1.Long-term survival outcomes and prognostic factors following radical resection of pancreatic body and tail cancer:a retrospective analysis of 992 patients
Dong XU ; Yang WU ; Kai ZHANG ; Nan LYU ; Qianqian WANG ; Pengfei WU ; Jie YIN ; Baobao CAI ; Guodong SHI ; Jianzhen LIN ; Yazhou WANG ; Lingdi YIN ; Zipeng LU ; Min TU ; Jianmin CHEN ; Feng GUO ; Jishu WEI ; Junli WU ; Wentao GAO ; Cuncai DAI ; Yi MIAO ; Kuirong JIANG
Chinese Journal of Surgery 2026;64(1):46-54
Objective:To investigate the survival outcomes and prognostic factors in patients undergoing radical resection for pancreatic body and tail cancer.Methods:A retrospective case series study was conducted on 992 patients who underwent radical resection for pancreatic body and tail cancer at the Pancreatic Center of the First Affiliated Hospital of Nanjing Medical University from January 2016 to June 2024. In this study, 577 (58.2%) were male and 415 (41.8%) were female,with an age of (65±9) years (range: 26 to 86 years). Follow-up continued until June 2024. Survival rates were estimated using the Kaplan-Meier method,and prognostic factors were identified using univariate and multivariate Cox proportional hazards models.Results:Among 992 patients,open surgery was the predominant approach (89.1%, 884/992), and radical antegrade modular pancreatosplenectomy (RAMPS) was performed in 317 patients (32.0%). Combined organ resection,venous resection,and arterial resection were performed in 23.5%, 9.3%,and 11.2% of patients,respectively. The rates of R0, R1-1 mm, and R1-direct resections were 49.8% (494/992),41.5% (412/992), and 8.7% (86/992),respectively. Stage ⅡB was the most common TNM stage (32.2%,319/992). A total of 801 patients (80.8%) received adjuvant chemotherapy. The median follow-up period was 32.0(8.8) months(range:3.2 to 105.3 months),during which 508 patients (51.2%) died. The overall median survival (OS) was 26.4 months,with 1-,3-, and 5-year survival rates of 79.0%,40.0%, and 29.0%, respectively. In the recent five years (from 2020 to 2024), the median OS improved significantly to 34.1 months compared to 20.0 months from 2016 to 2019 ( P<0.01). Histological subtype analysis showed that the median OS time was 26.7 months for pancreatic ductal adenocarcinoma (PDAC, n=855),58.9 months for invasive intraductal papillary mucinous carcinoma (IPMC, n=32),and 15.7 months for adenosquamous carcinoma of pancreas (ASCP, n=73) ( P=0.001). Among PDAC patients, adjuvant chemotherapy significantly improved survival (29.1 months vs. 14.4 months, P<0.01);in IPMC patients, adjuvant chemotherapy also extended survival (65.7 months vs. 58.9 months, P=0.047). Although ASCP patients receiving chemotherapy had a longer median OS time than those without (18.8 months vs. 8.9 months),the difference was not statistically significant ( P=0.151). Multivariate Cox regression analysis in PDAC patients indicated that adjuvant chemotherapy, R0 resection, T stage,N stage,and tumor differentiation were independent prognostic factors ( P<0.01). The median OS time by TNM stage was:not reached for stage ⅠA, 51.6 months for ⅠB, 25.5 months for ⅡA, 23.7 months for ⅡB, 23.0 months for Ⅲ, and 14.4 months for Ⅳ. The median OS time for R0,R1-1 mm,and R1-direct resections was 34.1,24.7,and 15.7 months,respectively ( P<0.01). Conclusion:Adjuvant chemotherapy,R0 resection,tumor stage,and differentiation are independent prognostic factors for pancreatic body and tail cancer.
2.Effect of compressive stress microenvironment on cytokines during fracture healing
Jiachen GUO ; Jun GAO ; Wenhao DAI ; Huayuan LIAO ; You JIANG ; Xi ZHANG
Chinese Journal of Tissue Engineering Research 2026;30(4):908-916
BACKGROUND:Fracture healing is a very complex physiological process,which is influenced by many factors.In recent years,the use of biomechanical factors in fracture healing has been a major focus in the field of orthopedics,and the mechanical stress environment around the fracture end has an important role in regulating fracture healing.Among them,the study of the mechanism of compressive mechanics on the cytokines of fracture ends is a hot spot for bone-related researchers.OBJECTIVE:To summarize the current status and recent advances in the study of the mechanism of action of compressive stress on cytokines in fracture healing in recent years.METHODS:A search with the keywords of"compressive stress,fracture healing,cytokine,bone morphogenetic protein,fibroblast growth factor,platelet-derived growth factor,vascular endothelial growth factor,interleukin,tumor necrosis factor-α"in Chinese and English was conducted in the CNKI,WanFang,PubMed,and Web of Science.Initially 506 articles were retrieved,and 94 eligible articles that met the criteria were screened and finally summarized.RESULTS AND CONCLUSION:Current studies have found that compressive stress has different effects on different cytokines during fracture healing,which can be achieved mainly by influencing cell signaling,gene expression regulation,and modulation of cell behavior.Among them,compressive stress can be linked to cytokines such as bone morphogenetic protein,fibroblast growth factor,platelet-derived growth factor,vascular endothelial growth factor,interleukin,and tumor necrosis factor-α.This process involves cell proliferation,differentiation and migration,inflammatory response,and changes in the environmental and nutritional conditions of the fracture end,which are key factors affecting fracture healing.The whole paper summarizes the complexity of cytokine action mechanism,the mechanism of compressive stress on its regulation needs to be further carried out in-depth research,and the problems and limitations in the research are considered and future prospects.
3.Effect of compressive stress microenvironment on cytokines during fracture healing
Jiachen GUO ; Jun GAO ; Wenhao DAI ; Huayuan LIAO ; You JIANG ; Xi ZHANG
Chinese Journal of Tissue Engineering Research 2026;30(4):908-916
BACKGROUND:Fracture healing is a very complex physiological process,which is influenced by many factors.In recent years,the use of biomechanical factors in fracture healing has been a major focus in the field of orthopedics,and the mechanical stress environment around the fracture end has an important role in regulating fracture healing.Among them,the study of the mechanism of compressive mechanics on the cytokines of fracture ends is a hot spot for bone-related researchers.OBJECTIVE:To summarize the current status and recent advances in the study of the mechanism of action of compressive stress on cytokines in fracture healing in recent years.METHODS:A search with the keywords of"compressive stress,fracture healing,cytokine,bone morphogenetic protein,fibroblast growth factor,platelet-derived growth factor,vascular endothelial growth factor,interleukin,tumor necrosis factor-α"in Chinese and English was conducted in the CNKI,WanFang,PubMed,and Web of Science.Initially 506 articles were retrieved,and 94 eligible articles that met the criteria were screened and finally summarized.RESULTS AND CONCLUSION:Current studies have found that compressive stress has different effects on different cytokines during fracture healing,which can be achieved mainly by influencing cell signaling,gene expression regulation,and modulation of cell behavior.Among them,compressive stress can be linked to cytokines such as bone morphogenetic protein,fibroblast growth factor,platelet-derived growth factor,vascular endothelial growth factor,interleukin,and tumor necrosis factor-α.This process involves cell proliferation,differentiation and migration,inflammatory response,and changes in the environmental and nutritional conditions of the fracture end,which are key factors affecting fracture healing.The whole paper summarizes the complexity of cytokine action mechanism,the mechanism of compressive stress on its regulation needs to be further carried out in-depth research,and the problems and limitations in the research are considered and future prospects.
4.Long-term survival outcomes and prognostic factors following radical resection of pancreatic body and tail cancer:a retrospective analysis of 992 patients
Dong XU ; Yang WU ; Kai ZHANG ; Nan LYU ; Qianqian WANG ; Pengfei WU ; Jie YIN ; Baobao CAI ; Guodong SHI ; Jianzhen LIN ; Yazhou WANG ; Lingdi YIN ; Zipeng LU ; Min TU ; Jianmin CHEN ; Feng GUO ; Jishu WEI ; Junli WU ; Wentao GAO ; Cuncai DAI ; Yi MIAO ; Kuirong JIANG
Chinese Journal of Surgery 2026;64(1):46-54
Objective:To investigate the survival outcomes and prognostic factors in patients undergoing radical resection for pancreatic body and tail cancer.Methods:A retrospective case series study was conducted on 992 patients who underwent radical resection for pancreatic body and tail cancer at the Pancreatic Center of the First Affiliated Hospital of Nanjing Medical University from January 2016 to June 2024. In this study, 577 (58.2%) were male and 415 (41.8%) were female,with an age of (65±9) years (range: 26 to 86 years). Follow-up continued until June 2024. Survival rates were estimated using the Kaplan-Meier method,and prognostic factors were identified using univariate and multivariate Cox proportional hazards models.Results:Among 992 patients,open surgery was the predominant approach (89.1%, 884/992), and radical antegrade modular pancreatosplenectomy (RAMPS) was performed in 317 patients (32.0%). Combined organ resection,venous resection,and arterial resection were performed in 23.5%, 9.3%,and 11.2% of patients,respectively. The rates of R0, R1-1 mm, and R1-direct resections were 49.8% (494/992),41.5% (412/992), and 8.7% (86/992),respectively. Stage ⅡB was the most common TNM stage (32.2%,319/992). A total of 801 patients (80.8%) received adjuvant chemotherapy. The median follow-up period was 32.0(8.8) months(range:3.2 to 105.3 months),during which 508 patients (51.2%) died. The overall median survival (OS) was 26.4 months,with 1-,3-, and 5-year survival rates of 79.0%,40.0%, and 29.0%, respectively. In the recent five years (from 2020 to 2024), the median OS improved significantly to 34.1 months compared to 20.0 months from 2016 to 2019 ( P<0.01). Histological subtype analysis showed that the median OS time was 26.7 months for pancreatic ductal adenocarcinoma (PDAC, n=855),58.9 months for invasive intraductal papillary mucinous carcinoma (IPMC, n=32),and 15.7 months for adenosquamous carcinoma of pancreas (ASCP, n=73) ( P=0.001). Among PDAC patients, adjuvant chemotherapy significantly improved survival (29.1 months vs. 14.4 months, P<0.01);in IPMC patients, adjuvant chemotherapy also extended survival (65.7 months vs. 58.9 months, P=0.047). Although ASCP patients receiving chemotherapy had a longer median OS time than those without (18.8 months vs. 8.9 months),the difference was not statistically significant ( P=0.151). Multivariate Cox regression analysis in PDAC patients indicated that adjuvant chemotherapy, R0 resection, T stage,N stage,and tumor differentiation were independent prognostic factors ( P<0.01). The median OS time by TNM stage was:not reached for stage ⅠA, 51.6 months for ⅠB, 25.5 months for ⅡA, 23.7 months for ⅡB, 23.0 months for Ⅲ, and 14.4 months for Ⅳ. The median OS time for R0,R1-1 mm,and R1-direct resections was 34.1,24.7,and 15.7 months,respectively ( P<0.01). Conclusion:Adjuvant chemotherapy,R0 resection,tumor stage,and differentiation are independent prognostic factors for pancreatic body and tail cancer.
5.Analyses of T lymphocyte subset levels and viral loads in human immunodeficiency virus antibody-confirmed positive cases in Suzhou from 2021 to 2024
Runfang TIAN ; Qiang SHEN ; Xuerong YA ; Yue DAI ; Qian GAO
Shanghai Journal of Preventive Medicine 2026;38(3):210-215
ObjectiveTo investigate the T lymphocyte subset levels and viral loads in newly human immunodeficiency virus (HIV) antibody-confirmed positive cases in Suzhou (2021‒2024), and to analyze potential influencing factors by integrating their demographic characteristics, immune status, and viral replication patterns, thereby providing evidence for HIV/acquired immune deficiency syndrome (AIDS) prevention and control. MethodsPeripheral whole blood samples were collected from newly confirmed HIV-positive cases in Suzhou from 2021 to 2024. T lymphocyte subset analysis and viral load testing were performed, and influencing factors were identified in combination with demographic characteristics. Logistic regression models were employed to identify factors associated with CD4+T lymphocyte counts ≤350 cells·μL-1, and Spearman’s rank correlation test was used to analyze the correlation between logarithmic value of viral load and CD4+/CD8+ ratio. ResultsAmong the 3 022 confirmed HIV-positive samples, the median CD4+T lymphocyte count was 298.00 cells·μL-1, with 882 cases (29.19%) showing CD4+ T lymphocyte counts <200 cells·μL-1. The median CD8+T lymphocyte count was 1 011.00 cells·μL-1. The median CD4+/CD8+ ratio was 0.28, with 32.46% of cases exhibiting CD4+/CD8+ ratios <0.20, and there were statistically significant differences in CD4+/CD8+ ratio among different genders, age groups, marital status, and sample sources (all P<0.05). Multivariate logistic regression analyses indicated that individuals aged ≥20 years, those who were divorced or widowed, and cases identified through medical institutions had a significantly higher proportion of CD4+T lymphocyte counts ≤350 cells·µL⁻¹ compared to those aged <20 years, unmarried individuals, and cases sourced from voluntary counseling and testing (VCT) clinics, respectively. The mean logarithmic value of viral load was (4.29±1.15) copies·mL-1. The logarithmic value of viral load demonstrated a significantly negative correlation with both CD4+/CD8+ ratio (r=-0.43, P<0.001) and CD4+T lymphocyte count (r=-0.37, P<0.001). ConclusionA substantial proportion of newly diagnosed HIV/AIDS cases in Suzhou are late presenters with high viral load levels. Targeted interventions should prioritize high-risk populations through enhanced active surveillance and the implementation of combined T lymphocyte subsets analysis and viral load testing, which can enable earlier case-finding and timely antiretroviral therapy initiation.
6.Expert consensus on the application of artificial intelligence in lung cancer screening, diagnosis, and treatment (2026 edition)
Wenzhao ZHONG ; Haibo WANG ; Yi HU ; Hao ZHANG ; Jigang DAI ; Junqiang FAN ; Guibin QIAO ; Fan YANG ; Jian HU ; Fengwei TAN ; Xuening YANG ; Qiang PU ; Zihao CHEN ; Hongxia TIAN ; Lunxu LIU ; Hecheng LI ; Xiaolong YAN ; Zongyang YU ; Zhenbin QIU ; Yihua SUN ; Jing HU ; Yuhang SHI ; Zhifei GUO ; Peng ZHANG ; Kezhong CHEN ; Shugeng GAO ; Yilong WU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(06):848-856
With the continuous deepening of the concept of precision diagnosis and treatment for lung cancer, how to achieve higher efficiency and accuracy in the screening, diagnosis, and treatment pathways in clinical practice has become an important issue that urgently needs to be overcome. The current clinical difficulty lies in the fact that despite continuous advancements in imaging and molecular diagnostic technologies, there are still limitations in manual efficiency and subjective experience when it comes to massive data analysis and multi-scale feature extraction. Artificial intelligence (AI), especially algorithm systems based on deep learning, is an innovative technology capable of deeply empowering medical big data. This method utilizes algorithms such as convolutional neural networks, combined with radiomics, pathomics, and multi-modal data fusion analysis, demonstrating immense potential in early precise detection and benign-malignant differentiation of pulmonary nodules, digital pathological subtype recognition and non-invasive prediction of driver genes, precise 3D surgical planning and automatic delineation of radiotherapy target volumes, as well as dynamic risk warning during follow-up. This innovative technology provides a brand-new solution for realizing intelligent and individualized lung cancer diagnosis and treatment models. This consensus, based on the latest evidence from evidence-based medicine and combined with the development trends in the AI field and real-world clinical needs, was ultimately formed by gathering the consensus opinions of multidisciplinary experts in radiology, pathology, thoracic surgery, and other fields. The main content covers the application specifications of AI in the three core scenarios of lung cancer screening, diagnosis, and treatment, the technical standards for data collection and algorithm validation, as well as the ethical and regulatory challenges faced at the current stage. It aims to clarify the applicable boundaries of AI as a clinical auxiliary decision support tool, providing scientific guidance and standardized exploration directions for peers currently engaged in or planning to carry out AI-assisted clinical diagnosis, treatment, and translation of lung cancer.
7.Analysis of oral health status and knowledge, attitude and practice intervention effects among third grade primary school students in Guizhou Province
Chinese Journal of School Health 2026;47(7):945-949
Objective:
To evaluate oral health status and knowledge, attitude and practice (KAP) among third grade primary school students after the implementation of the Comprehensive Intervention Project for Childhood Oral Diseases in Guizhou Province, so as to provide evidence for program optimization.
Methods:
Using a multistage cluster sampling method, oral examinations and questionnaire surveys were conducted among third grade primary school students in schools covered by the Comprehensive Intervention Project for Childhood Oral Diseases in Guizhou Province (intervention group, n =1 030) and schools not covered by the program (control group, n =1 130) in November 2023. A follow up survey was conducted one year after the project s implementation (December 2024) to evaluate the differences in oral health status and KAP between the two groups. The t-test and χ 2 test were used to compare means and rates, respectively.
Results:
One year after implementation, the permanent caries prevalence, caries filling ratio, mean dmft/DMFT, and mean simplified debris index in the intervention group were 33.3%, 22.3 %, 3.44±3.10, 0.77±0.56, which were all better than those in the control group (39.8%, 17.3%, 3.89±2.85, and 0.87± 0.63 ) ( χ 2/ t =9.87, 8.78, -2.59, -3.91,all P <0.05). After intervention, the levels of oral health knowledge, attitude and behaviors in the intervention group were better than those in the control group ( Z =7.69, 2.35, 2.10, all P <0.05). Except for the item "fluoride has no protective effect on teeth", the correct response rates of other oral health knowledge items in the intervention group were higher than those in the control group ( χ 2=3.92-163.94, all P <0.05). The reported rates of tooth brushing related behaviors and sugary beverage consumption were higher in the intervention group than in the control group ( χ 2=4.02-11.42,all P <0.05).
Conclusions
The Comprehensive Intervention Project for Childhood Oral Diseases improves children s oral health status, oral health knowledge, and some oral health behaviors, but has limited effects on some behaviors and oral health attitudes. Future efforts should focus on the factors influencing the transformation of children s oral health attitudes and behaviors, along with strengthening long term follow up evaluations.
8.Expression and clinical significance of RAB24 gene in hepatocellular carcinoma based on multi-source databases and clinical cohort validation
Yali GUO ; Yangchen WANG ; Jianhua YANG ; Xiang GAO ; Wenmei MA ; Nan DING ; Qiang HOU ; Wu DAI ; Limei WEN ; Junping HU
Acta Universitatis Medicinalis Anhui 2026;61(9):1647-1656
ObjectiveTo investigate the mRNA expression profile and clinical significance of the RAB24 gene in hepatocellular carcinoma (HCC) based on multi-source database including The Cancer Genome Atlas (TCGA) and clinical cohort validation. MethodsData from TCGA (n=424) were utilized to evaluate the prognostic value of RAB24 expression via Kaplan-Meier analysis and Cox regression models. An independent clinical cohort comprising 90 HCC and 30 paracancerous tissues was established to validate protein expression and histopathological features through immunohistochemistry (IHC) and routine histological staining. The TIMER database was employed to analyze the association between RAB24 and the tumor microenvironment (TME). Furthermore, integrated with LinkedOmics, GSEA and GSVA algorithms were used to quantitatively characterize the core molecular pathways regulated by RAB24. ResultsThe mRNA expression level of RAB24 in HCC was significantly higher than that in non-tumor liver tissues (P<0.05). Kaplan-Meier analysis revealed that the overall survival (OS) of patients in the RAB24 low-expression group was significantly longer compared to the high-expression group (HR=1.570, Log-rank P=0.01). Cox proportional hazards regression analysis demonstrated that RAB24 expression (HR=1.480, P=0.028), T stage (HR=2.949, P<0.001), M stage (HR=4.077, P=0.017), and tumor residual status (HR=2.317, P<0.001) were independent prognostic factors for HCC. RAB24 expression was highly correlated with alpha-fetoprotein (AFP) levels and immune infiltration levels (P<0.01), and showed a significant, low-level positive correlation with the TP53 gene (Rho=0.31, P<0.01). Quantitative analysis of the RAB24 protein in clinical samples validated that RAB24 expression in HCC tissues was significantly elevated compared to non-tumor liver tissues (P<0.05). TIMER analysis confirmed that RAB24 expression was highly associated with the infiltration of multiple immune cells (such as B cells and NK cells), as well as stromal and tumor purity scores in tumor tissues (P<0.01). GSEA/GSVA enrichment revealed that the P53, MYC, and mTORC1 signaling pathways were activated in the RAB24 high-expression group; correlation analysis confirmed that the RAB24 expression level exhibited a significant, low-level positive correlation with the ribosome pathway activity score (r=0.23, P<0.01). ConclusionsThe RAB24 gene, as a poor prognostic factor for HCC patients, is a potential biomarker for HCC diagnosis, treatment and prognosis. The study is expected to lay a theoretical foundation for the precise diagnosis and treatment of clinical HCC.
9.Analysis of Postoperative Obesity and Glucolipid Metabolism Characteristics in Children and Adolescent with Craniopharyngioma
Zulin LIU ; Chenchen GAO ; Dilong WANG ; Huilian DAI ; Lele HOU ; Hui OU ; Zhe MENG ; Liyang LIANG
Journal of Sun Yat-sen University(Medical Sciences) 2026;47(4):747-755
ObjectiveTo investigate the incidence, glucolipid metabolism characteristics, and associated factors of postoperative overweight/obesity in children and adolescent with craniopharyngioma. MethodsA retrospective study was conducted using follow-up data from 44 patients (aged 0-18 years) diagnosed with craniopharyngioma who underwent surgical treatment and received follow-up care at Sun Yat-sen Memorial Hospital, Sun Yat-sen University, between January 2006 and February 2024. The incidence and glucolipid metabolism characteristics of overweight/obesity were summarized, and potential influencing factors were analyzed. ResultsA total of 44 patients were enrolled. The mean age at surgery was (8.57 ± 4.25) years, and the mean age at last follow-up was (16.02 ± 5.36 )years. The mean follow-up duration was (7.45 ± 4.64) years (range, 8 months to 17.5 years). The preoperative incidence of overweight/obesity was 40.91% (predominantly overweight, 27.27%), which increased to 68.18% postoperatively (predominantly obesity, 50.00%). Postoperatively, all patients (44/44, 100%) underwent fasting plasma glucose (FPG) testing, among whom 2 (4.55%) had impaired fasting glucose (IFG). Fasting insulin (FINS) was measured in 20 patients, and insulin resistance was identified in 11 (55.00%). Oral glucose tolerance testing (OGTT) with insulin release assessment was performed in 12 patients, and all (100%) exhibited abnormal insulin secretion, including 5 (41.67%) with hyperinsulinemia and 3 (25.00%) diagnosed with diabetes mellitus (DM). All patients (44/44, 100%) underwent lipid profile assessment. The incidence of dyslipidemia was 81.82% (36/44), including elevated non-high-density lipoprotein cholesterol (29/44, 65.91%), hypertriglyceridemia (29/44, 65.91%), low high-density lipoprotein cholesterol (22/44, 50.00%), and mixed hyperlipidemia (13/44, 29.55%). Logistic regression analysis indicated that preoperative overweight/obesity and postoperative abnormal glucose metabolism were significant factors associated with postoperative overweight/obesity. Compared with normal-weight patients, those with postoperative overweight/obesity had higher FINS levels (14.22 mU/L vs. 3.57 mU/L), higher insulin resistance index(HOMA-IR) (2.88 vs. 0.52), and a higher incidence of abnormal glucose metabolism (77.78% vs. 23.08%). However, no significant difference was observed in the incidence of dyslipidemia (94.44% vs. 73.08%). ConclusionsChildren and adolescent with craniopharyngioma exhibit a higher incidence of overweight/obesity than healthy peers preoperatively, which becomes more pronounced after surgery. This is accompanied by a high incidence of glucolipid metabolic disorders, placing these patients at increased risk of metabolic syndrome, which warrants clinical attention and regular metabolic assessment. In patients who develop postoperative obesity, particular attention should be given to the risk of glucose metabolism abnormalities, and further monitoring of glucose homeostasis is recommended.
10.Interpretation and Implementation Paths of Specification for Quality Control in Traditional Chinese Medicine Clinical Trials
Haoling ZHANG ; Yanling GAO ; Guanhua REN ; Panbo QIU ; Yiming WANG ; Qingna LI ; Zhenzhen QIAN ; Guoyuan ZHANG ; Xinyue DAI ; Leping WANG ; Rui GAO
Journal of Traditional Chinese Medicine 2026;67(20):2173-2178
Specification for Quality Control in Traditional Chinese Medicine Clinical Trials(GB/T 47336-2026) is the first national standard in the field of clinical research on traditional Chinese medicine (TCM), aims to address the core issue that the quality shortcomings of current TCM clinical research restrict the transformation of achievements and international recognition. Through the interpretation of the core contents of this standard, including its scope of application, graded quality control system, TCM-specific quality control requirements, implementation and responsible entities, responsibilities of quality control personnel, formulation of quality control plans, critical nodes of quality control, and quality control archive management, it is believed that the promotion and implementation of this standard are of great significance for improving the standard system of TCM clinical research, enhancing research quality, optimizing the quality management model, and promoting the internationalization process of TCM. Meanwhile, the implementation paths for the standard are discussed, including carrying out pilot applications in institutions, establishing publicity, implementation, and training mechanisms, encouraging multi-party collaborative supervision, and setting up implementation feedback mechanisms. On this basis, the challenges that may be encountered during implementation, such as resource input pressure, difficulties in implementing TCM-specific quality control, and a relative shortage of interdisciplinary composite talents, are sorted out, and corresponding strategies are proposed, which can provide references for relevant researchers and practitioners.


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