Conducting drug clinical trials can enhance hospitals' clinical research capabilities and influence,making it particularly important to improve the management efficiency of trial projects through multiple approaches.Remote monitoring sys-tems enable clinical researchers to remotely access hospital diagnosis and treatment-related systems online,allowing timely,se-cure,and standardized review of subjects' source data and key data traceability.These systems monitor the progress of drug clini-cal trial projects,control project risks to ensure compliance with laws,regulations,trial protocols,and standard operating proce-dures,and safeguard the rights of subjects.In the internet era,remote monitoring systems complement on-site monitoring,enhan-cing hospitals' risk resilience in drug clinical trials while improving efficiency and reducing costs.This paper analyzes recent do-mestic and international laws,regulations,policy directions,and research progress in remote monitoring for clinical trials,dis-cusses current challenges and shortcomings,and provides recommendations and insights for the future informatization development of remote monitoring systems in hospital drug clinical trials.

Conducting drug clinical trials can enhance hospitals' clinical research capabilities and influence,making it particularly important to improve the management efficiency of trial projects through multiple approaches.Remote monitoring sys-tems enable clinical researchers to remotely access hospital diagnosis and treatment-related systems online,allowing timely,se-cure,and standardized review of subjects' source data and key data traceability.These systems monitor the progress of drug clini-cal trial projects,control project risks to ensure compliance with laws,regulations,trial protocols,and standard operating proce-dures,and safeguard the rights of subjects.In the internet era,remote monitoring systems complement on-site monitoring,enhan-cing hospitals' risk resilience in drug clinical trials while improving efficiency and reducing costs.This paper analyzes recent do-mestic and international laws,regulations,policy directions,and research progress in remote monitoring for clinical trials,dis-cusses current challenges and shortcomings,and provides recommendations and insights for the future informatization development of remote monitoring systems in hospital drug clinical trials.

Objective:To mine the drugs that may cause capillary leak syndrome (CLS), and evaluate the risk of CLS, and provide reference for safe and rational use of drugs in clinic.Methods:Adverse event (AE) reports with the preferred term "capillary leak syndrome" from the 1st quarter of 2004 to the 4th quarter of 2023 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FEARS) database. Reporting odds radio (ROR) method and proportional reporting ratio (PRR) method were used to mine the AE risk signals. Drugs with report number ≥3, lower limit of the 95% confidence interval ( CI) of ROR value >1, PRR ≥2, χ2 ≥4 were grouped and classified according to the Anatomical Therapeutic Chemical Classification (ATC) system. The top 20 drugs in ROR values were selected, and a risk assessment for drugs potentially causing CLS was performed by reviewing drug labels, adverse reaction datasets, and relevant literature. Results:A total of 1 033 AE reports related to CLS were collected, involving 558 primary suspected drugs associated with CLS. The top 5 types of drugs that the most commonly causing CLS were antineoplastic and immunomodulating agents, systemic hormonal preparations, anti-infectives for systemic uses, cardiovascular system, and alimentary tract and metabolism. The risk assessment results showed that 13 drugs of the top 20 drugs in signal intensity (clofarabine, gemcitabine, interleukin-3, denileukin diftitox, dinutuximab, filgrastim, trabectedin, cytarabine, busulfan, docetaxel, trastuzumab, vildagliptin and melphalan) were high-risk drugs causing CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin, and melphalan were not recorded to cause CLS in the labels. The other 7 drugs (asparaginase, fludarabine, amphotericin B, bosutinib, daunorubicin, ponatinib, and bleomycin) were low-risk drugs causing CLS.Conclusions:Thirteen drugs are high-risk drugs that may cause CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin and melphalan are not recorded causing CLS in the labels. It is suggested that clinicians and pharmacists should be vigilant against high-risk drugs, especially those not recorded causing CLS in the labels.

Objective:To mine the drugs that may cause capillary leak syndrome (CLS), and evaluate the risk of CLS, and provide reference for safe and rational use of drugs in clinic.Methods:Adverse event (AE) reports with the preferred term "capillary leak syndrome" from the 1st quarter of 2004 to the 4th quarter of 2023 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FEARS) database. Reporting odds radio (ROR) method and proportional reporting ratio (PRR) method were used to mine the AE risk signals. Drugs with report number ≥3, lower limit of the 95% confidence interval ( CI) of ROR value >1, PRR ≥2, χ2 ≥4 were grouped and classified according to the Anatomical Therapeutic Chemical Classification (ATC) system. The top 20 drugs in ROR values were selected, and a risk assessment for drugs potentially causing CLS was performed by reviewing drug labels, adverse reaction datasets, and relevant literature. Results:A total of 1 033 AE reports related to CLS were collected, involving 558 primary suspected drugs associated with CLS. The top 5 types of drugs that the most commonly causing CLS were antineoplastic and immunomodulating agents, systemic hormonal preparations, anti-infectives for systemic uses, cardiovascular system, and alimentary tract and metabolism. The risk assessment results showed that 13 drugs of the top 20 drugs in signal intensity (clofarabine, gemcitabine, interleukin-3, denileukin diftitox, dinutuximab, filgrastim, trabectedin, cytarabine, busulfan, docetaxel, trastuzumab, vildagliptin and melphalan) were high-risk drugs causing CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin, and melphalan were not recorded to cause CLS in the labels. The other 7 drugs (asparaginase, fludarabine, amphotericin B, bosutinib, daunorubicin, ponatinib, and bleomycin) were low-risk drugs causing CLS.Conclusions:Thirteen drugs are high-risk drugs that may cause CLS, among which cytarabine, docetaxel, busulfan, trastuzumab, vildagliptin and melphalan are not recorded causing CLS in the labels. It is suggested that clinicians and pharmacists should be vigilant against high-risk drugs, especially those not recorded causing CLS in the labels.

Pan-vascular medicine is an emerging discipline focusing on atherosclerotic diseases,with the concept of multidisciplinary integration,emphasizing on exploring the mechanism of disease development from the whole of the organism's structure and function.At present,the basic mechanism system of pan-vascular diseases has yet to be perfected.The pan-vascular concept is highly compatible with the idea of Chinese medicine that focuses on the overall view.Deficiency of all qi is the root cause of pan-vascular diseases,while phlegm,blood stasis,and water-dampness and other tangible evils stagnate in the veins and channels as the symptoms of the disease,therefore,the disease mechanism can be highly summarized as"stagnation due to qi deficiency".Deficiency leads to the stagnation,blocking the veins and channels,and the deficiency worsens due to the stagnation and then damages the veins and channels,thus,it develops into a disease.Based on the theory of"stagnation due to qi deficiency",this paper takes endothelial cell dysfunction as the entry point of pan-vascular diseases,and considers that low endothelial cell immunity is the initiating factor of pan-vascular diseases,and that the widespread persistence of microinflammatory state is the key pathology to pan-vascular diseases.

Objective:To explore the medical experience and staged care needs of patients undergoing ophthalmic ambulatory surgery.Methods:In this qualitative study, 21 ophthalmic ambulatory surgery patients from Henan Provincial Ophthalmology Hospital were selected by purposive sampling for semi-structured in-depth interviews from February to June 2022, and the content of the interviews was analyzed by Colaizzi's analysis.Results:A total of 4 first-level themes were extracted from the content analysis, including medical experience, preoperative preparation-related information needs, nursing needs for postoperative complications, and home rehabilitation nursing and follow-up needs. Among them, the medical experience included saving time for medical treatment, insufficient preoperative preparation, and anxiety.Conclusions:For ophthalmic ambulatory surgery patients, it is necessary to strengthen information support, provide targeted health education for ambulatory surgery, provide psychological and emotional support, and further improve the postoperative rehabilitation management process to enhance the quality of nursing services for ambulatory surgery.

Objective:To retrieve the evidence of scraping operation in patients with neck, shoulder and low back pain, and evaluate and summarize the evidence.Methods:Identified evidence-based problems based on the population, intervention, professional, outcome, setting and type of evidence (PIPOST) model, and searched UpToDate, British Medical Journal (BMJ) Clinical Evidence, Guidelines International Network, Registered Nurses' Association of Ontario, Scottish Intercollegiate Guidelines Network, New Zealand Guidelines Group, World Health Organization, American College of Physicians Club, BMJ Best Practice, Agency for Healthcare Research and Quality, Joanna Briggs Institute Evidence-Based Health Care Center Database, Nursing Consult, China Guideline Clearinghouse, Cochrane Library, Embase, PubMed, CINAHL, Web of Science, Medlive, China National Knowledge Infrastructure and SinoMed. The retrieval time limit was from March 1, 2012 to April 30, 2022. Four researchers independently evaluated the quality of the article, and two researchers summarized the evidence of the included article.Results:A total of 9 articles were included, including 1 guideline, 2 systematic reviews, and 6 randomized controlled trials. A total of 20 pieces of scraping application evidence were extracted from patients with neck, shoulder and low back pain, including 6 aspects, involving preparation before scraping, scraping intervention methods, scraping degree, precautions, contraindications, and handling of abnormal conditions.Conclusions:The best evidence of scraping therapy to improve patients' neck, shoulder and low back pain summarized in this study can provide a reference for improving the operation practice of medical and nursing staffs and nursing outcomes.

Although the development of COVID-19 vaccines has been a remarkable success, the heterogeneous individual antibody generation and decline over time are unknown and still hard to predict. In this study, blood samples were collected from 163 participants who next received two doses of an inactivated COVID-19 vaccine (CoronaVac®) at a 28-day interval. Using TMT-based proteomics, we identified 1,715 serum and 7,342 peripheral blood mononuclear cells (PBMCs) proteins. We proposed two sets of potential biomarkers (seven from serum, five from PBMCs) at baseline using machine learning, and predicted the individual seropositivity 57 days after vaccination (AUC = 0.87). Based on the four PBMC's potential biomarkers, we predicted the antibody persistence until 180 days after vaccination (AUC = 0.79). Our data highlighted characteristic hematological host responses, including altered lymphocyte migration regulation, neutrophil degranulation, and humoral immune response. This study proposed potential blood-derived protein biomarkers before vaccination for predicting heterogeneous antibody generation and decline after COVID-19 vaccination, shedding light on immunization mechanisms and individual booster shot planning.
Humans ; COVID-19 Vaccines ; Leukocytes, Mononuclear ; Proteomics ; COVID-19/prevention & control* ; Vaccination ; Antibodies ; Antibodies, Viral ; Antibodies, Neutralizing

Aconitine,a common and main toxic component of Aconitum,is toxic to the central nervous system.However,the mechanism of aconitine neurotoxicity is not yet clear.In this work,we had the hypothesis that excitatory amino acids can trigger excitotoxicity as a pointcut to explore the mechanism of neurotoxicity induced by aconitine.HT22 cells were simulated by aconitine and the changes of target cell metabolites were real-time online investigated based on a microfluidic chip-mass spectrometry system.Meanwhile,to confirm the metabolic mechanism of aconitine toxicity on HT22 cells,the levels of lactate dehydrogenase,intracellular Ca2+,reactive oxygen species,glutathione and superoxide dismutase,and ratio of Bax/Bcl-2 protein were detected by molecular biotechnology.Integration of the detected results revealed that neurotoxicity induced by aconitine was associated with the process of excitotoxicity caused by glutamic acid and aspartic acid,which was followed by the accumulation of lactic acid and reduction of glucose.The surge of extracellular glutamic acid could further lead to a series of cascade reactions including intracellular Ca2+overload and oxidative stress,and eventually result in cell apoptosis.In general,we illustrated a new mechanism of aconitine neurotoxicity and presented a novel analysis strategy that real-time online monitoring of cell metabolites can provide a new approach to mechanism analysis.

Tbx18,Wt1,and Tcf21 have been identified as epicardial markers during the early embryonic stage.However,the gene markers of mature epicardial cells remain unclear.Single-cell transcriptomic analysis was performed with the Seurat,Monocle,and CellphoneDB packages in R software with standard pro-cedures.Spatial transcriptomics was performed on chilled Visium Tissue Optimization Slides(10x Genomics)and Visium Spatial Gene Expression Slides(10x Genomics).Spatial transcriptomics analysis was performed with Space Ranger software and R software.Immunofluorescence,whole-mount RNA in situ hybridization and X-gal staining were performed to validate the analysis results.Spatial transcriptomics analysis revealed distinct transcriptional profiles and functions between epicardial tissue and non-epicardial tissue.Several gene markers specific to postnatal epicardial tissue were identified,including Msln,C3,Efemp1,and Upk3b.Single-cell transcriptomic analysis revealed that cardiac cells from wildtype mouse hearts(from embryonic day 9.5 to postnatal day 9)could be categorized into six major cell types,which included epicardial cells.Throughout epicardial development,Wt1,Tbx18,and Upk3b were consistently expressed,whereas genes including Msln,C3,and Efemp1 exhibited increased expression during the mature stages of development.Pseudotime analysis further revealed two epicardial cell fates during maturation.Moreover,Upk3b,Msln,Efemp1,and C3 positive epicardial cells were enriched in extracellular matrix signaling.Our results suggested Upk3b,Efemp1,Msln,C3,and other genes were mature epicardium markers.Extracellular matrix signaling was found to play a critical role in the mature epicardium,thus suggesting potential therapeutic targets for heart regeneration in future clinical practice.