ObjectiveTo establish an animal model of atrial fibrillation（AF） that accurately reflects the phlegm-heat and blood stasis（TRYZ） pathogenesis in traditional Chinese medicine. MethodsForty SPF-grade SD rats were randomly assigned using a random number table to the following groups：the control group， the TRYZ+AF group，the AF group and the TRYZ group， with ten rats in each group. The TRYZ+AF and TRYZ groups underwent a high-fat diet combined with intraperitoneal lipopolysaccharide（LPS） injection to simulate the pathological alterations of TRYZ syndrome. Groups TRYZ+AF and AF were induced with acetylcholine-calcium chloride（Ach-CaCl₂） via caudal vein injection to induce AF. The control group received no intervention and was maintained under normal conditions. The modeling period lasted 3 weeks. Electrocardiography was used to assess AF episodes and duration， echocardiography evaluated left atrial dimensions and cardiac function， fully automated biochemical analyzer measured the levels of total cholesterol（TC）， triglycerides（TG）， high-density lipoprotein cholesterol（HDL-C） and low-density lipoprotein cholesterol（LDL-C）， hemoreometer analyzed the whole blood viscosity， plasma viscosity， and whole blood reduced viscosity， a coagulation analyzer assessed prothrombin time（PT）， activated partial thromboplastin time（APTT）， thrombin time（TT）， and fibrinogen（FIB）， enzyme-linked immunosorbent assay（ELISA） was used to determine the levels of C-reactive protein（CRP）， interleukin（IL）-1β， IL-6， IL-17， tumour necrosis factor（TNF）-α， matrix metalloproteinase-9（MMP-9）， galectin-3（Gal-3）， Collagen Ⅰ， and α-smooth muscle actin（α-SMA）. Hematoxylin-eosin（HE） staining and Masson's trichrome staining were used to analyze pathological changes in atrial myocardium， Western blot was employed to detect MMP-9， Collagen Ⅰ and α-SMA protein expression in myocardial tissue， real-time quantitative polymerase chain reaction（Real-time PCR） evaluated fibrous factor gene expression levels. Changes in the TRYZ syndrome were assessed via body weight， tongue color［red（R）， green（G）， and blue（B）］， and rectal temperature. Ultra-performance liquid chromatography-quadrupole-time-of-flight mass spectrometry（UPLC-Q-TOF-MS） was employed to detect differential metabolites between the control group and the TRYZ+AF group. ResultsFollowing three weeks of sustained modeling， compared with the control group， rats in the TRYZ+AF and the TRYZ groups exhibited reduced body weight， dry faeces， elevated rectal temperature， dark red tongue， decreased RGB values on the tongue surface， and markedly elevated TC and LDL-C levels（P<0.05， P<0.01）. The TRYZ+AF， TRYZ， and AF groups exhibited significantly decreased TT， APTT and PT， along with markedly elevated whole blood viscosity and FIB（P<0.05， P<0.01）. Rats in the TRYZ+AF and AF groups exhibited AF rhythm， markedly decreased heart rate， prolonged RR intervals， enlarged left atrium， and significantly reduced ejection fraction and shortening fraction（P<0.05， P<0.01）. Serum levels of CRP， IL-1β， IL-6， IL-17， TNF-α， MMP-9， Gal-3， Collagen Ⅰ， and α-SMA were elevated in rats from the TRYZ+AF， TRYZ， and AF groups compared to the control group， with the most pronounced increase observed in the TRYZ+AF group（P<0.05， P<0.01）. Histopathology revealed that the collagen fiber deposition in the atrial of rats in the TRYZ+AF， TRYZ and AF groups was higher than that in the control group（P<0.05， P<0.01）. Western blot and Real-time PCR results further demonstrated that the protein and mRNA expression levels of MMP-9， Collagen Ⅰ and α-SMA in the myocardial tissue of the TRYZ+AF group were higher than those in the other three groups（P<0.05， P<0.01）. Metabolomic analysis revealed 173 differentially expressed metabolites in the TRYZ+AF group and the control group， primarily enriched in pathways such as glycerophospholipid metabolism and glycolysis/gluconeogenesis. ConclusionThis study successfully establishes a rat model of AF integrated with the TRYZ syndrome， demonstrating the pathological process where the interactions of phlegm， heat and stasis jointly trigger tremor， this provides a reliable experimental tool for in-depth research into the biological basis of this disease syndrome.

Radiotherapy is a crucial treatment modality for head and neck tumors. However, while effectively killing tumor cells, it significantly disrupts the homeostasis of the oral microecology, which is closely associated with various complications such as radiation-induced oral mucositis. Literature review indicates that as radiotherapy doses accumulate and treatment durations extend, the richness and diversity of the oral microbiota show a declining trend, with the genus Streptococcus decreasing most markedly. In contrast, radiotherapy selectively promotes the proliferation of bacterial phyla such as Proteobacteria and Bacteroidetes, which are rich in opportunistic pathogens. Mechanistically, radiotherapy activates the nuclear factor-kappa B pathway, triggering chronic inflammation and oxidative stress, damaging the epithelial barrier, suppressing local immunity, and causing damage to organs such as the salivary glands. It can also induce systemic diseases via the oral-gut axis, forming a multi-level, interconnected pathogenic network. In terms of interventions, treatment strategies including probiotics and prebiotics have shown promising efficacy against side effects such as radiation-induced oral mucositis. Saliva-based oral microbiota transplantation is an emerging strategy that is expected to become widely utilized for restoring oral microecological balance. Existing interventions provide preliminary pathways for clinical practice, but this field still faces several key scientific questions. The association between oral microecology and systemic diseases remains largely correlative, lacking causal evidence. Furthermore, critical parameters for oral microbiota transplantation, such as donor screening criteria, transplantation protocols, and long-term safety, are not yet well-defined. Therefore, future research should focus on conducting large-scale clinical trials to establish standardized protocols and safety evaluation systems for oral microecological interventions, and explore combined treatment therapies such as probiotics, prebiotics, and microbiota transplantation to advance the development of personalized precision modulation. These will enable more effective management of radiotherapy-induced oral microecological dysbiosis and improve treatment outcomes and quality of life for patients with head and neck tumors.

Objective To explore the distribution of clinical features and the correlation between TCM syndromes and laboratory indicators in patients with atrial fibrillation.Methods Retrospective analysis was performed on 924 patients with atrial fibrillation who were hospitalized in Xiyuan Hospital of China Academy of Chinese Medical Sciences from January 2016 to December 2023.The distribution pattern of TCM syndromes in patients with atrial fibrillation was analyzed,and the correlation between TCM syndromes and age,gender,past history,inflammatory indicators and biochemical indicators were explored.Results The study included 924 atrial fibrillation patients,predominantly female and mostly middle-aged or elderly.The main TCM syndrome types were qi-yin deficiency syndrome,qi deficiency and blood stasis syndrome,phlegm fire disturbance syndrome and phlegm blood stasis obstruction syndrome.Correlation analysis showed that patients with qi-yin deficiency syndrome had lower total protein and globulin,and the two were negatively correlated;qi deficiency and blood stasis syndrome were positively correlated with high density lipoprotein cholesterol levels;patients with phlegm fire disturbance syndrome were mostly male,younger in age and had a higher proportion of smoking history.They were negatively correlated with gender,age,and smoking history,and positively correlated with comorbidities of coronary heart disease,white blood cells,neutrophils,total protein,albumin,and globulin;patients with phlegm blood stasis obstruction syndrome were positively correlated with creatine kinase and uric acid,with statistical significance(P<0.05).Conclusion The TCM syndrome of atrial fibrillation is mainly characterized by qi-yin deficiency,and the proportion of phlegm and fire disturbance syndrome is increasing year by year.There is a correlation between the TCM syndromes of atrial fibrillation and clinical features(gender,age,past history),laboratory indicators such as inflammatory markers(WBC,NE,SII,NLR),total proteins,globulins,high density lipoprotein cholesterol,creatine kinase and uric acid,which can provide a guide to the"differentiation of disease,syndromes and body"in the diagnosis of atrial fibrillation.

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.

Objective:To summarize assessment tools for taste dysfunction in patients with head and neck cancer and provide a reference for clinical evaluation by healthcare professionals.Methods:A computer-based search was conducted in PubMed, Web of Science, Embase, CINAHL, China Biology Medicine disc, China National Knowledge Infrastructure, Wanfang Data, and VIP for literature on taste dysfunction in head and neck cancer from database inception to May 10, 2025.Results:A total of 31 articles were included: five on tool development, three on tool validation, five on cross-cultural adaptation, and 18 on tool application.A total of 16 assessment tools were identified overall: ten subjective instruments and six objective instruments. Reliability and validity were most commonly examined using internal consistency reliability and criterion-related validity.Conclusions:A wide variety of tools exist for assessing taste dysfunction in patients with head and neck cancer. Tool selection should be based on clinical context and patient characteristics. Future work should develop disease-specific, locally adapted instruments aligned with the features of head and neck cancer.

Objective:To compare the impact of the AlignRT-based optical guidance method with the traditional marker line method on the accuracy of positioning, and explore the effect of patient′s different thoracic characteristic parameters on the precision of optical guidance positioning.Methods:A total of sixty breast cancer patients who received post breast-conserving radiotherapy at Anhui Cancer Hospital from July 2022 to September 2023 were retrospectively selected. Then these patients were equally divided into traditional cross hairs set-up (marker line group) and surface-guided set-up (SGRT group). The cone-beam CT scanning results were used as the gold standard, the three-dimensional set-up errors and the CTV-PTV target area external radiotherapy boundaries of two groups were studied comparatively. Multiple patient′s thoracic characteristic parameters were defined and the correction between each parameter and set-up error of SGRT was analyzed.Results:The mean value of three-dimensional set-up errors in the SGRT group and the marker line group was within 0.2 cm and 0.5 cm, respectively. The differences in three-dimensional set-up errors and total displacements between two groups were statistically significant ( z=-2.93, -3.21, -2.59, -4.76, P<0.05). The SGRT group reduced the CTV-PTV boundary from 0.5 cm of conventional marker line group to 0.3 cm. The thoracic aspect ratio H/W, the affected side pinch angle α1, and the healthy side pinch angle α2 were positively correlated with the x-direction posing error ( r=0.49, 0.59, 0.71, P<0.05); whereas, the affected side and the healthy side mammary gland heights D1 and D2 were negatively correlated with the z-direction posing error ( r=-0.46, -0.49, P<0.05). Conclusions:For breast-conserving postoperative radiotherapy patients, SGRT can obtain a more accurate radiotherapy set-up than the traditional marker line method, and can effectively reduce the target area externally expanded range. Meanwhile, the monitoring accuracy of SGRT is affected by the patient′s thoracic characteristic parameters, and clinical attention should be paid to breast-conserving radiotherapy patients with thick body shape, narrow body width, and small breast glands.

Objective:To analyze and clarify the conceptual connotation of health behaviors in traditional Chinese medicine (TCM) .Methods:A three-phase hybrid concept analysis method was used. In the theoretical phase, a systematic literature search was conducted in China National Knowledge Infrastructure, Wanfang Data, VIP, China Biology Medicine disc, PubMed, Web of Science, ProQuest, and EBSCO, covering publications up to April 30, 2024. In the fieldwork study, using the purposive sampling method, 8 community residents, 2 family members of residents, and 2 community workers were selected from Wuhan, Yichang, Neijiang, Zigong, Taiyuan, and Dongguan for semi-structured interviews from December 2023 to April 2024. In the analytical, data were compared and integrated.Results:TCM health behaviors are defined as multidimensional and multi-stage actions guided by TCM theories and techniques, aimed at preventing, maintaining, or promoting physical, mental, social, and moral well-being of oneself and others. A total of 8 core attributes were identified: acupoint-based health preservation, diet and herbal maintenance, daily routine regulation, exercise and qigong practice, emotional cultivation, simple lifestyle adjustments, utilization of TCM health resources, and participation in TCM health-related decision-making. Antecedents involve individual, social, environmental, and TCM-specific factors, while consequences include self-health promotion, support of others' well-being, and the dissemination of TCM culture.Conclusions:This study clarified the conceptual structure of TCM health behaviors. The findings can inform the development of localized assessment tools and intervention strategies, thereby supporting clinical nursing practice.

Objective:To compare the impact of the AlignRT-based optical guidance method with the traditional marker line method on the accuracy of positioning, and explore the effect of patient′s different thoracic characteristic parameters on the precision of optical guidance positioning.Methods:A total of sixty breast cancer patients who received post breast-conserving radiotherapy at Anhui Cancer Hospital from July 2022 to September 2023 were retrospectively selected. Then these patients were equally divided into traditional cross hairs set-up (marker line group) and surface-guided set-up (SGRT group). The cone-beam CT scanning results were used as the gold standard, the three-dimensional set-up errors and the CTV-PTV target area external radiotherapy boundaries of two groups were studied comparatively. Multiple patient′s thoracic characteristic parameters were defined and the correction between each parameter and set-up error of SGRT was analyzed.Results:The mean value of three-dimensional set-up errors in the SGRT group and the marker line group was within 0.2 cm and 0.5 cm, respectively. The differences in three-dimensional set-up errors and total displacements between two groups were statistically significant ( z=-2.93, -3.21, -2.59, -4.76, P<0.05). The SGRT group reduced the CTV-PTV boundary from 0.5 cm of conventional marker line group to 0.3 cm. The thoracic aspect ratio H/W, the affected side pinch angle α1, and the healthy side pinch angle α2 were positively correlated with the x-direction posing error ( r=0.49, 0.59, 0.71, P<0.05); whereas, the affected side and the healthy side mammary gland heights D1 and D2 were negatively correlated with the z-direction posing error ( r=-0.46, -0.49, P<0.05). Conclusions:For breast-conserving postoperative radiotherapy patients, SGRT can obtain a more accurate radiotherapy set-up than the traditional marker line method, and can effectively reduce the target area externally expanded range. Meanwhile, the monitoring accuracy of SGRT is affected by the patient′s thoracic characteristic parameters, and clinical attention should be paid to breast-conserving radiotherapy patients with thick body shape, narrow body width, and small breast glands.

Objective To evaluate the clinical efficacy of a novel sleep-aid decoction in treating elderly insomnia patients with different traditional Chinese medicine (TCM) constitutional types, and its effects on neurotransmitter and inflammatory factor levels. Methods A total of 200 patients with four different TCM constitutions-peaceful, Qi-deficient, Yin-deficient, and Yang-deficient-were recruited. Peripheral blood neurotransmitter and inflammatory factor levels were measured for variations among insomnia patients across different constitutions. These patients were treated using the novel sleep-aid decoction, the effects of which were evaluated based on changes in neurotransmitters and inflammatory factors. Results Compared to the peaceful constitution group, insomnia patients with Qi-deficient, Yin-deficient, and Yang-deficient constitutions exhibited significantly elevated baseline levels of neurotransmitters (5-HT, GABA) and inflammatory factors (IL-6, TNF-α, IL-1β, CRP). Following the treatment, the Qi-deficient and Yin-deficient groups showed a marked increase in 5-HT levels, restored balance of Glu, GABA, and melatonin, and significant reductions in IL-6 and TNF-α levels. The overall effective rate was 83.5%, with optimal efficacy observed in the Qi-deficient (97.72%) and Yin-deficient (95.34%) groups. Conclusion The novel sleep-aid decoction is effective in treating insomnia in elderly patients, with the best results observed in the Qi-deficient and Yin-deficient constitution groups.
Humans ; Sleep Initiation and Maintenance Disorders/blood* ; Aged ; Male ; Female ; Drugs, Chinese Herbal/therapeutic use* ; Medicine, Chinese Traditional ; Middle Aged ; Tumor Necrosis Factor-alpha/blood* ; Sleep Aids, Pharmaceutical/therapeutic use* ; Anti-Inflammatory Agents/therapeutic use* ; Interleukin-6/blood* ; Interleukin-1beta/blood* ; Neurotransmitter Agents/blood* ; Aged, 80 and over ; C-Reactive Protein/metabolism*

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.