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.

To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems， including insufficient safety information in package inserts， amplified medication risks in special populations， and non-standard clinical practices， thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China （2019 revision） and the GB/T 1.1—2020 standard， a systematic search was performed in the Chinese Pharmacopoeia （2020 edition）， the Catalog of Medicines Covered by Medical Insurance （2022 edition）， Chinese databases ［China Network of Knowledge Infrastructure （CNKI）， Wanfang Data （Wanfang）， and VIP journal resource integration service platform （VIP）］， and international databases （Cochrane Library， PubMed， and EMbase）. Guideline outlines were developed through questionnaire surveys， expert interviews， and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine （TCM） incompatibility， as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia （2020 edition） and 58 from the Catalog of Medicines Covered by Medical Insurance （2022 edition）. Safety-related items in the corresponding package inserts were collected， and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting， and opinions from 61 external experts were solicited. A pharmacovigilance framework was established， covering the full chain of "monitoring， identification， assessment， and control". Based on seven anatomical sites， including nasal， ocular， and oral mucosa， a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions"， "Contraindications"， and "Precautions"， clinical procedure standardization in healthcare institutions， risk control， and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration， filling the current gap in international pharmacovigilance standards in this field， while offering technical support for safety management across the full life cycle of medicines for mucosal administration.

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.

To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems， including insufficient safety information in package inserts， amplified medication risks in special populations， and non-standard clinical practices， thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China （2019 revision） and the GB/T 1.1—2020 standard， a systematic search was performed in the Chinese Pharmacopoeia （2020 edition）， the Catalog of Medicines Covered by Medical Insurance （2022 edition）， Chinese databases ［China Network of Knowledge Infrastructure （CNKI）， Wanfang Data （Wanfang）， and VIP journal resource integration service platform （VIP）］， and international databases （Cochrane Library， PubMed， and EMbase）. Guideline outlines were developed through questionnaire surveys， expert interviews， and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine （TCM） incompatibility， as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia （2020 edition） and 58 from the Catalog of Medicines Covered by Medical Insurance （2022 edition）. Safety-related items in the corresponding package inserts were collected， and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting， and opinions from 61 external experts were solicited. A pharmacovigilance framework was established， covering the full chain of "monitoring， identification， assessment， and control". Based on seven anatomical sites， including nasal， ocular， and oral mucosa， a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions"， "Contraindications"， and "Precautions"， clinical procedure standardization in healthcare institutions， risk control， and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration， filling the current gap in international pharmacovigilance standards in this field， while offering technical support for safety management across the full life cycle of medicines for mucosal administration.

ObjectiveThis paper aims to investigate the distribution patterns of traditional Chinese medicine syndromes in patients with chronic hepatitis B （CHB） comorbid with metabolically associated fatty liver disease （MAFLD） and analyze their correlation with clinical characteristics and the progression of liver fibrosis. MethodsA cross-sectional study method was employed， and 506 patients with CHB comorbid with MAFLD who attended the Hepatology Outpatient Department of Public Health Clinical Center of Chengdu from June 2024 to December 2024 were enrolled. General information， traditional Chinese medicine syndromes information， laboratory indicators， and imaging examination results were collected using case report forms （CRF）. Tongue images of patients were acquired using a tongue diagnosis instrument， and tongue feature parameters were extracted using computer image processing technology. Frequency analysis， factor analysis， and cluster analysis， and other methods were used to explore syndrome categories and distribution patterns. Non-parametric tests were used to compare the differences in clinical characteristics among different syndromes. Univariate and multivariate logistic regression analyses were performed to investigate the correlation between traditional Chinese medicine syndromes and the progression of liver fibrosis. ResultsThe main traditional Chinese medicine syndromes in patients with CHB comorbid with MAFLD were mainly dominated by damp-heat accumulation syndrome， liver stagnation and spleen deficiency syndrome， and phlegm-blood stasis syndrome， with damp-heat accumulation syndrome accounting for the highest proportion （41.89%）. Compared with those without damp-heat accumulation syndrome， patients with damp-heat accumulation syndrome had significantly lower tongue proper H value， tongue coating H value， and tongue coating a^* value （P<0.05）， significantly higher tongue coating b^* value （P<0.05）， significantly increased levels of white blood cell （WBC）， red blood cell （RBC）， hemoglobin （HGB）， and glucose （GLU）， increased CAP values （P<0.05）， a higher proportion of males （P<0.05）， and a younger age （P<0.05）. Univariate and multivariate logistic regression analyses show that age， hepatitis B surface antigen （HBsAg）， diabetes， and damp-heat accumulation syndrome are independent risk factors for liver fibrosis （P<0.05）， and that damp-heat accumulation syndrome is predominantly distributed in liver fibrosis stage F0-F1. ConclusionDamp-heat accumulation syndrome is a typical syndrome in patients with CHB comorbid with MAFLD， which is significantly associated with enhanced inflammatory response， metabolic disorders， and early liver fibrosis， and is a key link in disease progression. Clinical attention and early intervention are needed.

BackgroundObstructive sleep apnea （OSA） represents a potential modifiable risk factor for cognitive impairment， while spatial navigation performance serves as a sensitive marker to detect such deficits at an early stage. Currently， polysomnography （PSG） is the gold standard for OSA diagnosis， with the apnea hypopnea index （AHI） used to stratify the disease severity. Nevertheless， AHI alone cannot fully explain the individual variability in cognitive impairment among OSA patients. Existing evidence indicates that sleep architecture disruption impairs spatial memory consolidation and subsequently alters spatial navigation through pathways independent of AHI， yet this hypothesis remains unvalidated in routine clinical OSA cohorts. ObjectiveTo compare the global cognitive function and spatial navigation performance across OSA patients of varying severities， and to analyze associated factors of spatial navigation performance， so as to provide clinical evidence for the early identification and intervention of cognitive impairment in OSA patients. MethodsThis cross-sectional study consecutively enrolled 135 outpatients from the Mental Health Center of Inner Mongolia Autonomous Region from March 8， 2024 to September 12， 2025. All participants completed PSG monitoring and fulfilled the OSA diagnostic criteria outlined in the Guidelines for the Diagnosis and Treatment of Adult Obstructive Sleep Apnea. Subjects were stratified into mild （5 ≤AHI < 15 events/h）， moderate （15 ≤ AHI < 30 events/h）， and severe （AHI ≥ 30 events/h） groups based on AHI values， and all PSG sleep architecture parameters were extracted for statistical analysis. Global cognitive function was evaluated using the Mini-Mental State Examination （MMSE）， the Trail Making Test （including TMT-A and TMT-B）， and two subtasks from the THINC Integrated Toolkit （THINC-it）： the Spotter test （choice reaction time， CRT） and the Codebreaker test （digit symbol substitution test， DSST）. Spatial navigation performance was assessed through the Santa Barbara Sense of Direction Scale （SBSOD） and the computerized AMUNET spatial navigation test. ResultsAmong the 135 OSA patients， 46 （34.07%） were classified into the mild group， 47 （34.82%） into the moderate group， and 42 （31.11%） into the severe group. In terms of cognitive function， there were no statistically significant intergroup differences across three groups in CRT， consecutive correct DSST responses， MMSE scores， and completion time of TMT-A and TMT-B （P>0.05）. Regarding spatial navigation performance， no statistically significant differences were observed among three groups in SBSOD scores and the outcomes of the four AMUNET subtasks （P>0.05）. Spearman correlation analyses revealed that the performance on the delayed allocentric AMUNET subtask was positively correlated with stage N2 duration， percentage of stage N2 sleep （N2%）， and rapid eye movement （REM） latency （r=0.277， 0.296， 0.239， P_FDR<0.05）. In contrast， this subtask exhibited negative correlations with REM duration， percentage of REM sleep （REM%）， stage N3 duration and percentage of stage N3 sleep （N3%） （r=-0.223–-0.175， P_FDR<0.05）. SBSOD score was positively correlated with the completion time of TMT-A and TMT-B （r=0.236， 0.278）， and negatively correlated with MMSE scores （r=-0.311）. For AMUNET indices， performance on the allocentric navigation subtask showed a positive correlation with CRT （r=0.013）. Moreover， performance of both egocentric and allocentric navigation subtasks yielded positive correlations with the completion time of TMT-A and TMT-B （r=0.191–0.265， P_FDR<0.05）. Performance on the egocentric， allocentric， and combined egocentric–allocentric navigation subtasks was negatively correlated with MMSE scores and the consecutive correct DSST responses （r=-0.318–-0.207， P_FDR<0.05）. Hierarchical multiple liner regression analysis demonstrated that after controlling for baseline characteristics and global cognitive function， N2% emerged as a positive predictor of the delayed allocentric navigation subtask performance （β=0.242， 95% CI： 0.104–1.463）. ConclusionPatients with OSA across all severity strata exhibit comparable global cognitive function and spatial navigation performance. Spatial memory is associated with sleep architecture parameters， among which N2% acts as an independent positive predictor of spatial memory performance. ［Funded by Natural Science Foundation Project of Inner Mongolia Autonomous Region （number， 2024QN08050）； Science and Technology Project for High-Level Clinical Specialty Development of Public Hospitals of the Capital Region under the Autonomous Region Health Commission of Inner Mongolia Autonomous Region in 2023 （number， 2023SGGZ047）］

Under the current upsurge of cross-disciplinary research between artificial intelligence （AI） and traditional Chinese medicine （TCM）， the inheritance of academic thought in TCM is confronted with the deep-seated predicament of cognitive paradigm dislocation. The existing AI model is based on the classical reasoning mode of formal logic and statistical probability， which is difficult to adapt to the nonlinear and holistic cognitive logic of TCM with image-based thinking and syndrome-differentiated treatment as the core， resulting in systematic misreading and loss of the core essence in digital inheritance. Based on this， this paper proposes to construct a new cognitive model oriented towards the context of TCM. Its essence is not to have AI imitate the thinking of TCM， but to establish an auxiliary understanding framework based on semantic mapping and relational reasoning. It is advocated that the role of AI should be reconstructed from a knowledge substitute to a clinical interactor， and its application boundary in the inheritance of TCM wisdom should be clarified. By establishing the theoretical framework and practical path of human-computer collaboration， this paper aims to provide a scientific basis for realizing the deep integration of AI technology and the academic thought in TCM.

Under the current upsurge of cross-disciplinary research between artificial intelligence （AI） and traditional Chinese medicine （TCM）， the inheritance of academic thought in TCM is confronted with the deep-seated predicament of cognitive paradigm dislocation. The existing AI model is based on the classical reasoning mode of formal logic and statistical probability， which is difficult to adapt to the nonlinear and holistic cognitive logic of TCM with image-based thinking and syndrome-differentiated treatment as the core， resulting in systematic misreading and loss of the core essence in digital inheritance. Based on this， this paper proposes to construct a new cognitive model oriented towards the context of TCM. Its essence is not to have AI imitate the thinking of TCM， but to establish an auxiliary understanding framework based on semantic mapping and relational reasoning. It is advocated that the role of AI should be reconstructed from a knowledge substitute to a clinical interactor， and its application boundary in the inheritance of TCM wisdom should be clarified. By establishing the theoretical framework and practical path of human-computer collaboration， this paper aims to provide a scientific basis for realizing the deep integration of AI technology and the academic thought in TCM.

By systematically analyzing the bottlenecks in current traditional Chinese medicine （TCM） efficacy evaluation， this study addresses the limitations of TCM efficacy assessment methods in terms of individualization， holism， and complexity representation. Drawing on the concepts and methodologies of evidence-based medicine and systems biology， this paper proposes a new evaluation path by integrating multidisciplinary technologies such as big data， artificial intelligence （AI）， omics techniques， and bioinformatics， and encompassing from foundational data， individualized evaluation， and mechanistic analysis to evidence translation. The path first integrates real-world data， multi-omics profiling， and dynamic monitoring via smart devices to construct a high-dimensional dynamic data foundation. Subsequently， leveraging this foundation， it combines digital twins， dynamic symptom networks， and reinforcement learning to develop a dynamic efficacy evaluation method based on individual self-reference， enabling a shift from group mean comparisons to individual potential outcome comparisons. Furthermore， adopting the systems biology paradigm， it employs dynamic omics monitoring and deep learning models to dissect the synergistic mechanisms of TCM compound prescriptions from network regulation， emergent effects， and dynamic evolution dimensions. Finally， it enhances real-world evidence strength through target trial emulation and causal inference， achieving model iteration via incremental learning. This path aims to advance efficacy evaluation from "point validation" to "systematic characterization" and from "outcome assessment" to "process mechanism elucidation，" providing methodological support for the modernization of TCM.

ObjectiveTo investigate the protective effect and mechanism of verbenalin on mouse mononuclear macrophage leukemia cells （RAW264.7） damaged by human coronavirus （HCoV）-229E infection， thereby providing experimental evidence for its development and application. MethodsRAW264.7 macrophages were infected with different concentrations of HCoV-229E to establish a coronavirus-induced macrophage injury model using the cell counting kit-8 （CCK-8） assay for assessing cell proliferation and viability. Cells were randomly divided into four groups： normal control， verbenalin group （125 μmol·L^-1）， model group （HCoV-229E）， and HCoV-229E + verbenalin group （HCoV-229E + 125 μmol·L^-1 verbenalin）. Cell viability was measured using the CCK-8 assay， and the maximum non-toxic concentration （CC₀）， half-maximal cytotoxic concentration （CC₅₀）， half-maximal effective concentration （EC₅₀）， and selectivity index （SI） of verbenalin were calculated. Calcein/PI double staining was used to assess cell viability and cytotoxicity， and JC-1 staining was applied to evaluate changes in mitochondrial membrane potential （MMP）. mito-Keima adenovirus labeling was used to assess mitophagy levels in each group. ResultsA macrophage infection model was successfully established by infecting RAW264.7 cells with the original concentration of HCoV-229E for 36 h. The CC₀ of verbenalin was 125 μmol·L^-1. The CC₅₀ was 448.25 μmol·L^-1. The EC₅₀ against HCoV-229E-infected cells was 46.28 μmol·L^-1， and the SI was 9.68. Compared with the normal group， the model group showed significantly reduced cell survival rate （P<0.01）， increased cell death rate （P<0.01）， decreased MMP （P<0.01）， and suppressed mitophagy （P<0.01）. In contrast， verbenalin treatment significantly improved cell survival rate （P<0.01）， reduced cell death rate （P<0.01）， alleviated MMP loss （P<0.01）， and enhanced mitophagy levels （P<0.01） compared with the model group. ConclusionVerbenalin can enhance the survival rate of macrophages following HCoV-229E infection. The underlying mechanism may be associated with the activation of mitophagy， maintenance of MMP stability， and alleviation of mitochondrial damage.