Surgical operation is the main treatment of oral and maxillofacial tumors.Dysphagia is a common postoperative complication.Swal-lowing disorder can not only lead to mis-aspiration,malnutrition,aspiration pneumonia and other serious consequences,but also may cause psychological problems and social communication barriers,affecting the quality of life of the patients.At present,there is no systematic evalua-tion and rehabilitation management plan for the problem of swallowing disorder after oral and maxillofacial tumor surgery in China.Combining the characteristics of postoperative swallowing disorder in patients with oral and maxillofacial tumors,summarizing the clinical experience of ex-perts in the field of tumor and rehabilitation,reviewing and summarizing relevant literature at home and abroad,and through joint discussion and modification,a group of national experts reached this consensus including the core contents of the screening of swallowing disorders,the phased assessment of prognosis and complications,and the implementation plan of comprehensive management such as nutrition management,respiratory management,swallowing function recovery,psychology and nursing during rehabilitation treatment,in order to improve the evalua-tion and rehabilitation of swallowing disorder after oral and maxillofacial tumor surgery in clinic.

Objective To explore the key active ingredients and action characteristics of Wenxing Jingjintong Gel Patch in the treatment of rheumatoid arthritis(RA)based on the systematic pharmacology and LC-MS/MS technology.Methods The information of active ingredient from Wenxing Jingjintong Gel Patch was established through LC-MS/MS analysis and literature retrieval.The targets of the active ingredients were predicted using Swiss Target Prediction platform and then mapped with the RA-related targets obtained from GeneCards,DrugBank,and OMIM databases to identify the intersecting targets.The"active ingredients-effective targets"network was constructed through the Cytoscape software.The shared targets were imported into STRING database to construct a protein-protein interaction network.GO function and KEGG pathway enrichment analysis were performed using the Metascape database.Molecular docking studies were conducted using AutoDock software to investigate the interactions between key ingredients and target proteins.Results A total of 142 active ingredients were identified in Wenxing Jingjintong Gel Patch by wsing LC-MS/MS,which were further supplemented to 174 through literature retrieval.There were 175 shared targets between the active ingredients and RA.It was anticipated that Wenxing Jingjintong Gel Patch exerted immune regulation and anti-inflammatory and analgesic effects through the interaction between key active ingredients such as berberine,neobavaisoflavone,and palmatine chloride with key targets,including TNF,IL6,and AKT1 to regulate PI3K/Akt1,JAK/STAT,and MAPK signaling pathways.In 1 152 molecular docking validation,94%of them had binding energies less than-5.0 kcal·mol-1,while 51%of them had binding energies less than-7.0 kcal·mol-1.It was indicated that there was a good binding affinity between the potential active ingredients and core targets.Conclusion This study predicted the active ingredients and action characteristics of Wenxing Jingjintong Gel Patch in the treatment of RA,which provided a theoretical basis for further clinical application and quality control.

Objective:To explore the latent classes of recurrence fear in nasopharyngeal carcinoma patients and analyze their influencing factors.Methods:From July 2021 to December 2023, convenience sampling was used to select nasopharyngeal carcinoma patients admitted to the Eye and ENT Hospital of Fudan University as research subjects. The survey was conducted using the General Information Questionnaire, Fear of Progression Questionnaire-Short Form, Brief Illness Perception Questionnaire, and Medical Coping Modes Questionnaire. Mplus 8.3 software was used for latent profile analysis. Multivariate logistic regression was used to analyze the factors influencing the different classes of recurrence fear in nasopharyngeal carcinoma patients.Results:A total of 208 questionnaires were distributed, and 208 valid questionnaires were collected, with a valid response rate of 100.00%. The recurrence fear score of 208 nasopharyngeal carcinoma patients was (34.01±8.32). The fear of recurrence in nasopharyngeal carcinoma patients included three latent classes: low fear (19.71%, 41/208), moderate fear (66.83%, 139/208), and high fear (13.46%, 28/208). There were statistically significant differences in gender, working condition, individual monthly income, tumor clinical stage, illness perception, and medical coping modes among nasopharyngeal carcinoma patients with different recurrence fear classes ( P<0.05) . Conclusions:Nasopharyngeal carcinoma patients generally have a fear of recurrence. Medical and nursing staff should focus on patients who are female, retired or unemployed, have low personal economic income, have high tumor stages, have severe negative illness perception, and have negative coping modes, and take effective intervention measures as soon as possible.

Drug clinical trials need to recruit suitable subjects to verify the safety and effectiveness of new drugs. Subject recruitment is a very important and challenging link in the whole process of drug clinical trials, and even directly affects the progress and final results of the trials. The medical ethics committee should give full play to the important function of ethical review, carefully review the whole process of subject recruitment from the perspective of science and ethics, and do a good job in the protection of the health and rights of subjects. This paper mainly discussed the basic principles of subject recruitment, the main problems existing in the recruitment process and the key contents of ethical review, so as to provide scientific references and suggestions for standardizing subject recruitment, protecting the rights and interests of subjects, and promoting the efficient and high-quality completion of drug clinical trials.

Humans ; Consensus ; Liver Neoplasms/therapy* ; China

Objective:To analyze the implementation of early essential newborn care (EENC) in baby-friendly hospitals in China.Methods:This is an investigation carried out using convenience sampling method. People in charge of labor ward, obstetric wards or neonatology department of the selected hospitals, such as baby-friendly hospitals with birth facilities, primary or higher level of hospitals, or general hospitals or those specialized in obstetrics and gynecology or materal and child health care centers, were selected as the subjects of the survey. Information about EENC practices in these hospitals was collected using a self-designed questionnaire sent through WeChat from April 1 to 30, 2021. Chi-square test was used for statistical analysis. Results:A total of 126 questionnaires were distributed and 124 (124 baby-friendly hospitals) were withdrawn. There were 74 hospitals in the eastern, 18 in the central and 32 in the western region. Among the 124 hospitals, tertiary hospitals, general hospitals, and maternity and child care hospitals accounted for 72.6% ( n=90), 64.5% ( n=80) and 35.5% ( n=44), respectively. There were no significant differences in the hospital type, levels, EENC coverage and training, or implementation of mainly recommended EENC practices among the hospitals in the eastern, central and western regions (all P>0.05). The implementation rate of at least one mainly recommended EENC practice was 79.0% (98/124) and there was no significant difference in the implementation rates among eastern, central and western regions [86.4% (64/74), 13/18 and 65.6% (21/32), χ2=6.60, P=0.159]. A total of 80 (64.5%) hospitals implemented 10 or more recommended EENC practices, and the implementation rates in eastern, central and western regions were 71.6% (53/74), 10/18 and 53.1% (17/32), respectively ( χ2=4.08, P=0.130). Among the 17 mainly recommended measures of EENC, in eastern, central and western hospitals, the implementation rates were 10.8% (8/74), 2/18 and 18.8% (6/32) for mother-infant skin-to-skin contact for 90 min after birth; 66.2% (49/74), 11/18 and 68.8% (22/32) for delayed umbilical cord clamping; and 25.7% (19/74), 7/18 and 21.9% (7/32) for delayed routine care following skin-to-skin contact, respectively ( χ2=6.57, 0.34 and 4.53, all P>0.05). Conclusions:There is a big gap between the implementation of EENC in most baby-friendly hospitals in eastern, central and western China and the recommendation of the World Health Organization. It is necessary to further strengthen and standardize the implementation of EENC practices in baby-friendly hospitals in our country to continuously improve the health of newborns.

Objective:To discuss ethical review and management of serious adverse events in anti-tumor drug clinical trials in a grade A tertiary cancer hospital for timely and effective protection of subjects.Methods:The main contents and ethical management of ethical review on serious adverse events were retrospectively analyzed including the number, distribution rules, and whether they were reported in time in clinical trials conducted in our hospital in 2021.Results:A total of 1 789 serious adverse events in 259 clinical trials were reported, with more male subjects than female, with an average age of 59.95 years, mainly concentrated in the 50~59 age and 60~69 age groups, accounting for 27.45% and 42.37% respectively. Digestive oncology department, thoracic oncology department and renal cancer melanoma department ranked in the top three for the number of clinical trials and reports of serious adverse events. The highest incidence of serious adverse events was hospitalization at 63.44% and the lowest incidence was disability at 0.39%. The highest proportion of serious adverse events possibly related to clinical trials was 35.72%. Expected serious adverse events accounted for 65.85% versus 34.15% unexpected ones, and the difference between different correlations of serious adverse events whether they were expected or not.was statistically significant. Among the measures taken by the investigator for the test drugs due to serious adverse events, drug discontinuation was the most, accounting for 42.54%, while 3.07% of the trial plans modified the study protocol/informed consent. Serious adverse events reported within 24 hours accounted for 87.20%, and those reported in 24 hours and beyond accounting for 12.80%. A statistically significant difference of the reporting time between the registered and investigator initiated clinical trials was observed.Conclusions:The ethics committee should attach importance to ethical review and management of serious adverse events, pay attention to whether they were reported timely and accurately, strengthen supervision, and effectively protect the safety and interests of the subjects.

Animals ; Antlers ; Exosomes ; Mesenchymal Stem Cells ; Osteoarthritis/therapy*

The outbreak of major infectious diseases such as COVID-19 are unpredictable. In order to prevent the rapid spread of the epidemic, it is necessary to quickly start the first-class response to public health emergencies, take prevention and control measures such as isolating confirmed patients, suspected cases and close contacts, tracking their activity tracks, and publishing their infection related information, which may cause the leakage of personal privacy and information. Take preventive and control measures, which needs to protect the public interests while taking into account individual rights and interests, including privacy protection, and obtaining public understanding and support. The ethical governance of personal privacy protection in the prevention and control of major infectious diseases needs to regulate the use of personal information according to laws and regulations, achieve effective ethical governance in multiple dimensions, establish and improve the supervision and management mechanism of personal privacy protection, enhance the privacy protection awareness of relevant departments and staff, increase the punishment for illegal acts, strengthen science popularization, promote public understanding, and improve the efficiency and effectiveness of prevention and control.

Objective:To analyze ethical management of subjects′ complaints in drug clinical trials in a cancer hospital.Methods:A retrospective analysis of the complaints of subjects received and properly handled by the ethics committee through telephone, e-mail and on-site reception during the drug clinical trial in our hospital. Case studies were conducted to analyze the reasons for the occurrence of some particular subjects′ complaints, processing procedures and resolution processes.Results:The number of subjects' complaints in clinical trials in our hospital decreased year by year. The ethics committee of our hospital would check it immediately and review it carefully after receiving the subjects′ complaints, and return the review decisions to the subjects and researchers, at the same time, follow up with board meeting report and documentation. Regarding to the reasons of the subject complaint, mainly identified were the failure to participate in clinical trials due to inclusion and exclusion criteria, withdraw by investigators due to safety concerns, and not satisfied with the compensation.Conclusions:When receiving subjects′ complaints, the ethics committee should manage them seriously, verify the reasons in time and follow up properly, act as a communication bridge between subjects, researchers and sponsors, try their best to resolve subjects′ complaints, and protect the rights and interests of subjects.