1.Banxia Xiexin Tang Ameliorates Cognitive Dysfunction in Rat Model of Vascular Dementia via AGE/RAGE Pathway
Shuzhi LIANG ; Zhongmin ZHAO ; Suyu HOU ; Dandan LUO ; Yan ZHANG ; Xijian LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):10-21
ObjectiveTo explore the mechanism by which Banxia Xiexin Tang (BXT) regulates the advanced glycation end products (AGE)/receptor for advanced glycation end products (RAGE) signaling pathway to reduce neuroinflammatory responses and ameliorate cognitive dysfunction in the rat model of vascular dementia (VD). MethodsThe components of BXT were detected by ultra performance liquid chromatography-quadrupole -orbitrap-tandem mass spectrometry(UPLC-Q-Orbitrap-MS/MS), and the core components and key action pathways were screened out by network pharmacology and molecular docking. Sixty SPF-grade male SD rats were randomly allocated into the sham and modeling groups by the random number table method. The VD model was replicated by the modified bilateral occlusion of the common carotid arteries (2-VO) method. The successfully modeled rats were randomly allocated into the model, low-, medium-, and high-dose (3.748 5, 7.497, 14.994 g·kg-1) BXT (BXT-L, BXT-M, and BXT-H), and nimodipine (NMP, 0.002 7 g·kg-1) groups according to the random number table method. The rats in the drug intervention groups were administrated with corresponding drugs by gavage, and the sham and model groups received the same amount of normal saline for 14 consecutive days. The Morris water maze, Y-maze, and new object recognition experiments were conducted to evaluate the cognitive dysfunction of rats. Hematoxylin-eosin (HE) staining was used to evaluate the histopathological changes of the hippocampal tissue in rats. The mRNA levels of AGE, RAGE, and phosphorylated nuclear factor-kappa B p65 (p-NF-κB p65) in the hippocampal tissue of rats were determined by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR). The expression of related proteins in the AGE/RAGE pathway in the hippocampal tissue of rats was determined by Western blot and immunohistochemistry (IHC). The levels of neurotransmitters and inflammatory mediators in the rat serum were measured by enzyme-linked immunosorbent assay (ELISA). ResultsThe chemical components of BXT were detected by UPLC-Q-Orbitrap-MS/MS. Network pharmacology and molecular docking identified the AGE/RAGE pathway as the key pathway. The results of the water maze, Y maze, and novel object recognition tests showed that compared with the sham group, the model group demonstrated prolonged successful latency and decreases in number of platform crossings, alternation rate, number of entries into the new arm, preference index, and discrimination index (P0.01). Compared with the model group, the BXT-H and BXT-M groups showed shortened successful latency (P0.01) and increases in number of platform crossings (P0.05), alternation rate (P0.01), number of entries into the new arm (P0.05), preference index (P0.01), and discrimination index (P0.01). HE results showed that compared with the sham group, the cells of model rats were loosely and disorderly arranged, and the nuclei were condensed. Compared with the model group, the pathological changes of the hippocampus in the BXT group were mitigated. Real-time PCR results showed that compared with the sham group, the model group presented up-regulated mRNA levels of AGE, RAGE, and p-NF-κB p65 in the hippocampus (P0.01), and compared with the model group, the BXT-H and BXT-M groups showcased down-regulated mRNA levels of AGE, RAGE, and p-NF-κB p65 (P0.01). Western blot results showed that compared with the sham group, the model group presented up-regulated expression of AGE, RAGE, p-NF-κB p65, and tumor necrosis factor-α (TNF-α) (P0.05), and compared with the model group, the BXT-H group presented down-regulated expression of AGE, RAGE, p-NF-κB p65, and TNF-α (P0.05). IHC results showed that compared with the sham group, the model group had increased expression of RAGE (P0.01), and compared with the model group, the BXT-H and BXT-M groups had reduced expression of RAGE (P0.01). ELISA results showed that compared with the sham group, the model group exhibited elevated levels of TNF-α and Interleukin-1β (IL-1β) and declined levels of acetylcholine (ACh) and dopamine (DA) in the serum (P0.01). Compared with the model group, the BXT-L, BXT-M, and BXT-H groups showed lowered levels of TNF-α and IL-1β in the serum (P0.05) and elevated levels of ACh and DA (P0.05). ConclusionBXT may ameliorate cognitive dysfunction in the rat model of VD by down-regulating the AGE/RAGE signaling pathway, reducing neuroinflammatory responses, and regulating neurotransmitter levels.
2.Targeted Regulation of Inflammation-related Signaling Pathways by Traditional Chinese Medicine for Prevention and Treatment of Atherosclerosis: A Review
Shuang ZHAO ; Mingxue ZHANG ; Ning LIU ; Jianan SU ; Yuhan AO ; Jing LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):273-283
Atherosclerosis (AS) is the main pathological basis of cardiovascular diseases and seriously threatens human quality of life. Its prevention and treatment urgently need breakthroughs. The inflammatory response, which runs through the physiological and pathological evolution process of AS, is one of the important mechanisms for AS occurrence. Currently, the treatment methods for AS in Western medicine are relatively mature. However, they have adverse reactions such as abnormal liver and kidney function, drug tolerance, target vessel restenosis, and stent thrombosis, which remain the key bottleneck restricting clinical efficacy. Traditional Chinese medicine (TCM), characterized by multiple components, multiple targets, and multi-pathway synergy, shows unique clinical application potential and efficacy advantages in the intervention of AS. This article reviewed the research progress of TCM in intervening in AS by regulating inflammatory-related signaling pathways, such as nuclear factor-κB (NF-κB), Toll-like receptors (TLRs), mitogen-activated protein kinase (MAPK), and Janus kinase/signal transducer and activator of transcription (JAK/STAT), in the past five years. It summarized the combined mechanism of action of TCM monomers, TCM pairs, and compound preparations in inhibiting the inflammatory cascade reaction through multiple targets, regulating lipid metabolism disorders, and improving vascular endothelial dysfunction and the imbalance of the microenvironment. It deepened the research on the molecular mechanism of TCM in anti-AS, so as to provide a scientific basis for the clinical transformation application and related theoretical research of TCM in anti-AS.
3.Banxia Xiexin Tang Ameliorates Cognitive Dysfunction in Rat Model of Vascular Dementia via AGE/RAGE Pathway
Shuzhi LIANG ; Zhongmin ZHAO ; Suyu HOU ; Dandan LUO ; Yan ZHANG ; Xijian LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):10-21
ObjectiveTo explore the mechanism by which Banxia Xiexin Tang (BXT) regulates the advanced glycation end products (AGE)/receptor for advanced glycation end products (RAGE) signaling pathway to reduce neuroinflammatory responses and ameliorate cognitive dysfunction in the rat model of vascular dementia (VD). MethodsThe components of BXT were detected by ultra performance liquid chromatography-quadrupole -orbitrap-tandem mass spectrometry(UPLC-Q-Orbitrap-MS/MS), and the core components and key action pathways were screened out by network pharmacology and molecular docking. Sixty SPF-grade male SD rats were randomly allocated into the sham and modeling groups by the random number table method. The VD model was replicated by the modified bilateral occlusion of the common carotid arteries (2-VO) method. The successfully modeled rats were randomly allocated into the model, low-, medium-, and high-dose (3.748 5, 7.497, 14.994 g·kg-1) BXT (BXT-L, BXT-M, and BXT-H), and nimodipine (NMP, 0.002 7 g·kg-1) groups according to the random number table method. The rats in the drug intervention groups were administrated with corresponding drugs by gavage, and the sham and model groups received the same amount of normal saline for 14 consecutive days. The Morris water maze, Y-maze, and new object recognition experiments were conducted to evaluate the cognitive dysfunction of rats. Hematoxylin-eosin (HE) staining was used to evaluate the histopathological changes of the hippocampal tissue in rats. The mRNA levels of AGE, RAGE, and phosphorylated nuclear factor-kappa B p65 (p-NF-κB p65) in the hippocampal tissue of rats were determined by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR). The expression of related proteins in the AGE/RAGE pathway in the hippocampal tissue of rats was determined by Western blot and immunohistochemistry (IHC). The levels of neurotransmitters and inflammatory mediators in the rat serum were measured by enzyme-linked immunosorbent assay (ELISA). ResultsThe chemical components of BXT were detected by UPLC-Q-Orbitrap-MS/MS. Network pharmacology and molecular docking identified the AGE/RAGE pathway as the key pathway. The results of the water maze, Y maze, and novel object recognition tests showed that compared with the sham group, the model group demonstrated prolonged successful latency and decreases in number of platform crossings, alternation rate, number of entries into the new arm, preference index, and discrimination index (P<0.01). Compared with the model group, the BXT-H and BXT-M groups showed shortened successful latency (P<0.01) and increases in number of platform crossings (P<0.05), alternation rate (P<0.01), number of entries into the new arm (P<0.05), preference index (P<0.01), and discrimination index (P<0.01). HE results showed that compared with the sham group, the cells of model rats were loosely and disorderly arranged, and the nuclei were condensed. Compared with the model group, the pathological changes of the hippocampus in the BXT group were mitigated. Real-time PCR results showed that compared with the sham group, the model group presented up-regulated mRNA levels of AGE, RAGE, and p-NF-κB p65 in the hippocampus (P<0.01), and compared with the model group, the BXT-H and BXT-M groups showcased down-regulated mRNA levels of AGE, RAGE, and p-NF-κB p65 (P<0.01). Western blot results showed that compared with the sham group, the model group presented up-regulated expression of AGE, RAGE, p-NF-κB p65, and tumor necrosis factor-α (TNF-α) (P<0.05), and compared with the model group, the BXT-H group presented down-regulated expression of AGE, RAGE, p-NF-κB p65, and TNF-α (P<0.05). IHC results showed that compared with the sham group, the model group had increased expression of RAGE (P<0.01), and compared with the model group, the BXT-H and BXT-M groups had reduced expression of RAGE (P<0.01). ELISA results showed that compared with the sham group, the model group exhibited elevated levels of TNF-α and Interleukin-1β (IL-1β) and declined levels of acetylcholine (ACh) and dopamine (DA) in the serum (P<0.01). Compared with the model group, the BXT-L, BXT-M, and BXT-H groups showed lowered levels of TNF-α and IL-1β in the serum (P<0.05) and elevated levels of ACh and DA (P<0.05). ConclusionBXT may ameliorate cognitive dysfunction in the rat model of VD by down-regulating the AGE/RAGE signaling pathway, reducing neuroinflammatory responses, and regulating neurotransmitter levels.
4.Targeted Regulation of Inflammation-related Signaling Pathways by Traditional Chinese Medicine for Prevention and Treatment of Atherosclerosis: A Review
Shuang ZHAO ; Mingxue ZHANG ; Ning LIU ; Jianan SU ; Yuhan AO ; Jing LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):273-283
Atherosclerosis (AS) is the main pathological basis of cardiovascular diseases and seriously threatens human quality of life. Its prevention and treatment urgently need breakthroughs. The inflammatory response, which runs through the physiological and pathological evolution process of AS, is one of the important mechanisms for AS occurrence. Currently, the treatment methods for AS in Western medicine are relatively mature. However, they have adverse reactions such as abnormal liver and kidney function, drug tolerance, target vessel restenosis, and stent thrombosis, which remain the key bottleneck restricting clinical efficacy. Traditional Chinese medicine (TCM), characterized by multiple components, multiple targets, and multi-pathway synergy, shows unique clinical application potential and efficacy advantages in the intervention of AS. This article reviewed the research progress of TCM in intervening in AS by regulating inflammatory-related signaling pathways, such as nuclear factor-κB (NF-κB), Toll-like receptors (TLRs), mitogen-activated protein kinase (MAPK), and Janus kinase/signal transducer and activator of transcription (JAK/STAT), in the past five years. It summarized the combined mechanism of action of TCM monomers, TCM pairs, and compound preparations in inhibiting the inflammatory cascade reaction through multiple targets, regulating lipid metabolism disorders, and improving vascular endothelial dysfunction and the imbalance of the microenvironment. It deepened the research on the molecular mechanism of TCM in anti-AS, so as to provide a scientific basis for the clinical transformation application and related theoretical research of TCM in anti-AS.
5.Epidemiologic Burden of Colorectal Cancer in Xishan District, Kunming City, Yunnan Province, 2018—2020
Mingzhu GAO ; Ruiqi CAI ; Sile LI ; Yuying PANG ; Yanyan YANG ; Weilin ZHANG ; Min ZHAO
Cancer Research on Prevention and Treatment 2026;53(2):142-151
Objective To analyze the epidemiologic burden of colorectal cancer in Xishan District, Kunming City, Yunnan Province from 2018 to 2020. Methods Indicators of epidemiologic burden were calculated, including incidence rate, mortality rate, age-specific incidence/mortality rates, potential years of life lost (PYLL), and disability-adjusted life years (DALY) based on the National Disease Control and Prevention Center’s "Cancer Information Registration and Reporting System" and "Cause of Death Registration System". Results From 2018 to 2020, the ASR (China) for the incidence of colorectal cancer in Xishan District, Kunming City increased from 25.27/105 to 26.29/105, while the ASR (China) for mortality decreased from 17.11/105 to 16.03/105. The PYLL in 2018–2020 were
6.Orthodontic treatment of skeletal maxillary protrusion with dual bite: a case report and literature review
ZHAO Zhuannong ; LIU Junfeng ; ZHANG Wenzhong ; LIU Chufeng
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(3):263-272
Objective:
To evaluate the clinical efficacy and stability of a centric relation (CR)-guided approach combined with micro-implant anchorage and long traction hooks for root-controlled retraction of the maxillary anterior teeth in a patient with skeletal maxillary protrusion and dual bite, and to provide a reference for clinical practice.
Methods:
A case of a 29-year-old female patient with skeletal maxillary protrusion and an asymptomatic discrepancy between the maximum intercuspation position (MIP) and CR (dual bite) was reported. First, the CR was identified and obtained by cone beam computed tomography examination and clinical techniques, then was stabilized by glass ionomer bite registration and myofunctional training. Maintaining the CR, the maxillary micro-implants combined with long traction hooks were used to correct skeletal maxillary protrusion by facilitating maxillary anterior teeth retraction, and finally a new intercuspal occlusion was established to maintain long-term stability. A literature review was conducted to contextualize the treatment rationale and key steps.
Results:
Post-treatment, a coordinated and stable functional occlusion was established in CR without temporomandibular joint symptoms, and the condylar location was coordinated with the glenoid fossa. Controlled root retraction of the maxillary anterior segment and facial profile improvement were achieved. At 3-year follow-up, both occlusion in the CR and condylar positions remained stable. The literature review indicated that, in patients with CR-MIP discrepancy, prioritizing the identification and stabilization of CR is critical, and micro-implant anchorage with long traction hooks effectively facilitates maxillary anterior teeth retraction and profile improvement.
Conclusion
For skeletal maxillary protrusion with dual bite, a CR-first strategy combined with micro-implant anchorage and long-hook mechanics for root-controlled anterior retraction can concurrently improve stomatognathic function and facial aesthetics, demonstrating favorable mid- to long-term stability.
7.Mechanisms of Mahuang Lianqiao Chixiaodoutang in Improving Obesity-type Polycystic Ovary Syndrome in Rats Based on PI3K/Akt Signaling Pathway
Shiwei HU ; Biran ZHU ; Jinrong ZHANG ; Luyao RUAN ; Ji KUANG ; Jianghuan HUA ; Zhe LIU ; Yanyue YAO ; Ji WANG ; Min ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):21-31
ObjectiveTo investigate the mechanisms by which Mahuang Lianqiao Chixiaodoutang (MLC) improves obesity-type polycystic ovary syndrome (PCOS) through the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway. MethodsThirty-six female Sprague-Dawley (SD) rats were randomly divided into a blank control group (Con) and an obesity-type PCOS model preparation group. The model was induced by gavage with letrozole (1 mg·kg-1) combined with a high-fat diet (HFD). After model establishment, the obesity-type PCOS model preparation group was further divided into the model group (Mod, normal saline), metformin group (Met, 0.3 g·kg-1), low-dose MLC group (MLC-L, 4.3 g·kg-1), medium-dose MLC group (MLC-M, 8.6 g·kg-1), and high-dose MLC group (MLC-H, 17.2 g·kg-1). Active components of MLC and targets of obesity-type PCOS were screened from databases, a protein-protein interaction (PPI) network was constructed, and gene ontology(GO)and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was performed. The gut microbiota structure was analyzed based on 16S rRNA sequencing and correlated with network pharmacology pathways. Body weight and estrous cycle were dynamically monitored. Ovarian morphology was observed by hematoxylin-eosin (HE) staining. Cell apoptosis was detected by terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL). Enzyme-linked immunosorbent assay (ELISA) was used to detect levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), anti-Müllerian hormone (AMH), testosterone (T), and estradiol (E2). Western blot was used to detect the protein expression levels of phosphorylated PI3K/PI3K (p-PI3K/PI3K), phosphorylated Akt/Akt (p-Akt/Akt), B-cell lymphoma-2 (Bcl-2), and Bcl-2-associated X protein (Bax). ResultsNetwork pharmacology screening identified 124 active components of MLC and 408 overlapping targets between the herbal formula and the disease. Core targets such as Akt1 and Bcl-2 were revealed. As indicated by 16S rRNA sequencing, the abundances of Lachnospiraceae, Lachnoclostridium, and Dorea were increased in the MLC groups (P<0.05), while the abundance of Veillonella was decreased (P<0.05). KEGG correlation analysis integrating network pharmacology and gut microbiota data showed significant enrichment of the PI3K/Akt signaling pathway. Animal experiments showed that, compared with the Mod group, body weight decreased to normal levels in the Met, MLC-M, and MLC-H groups. The estrous cycle became regular. The number of corpora lutea increased and cystic follicles decreased. Serum levels of T, FSH, and LH/FSH were reduced (P<0.05, P<0.01), while the E2 level was increased (P<0.01). Ovarian cell apoptosis was reduced (P<0.01), and the protein expression levels of p-PI3K/PI3K, p-Akt/Akt, and Bcl-2 in ovarian tissue were significantly increased, whereas Bax protein expression was significantly decreased (P<0.05, P<0.01). ConclusionMLC can regulate gut microbiota structure, effectively improve ovarian pathology in rats with obesity-type PCOS, and inhibit ovarian granulosa cell apoptosis. The mechanism may be associated with upregulation of the PI3K/Akt signaling pathway.
8.Exploring on Processing Mechanism of Enhanced "Invigorating Spleen and Stopping Diarrhea" Effect of Soil-fried Atractylodis Macrocephalae Rhizoma Based on "Microscopic Characterization, Chemical Analysis and Pharmacodynamic Evaluation" Trinity
Guoshun SHAN ; Yuyan XIAO ; Chu YUAN ; Xiuai CHEN ; Qimiao ZHAO ; Xiang LIU ; Hao WU ; Ke ZHANG ; Siqi LIU ; Yongduo YU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):182-193
ObjectiveTo analyze the processing mechanism underlying the enhanced effect of invigorating spleen and stopping diarrhea of soil-fried Atractylodis Macrocephalae Rhizoma(AMR) by analyzing the changes of microstructure, chemical composition and anti-ulcerative colitis(UC) activity before and after soil stir-frying. MethodsThe microstructure and elemental composition of AMR before and after soil stir-frying were analyzed by scanning electron microscopy-energy dispersive spectroscopy(SEM-EDS), to investigate the differences in microstructure and the underlying causes. Ultra-high performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS) coupled with UNIFI 1.9.2 natural product analysis platform were used to analyze and identify the chemical constituents in raw and soil-fried products, and multivariate statistical methods including principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to explore the differences and sources of chemical constituents between them. A dextran sulfate sodium(DSS)-induced UC mouse model was established. The method of disease activity index(DAI) was used to evaluate the severity of intestinal inflammation. Hematoxylin-eosin(HE) staining was used to observe the pathological changes of colon tissue, enzyme-linked immunosorbent assay(ELISA) was used to detect the levels of inflammatory factors, Real-time quantitative polymerase chain reaction(Real-time PCR) and Western blot were used to analyze the expressions of key genes and proteins involved in the intestinal mucosal barrier. The 16S rRNA sequencing was used to evaluate the diversity of intestinal flora, headspace gas chromatography-mass spectrometry(HS-GC-MS) was used to explore the levels of short-chain fatty acids(SCFAs) in feces. Base on the above findings, this paper investigated the effects of raw and soil-fried AMR on the biological, chemical, mechanical and immune barriers of model animals, and the differences in pharmacological effects and underlying mechanisms from the perspective of regulating the intestinal mucosal barrier in UC mice. ResultsSEM observation revealed numerous hearth soil particles on the surface of soil-fried AMR, accompanied by bubble-like bulges. At the same time, there were many cracks and folds on the surface of the hearth soil. EDS analysis revealed that the contents of Si, Al, Mg and Ca in soil-fried AMR were significantly higher than those of raw products, and these elements constituted the primary components of hearth soil. UPLC-Q-TOF-MS combined with database comparison was used to identify the chemical constituents of raw and soil-fried AMR. In positive ion mode, a total of 132 components were identified, primarily comprising three categories of terpenoids, polyphenols and amino acids. In negative ion mode, a total of 40 components were identified, primarily polyphenolic and glycoside compounds. Among them, the contents of sesquiterpenes and polyphenolic acids were changed significantly before and after processing. Soil-fried AMR could reduce the DAI score of UC mice, alleviate the shortening of colon length, reduce the levels of pro-inflammatory factors such as interleukin(IL)-17, IL-18, γ-interferon(IFN-γ) and tumor necrosis factor(TNF)-α in serum, increase the levels of anti-inflammatory factors such as secretory immunoglobulin A(sIgA), IL-10, IL-4 and transforming growth factor-β(TGF-β) in serum, increase the expressions of key genes and proteins of intestinal mucosal barrier such as tight junction protein-1(ZO-1), Occludin, Claudin-1 and mucin 2(MUC2) in colonic mucosa, and improve the disorders of intestinal flora diversity and the levels of SCFAs(P<0.05, P<0.01). The raw and stir-fried products of AMR also exhibited the aforementioned effects, but they were weaker than the soil-fried products. Additionally, the auxiliary material hearth soil also had a certain pharmacodynamic effect. ConclusionSoil-fried AMR can enhance the protective effect on intestinal mucosal barrier in UC mice. These changes or heating-induced alterations in the microscopic structure and chemical composition of AMR may be attributed to the dual effects of adsorption of hearth soil.
9.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.
10.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions (T/CACM 1563.2-2024) were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine (TCM). This guideline was jointly developed with 23 authoritative medical and research institutions in China, under the lead of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM (including research and development, marketing, and application) and to establish a four-dimensional framework of "organizational structure, institutional system, information platform, and vigilance activities". Key components included the establishment of a TCM Safety Committee, the construction of nine core systems, the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B standards, alongside the risk monitoring, identification, assessment, and control during clinical trials and post-marketing phases. Therefore, this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations, the guideline compilation involved multiple rounds of expert interviews, systematic evidence integration, and broad consensus. This guideline was specified to be applicable to medical institutions at all levels, primarily addressing core issues, including the difficulty in adverse reaction identification, low reporting rates, and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous, ensuring alignment with current national laws and regulations, and was registered internationally. In the future, implementation will be promoted through standardized training, tiered dissemination, as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks, ensure patient medication safety, and promote the high-quality development of TCM.


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