The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

Objective:To explore the impact of lifestyle on TCM constitutions among female medical workers at Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine using questionnaires; To provide references for optimizing their health management.Methods:A cross-sectional study was conducted. A total of 500 female medical workers were randomly selected from Xiyuan Hospital from April to December 2022 to complete the questionnaires. The relationship between lifestyle and constitutions of female medical workers was analyzed.Results:A total of 457 cases completed the questionnaires. Among the 9 constitutions, 102 people (22.32%) had a peaceful constitution, while 355 people (77.68%) had a biased constitution; the top three biased constitutions were qi stagnation constitution 90 people (19.69%), yang deficiency constitution 83 people (18.16%), and phlegm-dampness constitution 56 people (12.25%). The factors that influenced physical constitutions according to the severity of lifestyle were: sleep, diet, mood, exercise, labor, environment, children, and education.Conclusions:Female medical workers have a high proportion of biased constitution, and the main types of biased constitution are qi stagnation constitution, yang deficiency constitution, and phlegm-dampness constitution. According to the existing biased constitution, targeted adjustments and interventions are carried out, and it is of great significance to protect and care for the health of female medical workers from the concept of preventive treatment of diseases with TCM.

Objective:To analyze the current status of the research in two emerging fields-digital health and digital medicine,and the distinctions and interconnections between them,and to explore critical cognitionfor benign development of this field.Methods:Based on bibliometric method,this study analyzed 1 747 papers published in two Q1 journals categorized under"medical informatics"in Chinese Academy of Sciences Journal Citation Reports between January 1st,2019,and June 30th,2024.A biclustering analysis of highly cited and source article was conducted using a"co-cited literature clustering and all articles citing this cluster"approach.Results:In 1 747 literature,a total of 28 classic high cited articles in digital medicinejournals and digital health journals were screened out afterthe literatures of irrelevant citations were deleted,and then,they were further analyzed.The clustering performancesof similar clusters for high cited articles of two kinds of journals were similar,and the difference of intra-cluster similarity(Isim)between them was not statistically significant(P>0.05).The inter-cluster similarity(Esim)of digital health journal was 0.0480,which was significantly higher than that of digital health journal,and the difference of that between them wasstatistically significant(t=-3.925,P<0.05).The clustering result of digital medicine was better,which whole research direction could be divided into deep learning-based ophthalmic medical image analysis,image recognition with artificial intelligence(AI),algorithm model of using AI,reporting standard and assessment method of digital medicine and scientific research by using AI.However,the contents of high cited literatures of digital health field had a lot of overlap with digital medicine field,and various clusters of literature have inconsistent themesafter these literatures were clustered.Conclusions:Research of digital medicine is tending towards two primary directions:specific application of AI,and theimprovement of digital medical standards and processes.Meanwhile,the articles and literatures with high quality in digital health still cannot divorce the medical field,and the discipline system still is immature.

Strengthening ideological and political work is crucial for promoting the high-quality development of public hospitals.From the perspective of the 5W theory of communication,this paper deconstructs and analyzes the five key elements within the ideological and political work of public hospitals:the communicator,the message,the channel,the audience,and the effect.It identifies existing challenges,including the multiple roles of communicators,a disconnect between message content and context,the overwhelming volume of information through numerous channels,the heightened subjective consciousness of the audi-ence,and a lack of feedback mechanisms for assessing effectiveness.The causes of these challenges are analyzed.Corresponding strategies are proposed,such as introducing multi-agent collaboration,strengthening the integration of Party building with profes-sional services,consolidating platform development,enhancing emotional communication,and establishing feedback agendas.These measures aim to improve the effectiveness and pertinence of ideological and political education in public hospitals,thereby advancing their high-quality development.

OBJECTIVE To investigate the mechanism of inhibition of breast cancer lung metastasis by Shugan Yishen Recipe by studying the effects of Shugan Yishen Recipe(SGYSR)on gene expression in the lung microenvironment of mice with breast cancer.METHODS A high metastasis model of breast cancer was constructed,and the mice were randomly divided into saline group,low,medium,high(0.5,1,2 g·kg-1)Shugan Yishen Recipe groups,and docetaxel group(5 mg·kg-1),and intervened for 28 days.HE staining was used to observe the lung tissue structure;transcriptome analysis was performed on the metastatic foci,and the key differential gene expression was screened by bioinformatics analysis of the GO and KEGG pathway characteristics of the gene ex-pression profiles,and the expression of key immune genes was analyzed by qPCR and Western blot.The expression of MDSCs was de-tected by flow cytometry;the expression of cytokines and chemokines including Cxcl2,and GM-CSF was detected by ELISA.RE-SULTS Compared with the saline group,the number of metastatic nodules in lung tissues of the middle and high dose groups of Shu-gan Yishen Recipe and docetaxel group were correspondingly lower;HE staining suggested that the degree of lung pathology was im-proved.There were 814 differentially expressed genes in the lung microenvironment of the high-dose group of Shugan Yishen Recipe and the saline group,of which 713 genes were down-regulated and 101 genes were up-regulated;screening for key inflammatory medi-ator genes in the Shugan Yishen Recipe group,Nfkbiz,Tnfaip3,Maff,Hspa1a,Hspb1 and Cxcl2,the inflammatory genes in the Shu-gan Yishen Recipe,as compared with that of the saline group,were significantly down-regulated(P<0.05,P<0.01),and ultimately its results were consistent with the trend of the transcriptome results.Western blot was used to verify the results at the protein level,and it was found that compared with the saline group,the protein expression levels of Nfkbiz,Tnfaip3,Maff,Hspa1a and Cxcl2 in the Shugan Yishen Recipe group were decreased(P<0.05,P<0.01),while the protein expression of Hspb1 was up-regulated(P<0.01).Both the Shugan Yishen Recipe group and the docetaxel group could inhibit the expression of MDSCs(P<0.001),and the ex-pression of Cxcl2,and GM-CSF decreased to a certain extent(P<0.05,P<0.01).CONCLUSION Shugan Yishen Recipe can in-hibit breast cancer lung metastasis and regulate the lung immune microenvironment genes in a wide range.

Objective To establish and evaluate a mouse model of acute myocardial infarction(AMI)with coronary heart disease(CHD)that integrates syndrome differentiation with disease diagnosis,based on the"deficiency-stagnation-toxicity"pathogenesis.Methods Forty-eight ICR mice were randomly divided into four groups using a random number table:sham-operated,normal diet,high-choline,and trimethylamine N-oxide(TMAO).From weeks 1 to 8,each group received corresponding dietary and water interventions.From the 9th week,the normal diet,high-choline,and TMAO groups underwent coronary artery ligation(left anterior descending artery,LAD).In contrast,the sham-operated group only had suture placement without ligation,maintaining the same dietary and water interventions.Data on general signs,body weight,food and water intake,urine and feces,auricle and paw conditions,and behavioral patterns were collected and compared macroscopically and microscopically to determine the syndrome type of the high-choline-induced AMI mouse model and observe changes in the"deficiency-stagnation-toxicity"syndrome indicators.After 12 weeks,echocardiography,hematoxylin-eosin(HE)staining,and Masson′s trichrome staining were used to assess cardiac function,myocardial tissue cellular morphology changes,and myocardial fibrosis levels,respectively.The stability and reliability of the model were evaluated by observing the fluorescence intensity of inflammatory cytokines in the myocardial tissues of each group using immunofluorescence.Results Mice in all groups post-AMI surgery exhibited significant weight loss,dull fur,lethargy,and reduced activity.Mice in the high-choline and TMAO groups showed more sluggish responses to stimuli.The high-choline and TMAO groups displayed increased food intake but slow weight gain from weeks 1 to 4,developing into a trend of"increased food and water intake with weight loss"from 5 to 8 weeks,accompanied by yellowish urine and dry stools(P<0.01).Postoperatively(9-12 weeks),body weight significantly decreased,with the most prominent weight loss observed in the high-choline group.The high-choline and TMAO groups exhibited abnormal RGB values in auricles and paws(P<0.01),and behavioral tests showed a significant decline in open-field activity(P<0.01).Cardiac function and pathological examinations revealed that,compared with the sham-operated and normal diet groups,mice in the high-choline and TMAO groups had increased left ventricular end-diastolic and end-systolic volumes(P<0.01),decreased left ventricular ejection fraction and fractional shortening(P<0.01),and elevated heart indices(P<0.05).HE staining of myocardial tissues indicated more pyknotic nuclei and inflammatory cell infiltration in the high-choline and TMAO groups.Masson′s trichrome staining showed extensive blue-stained collagen fiber distribution in the infarct border zones of the high-choline and TMAO groups,with aggravated fibrosis(P<0.05).Immunofluorescence revealed elevated interleukin-1 beta and tumor necrosis factor-alpha levels in the high-choline and TMAO groups compared with the sham-operated and normal diet groups(P<0.01).Conclusion A high-choline diet combined with LAD ligation successfully established an animal model of AMI with CHD that integrates syndrome differentiation with disease diagnosis,based on the"deficiency-stagnation-toxicity"pathogenesis.This model not only embodies the traditional Chinese medicine theory′s understanding of the pathogenic features of"deficiency-stagnation-toxicity",but also serves as a reference for assessing the interventional effects of Chinese herbal compound prescriptions and facilitating research on syndrome patterns in traditional Chinese medicine.

OBJECTIVE To investigate the mechanism of inhibition of breast cancer lung metastasis by Shugan Yishen Recipe by studying the effects of Shugan Yishen Recipe(SGYSR)on gene expression in the lung microenvironment of mice with breast cancer.METHODS A high metastasis model of breast cancer was constructed,and the mice were randomly divided into saline group,low,medium,high(0.5,1,2 g·kg-1)Shugan Yishen Recipe groups,and docetaxel group(5 mg·kg-1),and intervened for 28 days.HE staining was used to observe the lung tissue structure;transcriptome analysis was performed on the metastatic foci,and the key differential gene expression was screened by bioinformatics analysis of the GO and KEGG pathway characteristics of the gene ex-pression profiles,and the expression of key immune genes was analyzed by qPCR and Western blot.The expression of MDSCs was de-tected by flow cytometry;the expression of cytokines and chemokines including Cxcl2,and GM-CSF was detected by ELISA.RE-SULTS Compared with the saline group,the number of metastatic nodules in lung tissues of the middle and high dose groups of Shu-gan Yishen Recipe and docetaxel group were correspondingly lower;HE staining suggested that the degree of lung pathology was im-proved.There were 814 differentially expressed genes in the lung microenvironment of the high-dose group of Shugan Yishen Recipe and the saline group,of which 713 genes were down-regulated and 101 genes were up-regulated;screening for key inflammatory medi-ator genes in the Shugan Yishen Recipe group,Nfkbiz,Tnfaip3,Maff,Hspa1a,Hspb1 and Cxcl2,the inflammatory genes in the Shu-gan Yishen Recipe,as compared with that of the saline group,were significantly down-regulated(P<0.05,P<0.01),and ultimately its results were consistent with the trend of the transcriptome results.Western blot was used to verify the results at the protein level,and it was found that compared with the saline group,the protein expression levels of Nfkbiz,Tnfaip3,Maff,Hspa1a and Cxcl2 in the Shugan Yishen Recipe group were decreased(P<0.05,P<0.01),while the protein expression of Hspb1 was up-regulated(P<0.01).Both the Shugan Yishen Recipe group and the docetaxel group could inhibit the expression of MDSCs(P<0.001),and the ex-pression of Cxcl2,and GM-CSF decreased to a certain extent(P<0.05,P<0.01).CONCLUSION Shugan Yishen Recipe can in-hibit breast cancer lung metastasis and regulate the lung immune microenvironment genes in a wide range.

Objective To establish and evaluate a mouse model of acute myocardial infarction(AMI)with coronary heart disease(CHD)that integrates syndrome differentiation with disease diagnosis,based on the"deficiency-stagnation-toxicity"pathogenesis.Methods Forty-eight ICR mice were randomly divided into four groups using a random number table:sham-operated,normal diet,high-choline,and trimethylamine N-oxide(TMAO).From weeks 1 to 8,each group received corresponding dietary and water interventions.From the 9th week,the normal diet,high-choline,and TMAO groups underwent coronary artery ligation(left anterior descending artery,LAD).In contrast,the sham-operated group only had suture placement without ligation,maintaining the same dietary and water interventions.Data on general signs,body weight,food and water intake,urine and feces,auricle and paw conditions,and behavioral patterns were collected and compared macroscopically and microscopically to determine the syndrome type of the high-choline-induced AMI mouse model and observe changes in the"deficiency-stagnation-toxicity"syndrome indicators.After 12 weeks,echocardiography,hematoxylin-eosin(HE)staining,and Masson′s trichrome staining were used to assess cardiac function,myocardial tissue cellular morphology changes,and myocardial fibrosis levels,respectively.The stability and reliability of the model were evaluated by observing the fluorescence intensity of inflammatory cytokines in the myocardial tissues of each group using immunofluorescence.Results Mice in all groups post-AMI surgery exhibited significant weight loss,dull fur,lethargy,and reduced activity.Mice in the high-choline and TMAO groups showed more sluggish responses to stimuli.The high-choline and TMAO groups displayed increased food intake but slow weight gain from weeks 1 to 4,developing into a trend of"increased food and water intake with weight loss"from 5 to 8 weeks,accompanied by yellowish urine and dry stools(P<0.01).Postoperatively(9-12 weeks),body weight significantly decreased,with the most prominent weight loss observed in the high-choline group.The high-choline and TMAO groups exhibited abnormal RGB values in auricles and paws(P<0.01),and behavioral tests showed a significant decline in open-field activity(P<0.01).Cardiac function and pathological examinations revealed that,compared with the sham-operated and normal diet groups,mice in the high-choline and TMAO groups had increased left ventricular end-diastolic and end-systolic volumes(P<0.01),decreased left ventricular ejection fraction and fractional shortening(P<0.01),and elevated heart indices(P<0.05).HE staining of myocardial tissues indicated more pyknotic nuclei and inflammatory cell infiltration in the high-choline and TMAO groups.Masson′s trichrome staining showed extensive blue-stained collagen fiber distribution in the infarct border zones of the high-choline and TMAO groups,with aggravated fibrosis(P<0.05).Immunofluorescence revealed elevated interleukin-1 beta and tumor necrosis factor-alpha levels in the high-choline and TMAO groups compared with the sham-operated and normal diet groups(P<0.01).Conclusion A high-choline diet combined with LAD ligation successfully established an animal model of AMI with CHD that integrates syndrome differentiation with disease diagnosis,based on the"deficiency-stagnation-toxicity"pathogenesis.This model not only embodies the traditional Chinese medicine theory′s understanding of the pathogenic features of"deficiency-stagnation-toxicity",but also serves as a reference for assessing the interventional effects of Chinese herbal compound prescriptions and facilitating research on syndrome patterns in traditional Chinese medicine.

Strengthening ideological and political work is crucial for promoting the high-quality development of public hospitals.From the perspective of the 5W theory of communication,this paper deconstructs and analyzes the five key elements within the ideological and political work of public hospitals:the communicator,the message,the channel,the audience,and the effect.It identifies existing challenges,including the multiple roles of communicators,a disconnect between message content and context,the overwhelming volume of information through numerous channels,the heightened subjective consciousness of the audi-ence,and a lack of feedback mechanisms for assessing effectiveness.The causes of these challenges are analyzed.Corresponding strategies are proposed,such as introducing multi-agent collaboration,strengthening the integration of Party building with profes-sional services,consolidating platform development,enhancing emotional communication,and establishing feedback agendas.These measures aim to improve the effectiveness and pertinence of ideological and political education in public hospitals,thereby advancing their high-quality development.

Objective To explore the influencing factors of immune-associated thyroid dysfunction caused by sintilimab treatment in solid tumors and construct a prediction model.Methods Medical records of patients diagnosed with solid tumors and treated with sintilimab at Peking University People's Hospital(Xizhimen Campus,Tongzhou Campus,Shijiazhuang Campus)from January 2023 to September 2024 were collected to explore the influencing factors that caused immune-related thyroid dysfunction using univariate and multifactorial binary logistic regression analyses and to establish a prediction model.The predictive effect of the model was assessed using the receiver operating characteristic(ROC)curve.Results A total of 120 patients were included,and 33 presented with immune-related thyroid dysfunction.Multifactorial logistic regression analysis revealed that thyroid-stimulating hormone(TSH)[OR=2.470,95%CI=(1.279,4.771)]and treatment cycles[OR=1.298,95%CI=(1.117,1.509)]were independent risk factors for the occurrence of immune-associated thyroid dysfunction,and the difference was statistically significant(P＜0.05).The area under the ROC curve was(0.897±0.043)[95%CI=(0.813,0.981)],the Yoden index was 0.703,and the model prediction accuracy was 86.5%.Conclusion The risk of immune-related thyroid dysfunction caused by sintilimab is high,and TSH and treatment cycle are the influencing factors,and the constructed model has certain predictive value and is of reference significance.