OBJECTIVES: Obtaining informed consent from research participants is an ethical and legal obligation for medical researchers in clinical studies. Electronic informed consent (eIC) is increasingly being adopted in clinical research worldwide. However, there is limited data on Chinese medical researchers' knowledge and attitudes toward eIC. This study aims to investigate their knowledge, attitudes, and influencing factors regarding eIC use in clinical research. METHODS: This cross-sectional study was conducted using stratified random sampling. From June to August 2022, medical researchers from 8 tertiary hospitals were surveyed via an online platform (Wenjuanxing). A self-developed eIC knowledge questionnaire and attitude scale were used to assess participants' understanding and perceptions of eIC. Univariate analysis was employed to explore factors influencing attitude scores and the correlation between knowledge and attitudes. A generalized linear model was used to analyze associations between demographic characteristics and attitude scores, including the frequency of difficulties in using smartphones or computers, preferred device for using eIC, and their interaction effects. Stratified analysis was further performed for significant interactions. RESULTS: A total of 399 valid questionnaires were collected. The mean accuracy rate on the eIC knowledge questionnaire was (94.88±15.50)%. Of the respondents, 74.9% had heard of eIC, and 84.5% preferred using mobile devices over computers to access eIC. The median attitude score was 3.41 (3.18, 3.76), indicating generally positive attitudes. Specifically, 81.7% found eIC more convenient than paper-based consent, 79.7% considered it more efficient, and 51.1% believed it could fully replace paper forms. However, 60.7% expressed concerns about data security and privacy, and 89.7% believed that relevant laws and regulations need improvement. Spearman correlation analysis showed a weak positive correlation between knowledge and attitude scores (r=0.171, P=0.001). Univariate analysis indicated that the frequency of difficulty using devices and preferred device for eIC were significantly associated with attitude scores (P<0.05). After adjusting for confounding factors, the generalized linear model demonstrated that participants who occasionally experienced had difficulty using devices had significantly lower attitude scores compared to those who never had difficulty (β=-0.040, 95% CI -0.071 to -0.009, P=0.012). Those who preferred using PCs had significantly lower attitude scores than those who preferred mobile devices (β=-0.066, 95% CI -0.108 to -0.023, P=0.002). Interaction analysis showed a significant interaction analysis showed a significant interaction between age and preferred device (P=0.011), particularly among participants aged ≥45-year (P<0.001). No other interactions were found to be significant (all P>0.05). CONCLUSIONS Medical researchers in China generally have a high level of knowledge and positive attitudes toward eIC, though concerns remain regarding data security and privacy. Future promotion of eIC in Chinese clinical research should be grounded in ethical considerations and address the specific needs of older users and mobile device users, while also enhancing researchers' competencies in using digital tools and eIC systems.
Humans ; Cross-Sectional Studies ; Informed Consent ; Surveys and Questionnaires ; Female ; Male ; Health Knowledge, Attitudes, Practice ; Adult ; Biomedical Research ; Research Personnel/psychology* ; Middle Aged ; China

Objective To investigate the effects of high-altitude hypoxic environment on the pharmacokinetic characteristics and brain tissue distribution of phenytoin sodium in epileptic rats.Methods A total of 70 male SPF-grade Wistar rats aged 2 months and weighing(200±20)g were used in the study.An epilepsy model was induced in the rats using the lithium chloride-pilocarpine method.The successfully modeled rats were randomly assigned to a normoxic treatment group and a high-altitude hypoxic treatment group.Phenytoin sodium was administered via intragastric gavage at a dose of 50 mg/kg in both groups.Blood samples were collected from the orbital venous plexus before treatment and 0.5,1,2,3,4,6,8,10,and 24 h post treatment.The animals were euthanized after the final blood collection,and samples of the liver and the whole brain tissue were collected.In the brain tissue distribution experiment,brain tissue samples were collected at 0.5,1,2,and 4 h after drug administration.The concentration of phenytoin sodium in rat plasma and brain tissue was determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS),and the pharmacokinetic parameters were calculated using WinNolin 8.1 software.The expression levels of CYP2C9 in liver tissue and those of P-gp in brain tissue of epileptic rats were determined by Western blot.Results Compared with those in the normoxia group,the peak concentration,peak time,and half-life of phenytoin sodium in the high-altitude hypoxia group were significantly decreased by 46.0%,42.3%,and 55.5%,respectively(all P<0.05);the clearance rate was significantly increased by 162.0%(P<0.05);and the area under the curve of plasma concentration-time curve was decreased by 45.6%(P<0.01).At 0.5,1,and 2 hours after administration,compared with that in the normoxia treatment group,the concentration of phenytoin sodium in the brain tissue of the high-altitude hypoxia treatment group was significantly decreased by 78.1%,63.5%,and 32.5%,respectively(all P<0.05).Western blot results showed that the expression levels of CYP2C9 in the liver tissue and P-gp in the brain tissue of rats in the high-altitude hypoxia group were approximately 1.78 and 1.65 times higher than those in the normoxia group,respectively(both P<0.05).Conclusion The hypoxic environment at high altitudes can promote the metabolism of phenytoin sodium,reduce its absorption efficiency,and change the characteristics its distribution in the brain,which may be related to the up-regulation of the expression of CYP2C9 in the liver and that of P-gp in the brain.

ObjectiveTo explore the function of DANCR during the differentiation of human embryonic stem cells （hESC） toward definitive endoderm （DE）. MethodsThe in vitro DE differentiation system was established and its efficiency was verified. The correlation between the expression level of DANCR and DE differentiation process was detected. Using lentivirus system， we stably knocked down DANCR in hESC. The shDANCR hESC line was applied to DE differentiation， using qPCR and Western blot to detect the expression of DE marker genes SOX17 and FOXA2， and that of primitive streak marker genes Brachyury （T）， EOMES， MIXL1 and GSC. Dual luciferase reporter assay and qPCR were used to confirm the interaction between DANCR and the WNT pathway during DE differentiation. ResultsThe in vitro differentiation system mimicked DE differentiation efficiently. And the expression of DANCR was gradually downregulated during differentiation. DANCR was efficiently knocked down in the shDANCR hESC line （P < 0.001）. Compared with those in the control group， the expression levels of primitive markers Brachyury （T）， EOMES， MIXL1 and GSC， as well as DE markers SOX17 and FOXA2， were significantly decreased in shDANCR groups （P < 0.05）. Furthermore， the transcriptional activity of the WNT pathway in shDANCR groups was lower than that in the control group （P < 0.05）. And RNA levels of downstream genes of the WNT pathway， FZD5， FZD8， SFRP1， FRZB and ANKRD6， were significantly decreased in shDANCR groups （P < 0.05）. However， differences in protein levels of the TGFβ pathway effectors SMAD2/3 and p-SMAD2 were statistically insignificant in shDANCR and control groups （P > 0.05）. Forced activation of β-CATENIN rescued DANCR knock down-induced deficiency in DE differentiation. ConclusionsThe expression of DANCR decreases during DE differentiation. DANCR may promote DE differentiation through modulating the activity of the WNT pathway.

Objective To investigate the antioxidant activity of bamboo stem extracts and the therapeutic effect of bamboo stem water extract on oxidative inflammation induced by tert butyl hydroperoxide (t-BHP) in human colon adenocarcinoma cells (Caco-2). Methods In this study, ABTS, DPPH, and FRAP assays were used to determine the extracellular antioxidant activity of petroleum ether extract, ethyl acetate extract, n-butanol extract, 95% ethanol extract, and distilled water extract from bamboo stems. The human intestinal Caco-2 cell line was used as the model cell, and t-BHP was selected as the oxidative stress modeling agent. The CCK-8 assay was used to detect cell viability and the optimal oxidative damage concentration of t-BHP. The content of MDA, 8-OHdG, TNF-α and IL-1β were detected to assess antioxidant stress effect. Results The five extracts of bamboo all had certain antioxidant activity, among which the water extract of bamboo stem had the best comprehensive antioxidant activity with high cell viability in Caco-2 cells. The optimal modeling concentration of t-BHP was 200 μMol/L. The water extract of bamboo stem significantly reduced the content of oxidative stress related biomarkers and inflammatory factors in Caco-2 cells induced by t-BHP. Conclusion The stem extracts of bamboo in Xianning City have strong in vitro antioxidant activity. Among them, the water extract of bamboo stem has a protective effect on t-BHP induced oxidative damage in Caco-2 cells, suggesting that the water extract possesses a potential to be developed as new antioxidant products for clinical prevention and treatment of oxidative damage related diseases.

Background::China is one of the countries with the largest burden of gastrointestinal and liver diseases (GILD) in the world. The GILD constitutes various causes of mortality and disability. The study aimed to investigate the trend of GILD in China using the Global Burden of Diseases Study 2019 (GBD 2019) data resources from 1990 to 2019.Methods::The data on the age-standardized mortality rates (ASMR) and disability-adjusted life years (DALYs) for GILD in China from 1990 to 2019 were collected from the GBD 2019 data resources. Furthermore, the ranking of the main causes of deaths and DALYs, as well as the trends of ASMR, DALYs, years of life lost (YLLs), and years of life lost due to disability (YLDs) per 1,000,000 in GILD were reported.Results::The ASMR and DALYs for stomach cancer, liver cancer, and esophageal cancer, which ranked top three among the GILDs from 1990 to 2019, were gradually decreasing. Significant decreases in the ASMR and DALYs were found in diarrheal diseases and acute hepatitis (A, E, and C). However, noteworthy increases were found in those of colon and rectum cancer (CRC) and pancreatic cancer. Trend of DALYs, mortality, and YLLs rates for most of GILD were decreasing from 1990 to 2019, except the burden of CRC and pancreatic cancer with an increasing trend. The DALYs, mortality and YLLs of most GILD diseases showed decreasing trends from 1990 to 2019, except the burden of CRC and pancreatic cancer with an increasing trends.Conclusions::The result of the GBD 2019 showed that the rates of most GILDs decreased in China; however, gastrointestinal and liver cancer, such as stomach cancer still held the top ranking. Furthermore, the shift from infectious diseases to non-communicable causes among GILD burden is occurring.

A Clinical pharmacist was fully involved in the anticoagulation drug treatment management process of a 104-year-old patient with a large area of cerebral infarction combined with chronic kidney disease stage Ⅴ and secondary deep vein thrombosis.After the patient was diagnosed with deep vein thrombosis,the clinical pharmacist comprehensively analyzed the patient's super-advanced age,history of atrial fibrillation,large area of cerebral infarction,extremely poor kidney function,deep vein thrombosis,and high bleeding risk indicated by the HAS-BLED score.They worked with the clinical doctor to develop an individualized anticoagulation treatment strategy for the patient.At the beginning of the treatment,warfarin was given to the patient at a daily dose of 1.25 mg,and the patient's coagulation indicators and kidney function were dynamically rechecked.The patient's blood creatinine level did not show significant changes throughout the anticoagulation treatment process.On the 8th day of medication,the patient's INR was 2.47,and the clinical pharmacist suggested adjusting the Warfarin to an alternate-day dose of 1.25 mg and 0.625 mg.Subsequently,the patient's INR was 2.41,and the condition improved,leading to discharge.Throughout the anticoagulation drug management process,the clinical pharmacist participated in the clinical decision-making for anticoagulant drug selection,provided professional medication guidance,and pharmacological monitoring to ensure the safe clinical use of drugs for special populations.

BackgroundPatients with schizophrenia are at high risk of suffering from metabolic syndrome. Most previous studies on the influencing factors of metabolic syndrome focused on the inpatients and limited ones on patients dwelling in community. ObjectiveTo explore the influencing factors at different risk levels of metabolic syndrome in community-dwelling patients with schizophrenia in Guangzhou， so as to provide references for future interventions on metabolic syndrome in this patient population. MethodsIn November 2021， 3 339 patients with schizophrenia who were registered in and administered by Guangzhou Mental Health Information System were included. All these patients had finished the physical examination in 2020， and whether they had metabolic syndrome was assessed basing on Guideline for the prevention and treatment of type 2 diabetes mellitus in China （2020 edition）. Patients were divided into high-risk group （n=423）， critical group （n=1 524） and metabolic syndrome group （n=1 392） according to the Chinese expert consensus on the management of metabolic syndrome in patients with schizophrenia. Multiple logistic regression analysis were performed on the risk factors of metabolic syndrome in community-dwelling patients with schizophrenia. ResultsThe prevalence rate of metabolic syndrome in community-dwelling patients with schizophrenia was 41.69%. Univariate analysis showed that the results in gender （χ²=44.610）， age （χ²=55.992）， marriage status （χ²=30.755）， illness course （χ²=25.913） and body mass index （χ²=829.265） were significantly different among the three groups （P<0.01）. Kruskal-Wallis H test showed that the levels of waist circumference （H=920.331）， systolic blood pressure （H=436.673）， diastolic blood pressure （H=393.337）， fasting blood glucose （H=807.304）， triglyceride （H=1 134.125） and high-density lipoprotein cholesterol （H=593.615） among the three groups were significantly different （P<0.01）. Logistic regression analysis showed that age ≥50 （OR=1.761， 95% CI： 1.087~2.853）， overweight （OR=2.418， 95% CI： 1.862~3.140） and obesity （OR=57.903， 95% CI： 14.340~233.802） were risk factors contributing to high-risk patients becoming critical population （P<0.05 or 0.01）. Female gender （OR=1.295， 95% CI： 1.034~1.622）， aged 40~49 （OR=2.597， 95% CI： 1.582~4.263）， age ≥50 （OR=4.392， 95% CI： 2.609~7.395）， overweight （OR=7.844， 95% CI： 6.018~10.223） and obesity （OR=426.785， 95% CI： 105.724~1 722.839） were risk factors for high-risk patients developing into metabolic syndrome population （P<0.05 or 0.01）. ConclusionThe prevalence rate of metabolic syndrome is higher in community-dwelling patients with schizophrenia. Female gender， older age， overweight and obesity would increase the risk of metabolic syndrome in schizophrenic patients. ［Funded by Health Science and Technology Project in Guangzhou （number， 20221A010028）］

【Objective】 To explore the emergency treatment of penoscrotal avulsion injury based on the American Association for Surgery and Trauma (AAST) penoscrotal injury grade. 【Methods】 Data of 30 patients with penoscrotal avulsion injury treated in our hospital with in-situ suture, skin grafting or skin flap during Oct.2003 and Dec.2017 were reviewed. 【Results】 Among the 30 patients, 29 received emergency surgery, including in-situ suturein 15 grade Ⅰ-Ⅲ cases, skin graft in 8 grade Ⅳ-Ⅴ cases, and skin flap in 6 cases;1 case received delayed operation due to wound infection on admission. In the perioperative period,25 cases had more than 90% wound healing, 3 cases had 70% wound healing after wound dressing change, and 2 cases had complete necrosis. Second-stage skin graft yielded satisfactory penoscrotal appearance. 【Conclusion】 According to the specific conditions of patients, reasonable surgical methods can be selected. For grade Ⅰ-Ⅲ patients, in-situ suture can be used, while for grade Ⅳ-Ⅴ patients, wound condition, age, fertility and other factors should be taken into consideration so as to preserve the function of testis to the maximum extent.

Objective To investigate the effect of MDM2 inhibitor RG-7388 on the proliferation, cell cycle, and apoptosis of diffuse large B-lymphoma (DLBCL) cells. Methods DLBCL cell strains SUDHL2 and HBL1 were treated with 2, 4, and 8 μmol/LRG7388, respectively. Cell proliferation was detected by CCK8 and EdU methods. Apoptosis was measured by Annexin V–FITC/PI double staining and Caspase 3/7-Glo enzyme activity methods. Cell cycle was assessed by flow cytometry. Changes in the expression of cell cycle and apoptosis-related proteins were determined by Western blot. Results The IC₅₀ of RG7388 for inhibiting SUDHL2 and HBL1 cells were 3.36 and 3.76 μmol/L, respectively, and the inhibitory effect of RG7388 was dose dependent. The proportions of G₁ phase and apoptotic cells in the SUDHL2 and HBL1 cells treated with different doses of RG7388 were significantly higher than those in the control group (all P<0.05). The activity of Caspase 3/7 increased gradually with RG7388 concentration, compared with that in the control group. The expression levels of p53, p27, p21, and PARP increased, whereas the expression of Mcl-1 and Bcl-x_L was down-regulated (all P<0.05). Conclusion MDM2 inhibitor RG-7388 inhibits the proliferation of DLBCL cells, triggers cell cycle arrest in the G₁ phase, and induces apoptosis through the p53 pathway.

Objective To investigate the correlation between TCM syndrome types and solar term of onset in patients with gastric cancer.Methods A total of 359 patients with gastric cancer admitted to the Cancer Center of the First Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2020 to August 2023 were included in this study,and the frequency distribution method was used to analyze their information such as sex,age,solar term of onset,differentiation,metastasis and TCM syndrome type.The solar term of onset corresponding to the onset date was calculated,and then the association between solar term of onset and TCM syndrome type in gastric cancer was analyzed.The circular distribution method was used to explore the peak of solar term of onset and TCM syndrome type.Results Among the 359 patients with gastric cancer included in this study,male patients were more than female patients(1.69∶1).The age of onset was mainly between 60 and 70 years old(117 cases,32.6%),and male patients(85 cases,72.6%)were more than female patients(32 cases,27.3%)in this age group.The most common TCM syndromes were qi and blood deficiency syndrome(160 cases,44.6%)and phlegm damp condensation syndrome(94 cases,26.2%).The onset of the disease mainly occurred in winter(132 cases,36.8%),and the peaks were light snow(31 cases,23.5%),major cold(25 cases,18.9%),heavy snow(23 cases,17.4%)and the start of winter(22 cases,16.7%).Qi and blood deficiency syndrome and phlegm damp condensation syndrome in patients with gastric cancer were correlated with solar terms and seasons(P<0.05).The 285 patients with gastric cancer were mainly poorly differentiated gastric cancer(175 cases,61.4%),mainly concentrated in winter(66 cases,37.7%).The main route of gastric cancer metastasis is lymph node metastasis,followed by liver and abdominal cavity metastasis.Conclusion Qi and blood deficiency syndrome and phlegm dampness condensation syndrome are common in patients with gastric cancer.The onset time of gastric cancer is mostly in winter,and the syndrome type is significantly correlated with the onset solar term and differentiation degree.