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.Efficacy Analysis of RCT of Arsenic-containing TCM Compound in Treatment of Myelodysplastic Syndrome Based on MMRM and Win Ratio
Daxiang SUN ; Peizhen JIANG ; Haixia DI ; Bing WU ; Qifeng LIU ; Jian LIU ; Jiahe LIANG ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):251-259
ObjectiveThis paper aims to conduct a secondary analysis of a randomized controlled trial on the treatment of myelodysplastic syndrome (MDS) with deficiency of both the spleen and kidney and blockage of toxin and blood stasis with an arsenic-containing traditional Chinese medicine compound, by applying the mixed model for repeated measure (MMRM) and the method of stratified composite outcome with win ratio. The analysis includes the assessment of hematological efficacy and the composite outcome evaluation of adverse reactions, so as to more comprehensively assess the therapy of this regimen. MethodsThe MMRM and win ratio methods were used to evaluate the efficacy of a prospective,multi-center,double-blind,randomized controlled study. The blood routine (hemoglobin concentration,neutrophil count, and platelet count) and biochemical indexes (aspartate aminotransferase,alanine aminotransferase,serum creatinine,and serum ferritin) of the patients were detected at the time of enrollment and at the end of each course of treatment in the laboratory department of Xiyuan Hospital. The patients' syndromes at the time of enrollment and after treatment were recorded and scored according to the therapy standard of traditional Chinese medicine for diseases and syndromes. MMRM was used to analyze the blood routine indexes of the experimental group and the control group. This method has the advantages of high data reliability and dynamic efficacy under intervention and time. The win ratio method was used to evaluate the composite outcome of traditional Chinese medicine syndrome scores and biochemical indexes according to the priority and to verify the clinical safety of arsenic-containing traditional Chinese medicine compound. ResultsThe results of MMRM analysis showed that the hemoglobin concentration of patients in the group with arsenic-containing traditional Chinese medicine compound increased significantly compared with that before treatment in the group,while that in the placebo group decreased significantly (P<0.01). When compared with that after treatment in the placebo group,the hemoglobin concentration of patients in the group with arsenic-containing traditional Chinese medicine compound increased significantly,and the mean difference of least squares (LS) was statistically significant (P<0.01). When compared with those before treatment in the group,there were no statistically significant differences in the neutrophil count and platelet count in both groups. After treatment,there were no statistically significant differences in the neutrophil count, platelet count, and the mean difference of LS between the two groups. The analysis results of win ratio showed that the group with arsenic-containing traditional Chinese medicine compound had a significant advantage in the comparison of composite outcomes,with a win ratio (95% CI) of 2.01 (1.24-3.27) (P<0.01),and that the possibility of "winning" in terms of safety was 2.01 times that of the placebo group. The safety advantage of the group with arsenic-containing traditional Chinese medicine compound mainly came from the traditional Chinese medicine syndrome scores,renal function indexes, and iron reserve capacity indexes,and the number of winning times was less than that of losing times in the comparison of liver function outcomes. ConclusionThe MMRM analysis proves that the arsenic-containing traditional Chinese medicine compound can significantly improve the hemoglobin concentration of patients with myelodysplastic syndrome with refractory cytopenia and multilineage dysplasia (MDS-RCMD) of the type of deficiency of both the spleen and kidney and blockage of toxin and blood stasis. This conclusion is not interfered with by time trends and individual relationships and methodologically improves the credibility of the therapy of the arsenic-containing traditional Chinese medicine compound in treating MDS. Four outcomes are evaluated by the win ratio method,namely traditional Chinese medicine syndromes,liver function,renal function, and iron reserve capacity,proving that the arsenic-containing traditional Chinese medicine compound has the comprehensive advantages of improving the survival quality of the patients and reducing adverse reactions. The win ratio outcome provides clear comparative indexes for the evaluation of adverse reactions,making it easier for regulatory authorities,medical staff, and patients to understand the safety of the arsenic-containing traditional Chinese medicine compound in clinical application.
3.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
4.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
5.Effect of different exercise interventions on patients with metabolic dysfunction-associated fatty liver disease: A systematic review and network Meta-analysis
Guodong MA ; Zhuojing SUN ; Song HU ; Zijun YE ; Mingchen MA ; Fei CUI ; Jiaju ZHU
Journal of Clinical Hepatology 2026;42(2):326-344
ObjectiveTo investigate the effect of different exercise interventions on metabolism and liver parameters in patients with metabolic dysfunction-associated fatty liver disease (MAFLD), and to provide evidence-based recommendations for clinical exercise rehabilitation. MethodsThis study was conducted according to the PRISMA guidelines, and the protocol was registered on the PROSPERO platform, with a registration number of CRD42025641717. PubMed, Web of Science, Scopus, Wiley Online Library, CNKI, Wanfang Data, and VIP were searched for related articles published up to September 2024. The Cochrane tool for assessing risk of bias was used to assess the quality of articles, and Stata MP 17.0 was used to perform the network meta-analysis. ResultsA total of 57 articles were included, involving 2 648 patients. The results showed that aerobic exercise combined with resistance exercise had the best effect in improving body mass index (mean difference [WMD]=-0.97, 95% confidence interval [CI]: -1.66 to -0.28], P<0.05, surface under the cumulative ranking curve [SUCRA]=85.4) and triglycerides (WMD=-29.6, 95%CI: -46.66 to 12.54, P<0.05, SUCRA=87.3); resistance exercise was the optimal intervention method for improving total cholesterol (WMD=-15.99, 95%CI: -24.19 to -7.79, P<0.05, SUCRA=79.9) and glutamine transaminase (WMD=-8.08, 95%CI: -12.13 to -4.02, P<0.05, SUCRA=87.3); low-intensity aerobic exercise had the best effect in improving aspartate aminotransferase (WMD=-4.3, 95%CI: -8.45 to -0.15, P<0.05, SUCRA=73.5), gamma-glutamyl transpeptidase (GGT) (WMD=-3.26, 95%CI: -7.79 to 1.27, P>0.05, SUCRA=82.3), and glycated hemoglobin (HbA1c) (WMD=-0.6, 95%CI: -2.02 to 0.82, P>0.05, SUCRA=78.8); moderate-intensity aerobic exercise was the optimal intervention modality to improve Homeostasis Model Assessment of Insulin Resistance (WMD=-0.92, 95%CI: -1.51 to -0.33, P<0.05, SUCRA=69.4). It should be noted that there were no significant differences in HbA1c and GGT across different exercise interventions (all P>0.05), suggesting that there was currently no sufficient statistical evidence to support that exercise could improve these two indicators. ConclusionBased on the comprehensive league table and cumulative probability ranking, aerobic exercise combined with resistance exercise, resistance exercise, and low- and moderate-intensity aerobic exercise may be the best exercise modality for improving key indicators in MAFLD patients, and targeted exercise modalities should be selected for intervention against different indicators; however, due to limitations of the original studies, further studies are needed for validation and exploration.
6.Academic Characteristics of Contemporary Chinese Medicine Masters in Treating Diabetic Kidney Disease Based on SrTO
Yu SUN ; Xiaodan WANG ; Yingzi CUI ; Tianying CHANG ; Fan LI ; Lisha WANG ; Chenxuan DONG ; Shoulin ZHANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):258-269
ObjectiveTo explore the academic characteristics of contemporary renowned Chinese medicine masters in treating diabetic kidney disease (DKD) from the perspectives of principles, methods, formulas, and medications. MethodsIn strict accordance with the Systematic Review of Text and Opinion (SrTO) process developed by the Joanna Briggs Institute (JBI), an Australian evidence-based healthcare center, the databases including China National Knowledge Infrastructure (CNKI), VIP Database, Wanfang Data, and China Biomedical Literature Service System (SinoMed) were searched. Based on predefined inclusion and exclusion criteria, text information extraction, quality evaluation, and text information synthesis were conducted sequentially. The data were analyzed and presented in the form of text and figures. ResultsA total of 215 articles related to 43 contemporary renowned experts in the fields of Chinese medicine nephrology and endocrinology were included. The study found that the academic thoughts of these masters in the treatment of DKD are extensive, involving multiple levels such as disease understanding, therapeutic strategies, formula application, and medication use. In terms of disease understanding, the primary pathogenesis is characterized by deficiency in the root and excess in the manifestation. It is emphasized that internal factors, such as congenital endowment deficiency, interact with external factors such as improper diet, emotional disturbances, invasion of exogenous pathogens, and delayed or inappropriate treatment, to jointly induce the disease. This further gives rise to various pathogenetic theories, including obstruction of renal collaterals by blood stasis, toxin-induced damage to renal collaterals, latent wind disturbing the kidney, and internal heat leading to mass formation. In terms of therapeutic strategies and medication use, the principal treatment method is to replenish Qi and nourish Yin. Stage-based and syndrome-differentiated treatments are advocated. Flexible use of insect-derived drugs and wind-dispelling drugs is emphasized, along with proficiency in applying classical formulas and drug pairs. Integrated internal and external treatments, as well as the combined application of multiple therapeutic approaches, are commonly employed for comprehensive management. Meanwhile, the concept of "preventive treatment of disease" is upheld, and individualized long-term management of patients is advocated. ConclusionThrough the SrTO process, the academic thoughts of contemporary renowned Chinese medicine masters in the treatment of DKD have been systematically and standardly synthesized, providing a scientific and standardized basis for future theoretical exploration.
7.Academic Characteristics of Contemporary Chinese Medicine Masters in Treating Diabetic Kidney Disease Based on SrTO
Yu SUN ; Xiaodan WANG ; Yingzi CUI ; Tianying CHANG ; Fan LI ; Lisha WANG ; Chenxuan DONG ; Shoulin ZHANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):258-269
ObjectiveTo explore the academic characteristics of contemporary renowned Chinese medicine masters in treating diabetic kidney disease (DKD) from the perspectives of principles, methods, formulas, and medications. MethodsIn strict accordance with the Systematic Review of Text and Opinion (SrTO) process developed by the Joanna Briggs Institute (JBI), an Australian evidence-based healthcare center, the databases including China National Knowledge Infrastructure (CNKI), VIP Database, Wanfang Data, and China Biomedical Literature Service System (SinoMed) were searched. Based on predefined inclusion and exclusion criteria, text information extraction, quality evaluation, and text information synthesis were conducted sequentially. The data were analyzed and presented in the form of text and figures. ResultsA total of 215 articles related to 43 contemporary renowned experts in the fields of Chinese medicine nephrology and endocrinology were included. The study found that the academic thoughts of these masters in the treatment of DKD are extensive, involving multiple levels such as disease understanding, therapeutic strategies, formula application, and medication use. In terms of disease understanding, the primary pathogenesis is characterized by deficiency in the root and excess in the manifestation. It is emphasized that internal factors, such as congenital endowment deficiency, interact with external factors such as improper diet, emotional disturbances, invasion of exogenous pathogens, and delayed or inappropriate treatment, to jointly induce the disease. This further gives rise to various pathogenetic theories, including obstruction of renal collaterals by blood stasis, toxin-induced damage to renal collaterals, latent wind disturbing the kidney, and internal heat leading to mass formation. In terms of therapeutic strategies and medication use, the principal treatment method is to replenish Qi and nourish Yin. Stage-based and syndrome-differentiated treatments are advocated. Flexible use of insect-derived drugs and wind-dispelling drugs is emphasized, along with proficiency in applying classical formulas and drug pairs. Integrated internal and external treatments, as well as the combined application of multiple therapeutic approaches, are commonly employed for comprehensive management. Meanwhile, the concept of "preventive treatment of disease" is upheld, and individualized long-term management of patients is advocated. ConclusionThrough the SrTO process, the academic thoughts of contemporary renowned Chinese medicine masters in the treatment of DKD have been systematically and standardly synthesized, providing a scientific and standardized basis for future theoretical exploration.
8.The SMAD-Pathway Mediates HMGB1-Induced Proliferation and Metastatic Progression in Cutaneous Squamous Cell Carcinoma Cells
De-De LIAN ; Xue Mei LI ; Yu-Xi JIA ; Ming-Wei ZHOU ; Xiang-Ru CHEN ; Yang-Yang TIAN ; Min LI ; Ming-Hui SUN ; Ye ZHAO ; Hong-Jun LI ; Qing-Ling ZHANG
Annals of Dermatology 2026;38(1):51-58
Background:
High-mobility group box protein 1 (HMGB1) is a chromatin-binding protein involved in arthritis, ischemia, sepsis, atherosclerosis, neurodegenerative disorders, meningitis, and cancer. HMGB1 exhibits dual roles in cancer, acting as either a tumor suppressor or oncoprotein depending on context.
Objective:
This research aimed to elucidate HMGB1’s functional significance in cutaneous squamous cell carcinoma (cSCC).
Methods:
We overexpressed HMGB1 in cSCC cell lines using recombinant adenovirus and examined its effects on cell proliferation, colony formation, and cell migration.
Results:
Immunohistochemical analysis revealed elevated HMGB1 expression levels in cSCC tissue relative to normal epidermis. To assess the influence of HMGB1, we employed recombinant adenoviruses expressing HMGB1 to transduce SCC cell lines (SCC12 and SCC13). Enhanced HMGB1 expression significantly promoted cellular proliferation and colony formation capacity.Notably, HMGB1 overexpression elevated the levels of proliferation regulators, including P63, SOX2, CDK4 and CDK6. Furthermore, HMGB1 overexpression substantially enhanced tumor invasiveness, accompanied by upregulation of epithelial-mesenchymal transition (EMT) biomarkers. Mechanistically, overexpression of HMGB1 enhanced transforming growth factor-β signaling by increasing phosphorylation of SMAD2/3, the key mediators of EMT.
Conclusion
These data imply that HMGB1 acts as a tumor-promoting factor in cSCC.
9.Diagnosis of bovine piroplasmosis: a review
Lin SHEN ; Yingying SUN ; Wei WANG ; Cheng DU ; Xiaojun WANG
Chinese Journal of Schistosomiasis Control 2026;38(3):314-322
Bovine piroplasmosis, caused by infections with genus of Babesia and Theileria, is a tick-borne hemoparasitic disease. Recovered cattle often become asymptomatic persistent carriers, which represent potential sources of infection, and the pathogens of some forms of bovine piroplasmosis have zoonotic potential, which greatly threatens the public health security. Currently, the etiological diagnostic approaches of bovine piroplasmosis mainly include microscopy of blood smears, PCR assay, fluorescent quantitative real-time PCR assay, and loop-mediated isothermal amplification, and serological assay mainly includes indirect fluorescent antibody assay, enzyme-linked immunosorbent assay and immunochromatographic assay. This article systematically reviews the advances in the application of etiological approaches and serological assay for diagnosis of bovine piroplasmosis, and proposes future directions in the development of bovine piroplasmosis diagnosis, so as to provide insights into effective surveillance and precision control of bovine piroplasmosis in China.
10.Multidimensional diagnostic biomarkers for functional cure of chronic hepatitis B
Heming SUN ; Fei KONG ; Xingyu WANG ; Junqi NIU ; Yanhang GAO
Journal of Clinical Hepatology 2026;42(7):1532-1540
Chronic hepatitis B (CHB) is a significant public health issue worldwide. The persistent presence of covalently closed circular DNA of the hepatitis B virus (HBV) and the integration of the viral genome are the main obstacles limiting the achievement of virological cure in CHB. Functional cure has now become an important goal in antiviral therapy for CHB, and its accurate determination and efficacy prediction rely on a comprehensive assessment of multidimensional diagnostic markers. This article systematically reviews the research advances in diagnostic markers associated with functional cure in CHB, focusing on the clinical value of serological and virological indicators (HBsAg quantification and HBV DNA), genomic, transcriptomic, proteomic, and metabolomic markers, and indicators associated with host innate immunity and adaptive immunity. Furthermore, it discusses future research directions such as the establishment of unified detection standards and the construction of predictive models combining multiple markers, in order to promote the precise assessment and individualized management of functional cure in CHB.

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