1.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
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.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
4.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.
5.Mechanisms of Intestinal Microecology in Hyperuricemia and Traditional Chinese Medicine Intervention:A Review
Mingyuan FAN ; Jiuzhu YUAN ; Hongyan XIE ; Sai ZHANG ; Qiyuan YAO ; Luqi HE ; Qingqing FU ; Hong GAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):329-338
In recent years, hyperuricemia (HUA) has shown a rapidly increasing incidence and tends to occur in increasingly young people, with a wide range of cardiac, renal, joint, and cancerous hazards and all-cause mortality associations. Western medicine treatment has limitations such as large liver and kidney damage, medication restriction, and easy recurrence. The intestine is the major extra-renal excretion pathway for uric acid (UA), and the intestinal microecology can be regulated to promote UA degradation. It offers great potential to develop UA-lowering strategies that target the intestinal microecology, which are promising to provide safer and more effective therapeutic approaches. Traditional Chinese medicine (TCM) can treat HUA via multiple targets and multiple pathways from a holistic view, with low toxicity and side effects. Studies have shown that intestinal microecology is a crucial target for TCM in the treatment of HUA. However, its specific mechanism of action has not been fully elucidated. Focusing on the key role of intestinal microecology in HUA, this review explores the relationship between intestinal microecology and HUA in terms of intestinal flora, intestinal metabolites, intestinal UA transporters, and intestinal barriers. Furthermore, we summarize the research progress in TCM treatment of HUA by targeting the intestinal microecology, with the aim of providing references for the development of TCM intervention strategies for HUA and the direction of future research.
6.TCM Research of Theories and Prescriptions on Blood Glucose Fluctuation in Diabetes Mellitus: A Review
Yongjiang ZHU ; Xiaoxu FU ; Hongyan XIE ; Chunguang XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):303-310
A systematic review of the traditional Chinese medicine (TCM) literatures published over the past decade on blood glucose fluctuations in diabetes mellitus was conducted to summarize related TCM research progress of theories and prescriptions, so as to provide references for future TCM theoretical exploration, basic research, and clinical prevention and treatment. Blood glucose fluctuation is an independent risk factor for chronic complications of diabetes mellitus, with significant progress made in TCM theories and prescription studies targeting this condition. The TCM theories include "spleen-pancreas homology", "liver controlling dispersion", "small intestine transforming qi and separating purity from turbidity", "Yi Qi Zhou Liu theory", "Xuan Fu Qi Ye theory", "Yin-fire theory" and so on, all of which emphasize "Qi". Prescription studies primarily utilize clinical trials, which evaluate plentiful indexes of blood glucose fluctuation such as the mean amplitude of glycemic excursion. Classical and self-formulated prescriptions are widely used, with various dosage forms such as decoctions, granules and capsules. "Qi-Yin deficiency" is the main syndrome of blood glucose fluctuation. Basic research focuses on mechanisms that improve blood glucose fluctuation and reduce chronic complications, such as the renin-angiotensin system regulating islet β cell's function, and the transforming growth factor-β1 inhibiting organ fibrosis. However, there are still some deficiencies in the evidential support and syndrome study of TCM theories, in the high-level evidence-based evaluation, efficacy comparison among multiple dosage forms, and the integration of TCM theories with prescription's clinical research, in the quantities, multi-level verifications, blood glucose fluctuation model establishment and intervention criteria as well as prescription-syndrome correspondence of prescription's basic research, and in the collaboration between clinical and basic research. Despite these challenges, TCM offers a promising approach to improving blood glucose fluctuation and reducing chronic complications in diabetes mellitus, with its rich theories, diverse methods, and proven efficacy.
7.Construction of the Chinese-Western Synergistic System for the Prevention and Treatment of Diabetic Lower Extremity Arterial Disease
Hong GAO ; Hongyan XIE ; Qingzhi LIANG ; Chunguang XIE
Journal of Sichuan University (Medical Sciences) 2025;56(3):633-639
Diabetic lower extremity arterial disease(DLEAD)is characterized by a low rate of diagnosis,low awareness,low treatment rate,high disability rate,and high mortality.Due to a lack of comprehensive prevention and treatment strategies or an integrated technological system,DLEAD has become a bottleneck in the prevention and control of diabetes mellitus at present.Traditional Chinese medicine(TCM)treatment of DLEAD offers the advantages of syndrome differentiation,evidence-based treatment,and holistic regulation.However,it lacks a comprehensive understanding of the through-course pathogenesis and unified standardized syndrome criteria.TCM treatment of DLEAD exerts multi-target and multi-pathway network effects,but the advantageous links are still not fully understood.TCM treatments can delay the onset and development of DLEAD,but the efficacy evaluation system remains incomplete.Furthermore,there is a lack of high-quality evidence-based medical evidence and clinical consensus and guidelines.Therefore,based on the idea of zhi wei bing,or treating the disease before it develops,in Chinese medicine,and focusing on the prevention and control of DLEAD,we have constructed a synergistic technical system that integrates traditional Chinese and Western medicine for the prevention and control of DLEAD.This system integrates prevention,diagnosis,treatment,mechanisms,and applications,so as to enhance the clinical effects of DLEAD prevention and control,and to create a new paradigm for collaborative traditional Chinese medicine and western medicine in the field of chronic disease management.
8.The Development of Chinese Herbal Formulae for Non-severe COVID-19 Based on Artificial Intelligence Technology and Investigation of Its Action Mechanisms
Wenting HUANG ; Liansheng QIAO ; Di YAN ; Tengwen LIU ; Hongmei CAO ; Hongyan GUO ; Zhi ZHANG ; Jing CHENG ; Lan XIE ; Qingquan LIU
Journal of Traditional Chinese Medicine 2024;65(1):103-112
ObjectiveTo develop traditional Chinese medicine (TCM) formulae for the treatment of nonsevere coronavirus disease 2019 (COVID-19) and to explore its anti-inflammatory mechanism. MethodsThe dysregulated signaling pathways were determined in macrophages from bronchoalveolar lavage fluid of COVID-19 patients and in lung epithelial cells infected with SARS-CoV-2 in vitro based on transcriptome analysis. A total of 102 TCM formulae for the clinical treatment of nonsevere COVID-19 were collected through literature. The pathway-reversing rates of these formulae in macrophages and lung epithelial cells were evaluated based on signature signaling pathways, and the basic formula was determined in conjunction with TCM theory. The commonly used Chinese materia medica for nonsevere COVID-19 were summarized from the 102 TCM formulae as abovementioned. And together with the screening results from the Pharmacopoeia of the People's Republic of China, a “Chinese materia medica pool” was esta-blished for the development of TCM formulae for COVID-19. The regulatory effects of each herb on signaling pathways were obtained based on targeted transcriptome analysis. Oriented at reversing dysregulated signaling pathways of COVID-19, the calculation was carried out, and the artificial intelligent methods for compositing formulae, that are exhaustive method and parallel computing, were used to obtain candidate compound formulas. Finally, with reference to professional experience, an innovative formula for the treatment of nonsevere COVID-19 was developed. The ethanol extract of the formula was evaluated for its anti-inflammatory effects by detecting the mRNA expression of interleukin 1b (Il1b), C-X-C motif chemokine ligand 2 (Cxcl2), C-X-C motif chemokine ligand 10 (Cxcl10), C-C motif chemokine ligand 2 (Ccl2), nitric oxide synthase 2 (Nos2), and prostaglandin-endoperoxide synthase 2 (Ptgs2) using reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in RAW264.7 cells treated with lipopolysaccharide (LPS). ResultsIn macrophages and lung epithelial cells, 34 dysregulated signaling pathways associated with COVID-19 were identified respectively. The effects of the 102 formulae for clinical treatment of nonsevere COVID-19 were evaluated based on the dysregulated signaling pathways and targeted transcriptome, and the result showed that Yinqiao Powder and Pingwei Powder (银翘散合平胃散, YQPWP) ranked first, reversing 91.18% of the dysregulated signaling pathways in macrophages and 100% of the dysregulated signaling pathways in lung epithelial cells. Additionally, YQPWP had the function of scattering wind and clearing heat, resolving toxins and removing dampness in accordance with the pathogenesis of wind-heat with dampness in COVID-19. It was selected as the basic formula, and was further modified and optimized to develop an innovative fomula Qiaobang Zhupi Yin (翘蒡术皮饮, QBZPY) based on expert experience and artificial intelligence in composing formulae. QBZPY can reverse all the dysregulated signaling pathways associated with COVID-19 in macrophages and lung epithelial cells, with the reversing rates of 100%. The chief medicinal of QBZPY, including Lianqiao (Fructus Forsythiae), Xixiancao (Herba Siegesbeckiae) and Niubangzi (Fructus Arctii), can down-regulate multiple signaling pathways related with virus infection, immune response, and epithelial damage. RT-qPCR results indicated that compared with the model group, the QBZPY group down-regulated the mRNA expression of Il1b, tumor necrosis factor (Tnf), Cxcl2, Cxcl10, Ccl2, Nos2 and Ptgs2 induced by LPS in RAW264.7 cells (P<0.05 or P<0.01). ConclusionBased on targeted transcriptome analysis, expert experience in TCM and artificial intelligence, QBZPY has been developed for the treatment of nonsevere COVID-19. The ethanol extract of QBZPY has been found to inhibit mRNA expression of several pro-inflammatory genes in a cellular inflammation model.
9.Research progress in effect of histone acetylation modifications on occurrence and development of periodontitis
Yi XIE ; Yang LIU ; Hongyan LI ; Xiaowei XU
Journal of Jilin University(Medicine Edition) 2024;50(5):1457-1464
Periodontitis is a chronic inflammatory disease caused by plaque biofilm,and the homeostasis of the periodontal microenvironment is crucial for periodontal health.The epigenetics explores how the environmental and other non-genetic factors regulate the gene expression without changing the DNA nucleotide sequence,thereby affecting the occurrence and development of this disease.The histone acetylation modification is one of the common epigenetic modifications,primarily regulated by the histone acetyltransferases and histone deacetylases.Imbalance in this regulation can lead to the gene regulatory disorders,causing the chronic inflammation,autoimmune diseases and cancer.Recent studies have shown there is a clear correlation between histone acetylation modifications and the development of periodontitis.This paper discusses the changes in histone acetylation modifications in the gingival epithelial cells,immune cells,and periodontal ligament stem cells during periodontitis,elucidating the role and molecular mechanisms of histone acetylation modifications in the development of periodontitis and providing the basis for the epigenetic treatment of periodontitis.
10.Mineralization regulation of MAGE-D1 on bone marrowmesenchymal stem cells in knockout mice
Mingjie LU ; Hongyan YUAN ; Dan XU ; Xuelian PENG ; Xuqiang ZOU ; Bo XIE ; Jingwen MAO ; Xiujie WEN
Journal of Army Medical University 2024;46(18):2069-2080
Objective To investigate the effect of melanoma associated antigen D1 (Mage-D1)on mouse femoral bone mass and mineralization ability of mouse bone marrow mesenchymal cells (BMSCs)and its potential molecular mechanism.Methods Female Mage-D1 gene knockout heterozygous mice and male wild-type (WT)mice were subjected as parent mice to breed Mage-D1 gene knockout homozygous (Mage-D1 KO)mice.PCR and agarose gel electrophoresis were used to identify male Mage-D1 knockout (Mage-D1 KO)mice and littermate male wild-type (WT)mice.Micro-CT scanning was performed to observe mouse femoral bone mass,and ELISA and chemical assay were employed to detect serum levels of calcium,phosphorus,calcitonin,and parathyroid hormone in mice.After primary cultured BMSCs were identified with flow cytometry,immunofluorescence staining was utilized to detect the expression of Mage-D1 in BMSCs.BMSCs were infected by Mage-D1 silencing lentivirus,and then the cells were divided into negative control group (sh-NC)and silencing group (sh-Mage-D1).Cell scratch assay was conducted to detect the migration ability of BMSCs,and flow cytometry and CCK-8 assay were conducted to detect the cycle change and proliferation ability of BMSCs.After mineralization induction,alkaline phosphatase (ALP) staining and alizarin red staining were performed;RT-qPCR and Western blotting were used to measure the expression levels of ALP,Runx2 and Col1.RT-qPCR was used to detect mineralization-related genes p75NTR and Msx1.Results Compared with the WT mice,the femoral cortical bone thickness,cortical bone mineral content,cancellous bone mineral content,trabecular number,and cancellous bone surface density were decreased,and trabecular separation was increased in the Mage-D1 knockout homozygous mice (P<0.05).There were no significant changes in the serum levels of calcium,phosphorus,calcitonin and parathyroid hormone in mice after Mage-D1 knockout.Mage-D1 was expressed in the whole BMSCs and was highly expressed in the nucleus and perinuclear regions.Compared with the sh-NC BMSCs,the sh-Mage-D1 group had decreased proliferation ability (P<0.01),enhanced migration ability (P<0.01),and decreased expression of ALP,Runx2 and Col1 genes (P<0.05)and protein (P<0.01)after mineralization induction,milder ALP and alizarin red stain,and lower expression levels of p75NTR and Msx1.Conclusion Mage-D1 knockout can significantly reduce femur bone mass in mice.It can promote the proliferation and inhibit migration of BMSCs,and positively regulate their mineralization in vitro,and the p75NTR-Dlx1/Msx1 signaling axis may be involved in the regulation of bone metabolism by Mage-D1.

Result Analysis
Print
Save
E-mail