SUN ; Dandan WEI ; Xin PENG ; Shanshan LI ; Yihan ZHAO ; Fuke YAO ; Shiqing JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):221-234
Tumorigenesis, invasion, and metastasis occur in the context of a persistent inflammatory microenvironment, and a variety of inflammatory factors can lead to the development of various tumors. Guided by the thought of "preventive treatment of disease" in TCM and the concept of tertiary prevention in modern medicine, it is of great significance to effectively intervene in the inflammatory stage of the disease, interrupt disease progression, prevent the occurrence of malignant tumors, and reverse the process of "inflammation-to-cancer transformation". Sinisan, a commonly used prescription in the Treatise on Febrile Diseases, has been widely applied in the treatment of precancerous lesions of the digestive system, demonstrating considerable advantages. This article reviewed literature from the past 20 years, summarizing the application of Sinisan in precancerous lesions of the digestive system from three aspects: the exploration of its prescription-syndrome relationship, clinical application, and mechanistic study. It is found that basic syndrome indications of Sinisan include harmonizing the Earth element to promote spleen-stomach transportation and transformation, soothing the liver and nourishing the Wood element to restore the smooth flow of Qi, and regulating Yin and Yang to relieve stagnation within the system. In clinical application, Sinisan has shown significant efficacy in atrophic gastritis and precancerous conditions such as intestinal metaplasia, gastric ulcer, ulcerative colitis, esophagitis, and pancreatitis. Mechanistic studies have revealed that Sinisan can inhibit inflammatory factors and improve the inflammatory microenvironment, inhibit cell proliferation and regulate apoptosis, exhibit anti-angiogenic and antitumorigenic effects, modulate immune function, and exert antioxidant effects. These mechanisms can be achieved by regulating pathways such as nuclear factor erythroid 2-related factor 2/heme oxygenase-1 (Nrf2/HO-1), farnesoid X receptor (FXR)/Nrf2, phosphatidylinositol 3-kinase/protein kinase B (PI3K/Akt), Takeda G protein-coupled receptor 5/cyclic adenosine monophosphate/protein kinase A (TGR5/cAMP/PKA), interleukin-4/signal transducer and activator of transcription 6 (IL-4/STAT6), Janus kinase/signal transducer and activator of transcription (JAK/STAT), RhoA/Rho-associated protein kinase (RhoA/ROCK), and transforming growth factor-β/Smad proteins (TGF-β/Smads), confirming Sinisan's role in reversing the inflammation-to-cancer transformation. The current research status of Sinisan in precancerous lesions of the digestive system was thoroughly examined through the above three aspects, along with the identification of limitations and areas for improvement in current research. The aim is to provide a basis and support for future in-depth research on Sinisan, promote the development of new integrated treatment models combining TCM and Western medicine for precancerous lesions, and aid in the research and development of drugs related to precancerous lesions.
6.Prediction of Pulmonary Nodule Progression Based on Multi-modal Data Fusion of CCNet-DGNN Model
Lehua YU ; Yehui PENG ; Wei YANG ; Xinghua XIANG ; Rui LIU ; Xiongjun ZHAO ; Maolan AYIDANA ; Yue LI ; Wenyuan XU ; Min JIN ; Shaoliang PENG ; Baojin HUA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):135-143
ObjectiveThis study aims to develop and validate a novel multimodal predictive model, termed criss-cross network(CCNet)-directed graph neural network(DGNN)(CGN), for accurate assessment of pulmonary nodule progression in high-risk individuals for lung cancer, by integrating longitudinal chest computed tomography(CT) imaging with both traditional Chinese and western clinical evaluation data. MethodsA cohort of 4 432 patients with pulmonary nodules was retrospectively analyzed. A twin CCNet was employed to extract spatiotemporal representations from paired sequential CT scans. Structured clinical assessment and imaging-derived features were encoded via a multilayer perceptron, and a similarity-based alignment strategy was adopted to harmonize multimodal imaging features across temporal dimensions. Subsequently, a DGNN was constructed to integrate heterogeneous features, where nodes represented modality-specific embeddings and edges denoted inter-modal information flow. Finally, model optimization was performed using a joint loss function combining cross-entropy and cosine similarity loss, facilitating robust classification of nodule progression status. ResultsThe proposed CGN model demonstrated superior predictive performance on the held-out test set, achieving an area under the receiver operating characteristic curve(AUC) of 0.830, accuracy of 0.843, sensitivity of 0.657, specificity of 0.712, Cohen's Kappa of 0.417, and F1 score of 0.544. Compared with unimodal baselines, the CGN model yielded a 36%-48% relative improvement in AUC. Ablation studies revealed a 2%-22% increase in AUC when compared to simplified architectures lacking key components, substantiating the efficacy of the proposed multimodal fusion strategy and modular design. Incorporation of traditional Chinese medicine (TCM)-specific symptomatology led to an additional 5% improvement in AUC, underscoring the complementary value of integrating TCM and western clinical data. Through gradient-weighted activation mapping visualization analysis, it was found that the model's attention predominantly focused on nodule regions and effectively captured dynamic associations between clinical data and imaging-derived features. ConclusionThe CGN model, by synergistically combining cross-attention encoding with directed graph-based feature integration, enables effective alignment and fusion of heterogeneous multimodal data. The incorporation of both TCM and western clinical information facilitates complementary feature enrichment, thereby enhancing predictive accuracy for pulmonary nodule progression. This approach holds significant potential for supporting intelligent risk stratification and personalized surveillance strategies in lung cancer prevention.
7.Chinese experts' consensus on principles of preoperative hair removal
Yiping MAO ; Jun ZHENG ; Lei LI ; Deyan YANG ; Bing ZHANG ; Lei YANG ; Wang JIA ; Peng KANG ; Hui JIAO ; Yun YANG ; Qi QI ; Shiqing FENG ; Xiao LONG ; Yuewei ZHANG ; Xiaohui WANG ; Lize WANG ; Yuan WEI ; Jichao ZHOU ; Minghui MAO ; Pengju XIN ; Hongyu TAN ; Dahong ZHANG ; Lianxin LIU ; Lei TAO ; Xietong WANG ; Xiaoning YUAN ; Mang CAI ; Li MU ; Fang DU ; Rongzhu CHEN ; Fengmao ZHAO ; Jiuzuo HUANG ; Mingzi ZHANG ; Jie ZHANG ; Baoguo WANG ; Kun WANG ; Fang LUO ; Jinhua ZHANG ; Nong HE ; Ling LYU ; Zhiyong ZONG
Chinese Journal of Nosocomiology 2025;35(10):1441-1449
To formulate an expert consensus on the principles of preoperative hair removal and provide scientific guidance for standardized removal of hair before surgical procedures so as to reduce the incidence of surgical site infections.METHODS Led by the Hospital Management Institute of National Health Commission of the People's Republic of China,this consensus was reached with the joint efforts from the expects of relevant fields such as surgeries,interventional therapies,nursing,and infection prevention and control.The consensus facilitates the classification and evaluation of literatures by following the evidence grade formulated by Oxford Evidence-based Medicine Center and focuses on the association of preoperative hair removal with surgical site infection,it reaches the evidence grade of expert consensus and recommendation intensity by integrating with discussions on meetings and clinical experience of the expects from relevant fields.RESULTS A total of 6 items of consensus were reached by summarizing the latest evidence on the aspects including the indications for preoperative hair removal,tools,range,timing and places.CONCLUSION The consensus,to some extent,make supplements to and complete the exiting regulations and standards.It provides guidance for the medical institutions to carry out the preoperative hair removal.
8.Evaluation of the efficacy and safety of TACE combined with anlotinib and sintilimab in the treatment of patient with CNLC stage ⅡB-ⅢB liver cancer
Gang TONG ; Yang HUA ; Wei PENG ; Ju ZHAO ; Junwen HU
China Oncology 2025;35(5):478-484
Background and purpose:China is a country with high incidence rate and mortality of liver cancer.In 2022,there were approximately 368 000 cases of liver cancer and 317 000 deaths in China.Extending the survival period of liver cancer patients is an urgent issue that we need to address.In recent years,tyrosine kinase inhibitor(TKI)alone or in combination with immune checkpoint inhibitors have achieved good results in the treatment of primary liver cancer.However,most studies did not include the combination of transcatheter arterial chemoembolization(TACE)treatment.We speculate that combining TKI drugs with immune checkpoint inhibitors and TACE therapy may provide greater benefits to liver cancer patients.Therefore,this study aimed to evaluate the short-term efficacy and safety of TACE combined with anlotinib and sintilimab in the treatment of liver cancer.Methods:This study is a single arm phase Ⅱ clinical trial approved by the ethics committee of The Third People's Hospital of Yibin(ethical approval numbers:2022009).Inclusion criteria:① Age 18-70 years;② Primary liver cancer confirmed by clinical diagnosis or histopathology;③ Eastern Cooperative Oncology Group(ECOG)performance status score of 0-1;④ China Liver Cancer Staging(CNLC)stage Ⅱb-Ⅲb;⑤ Adequate cardiopulmonary function;⑥ Child-Pugh score≤8 points;⑦ At least one measurable tumor lesion according to the modified Response Evaluation Criteria in Solid Tumors(mRECIST)version 1.1.From November 1,2021 to March 1,2024,we recruited 61 patients,of whom 39 met the criteria.Firstly,all enrolled patients received TACE treatment.Approximately one week after the initial TACE procedure,12 mg of anlotinib(adjusted according to tolerance)was administered orally on days 1-14,every 3 weeks;Simultaneously 200 mg of sintilimab was administered intravenously on day 1,every 3 weeks.After completing 2 cycles of treatment,efficacy evaluation was conducted according to the modified Response Evaluation Criteria in Solid Tumors(mRECIST)1.1.The primary observation indicators of the study were objective response rate(ORR),and the secondary observation indicators were median progression-free survival(mPFS),disease control rate(DCR)and safety.Results:The ORR of this study was 76.9%,DCR was 94.9%,and mPFS was 9.2 months(95%CI:2.317-16.083).39 cases(100%)had grade 1-2 adverse reactions,15 cases(38.5%)had grade 3 adverse reactions,5 cases(12.8%)had grade 4 adverse reactions,and 1 patient died due to upper gastrointestinal bleeding.In the stage mainly treated with TACE combined with TKI and immunotherapy,the incidence of grade 3-4 adverse reactions was higher compared with the stage mainly treated with anlotinib combined with sintilimab.The vast majority of adverse reactions can be recovered through conventional treatment methods.Conclusion:TACE combined with anlotinib and sintilimab has a definite therapeutic effect and overall safety and controllability in the treatment of CNLC stage Ⅱb-Ⅲb liver cancer.This combination therapy may provide a new treatment model for CNLC stage Ⅱb-Ⅲb liver cancer patients.However,further exploration is needed to address the pain,vomiting,decreased appetite,liver function damage,upper gastrointestinal bleeding,and other issues caused by this treatment mode.
9.Research on quality management for operation of first aid equipment based on the combination of SWOT analysis method and AHP
Jin FU ; Xiaoli ZHAO ; Kai ZENG ; Wei SONG ; Xiongjun PENG ; Jing ZHOU ; Dongsheng LU
China Medical Equipment 2025;22(6):129-134
Objective:To construct a quality analysis model by combining the strengths-weaknesses-opportunities-threats(SWOT)analysis method and analytic hierarchy process(AHP),and to explore its application value in the quality management for operation of first aid equipment of hospital.Methods:The advantages,disadvantages,opportunities and threats of management for equipment were analyzed according to SWOT model,and the operation quality of equipment was positioning analyzed by AHP,and comprehensive management countermeasures were formulated from the aspects of personnel,system,preventive maintenance,information management and cooperation between institutes and enterprises.A total of 215 first aid equipment in clinical use in Qilu Hospital of Shandong University from January 2021 to December 2024 were selected.In these equipment,171 equipment from January 2021 to December 2022 were managed by using the conventional management mode,and 195 equipment(including 151 using equipment under the conventional management mode and 44 newly added equipment)from January 2023 to December 2024 were managed by using the strategic management mode with quality analysis model.The operation quality and management level of the two management modes for the equipment were compared.A self-made survey questionnaire was used to investigate the satisfaction scores of nurses of operating equipment,doctors of clinical department,medical engineers and administrators for the service effects of equipment under the two management modes,who use and manage the first aid equipment in hospital.Results:The average failure rate,risk rate,alarm rate and unqualified rate of first aid equipment in hospitals,which adopted the strategic management mode,were respectively(0.72±0.42)%,(1.08±0.70)%,(1.18±0.48)%and(1.33±0.63)%,all of which were lower than those of the conventional management mode,and the differences were statistically significant(t=3.629,2.792,2.179,2.396,P<0.05).The management level scores of monitors,ventilators,defibrillators,high-frequency electrosurgical knives and other first aid equipment,which adopted the strategic management mode,were respectively(94.69±1.68),(95.84±2.52),(95.38±2.85),(95.69±2.02)and(94.17±4.89)points,all of which were higher than those of the conventional management mode,and the differences were statistically significant(t=4.797,2.403,2.390,3.825,2.196,P<0.05).The satisfaction scores of nurses of operating equipment,doctors of clinical department,medical engineers and administrators for first aid equipment of adopting strategic management mode were all higher than those of adopting conventional management mode,and the difference were statistically significant(t=3.666,3.336,4.275,4.292,P<0.05).Conclusion:The quality analysis model of first aid equipment of hospital can improve the operation quality and management level of first aid equipment,and reduce the equipment's failure rate and the unqualified rate of quality inspection,and improve the service effect of first aid equipment.
10.The expression of LAMB3 and ITGB4 in esophageal squamous cell carcinoma and their relationship with clinicopathological features
Yali ZHAO ; Sheng WU ; Wei PENG ; Wanxiang WANG ; Haoran ZHANG ; Zhenzhong FENG ; Li MA ; Xian WANG
Chinese Journal of Clinical and Experimental Pathology 2025;41(10):1301-1307,1313
Purpose To investigate the expression of LAMB3 and ITGB4 in esophageal squamous cell carcinoma(ESCC)and analyze their associations with clinicopathological features.Methods Bioinformatics was used to assess the expression of LAMB3 and ITGB4 in pan-cancer and ESCC.Immunohistochemistry was performed to evaluate their expression and distribution in ESCC tissues,and correlations clinicopathological features were analyzed.Follow-up data were collected to construct Kaplan-Meier survival curves,and Cox regression analysis was proformed to determine their prognostic significance.Results Bioinformatics analysis showed that LAMB3 and ITGB4 were highly expressed in ES-CC tissues(P<0.001).Immunohistochemistry confirmed that both proteins were localized in the cytoplasm and membrane of tumor cells.High LAMB3 expression was significantly associated with poor differentiation(P<0.001),lymph node metastasis(P=0.015),and T staging(P<0.001).High ITGB4 expression was significantly correlated with poor differentiation(P=0.004)and advanced T staging(P=0.004).Cox regression analysis identified high ex-pression of LAMB3 and ITGB4 as independent prognostic factors for overall survival[HR=4.97(95%CI:2.73-9.02);HR=2.33(95%CI:1.36-3.99)].Conclusion LAMB3 and ITGB4 are highly expressed in ESCC.High LAMB3 expression is associated with tumor differentiation,lymph node metastasis,and T staging,while high ITGB4 expression is correlated with tumor differentiation and T staging.Patients with high expression of LAMB3 or ITGB4 have poorer overall survival,suggesting that these proteins may serve as prognostic biomarkers for unfavorable outcome in ESCC.

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