1.Ethical considerations in the application of artificial intelligence health monitoring devices
Ruyi HOU ; Tingyu DUAN ; Miao HE
Chinese Medical Ethics 2025;38(9):1191-1198
Artificial intelligence (AI) health monitoring devices use AI technology and non-invasive sensors to collect individual data, compare it with big data, and provide real-time monitoring and data analysis of users’ physiological and psychological health, so as to provide personalized health recommendations and health risk warnings. AI health monitoring devices greatly enhance individuals’ self-health management abilities and improve their quality of life through round-the-clock uninterrupted monitoring and tracking. However, they also harbor a series of ethical risks, such as user privacy breaches, the digitization of physical sensations, and potential impacts on human subjectivity. Therefore, under the guidance of the principles of privacy and data protection, inclusiveness and fairness, transparency, and explainability, relevant departments should protect personal privacy with perfect laws and regulations, reduce algorithmic bias, ensure disclosure and transparency to promote user understanding, while adhering to the people-oriented principle approach and conducting responsible research and development of interpretable algorithm models for AI health monitoring devices.
2.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
3.The interval of rescue treatment does not affect the efficacy and safety of Helicobacter pylori eradication: A prospective multicenter observational study.
Minjuan LIN ; Junnan HU ; Jing LIU ; Juan WANG ; Zhongxue HAN ; Xiaohong WANG ; Zhenzhen ZHAI ; Yanan YU ; Wenjie YUAN ; Wen ZHANG ; Zhi WANG ; Qingzhou KONG ; Boshen LIN ; Yuming DING ; Meng WAN ; Wenlin ZHANG ; Miao DUAN ; Shuyan ZENG ; Yueyue LI ; Xiuli ZUO ; Yanqing LI
Chinese Medical Journal 2025;138(12):1439-1446
BACKGROUND:
The effect of the interval between previous Helicobacter pylori (H. pylori) eradication and rescue treatment on therapeutic outcomes remains unknown. The aim of this study was to investigate the association between eradication rates and treatment interval durations in H. pylori infections.
METHODS:
This prospective observational study was conducted from December 2021 to February 2023 at six tertiary hospitals in Shandong, China. We recruited patients who were positive for H. pylori infection and required rescue treatment. Demographic information, previous times of eradication therapy, last eradication therapy date, and history of antibiotic use data were collected. The patients were divided into four groups based on the rescue treatment interval length: Group A, ≥4 weeks and ≤3 months; Group B, >3 and ≤6 months; Group C, >6 and ≤12 months; and Group D, >12 months. The primary outcome was the eradication rate of H. pylori . Drug compliance and adverse events (AEs) were also assessed. Pearson's χ2 test or Fisher's exact test was used to compare eradication rates between groups.
RESULTS:
A total of 670 patients were enrolled in this study. The intention-to-treat (ITT) eradication rates were 88.3% (158/179) in Group A, 89.6% (120/134) in Group B, 89.1% (123/138) in Group C, and 87.7% (192/219) in Group D. The per-protocol (PP) eradication rates were 92.9% (156/168) in Group A, 94.5% (120/127) in Group B, 94.5% (121/128) in Group C, and 93.6% (190/203) in Group D. There was no statistically significant difference in the eradication rates between groups in either the ITT ( P = 0.949) or PP analysis ( P = 0.921). No significant differences were observed in the incidence of AEs ( P = 0.934) or drug compliance ( P = 0.849) between groups.
CONCLUSION:
The interval duration of rescue treatment had no significant effect on H. pylori eradication rates or the incidence of AEs.
REGISTRATION
ClinicalTrials.gov , NCT05173493.
Humans
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Helicobacter Infections/drug therapy*
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Helicobacter pylori/pathogenicity*
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Male
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Female
;
Prospective Studies
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Middle Aged
;
Anti-Bacterial Agents/adverse effects*
;
Adult
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Aged
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Treatment Outcome
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Proton Pump Inhibitors/therapeutic use*
4.The systemic inflammatory response index as a risk factor for all-cause and cardiovascular mortality among individuals with coronary artery disease: evidence from the cohort study of NHANES 1999-2018.
Dao-Shen LIU ; Dan LIU ; Hai-Xu SONG ; Jing LI ; Miao-Han QIU ; Chao-Qun MA ; Xue-Fei MU ; Shang-Xun ZHOU ; Yi-Xuan DUAN ; Yu-Ying LI ; Yi LI ; Ya-Ling HAN
Journal of Geriatric Cardiology 2025;22(7):668-677
BACKGROUND:
The association of systemic inflammatory response index (SIRI) with prognosis of coronary artery disease (CAD) patients has never been investigated in a large sample with long-term follow-up. This study aimed to explore the association of SIRI with all-cause and cause-specific mortality in a nationally representative sample of CAD patients from United States.
METHODS:
A total of 3386 participants with CAD from the National Health and Nutrition Examination Survey (NHANES) 1999-2018 were included in this study. Cox proportional hazards model, restricted cubic spline (RCS), and receiver operating characteristic curve (ROC) were performed to investigate the association of SIRI with all-cause and cause-specific mortality. Piece-wise linear regression and sensitivity analyses were also performed.
RESULTS:
During a median follow-up of 7.7 years, 1454 all-cause mortality occurred. After adjusting for confounding factors, higher lnSIRI was significantly associated with higher risk of all-cause (HR = 1.16, 95% CI: 1.09-1.23) and CVD mortality (HR = 1.17, 95% CI: 1.05-1.30) but not cancer mortality (HR = 1.17, 95% CI: 0.99-1.38). The associations of SIRI with all-cause and CVD mortality were detected as J-shaped with threshold values of 1.05935 and 1.122946 for SIRI, respectively. ROC curves showed that lnSIRI had robust predictive effect both in short and long terms.
CONCLUSIONS
SIRI was independently associated with all-cause and CVD mortality, and the dose-response relationship was J-shaped. SIRI might serve as a valid predictor for all-cause and CVD mortality both in the short and long terms.
5.Mechanism and Application of Chinese Herb Medicine in Treatment of Peripheral Nerve Injury.
Yu-Qing CHEN ; Yan-Xian ZHANG ; Xu ZHANG ; Yong-Mei LYU ; Zeng-Li MIAO ; Xiao-Yu LIU ; Xu-Chu DUAN
Chinese journal of integrative medicine 2025;31(3):270-280
Peripheral nerve injury (PNI) encompasses damage to nerves located outside the central nervous system, adversely affecting both motor and sensory functions. Although peripheral nerves possess an intrinsic capacity for self-repair, severe injuries frequently result in significant tissue loss and erroneous axonal junctions, thereby impeding complete recovery and potentially causing neuropathic pain. Various therapeutic strategies, including surgical interventions, biomaterials, and pharmacological agents, have been developed to enhance nerve repair processes. While preclinical studies in animal models have demonstrated the efficacy of certain pharmacological agents in promoting nerve regeneration and mitigating inflammation, only a limited number of these agents have been translated into clinical practice to expedite nerve regeneration. Chinese herb medicine (CHM) possesses a longstanding history in the treatment of various ailments and demonstrates potential efficacy in addressing PNI through its distinctive, cost-effective, and multifaceted methodologies. This review critically examines the advancements in the application of CHM for PNI treatment and nerve regeneration. In particular, we have summarized the most commonly employed and rigorously investigated CHM prescriptions, individual herbs, and natural products, elucidating their respective functions and underlying mechanisms in the context of PNI treatment. Furthermore, we have deliberated on the prospective development of CHM in both clinical practice and fundamental research.
Drugs, Chinese Herbal/pharmacology*
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Humans
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Peripheral Nerve Injuries/drug therapy*
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Animals
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Nerve Regeneration/drug effects*
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Medicine, Chinese Traditional
6.Exploration of the driving mechanisms for the downward flow of high-quality medical resources in loose medical alliances:A qualitative comparative analysis from the perspective of Micro-cooperation theory
Jun CHEN ; Jia-Miao NIU ; Ze-Yu YI ; Hui DUAN
Chinese Journal of Health Policy 2024;17(8):50-57
Objective:To explore and stimulate the pathway mechanism for doctors from core hospitals,which are the high-quality medical resources in loose medical alliances,to sink to the grassroots level on their own initiative and continue to participate in the co-operation,so as to provide useful references for improving the effectiveness of cooperation within medical alliances.Methods:The fuzzy set Qualitative Comparative Analysis(fsQCA)method was used to investigate 205 doctors in the core hospitals of a loose medical alliance in District X of City B.This investigation was grounded in relationship commitment theory,motivation theory,social exchange theory,and cooperation reinforcement theory.Results:The level of relationship commitment of doctors in the core hospitals to proactively participate in cooperation was influenced by multiple factors,including doctors'perception of job significance,opportunity cost perception,organizational support,and teamwork experience.This resulted in the formation of three concurrent driving mechanism pathways:merger-driven effect,experience-enhancing effect,and altruistic trigger effect.Among these factors,the perception of work significance was a necessary condition,and cooperative experience played an important role in doctors'continuous participation.Conclusion:The level of relational commitment of doctors to participate in cooperative efforts is driven by a combination of various factors,with different incentive mechanisms exhibiting heterogeneity within loose medical alliances.Designing appropriate incentive and support strategies tailored to specific contexts can effectively drive the proactive downward flow of high-quality medical resources from core hospitals within loose medical alliances.
7.Impact of δ-catenin expression level on resting-state brain function in breast cancer patients
Mingtuan XUE ; Wei DU ; Jiajun CAO ; Yuhan JIANG ; Duan SONG ; Junyi ZHANG ; Yanwei MIAO
Chinese Journal of Medical Imaging Technology 2024;40(5):724-729
Objective To explore the impact of δ-catenin expression level on resting-state brain function in breast cancer patients.Methods Totally 104 female breast cancer patients were prospectively enrolled and divided into δ-catenin high expression group(DH group,n=51)and δ-catenin low expression group(DL group,n=53)according to δ-catenin expression level,while 36 female healthy volunteers were selected as controls(control group).Neuropsychological tests were performed,and resting-state functional MRI(rs-fMRI)were acquired,then parameters of brain function,including amplitude of low frequency fluctuation(ALFF),fractional ALFF(fALFF),regional homogeneity(ReHo)and functional connectivity strength(FCS)of brain regions with differences among groups were obtained.Spearman correlation analysis was used to evaluate the correlations of function parameters of brain regions with general data and neuropsychological test scores.Results Significant differences of fALFF,ReHo and FCS values were found among 3 groups(familywise error rate[FWE]correction,all P<0.05).fALFF value of left inferior temporal gyrus in DH and DL groups were both higher than that in control group(FWE correction,both P<0.05),ReHo value of right inferior temporal gyrus in DH group,as well as of right middle temporal gyrus,right inferior temporal gyrus and right fusiform gyrus in DL group were all lower than that in control group(FWE correction,all P<0.05),FSC value of left lenticular nucleus,left putamen,left fusiform gyrus,left calcarine fissure surrounding cortex and left inferior temporal gyrus in DH group were all higher than that in DL group(FWE correction,all P<0.05),FSC value of left lenticular nucleus,left putamen,left fusiform gyrus and left calcarine fissure surrounding cortex in DH group were all higher than that in control group(FWE correction,all P<0.05),while FSC value of left lingual gyrus,left lenticular nucleus and left putamen were both higher than that in control group(FWE correction,both P<0.05).In brain regions with different fMRI indexes between DH group and DL group,FSC values were lowly positively correlated with CogPCA results(r=0.313,P<0.05).In brain regions with different fMRI indexes between DH group and control group,fALFF value were lowly positively correlated with trail making test A(TMT A)and trail making test B(TMT B)(r=0.301,0.310,both P<0.05),ReHo values were lowly negatively correlated with TMT B(r=-0.307,P<0.05),FCS values were weakly/lowly positively correlated with TMT A and TMT B(r=0.282,0.309,both P<0.05)and lowly negatively correlated with results of digital symbol substitution test(DSST)(r=-0.363,P<0.05).In brain regions with different fMRI indexes between DL group and control group,fALFF values were weakly/lowly negatively correlated with results of mini mental state examination(MMSE),Montreal cognitive assessment(MoCA),auditory verbal learning test(AVLT)short-term memory and DSST(r=-0.399,-0.362,-0.344,-0.288,all P<0.05).Conclusion The expression level of δ-catenin had certain impact on brain function of breast cancer patients,resulted in asymmetry changes of brain network in bilateral hemispheres,as well as memory loss through affecting left inferior temporal gyrus,left lenticular nucleus,left putamen and left fusiform gyrus.
8.Feasibility study of the post process of CTA on head and neck based on AI deep learning on stenosis assessment
Miao DUAN ; Lianjun YANG ; Zechun GUO ; Yan ZHANG ; Jialin CHEN ; Feng WANG ; Li ZHANG
China Medical Equipment 2024;21(10):51-55
Objective:To explore the feasibility of the post process of computed tomography angiography(CTA)on head and neck based on artificial intelligence(AI)deep learning on stenosis assessment.Methods:A total of 108 patients who underwent CTA on head and neck at Shunyi Hospital of Beijing Traditional Chinese Medicine Hospital from January 2022 to June 2023 were selected,and they were divided into an AI group(54 cases)and a manual group(54 cases)based on different diagnostic methods.Dual source CT was used to conduct examination,and data was transmitted to"Shenrui Dr.Wise Head and Neck CTA Intelligent Assistance System"and"Siemens Syngo View Post Process Workstation".The image evaluation was conducted on a 5-point scale.The time-consuming of post process and diagnosis of CTA images of the artery of head and neck between two groups were observed and compared,and the quality of CTA images of the artery of head and neck,and the diagnostic results of the degree of the artery stenosis of head and neck also were observed and compared between two groups.Results:The differences of the time-consuming of post process of images and the time-consuming of diagnosis between two groups were all statistically significant(t=52.315,24.509,P<0.05),respectively.The intra-group correlation coefficient(ICC)of each branch of the artery of head and neck was 0.996 between two physicians.In AI group,the score of common carotid artery was(4.77±0.12),and the score of internal carotid artery was(4.56±0.13),and the score of vertebral artery was(4.55±0.16),and the score of middle cerebral artery was(4.78±0.16).In manual group,the score of common carotid artery was(3.02±0.12),and the score of internal carotid artery was(3.02±0.12),and the score of vertebral artery was(3.02±1.14),and the score of middle cerebral artery was(3.11±1.09).The differences of the image scores of each main branch of the artery of head and neck between two groups were significant(t=107.165,94.590,13.812,15.753,P<0.05),respectively,and scores of AI group all higher than these of manual group.The result of digital subtraction angiography(DSA)was used as the"gold standard".A total of 44 stenosis arteries were included for comparison,and the DSA results indicated that there were 12 cases with mild stenosis,12 cases with moderate stenosis and 10 cases with severe stenosis in AI group,and there were 12 cases with mild stenosis,8 cases with moderate stenosis and 7 cases with severe stenosis in manual group.There was a favorable diagnostic consistency in AI group(Kappa=0.898,P<0.05).The compliance rate of each stenosis of AI group was higher than that of manual group.The sensitivity(96.80%)and specificity(66.52%)of AI group were all higher than those(68.36 and 14.75%)of manual group,and the difference of specificity was significant.Conclusion:The time-consuming of post process,the time-consuming of diagnosis and the quality of CTA image of the artery of head and neck in AI mode are better than those in manual mode,and the consistency of diagnostic efficacy between two modes is favorable.
9.Construction and evaluation of a prognostic model for clear cell renal cell carcinoma based on carbohydrate metabolism-related genes
Duan SHUANGSHUANG ; Gulinaizaier ABUDUSAIMAITI ; Sun MIAO ; Liu HUIBIN
Chinese Journal of Clinical Oncology 2024;51(10):493-499
Objective:To establish a carbohydrate metabolism-related genes(CRGs)prognostic model for clear cell renal cell carcinoma(ccRCC)and investigate its clinical value.Methods:ccRCC mRNA expression data were sourced from The Cancer Genome Atlas(TCGA)data-base.CRGs were retrieved from the MSigDB and KEGG databases.A prognostic model based on CRGs was constructed using the LASSO lin-ear regression model,and the risk score(RS)was calculated.Patients were assigned into high-and low-risk groups according to the median RS.Differences in survival,immune infiltration,mutation,and immune response between the two groups were analyzed using Kaplan-Meier curves and bioinformatics methods.Constructing a nomogram based on the RS and clinical features and validating its accuracy of prognostic predictions.The expression of CRGs in the ccRCC samples was detected using RT-qPCR.Results:A total of eight key genes were utilized to construct a prognostic risk model for ccRCC.Survival analysis revealed that patients in the low-risk group had a better prognosis(P<0.001).Bioinformatics analysis showed that the RS correlated with immune cell infiltration,mutation,and immune responses.The nomogram based on the RS and clinical features demonstrated a strong predictive ability for prognosis.In vitro experiments confirmed notable differences in the expression of the eight CRGs between ccRCC and adjacent non-malignant tissues.Conclusions:A prognostic model based on CRGs can effectively predict the prognosis of patients with ccRCC.
10.Study on the mechanism of astragaloside Ⅰ inhibiting podocyte pyroptosis in diabetic kidney disease
Yafei DUAN ; Xiancong SHI ; Liang ZHAO ; Mingzhen LYU ; Xinqi REN ; Yulei GU ; Jiangyan XU ; Zhenqiang ZHANG ; Jinxin MIAO ; Zhishen XIE ; Xiaowei ZHANG
Journal of Beijing University of Traditional Chinese Medicine 2024;47(10):1408-1415
Objective To investigate the mechanism of astragaloside Ⅰ,the active constituent of milkvetch root,in inhibiting podocyte injury and improving diabetic kidney disease.Methods According to the body weight,60 male db/db mice were randomly divided into the model group,astragaloside Ⅰ low-dose group(10 mg/kg),astragaloside Ⅰ medium-dose group(20 mg/kg),astragaloside Ⅰ high-dose group(40 mg/kg),and valsartan group(10mg/kg),with 12 mice per group.Twelve db/db littermate control db/m mice were used as the control group.The drug was administered by gavage for 8 weeks.Transmission electron microscope was used to observe the ultrastructure of the kidney;immunohistochemistry and Western blotting were used to detect the expression of nephrotic protein(nephrin),a marker of renal podocytes;enzyme-linked immunosorbent assay was used to detect the contents of interleukin-1β(IL-1β)and interleukin-18(IL-18)in the serum of mice;Western blotting was used to detect the protein expressions of NOD-like receptor thermoprotein domain-related protein 3(NLRP3),cysteinyl aspartate specific proteinase 1(Caspase-1),and Gasdermin D(GSDMD)in kidney tissue.Results Compared with the control group,the glomeruli of the model group showed obvious podocyte loss and foot process fusion;the protein expression of nephrin was decreased(P<0.05);the contents of IL-1 β and IL-18 in serum were increased(P<0.05);the protein expressions of NLRP3,Cleaved-Caspase-1,and GSDMD-N were increased(P<0.05).Compared with the model group,the renal pathological damage in the astragaloside Ⅰ administration groups were alleviated;the protein expression of nephrin was increased(P<0.05);the contents of IL-1β and IL-18 in serum were decreased(P<0.05);the protein expressions of NLRP3,Cleaved-Caspase-1,and GSDMD-N were decreased(P<0.05).Conclusion Astragaloside Ⅰ may play a role in intervening diabetic kidney disease by inhibiting pyroptosis and improving podocyte injury.

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