Objective To analyze the problems in the operation and management of drug clinical trials and put forward targeted suggestion. Methods An electronic questionnaire survey was conducted among medical staff in about 80 hospitals in the yangtze river delta region. Results 606 valid questionnaires were received. 71% of the respondents expressed their willingness to study and participate in drug clinical trials. There were significant differences in the cognitive demands, willingness and motivation of the respondents with different occupations and educational backgrounds about the drug clinical trial work （P<0.05）. During the operation of drug clinical trials, respondents reported the main factors affecting the quality of clinical trials which including good clinical practice (GCP) awareness and subjective enthusiasm of investigators （response rate 27%）, job stability of supervisors and research coordinators （27%）, compliance of subjects （45%）, quality control of the whole process of the circulation of test drugs, medical devices and biological samples （52%）, and the informatization level of clinical trial institutions （30%）. Conclusion Hospitals, institutions and project teams could take measures to cultivate and stabilize the drug clinical trial talent team, improve the quality management system of drug clinical trials, improve work efficiency, and promote the high-quality development of drug clinical trials in medical institutions.

Objective: To investigate the status and influencing factors of nutritional health knowledge awareness among primary and middle school students in Wenzhou City, Zhejiang Province, so as to provide a basis for carrying out targeted nutrition health education for students. Methods: The stratified cluster random sampling method was used to select students from 48 schools across 12 counties (cities and districts) in Wenzhou City as survey subjects from October 2023 to February 2024. Basic information, parental information, and nutritional health knowledge were collected using the Questionnaire on nutritional health knowledge for School-Age Children. The awareness rate of nutritional health knowledge was analyzed. Multivariable logistic regression model was used to analyze the influencing factors for nutritional health knowledge awareness among primary and middle school students. Results: The survey included 4 405 boys, accounting for 51.42%, and 4 161 girls, accounting for 48.58%. The sample consisted of 2 497 pupils in Grades 1-3 (29.15%), 2 591 pupils in Grades 4-6 (30.25%), 1 739 junior high school students (20.30%), and 1 739 senior high school students (20.30%). The median score of nutrition health knowledge was 75.00 (interquartile range, 19.00), and the awareness rate was 4 524 (52.81%). Multivariable logistic regression analysis showed that girls (OR=1.317, 95%CI: 1.198-1.447), primary school students (Grades 1-3, OR=7.830, 95%CI: 6.444-9.513; Grades 4-6, OR=1.276, 95%CI: 1.066-1.528), and those whose mothers had an educational level above junior high school (senior high school/technical secondary school/technical school/junior college, OR=1.188, 95%CI: 1.044-1.352; bachelor' s degree or above, OR=1.194, 95%CI: 1.024-1.392) had a higher likelihood of nutrition and health knowledge awareness. Conversely, students who were overweight or obese (OR=0.798, 95%CI: 0.671-0.950), lived in school (OR=0.763, 95%CI: 0.650-0.895), and had a daily outdoor activity duration of <30 minutes (OR=0.641, 95%CI: 0.570-0.721) had a lower likelihood of nutritional health knowledge awareness. Conclusions The awareness rate of nutritional health knowledge among primary and middle school students in Wenzhou City needs to be improved, and is mainly influenced by gender, educational stage, body mass index, mother' s educational level, and outdoor activity duration. It is recommended to implement differentiated health education strategies and build a "family-school-community" linkage mechanism to improve students' nutrition health literacy.

Objective:To evaluate the effect of different psychosocial interventions on fertility concerns in cancer patients using network Meta-analysis.Methods:Randomized controlled trials or quasi-experimental studies on the effects of different psychosocial interventions on fertility concerns in cancer patients were electronically searched in China National Knowledge Infrastructure, Wanfang Data, VIP, China Biology Medicine disc, PubMed, Embase, Cochrane Library, CINAHL, Web of Science and PsycINFO. The search period was from database establishment to October 31, 2024. Two researchers independently conducted literature screening and data extraction. Conventional Meta-analysis of the included literature was performed using RevMan 5.4, and network Meta-analysis was performed using Stata 18.0.Results:A total of 10 studies involving 835 cancer patients and seven psychosocial interventions were included. Network Meta-analysis showed that there was a statistically significant difference in the intervention effect of fertility counseling ( MD=18.24, 95% CI: 2.85-33.62, P<0.05) and mental awareness training ( MD=17.97, 95% CI: 3.09-32.85, P<0.05) on fertility concerns in cancer patients as compared to routine nursing. The ranked probability plot showed that fertility counseling and mental awareness training had superior results. Conclusions:Fertility counseling has a superior effect on fertility concerns in cancer patients. Mental awareness training may be effective in improving fertility concerns in cancer patients, and further research is needed to validate the effectiveness of mindfulness-based stress reduction, cognitive behavioral therapy, dyadic coping interventions, and educational interventions in improving fertility concerns in cancer patients.

High mobility group box 1 (HMGB1), when released extracellularly, plays a pivotal role in the development of spinal cord synapses and exacerbates autoimmune diseases within the central nervous system. In experimental autoimmune encephalomyelitis (EAE), a condition that models multiple sclerosis, the levels of extracellular HMGB1 and interleukin-33 (IL-33) have been found to be inversely correlated. However, the mechanism by which IL-33 deficiency enhances HMGB1 release during EAE remains elusive. Our study elucidates a potential signaling pathway whereby the absence of IL-33 leads to increased binding of P300/CBP-associated factor with HMGB1 in the nuclei of astrocytes, upregulating HMGB1 acetylation and promoting its release from astrocyte nuclei in the spinal cord of EAE mice. Conversely, the addition of IL-33 counteracts the TNF-α-induced increase in HMGB1 and acetylated HMGB1 levels in primary astrocytes. These findings underscore the potential of IL-33-associated signaling pathways as a therapeutic target for EAE treatment.
Animals ; Encephalomyelitis, Autoimmune, Experimental/metabolism* ; Astrocytes/metabolism* ; Interleukin-33/metabolism* ; HMGB1 Protein/metabolism* ; Acetylation ; Mice, Knockout ; Mice, Inbred C57BL ; p300-CBP Transcription Factors/metabolism* ; Mice ; Spinal Cord/metabolism* ; Cells, Cultured ; Female ; Signal Transduction

OBJECTIVE To establish drug utilization evaluation （DUE） criteria for pyrotinib to promote its appropriate application in clinical practice. METHODS Based on the label of Pyrotinib maleate tablets， with relevant guiding principles and diagnostic and treatment guidelines as the evaluation basis， DUE criteria for pyrotinib were determined through the Delphi method. Attribute hierarchical model （AHM） and entropy weight method （EWM） were used to combine and assign weights to each indicator within the DUE criteria. Additionally， the weighted technique for order preference by similarity to an ideal solution （TOPSIS） method was applied to perform rationality evaluation of medication in archived medical records from Hainan Provincial Tumor Hospital and Hainan Western Central Hospital regarding the use of pyrotinib from November 2019 to November 2023. RESULTS The established DUE criteria for pyrotinib included 4 primary indicators （prescription authority， indications for use， medication process， and medication outcomes） and 11 secondary indicators. The secondary indicators with higher weights were the route of administration and dosage （0.257） and indications in the label （0.241）. Among the 88 archived cases included， there were 28 cases of inappropriate medication （31.82%）， 43 cases of generally appropriate medication （48.86%）， and 17 cases of appropriate medication （19.32%）. The main issues related to inappropriate medication involved off-label use （42.05%） and inappropriate routes of administration and dosage （43.18%）. CONCLUSIONS DUE criteria for pyrotinib established using the AHM-EWM-weighted TOPSIS method is highly operational and results in quantifiable evaluation outcomes. The overall rationality of the use of pyrotinib in the above hospitals remains to be improved， and there are some issues， like the off-label use，and inappropriate routes of administration and dosage being liaoyylyy@163.com unreasonable.

OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution,providing a basis for optimizing the training system for committee members,improving the quality of ethical review,and fully safeguarding the safety and rights of subjects.METHODS Using methods such as literature research and expert consultation,a preliminary core competency evaluation index system was constructed.The Delphi method was employed to revise and validate it,ultimately forming an evaluation index system for the core competencies of ethics committee members.Based on this system,a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide,comparing their importance rating and self-assessment scores of the core competency indexes.RESULTS The evaluation system constructed included 4 primary indicators(ethics and professional knowledge,ethics review ability,communication and expression ability,moral integrity and work style)and 39 secondary indicators(familiarity with the content of clinical trial-related laws and regulations,ability to complete project ethics review and identify ethical defects in research protocols within a short period of time,ability to judge the scientific value of clinical research,etc.).The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge,ethical norms,review efficiency,risk judgment,and problem analysis.The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38.CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members.It can provide a scientific framework for committee member training,qualification certification,and standardized management of ethics committees.

OBJECTIVE To establish a core competency evaluation system for drug clinical trial quality management personnel in China and validate its application. METHODS Based on the scope of work， responsibilities， and role positioning of quality management personnel in drug clinical trials， a preliminary draft of the core competency evaluation system was constructed through literature analysis and expert consultation. The draft was refined through a Delphi method involving 17 experts who provided feedback and revisions， ultimately forming a complete evaluation system. The developed system was applied to conduct electronic surveys from March to May 2024 among 110 quality management personnel from 38 drug clinical trial institutions， comparing their scores on indicator importance and self-assessed capabilities. RESULTS The response rate of both rounds of questionnaire survey was 100%， with Kendall’s W coefficients of 0.256 and 0.277 （P＜0.001 for both）， and an expert authority coefficient of 0.946. The finalized evaluation system for core competencies of clinical trial quality management personnel comprised 9 primary indicators， covering individual professional competence， communication skills， implementation condition verification， informed consent process review， clinical trial execution monitoring， adverse event disposal， reporting and documentation， trial record examination， trial report auditing， and inspection of other tasks， and 107 secondary indicators. Empirical research revealed significant discrepancies between importance scores and self-assessed competency scores across 70 indicators among 110 respondents （P＜0.05）. Indicators with relatively notable gaps between importance scores and self-assessed competency scores included in-depth understanding of Good Clinical Practice （GCP） requirements （0.34-point gap）， familiarity with national and institutional clinical trial inspection priorities （0.24-point gap），etc. CONCLUSIONS The indicator system constructed in this study has good scientificity and reliability. Clinical trial quality management personnel demonstrate deficiencies in multiple critical competencies， highlighting the urgent need for targeted training programs to enhance their overall professional capabilities.

Objective:To analyze the epidemiological characteristics and influencing factors of single-cigarette use and dual cigarette-cigar use in China.Methods:This study was a cross-sectional study that selected 85 638 urban and rural residents who met the inclusion criteria from the 2018 China Health Literacy Survey as research subjects. An analysis was conducted on 21 849 users of cigarettes and cigars among them. Due to the small number of individuals who exclusively used cigars (247 cases), the research subjects were divided into two categories: exclusive cigarette users and dual users of cigarettes and cigars. The groups were categorized by age (18-34 years, 35-54 years, ≥55 years), gender (male, female), education level (primary school and below, junior high school and high school, university and above) and annual household income (<20 000 yuan, 20 000-<80 000 yuan, ≥80 000 yuan) to compare the tobacco usage rate and conduct subgroup analyses for each subgroup. Multivariate logistic regression analysis was employed, incorporating general demographic characteristic information to explore the influencing factors of exclusive cigarette use and dual use of cigarettes and cigars, respectively.Results:The rate of exclusive cigarette use in our country was 24.3%, while the dual use rate of cigarettes and cigars was 0.9%. The exclusive cigarette use rate and the dual use rate of cigarettes and cigars among males were significantly higher than those among females (48.25% vs 2.48%, and 1.84% vs 0.06%) (both P<0.001). For males, the high-risk factors for exclusive cigarette use included living in urban areas ( OR: 1.37, 95% CI: 1.23-1.54), being Han ethnicity ( OR: 1.73, 95% CI: 1.51-1.98), and having an annual household income ≥20 000 yuan ( OR: 1.54, 95% CI: 1.38-1.82) while having a junior high school education or higher was a protective factor ( OR: 0.68, 95% CI: 0.52-0.90). Age≥35 years ( OR: 3.36, 95% CI: 2.62-4.32) and having a junior high school education or higher ( OR: 1.30, 95% CI: 1.02-1.67) were risk factors for dual use of cigarettes and cigars in males. Among females, living in urban areas ( OR: 1.53, 95% CI: 1.19-1.97) and being Han ethnicity ( OR: 5.96, 95% CI: 4.47-7.96) were risk factors for exclusive cigarette use, while having a university education or higher was a protective factor ( OR: 0.28, 95% CI: 0.18-0.42). However, for female dual use of cigarettes and cigars, no significant effects were observed for any demographic characteristics. Conclusions:The use rate of cigarettes alone in China is significantly higher than that of cigarette-cigar dual use, and the rates of cigarette use alone and cigarette-cigar dual use in men are significantly higher than those in women. Tobacco use is being affected by sociodemographic factors, among which place of residence, ethnicity and education level are the main influencing factors of cigarette use alone, and gender, age and education level are the main influencing factors of cigarette-cigar dual use.

Objective:To establish a prognostic model and explore its clinical application based on disease progression within 24 months(POD24)in patients with multiple myeloma(MM).Methods:A total of 289 patients newly diagnosed with MM at Wuxi People's Hospital from January 2007 to June 2022 were selected as the training group for retrospective analysis.A prognostic model based on POD24 was constructed using Cox univariate and multivariate analyses of overall survival(OS).A total of 184 patients from The First Affiliated Hospital of Soochow University from August 2015 to December 2019 were included in the validation group to verify the predictive efficacy of the model.Results:Age,β2-microglobulin,Calcium,and POD24 were independent prognostic factors for MM.Patients in the high-risk group(≥2 points)had shorter OS(25.0 months vs.60.0 months)and progression-free survival(PFS)(14.0 months vs.56.0 months)than those in the low-risk group(<2 points).In addition,OS and PFS differed between the high-and low-risk groups in the entire validation group,as well as in each patient subgroup(P<0.05).Conclusions:The prognostic model based on POD24,age,β2 microglobulin,and Calcium holds prognostic value for patients newly diagnosed with MM in clinical practice.

Objective:To establish a prognostic model and explore its clinical application based on disease progression within 24 months(POD24)in patients with multiple myeloma(MM).Methods:A total of 289 patients newly diagnosed with MM at Wuxi People's Hospital from January 2007 to June 2022 were selected as the training group for retrospective analysis.A prognostic model based on POD24 was constructed using Cox univariate and multivariate analyses of overall survival(OS).A total of 184 patients from The First Affiliated Hospital of Soochow University from August 2015 to December 2019 were included in the validation group to verify the predictive efficacy of the model.Results:Age,β2-microglobulin,Calcium,and POD24 were independent prognostic factors for MM.Patients in the high-risk group(≥2 points)had shorter OS(25.0 months vs.60.0 months)and progression-free survival(PFS)(14.0 months vs.56.0 months)than those in the low-risk group(<2 points).In addition,OS and PFS differed between the high-and low-risk groups in the entire validation group,as well as in each patient subgroup(P<0.05).Conclusions:The prognostic model based on POD24,age,β2 microglobulin,and Calcium holds prognostic value for patients newly diagnosed with MM in clinical practice.