2.Medical researchers' knowledge and attitudes toward electronic informed consent in clinical research.
Xin TAN ; Ying WU ; Yuqiong ZHONG ; Xing LIU ; Xiaomin WANG
Journal of Central South University(Medical Sciences) 2025;50(2):290-300
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
3.Preclinical and clinical studies on Qin-Zhu-Liang-Xue decoction: insights from network pharmacology and implications for atopic dermatitis treatment.
Keke HUANG ; Qingkai LIU ; Ruoxi ZHANG ; Hua NIAN ; Ying LUO ; Yue LUO ; Xiaoya FEI ; Le KUAI ; Bin LI ; Yimei TAN ; Su LI ; Xin MA
Frontiers of Medicine 2025;19(1):134-148
To investigate the protective effects and underlying mechanisms of Qin-Zhu-Liang-Xue decoction (QZLX) in atopic dermatitis (AD) and glucocorticoid resistance, we conducted a single-blinded, randomized controlled clinical trial to evaluate the efficacy and safety of this concoction. Network pharmacology analysis was performed and validated through clinical studies. The efficacy, safety, and mechanism of action of QZLX and glucocorticoid receptor (GR) α recombinant protein were assessed in AD mice induced by 2,4-dinitrofluorobenzene (DNFB). Correlation analysis was performed to determine the clinical relevance of GRα. The trial demonstrated that patients who received QZLX showed considerable improvements in their Scoring Atopic Dermatitis (SCORAD) and Dermatology Life Quality Index (DLQI) scores compared with those who received mizolastine at week 4. Network pharmacological analysis identified GRα as a key target for QZLX in AD treatment. QZLX administration increased the serum GRα expression in AD patients, alleviated AD symptoms in mice, decreased inflammatory cytokine expression, and increased GRα expression without affecting liver or kidney function. In addition, GRα recombinant protein improved AD-like skin lesions in DNFB-induced mice. A negative correlation was observed between GRα expression and clinical parameters, including SCORAD, DLQI, and serum IgE levels. QZLX alleviates AD symptoms through the upregulation of GRα and thus presents a novel therapeutic strategy for the prevention of glucocorticoid resistance in AD management.
Dermatitis, Atopic/drug therapy*
;
Animals
;
Drugs, Chinese Herbal/administration & dosage*
;
Humans
;
Mice
;
Network Pharmacology
;
Male
;
Female
;
Adult
;
Receptors, Glucocorticoid/metabolism*
;
Disease Models, Animal
;
Single-Blind Method
;
Middle Aged
;
Young Adult
4.Sonogenetics and its application in military medicine
Ying-Tan ZHUANG ; Bo-Yu LUO ; Xiao-Dong ZHANG ; Tuo-Yu LIU ; Xin-Yue FAN ; Guo-Hua XIA ; Qing YUAN ; Bin ZHENG ; Yue TENG
Medical Journal of Chinese People's Liberation Army 2024;49(3):360-366
Sonogenetics is an emerging synthetic biology technique that uses sound waves to activate mechanosensitive ion channel proteins on the cell surface to regulate cell behavior and function.Due to the widespread presence of mechanically sensitive ion channel systems in cells and the advantages of non-invasion,strong penetrability,high safety and high accuracy of sonogenetics technology,it has great development potential in basic biomedical research and clinical applications,especially in neuronal regulation,tumor mechanism research,sonodynamic therapy and hearing impairment.This review discusses the basic principles of sonogenetics,the development status of sonogenetics and its application in the prevention and treatment of noise-induced hearing loss,summarizes and analyzes the current challenges and future development direction,thus providing a reference for further research and development of sonogenetics in the field of military medicine.
6.The construction of integrated urban medical groups in China:Typical models,key issues and path optimization
Hua-Wei TAN ; Xin-Yi PENG ; Hui YAO ; Xue-Yu ZHANG ; Le-Ming ZHOU ; Ying-Chun CHEN
Chinese Journal of Health Policy 2024;17(1):9-16
This paper outlines the common aspects of constructing integrated urban medical groups,focusing on governance,organizational restructuring,operational modes,and mechanism synergy.It then delves into the challenges in China's group construction,highlighting issues with power-responsibility alignment,capacity evolution,incentive alignment,and performance evaluation.Finally,the paper suggests strategies to enhance China's compact urban medical groups,focusing on governance reform,capacity building,benefit integration,and performance evaluation.
7.Correlation of DNA Damage Repair Gene FANCI with Prognosis and Immune Infiltration of Hepatocellular Carcinoma
Ying YOU ; Mei-hua MEI ; Ning-xin TAN ; Yi-li CHEN ; Pei-dong CHI ; Xiao-shun HE ; Jun-qi HUANG
Journal of Sun Yat-sen University(Medical Sciences) 2023;44(1):51-62
ObjectiveTo evaluate the expression level of DNA damage repair gene FANCI in hepatocellular carcinoma (HCC) and its relationship with prognosis, clinical stage and immune infiltration. MethodsIn this study, TCGA, GTEx, TIMER2.0, HPA database and qRT-PCR, western blot and immunohistochemistry were used to analyze the expression of FANCI in HCC and its correlation with different clinical stages; Kaplan-Meier Plotter database was used to explore the relationship between FANCI and the prognosis of HCC; the TISIDB database was used to analyze the relationship between FANCI and immune cell infiltration and immune checkpoints in HCC; the STRING database was used to detect the protein binding with FANCI; the TCGA and GTEx databases were used for GO and KEGG enrichment analysis; Cell experiments were used to explore the role of FANCI in HCC. ResultsCompared with normal tissues, the mRNA and protein expression levels of FANCI in tumor tissues were up-regulated (P<0.001); and HCC patients with high expression of FANCI had poor prognosis (P<0.001); the expression of FANCI in tumor tissues was positively correlated with the number of activated CD4+ T cells, the number of Th2 cells and the expression of immune checkpoints, and B-cell and macrophage infiltration was significantly lower in the FANCI high expression group (P<0.01); GO and KEGG enrichment analysis showed that FANCI-related genes were enriched in various biological processes such as amino acid transmembrane transporter activity; Cell experiments showed that knockdown of FANCI could inhibit the proliferation, invasion and migration of HCC (P<0.05). ConclusionsFANCI is highly expressed in hepatocellular carcinoma tissues, which may play a role in suppressing anti-tumor immunity and acting on pathways such as amino acid transmembrane transport, and is associated with poor prognosis. The proliferation, invasion and migration ability of hepatocellular carcinoma are inhibited after knocking down FANCI.
8.Associations of genetic variations in pyroptosis related genes with acute adverse events in postoperative rectal cancer patients receiving concurrent chemoradiotherapy.
Hong Xia CHEN ; Ning Xin REN ; Jie YANG ; Jin Na CHEN ; Qi Xuan LU ; Yan Ru FENG ; Ying HUANG ; Lu Qian YIN ; Dong Xi LIN ; Ye Xiong LI ; Jing JIN ; Wen TAN
Chinese Journal of Oncology 2023;45(2):146-152
Objective: This study aims to investigate the associations between genetic variations of pyroptosis pathway related key genes and adverse events (AEs) of postoperative chemoradiotherapy (CRT) in patients with rectal cancer. Methods: DNA was extracted from the peripheral blood which was collected from 347 patients before CRT. Sequenom MassARRAY was used to detect the genotypes of 43 haplotype-tagging single nucleotide polymorphisms (htSNPs) in eight pyroptosis genes, including absent in melanoma 2 (AIM2), caspase-1 (CASP1), caspase-4(CASP4), caspase-5 (CASP5), caspase-11 (CASP11), gasdermin D (GSDMD), gasdermin E (GSDME) and NLR family pyrin domain containing 3 (NLRP3). The associations between 43 htSNPs and AEs were evaluated by the odd ratios (ORs) and 95% confidence intervals (CIs) by unconditional logistic regression models, adjusted for sex, age, clinical stage, tumor grade, Karnofsky performance status (KPS), surgical procedure, and tumor location. Results: Among the 347 patients with rectal cancer underwent concurrent CRT with capecitabine after surgery, a total of 101(29.1%) occurred grade ≥ 2 leukopenia. rs11226565 (OR=0.41, 95% CI: 0.21-0.79, P=0.008), rs579408(OR=1.54, 95% CI: 1.03-2.29, P=0.034) and rs543923 (OR=0.63, 95% CI: 0.41-0.98, P=0.040) were significantly associated with the occurrence of grade ≥ 2 leukopenia. One hundred and fifty-six (45.0%) had grade ≥ 2 diarrhea, two SNPs were significantly associated with the occurrence of grade ≥ diarrhea, including CASP11 rs10880868 (OR=0.55, 95% CI: 0.33-0.91, P=0.020) and GSDME rs2954558 (OR=1.52, 95% CI: 1.01-2.31, P=0.050). In addition, sixty-six cases (19.0%) developed grade ≥2 dermatitis, three SNPs that significantly associated with the risk of grade ≥2 dermatitis included GSDME rs2237314 (OR=0.36, 95% CI: 0.16-0.83, P=0.017), GSDME rs12540919 (OR=0.52, 95% CI: 0.27-0.99, P=0.045) and NLRP3 rs3806268 (OR=1.51, 95% CI: 1.03-2.22, P=0.037). There was no significant difference in the association between other genetic variations and AEs of rectal cancer patients (all P>0.05). Surgical procedure and tumor location had great impacts on the occurrence of grade ≥2 diarrhea and dermatitis (all P<0.01). Conclusion: The genetic variants of CASP4, CASP11, GSDME and NLRP3 are associated with the occurrence of AEs in patients with rectal cancer who received postoperative CRT, suggesting they may be potential genetic markers in predicting the grade of AEs to achieve individualized treatment of rectal cancer.
Humans
;
Pyroptosis
;
NLR Family, Pyrin Domain-Containing 3 Protein/metabolism*
;
Gasdermins
;
Chemoradiotherapy/adverse effects*
;
Rectal Neoplasms/surgery*
;
Caspases/metabolism*
;
Diarrhea/chemically induced*
;
Leukopenia/genetics*
;
Genetic Variation
;
Dermatitis
9.Clinical efficacy and long-term immunogenicity of an early triple dose regimen of SARS-CoV-2 mRNA vaccination in cancer patients.
Matilda Xinwei LEE ; Siyu PENG ; Ainsley Ryan Yan Bin LEE ; Shi Yin WONG ; Ryan Yong Kiat TAY ; Jiaqi LI ; Areeba TARIQ ; Claire Xin Yi GOH ; Ying Kiat TAN ; Benjamin Kye Jyn TAN ; Chong Boon TEO ; Esther CHAN ; Melissa OOI ; Wee Joo CHNG ; Cheng Ean CHEE ; Carol L F HO ; Robert John WALSH ; Maggie WONG ; Yan SU ; Lezhava ALEXANDER ; Sunil Kumar SETHI ; Shaun Shi Yan TAN ; Yiong Huak CHAN ; Kelvin Bryan TAN ; Soo Chin LEE ; Louis Yi Ann CHAI ; Raghav SUNDAR
Annals of the Academy of Medicine, Singapore 2023;52(1):8-16
INTRODUCTION:
Three doses of SARS-CoV-2 mRNA vaccines have been recommended for cancer patients to reduce the risk of severe disease. Anti-neoplastic treatment, such as chemotherapy, may affect long-term vaccine immunogenicity.
METHOD:
Patients with solid or haematological cancer were recruited from 2 hospitals between July 2021 and March 2022. Humoral response was evaluated using GenScript cPASS surrogate virus neutralisation assays. Clinical outcomes were obtained from medical records and national mandatory-reporting databases.
RESULTS:
A total of 273 patients were recruited, with 40 having haematological malignancies and the rest solid tumours. Among the participants, 204 (74.7%) were receiving active cancer therapy, including 98 (35.9%) undergoing systemic chemotherapy and the rest targeted therapy or immunotherapy. All patients were seronegative at baseline. Seroconversion rates after receiving 1, 2 and 3 doses of SARS-CoV-2 mRNA vaccination were 35.2%, 79.4% and 92.4%, respectively. After 3 doses, patients on active treatment for haematological malignancies had lower antibodies (57.3%±46.2) when compared to patients on immunotherapy (94.1%±9.56, P<0.05) and chemotherapy (92.8%±18.1, P<0.05). SARS-CoV-2 infection was reported in 77 (28.2%) patients, of which 18 were severe. No patient receiving a third dose within 90 days of the second dose experienced severe infection.
CONCLUSION
This study demonstrates the benefit of early administration of the third dose among cancer patients.
Humans
;
SARS-CoV-2
;
COVID-19/prevention & control*
;
Treatment Outcome
;
Neoplasms/drug therapy*
;
Hematologic Neoplasms
;
Vaccination
;
RNA, Messenger
;
Antibodies, Viral
;
Immunogenicity, Vaccine
10.Mechanism of Buyang Huanwu Decoction glycosides against atherosclerotic inflammation through NF-κB signaling pathway.
Xin-Ying FU ; Zheng-Ji SUN ; Qing-Yin LONG ; Wei TAN ; Yan-Jun LI ; Lu WU ; Qing-Hu HE ; Wei ZHANG
China Journal of Chinese Materia Medica 2023;48(1):202-210
This study aims to explore the effect of Buyang Huanwu Decoction glycosides on the inflammatory response of apolipoprotein E~(-/-)(ApoE~(-/-)) mice and RAW264.7 cells through nuclear factor kappa-B(NF-κB) signaling pathway. In the in vivo experiment, ApoE~(-/-) mice were fed with high-fat diets for 12 weeks to induce the animal model of atherosclerosis, and 75 μg·mL~(-1) oxidized low-density lipoprotein(Ox-LDL) incubated RAW264.7 cells for 24 h to establish the atherosclerosis cell model. Automatic biochemical analyzer, hematoxylin-eosin(HE) staining, enzyme-linked immunosorbent assay(ELISA), Western blot, and droplet digital polymerase chain reaction(PCR) were used to determine the blood lipid levels, aortic intimal thickness, inflammatory factor content, NF-κB pathway-related proteins, and mRNA expression levels, and evaluate arterial atherosclerotic lesions and anti-atherosclerotic mechanisms of the drug. The model of atherosclerosis was successfully established in ApoE~(-/-) mice after 12 weeks of feeding with high-fat diets. In the model group, the plasma levels of total cholesterol(TC), triglyceride(TG), and low-density lipoprotein cholesterol(LDL-C) were increased(P<0.01), the intima of the blood vessels was thickened, the levels of inflammatory factors tumor necrosis factor-α(TNF-α) and interleukin-6(IL-6) were increased, and the protein and mRNA expressions of NF-κB and inhibitor of NF-κB(IκBα) were significantly increased as compared with the control group. Compared with the model group, the high-dose Buyang Huanwu Decoction glycoside group decreased the plasma levels of TC, TG, and LDL-C, reduced the plaque area and thickness and the content of inflammatory factor TNF-α, and inhibited the protein and mRNA expressions of NF-κB and IκBα, with the effect same as Buyang Huanwu Decoction. In the in vivo experiment, 75 μg·mL~(-1) Ox-LDL stimulated RAW264.7 cells for 24 h to successfully establish a foam cell model. As compared with the control group, the nuclear amount of NF-κB and the protein and mRNA expressions of IκBα in the model group increased. Compared with the model group, the middle-dose and high-dose Buyang Huanwu Decoction glycoside groups decreased the nuclear amount of NF-κB and the protein and mRNA expressions of IκBα. The above results show that the glycosides are the main effective substances of Buyang Huanwu Decoction against atherosclerosis, which inhibit the NF-κB pathway and reduce the inflammatory response, thus playing the role against atherosclerotic inflammation same as Buyang Huanwu Decoction.
Mice
;
Animals
;
NF-kappa B/metabolism*
;
NF-KappaB Inhibitor alpha/metabolism*
;
Tumor Necrosis Factor-alpha/metabolism*
;
Glycosides/pharmacology*
;
Cholesterol, LDL
;
Atherosclerosis/genetics*
;
Signal Transduction
;
Inflammation/drug therapy*
;
Interleukin-6
;
Apolipoproteins E/pharmacology*
;
RNA, Messenger/metabolism*

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