1.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
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.
2.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
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.
3.OBE-CDIO model of teaching for curriculum of exercise rehabilitation training
Hua LIU ; Liyuan WANG ; Xin MA ; Jing LI ; Li WANG
Chinese Journal of Rehabilitation Theory and Practice 2026;32(3):270-275
ObjectiveTo investigate the effectiveness of teaching pedagogy based on outcome-based education (OBE) and conceive-design-implement-operate (CDIO) model in the teaching of exercise rehabilitation training. MethodsTwenty-seven postgraduate students majoring in exercise rehabilitation training of grade 2024 at Capital University of Physical Education and Sports were randomly divided into control group (n = 13) and experimental group (n = 14). The control group received routine teaching methods, while the experimental group received teaching of OBE-CDIO. After the course, theoretical scores, objective structured clinical examination (OSCE) scores and teaching satisfaction via questionnaire were compared between two groups. ResultsAfter the course, there was no significant difference in theoretical scores between two groups (t = 1.103, P > 0.05). Scores in all stations of OSCE were higher in the experimental group than in the control group (t > 2.181, P < 0.05), as well as the satisfaction scores of learning, enthusiasm, organization, group interaction, individual affinity, workload and examination (|t| > 3.781, P < 0.001). ConclusionThe teaching pedagogy based on the OBE-CDIO model can improve practical competence and teaching satisfaction among postgraduate students majoring in exercise rehabilitation training.
4.OBE-CDIO model of teaching for curriculum of exercise rehabilitation training
Hua LIU ; Liyuan WANG ; Xin MA ; Jing LI ; Li WANG
Chinese Journal of Rehabilitation Theory and Practice 2026;32(3):270-275
ObjectiveTo investigate the effectiveness of teaching pedagogy based on outcome-based education (OBE) and conceive-design-implement-operate (CDIO) model in the teaching of exercise rehabilitation training. MethodsTwenty-seven postgraduate students majoring in exercise rehabilitation training of grade 2024 at Capital University of Physical Education and Sports were randomly divided into control group (n = 13) and experimental group (n = 14). The control group received routine teaching methods, while the experimental group received teaching of OBE-CDIO. After the course, theoretical scores, objective structured clinical examination (OSCE) scores and teaching satisfaction via questionnaire were compared between two groups. ResultsAfter the course, there was no significant difference in theoretical scores between two groups (t = 1.103, P > 0.05). Scores in all stations of OSCE were higher in the experimental group than in the control group (t > 2.181, P < 0.05), as well as the satisfaction scores of learning, enthusiasm, organization, group interaction, individual affinity, workload and examination (|t| > 3.781, P < 0.001). ConclusionThe teaching pedagogy based on the OBE-CDIO model can improve practical competence and teaching satisfaction among postgraduate students majoring in exercise rehabilitation training.
5.OBE-CDIO model of teaching for curriculum of exercise rehabilitation training
Hua LIU ; Liyuan WANG ; Xin MA ; Jing LI ; Li WANG
Chinese Journal of Rehabilitation Theory and Practice 2026;32(3):270-275
ObjectiveTo investigate the effectiveness of teaching pedagogy based on outcome-based education (OBE) and conceive-design-implement-operate (CDIO) model in the teaching of exercise rehabilitation training. MethodsTwenty-seven postgraduate students majoring in exercise rehabilitation training of grade 2024 at Capital University of Physical Education and Sports were randomly divided into control group (n = 13) and experimental group (n = 14). The control group received routine teaching methods, while the experimental group received teaching of OBE-CDIO. After the course, theoretical scores, objective structured clinical examination (OSCE) scores and teaching satisfaction via questionnaire were compared between two groups. ResultsAfter the course, there was no significant difference in theoretical scores between two groups (t = 1.103, P > 0.05). Scores in all stations of OSCE were higher in the experimental group than in the control group (t > 2.181, P < 0.05), as well as the satisfaction scores of learning, enthusiasm, organization, group interaction, individual affinity, workload and examination (|t| > 3.781, P < 0.001). ConclusionThe teaching pedagogy based on the OBE-CDIO model can improve practical competence and teaching satisfaction among postgraduate students majoring in exercise rehabilitation training.
6.Application of presentation-assimilation-discussion-based classroom-community collaborative teaching in sports rehabilitation therapy under sports-medicine integration
Hua LIU ; Jing LI ; Liyuan WANG ; Xin MA ; Li WANG
Chinese Journal of Rehabilitation Theory and Practice 2026;32(4):482-487
ObjectiveTo explore the effect of presentation-assimilation-discussion (PAD) classroom model-based classroom-community collaborative teaching on course of sports rehabilitation therapy under the background of sports-medicine integration. MethodsFrom Febrary, 2024 to June, 2025, a total of 46 undergraduate students majoring in sports rehabilitation (Grade 2022, Capital University of Physical Education and Sports) were randomly divided into control group (n = 23) and experimental group (n = 23). The control group received routine lectures combined with laboratory practice, while the experimental group was taught using a classroom-community collaborative teaching based on PAD classroom structure. The two groups were compared in terms of excellent rate in practical assessment, achievement in higher-order dimensions of Bloom's Taxonomy, real-case rehabilitation scenario transformation ability and teaching satisfaction at the end of the semester. ResultsAt the end of the semester, the excellent rate in practical assessment was 60.87% in the experimental group, higher than 21.74% in the control group (χ² = 7.725, P < 0.05), while the scores in the analyse, evaluation and creation dimensions of Bloom's Taxonomy were significantly higher (t > 8.490, P < 0.001), real-case rehabilitation scenario transformation ability was better (t > 3.873, P < 0.001) and teaching satisfaction was higher (χ² = 8.576, P = 0.003). ConclusionPAD-based classroom-community collaborative teaching can effectively improve practical skills, higher-order cognitive abilities and practical application abilities among students majoring in sports rehabilitation.
7.Structural and Functional Abnormalities of White-matter Tracts in Male College Smokers
Xiao-Jiao LI ; Da-Hua YU ; Ting XUE ; Kai YUAN ; Zhen-Zhen MAI ; Xu-Wen WANG ; Fang DONG ; Juan WANG ; Yu-Xin MA
Progress in Biochemistry and Biophysics 2026;53(6):1770-1779
ObjectiveThe present study aimed to investigate alterations in white matter microstructure and spontaneous neural activity in male college smokers, and to further explore their associations with nicotine dependence. Given that adolescence and early adulthood represent critical periods for brain maturation, particularly for white matter development, understanding the neural correlates of smoking behavior during this stage is of substantial importance for both neuroscience and public health. MethodsA total of 115 male undergraduate students were initially recruited for this study. After quality control and exclusion procedures, 52 male college smokers and 42 demographically matched healthy non-smokers were included in the final analysis. All participants underwent multimodal magnetic resonance imaging (MRI), including diffusion tensor imaging (DTI) and resting-state functional MRI (rs-fMRI). White matter fiber tracts were reconstructed using the automated fiber quantification (AFQ) method, which enables precise identification and quantification of major fiber bundles. Eighteen major white matter tracts were segmented for each participant. Along the core trajectory of each tract, 100 equidistant nodes were sampled. Fractional anisotropy (FA) was calculated at each node to assess white matter microstructural integrity, while amplitude of low-frequency fluctuation (ALFF) was computed to evaluate spontaneous neural activity within white matter tracts. Between-group differences in FA and ALFF were assessed using two-sample t-tests, with appropriate corrections applied for multiple comparisons. Furthermore, Pearson correlation analyses were conducted to examine the relationships between imaging-derived metrics (FA and ALFF values in regions showing significant group differences) and nicotine dependence severity, as measured by the Fagerström test for nicotine dependence (FTND). ResultsCompared with healthy non-smokers, male college smokers exhibited significantly increased FA values in several white matter tracts, including the left thalamic radiation, right corticospinal tract, forceps major of the corpus callosum, left uncinate fasciculus, and right arcuate fasciculus. These findings suggest altered microstructural organization or increased directional coherence within these pathways. In addition, smokers demonstrated significantly elevated ALFF values in the forceps major, right uncinate fasciculus, and left arcuate fasciculus, indicating enhanced spontaneous neural activity in these white matter regions. Correlation analyses revealed that FA values in the left thalamic radiation and right corticospinal tract were negatively correlated with FTND scores, suggesting that higher levels of nicotine dependence were associated with reduced microstructural integrity or altered fiber organization in these regions. In contrast, ALFF values in the forceps major and right uncinate fasciculus were positively correlated with FTND scores, indicating that greater nicotine dependence was associated with increased spontaneous neural activity in specific white matter pathways. ConclusionThe present study provides evidence that male college smokers exhibit distinct alterations in both white matter microstructure and functional activity. These abnormalities are not uniformly distributed but rather localized to specific fiber tracts implicated in sensorimotor processing, interhemispheric communication, and higher-order cognitive and emotional regulation. Importantly, the observed associations between imaging metrics and nicotine dependence severity suggest that these structural and functional alterations may reflect neurobiological mechanisms underlying addiction. The combination of AFQ-based tract profiling and multimodal MRI offers a sensitive approach for detecting subtle changes along white matter pathways, highlighting its potential utility in identifying neuroimaging biomarkers of nicotine dependence. Overall, these findings indicate that smoking during early adulthood may disrupt ongoing white matter maturation, potentially leading to long-term consequences for brain function. This study provides novel insights into the neural basis of nicotine dependence and underscores the importance of early intervention and prevention strategies targeting young smokers.
8.Comparison master's training programs in sports rehabilitation based on rehabilitation competency framework
Hua LIU ; Xin MA ; Jing LI ; Liyuan WANG ; Li WANG
Chinese Journal of Rehabilitation Theory and Practice 2026;32(8):984-992
ObjectiveTo analyze the distribution characteristics of competency structures in master's training programs in sports rehabilitation at Chinese universities based on the rehabilitation competency framework (RCF). MethodsUsing RCF as the theoretical analytical framework, master's training programs from Chinese universities offering sports rehabilitation programs or related training tracks were selected as study objects. A combination of text analysis and competency mapping was employed to conduct a systematic comparative analysis of training objectives, curriculum systems and training components. ResultsA total of 16 master's training programs in sports rehabilitation were included. Research-related competencies were well covered across the included programs, whereas competencies related to practice, and management and leadership were relatively insufficient. These competencies were often presented in fragmented or subsidiary forms and lacked systematic alignment with curriculum objectives and assessment mechanisms. In addition, insufficient coordination between curriculum systems and training components was observed. ConclusionThe current master's training programs in sports rehabilitation exhibit a certain degree of imbalance in their competency structure. This imbalance is mainly manifested in the insufficient and unsystematic integration of practice-related competencies as well as management and leadership competencies across training objectives, curriculum design, and assessment components. RCF enables a diagnostic analysis of the alignment between training elements and competency dimensions, allowing for the clear identification of structural gaps and biases within existing training systems. Consequently, it provides an explicit reference framework for practice-oriented curriculum reconstruction and the optimization of competency-based assessment mechanisms.
9.Controllability Analysis of Structural Brain Networks in Young Smokers
Jing-Jing DING ; Fang DONG ; Hong-De WANG ; Kai YUAN ; Yong-Xin CHENG ; Juan WANG ; Yu-Xin MA ; Ting XUE ; Da-Hua YU
Progress in Biochemistry and Biophysics 2025;52(1):182-193
ObjectiveThe controllability changes of structural brain network were explored based on the control and brain network theory in young smokers, this may reveal that the controllability indicators can serve as a powerful factor to predict the sleep status in young smokers. MethodsFifty young smokers and 51 healthy controls from Inner Mongolia University of Science and Technology were enrolled. Diffusion tensor imaging (DTI) was used to construct structural brain network based on fractional anisotropy (FA) weight matrix. According to the control and brain network theory, the average controllability and the modal controllability were calculated. Two-sample t-test was used to compare the differences between the groups and Pearson correlation analysis to examine the correlation between significant average controllability and modal controllability with Fagerström Test of Nicotine Dependence (FTND) in young smokers. The nodes with the controllability score in the top 10% were selected as the super-controllers. Finally, we used BP neural network to predict the Pittsburgh Sleep Quality Index (PSQI) in young smokers. ResultsThe average controllability of dorsolateral superior frontal gyrus, supplementary motor area, lenticular nucleus putamen, and lenticular nucleus pallidum, and the modal controllability of orbital inferior frontal gyrus, supplementary motor area, gyrus rectus, and posterior cingulate gyrus in the young smokers’ group, were all significantly different from those of the healthy controls group (P<0.05). The average controllability of the right supplementary motor area (SMA.R) in the young smokers group was positively correlated with FTND (r=0.393 0, P=0.004 8), while modal controllability was negatively correlated with FTND (r=-0.330 1, P=0.019 2). ConclusionThe controllability of structural brain network in young smokers is abnormal. which may serve as an indicator to predict sleep condition. It may provide the imaging evidence for evaluating the cognitive function impairment in young smokers.
10.Network pharmacology-based mechanism of combined leech and bear bile on hepatobiliary diseases
Chen GAO ; Yu-shi GUO ; Xin-yi GUO ; Ling-zhi ZHANG ; Guo-hua YANG ; Yu-sheng YANG ; Tao MA ; Hua SUN
Acta Pharmaceutica Sinica 2025;60(1):105-116
In order to explore the possible role and molecular mechanism of the combined action of leech and bear bile in liver and gallbladder diseases, this study first used network pharmacology methods to screen the components and targets of leech and bear bile, as well as the related target genes of liver and gallbladder diseases. The selected key genes were subjected to interaction network and GO/KEGG enrichment analysis. Then, using sodium oleate induced HepG2 cell lipid deposition model and

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