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 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.

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.

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.

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.

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.

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.

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.

Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Male ; Double-Blind Method ; Drugs, Chinese Herbal/therapeutic use* ; Tic Disorders/drug therapy* ; Treatment Outcome

OBJECTIVE: To investigate the clinical features and prognosis of central nervous system (CNS) invasion in peripheral T-cell lymphoma (PTCL) and construct a risk prediction model for CNS invasion. METHODS: Clinical data of 395 patients with PTCL diagnosed and treated in the First Affiliated Hospital of Zhengzhou University from 1st January 2013 to 31st December 2022 were analyzed retrospectively. RESULTS: The median follow-up time of 395 PTCL patients was 24(1-143) months. There were 13 patients diagnosed CNS invasion, and the incidence was 3.3%. The risk of CNS invasion varied according to pathological subtype. The incidence of CNS invasion in patients with anaplastic large cell lymphoma (ALCL) was significantly higher than in patients with angioimmunoblastic T-cell lymphoma (AITL) (P <0.05). The median overall survival was significantly shorter in patients with CNS invasion than in those without CNS involvement, with a median survival time of 2.4(0.6-127) months after diagnosis of CNS invasion. The results of univariate and multivariate analysis showed that more than 1 extranodal involvement (HR=4.486, 95%CI : 1.166-17.264, P =0.029), ALCL subtype (HR=9.022, 95%CI : 2.289-35.557, P =0.002) and ECOG PS >1 (HR=15.890, 95%CI : 4.409-57.262, P <0.001) were independent risk factors for CNS invasion in PTCL patients. Each of these risk factors was assigned a value of 1 point and a new prediction model was constructed. It could stratify the patients into three distinct groups: low-risk group (0-1 point), intermediate-risk group (2 points) and high-risk group (3 points). The 1-year cumulative incidence of CNS invasion in the high-risk group was as high as 50.0%. Further evaluation of the model showed good discrimination and accuracy, and the consistency index was 0.913 (95%CI : 0.843-0.984). CONCLUSION The new model shows a precise risk assessment for CNS invasion prediction, while its specificity and sensitivity need further data validation.
Humans ; Lymphoma, T-Cell, Peripheral/pathology* ; Prognosis ; Retrospective Studies ; Central Nervous System Neoplasms/pathology* ; Neoplasm Invasiveness ; Male ; Female ; Central Nervous System/pathology* ; Middle Aged ; Adult