ObjectiveTo investigate the current status and related factors of maternal influenza vaccination willingness among pregnant and postpartum women in Shanghai and Liaoning Province, China, and to explore the facilitators and barriers affecting vaccination uptake, so as to provide references for future practices in promoting maternal influenza immunization in China. MethodsA convergent mixed-methods research was conducted. From January to March 2024, a questionnaire survey was conducted among women attending prenatal and postnatal care at 7 medical institutions in Shanghai and Dalian, Liaoning Province, which aimed to assess pregnant women’s knowledge about influenza vaccine and their willingness to vaccination during pregnancy, as well as to identify the related factors. In addition, purposive sampling method was used to conduct in-depth interviews with pregnant women and perinatal healthcare service providers to explore their perspectives on influenza vaccination during pregnancy, including the reasons for their willingness or unwillingness to receive ( or recommend) the vaccine, and the relevant facilitators and barriers to vaccination. ResultsA total of 366 pregnant and postpartum women participated in the questionnaire survey, and 9.56% (35/366) of them were willing to receive the influenza vaccine during pregnancy. The results of multivariate logistic stepwise regression analyses showed that primipara (aOR=0.158, 95%CI: 0.037‒0.671, P=0.012), family members’ support for influenza vaccination during pregnancy (aOR=0.015, 95%CI: 0.003‒0.082, P<0.001) were associated with higher willingness to receive influenza vaccine during pregnancy. Absence of influenza infection during pregnancy (aOR=5.383, 95%CI: 1.801‒16.092, P<0.001), and lack of knowledge regarding influenza vaccination during pregnancy (aOR=11.294, 95%CI: 3.593‒35.496, P<0.01) were associated with lower willingness to receive influenza vaccine during pregnancy. Qualitative findings indicated that the facilitators to vaccination willingness among pregnant and postpartum women included the recommendation of healthcare service providers, adequate knowledge of influenza vaccine information and family members’ support for vaccination. Conversely, the barriers to vaccination willingness included low recommendation from the healthcare service providers, lack of knowledge about the safety of influenza vaccine during pregnancy and inadequate attention to influenza and influenza vaccine. ConclusionThe willingness to receive influenza vaccination among pregnant and postpartum women in Shanghai and Liaoning Province is relatively low. It is recommended that China should promptly improve the evidence-based system for the safety and efficacy of influenza vaccines for pregnant and postpartum women, along with an establishment of the mechanism for addressing adverse reactions. Furthermore, it is essential to enhance educational outreach to pregnant and postpartum women, their families, and healthcare service providers, thereby increasing the accessibility of information regarding influenza vaccination, which are expected to enhance the willingness of pregnant and postpartum women to receive the vaccine.

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.

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 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.

BACKGROUND: The fetal growth charts in widest use in China were published by Hadlock >35 years ago and were established on data from several hundred of American pregnant women. After that, >100 fetal growth charts were published around the world. We attempted to assess the impact of applying the long-standing Hadlock charts and other charts in a Chinese population and to compare their ability to predict newborn small for gestational age (SGA). METHODS: For this retrospective observational study, we reviewed all pregnant women ( n  = 106,455) who booked prenatal care with ultrasound measurements for fetal biometry at the Shenzhen Maternity and Child Healthcare Hospital between 2012 and 2019. A fractional polynomial regression model was applied to generate Shenzhen fetal growth chart ranges for head circumference (HC), biparietal diameter (BPD), abdominal circumference (AC), and femur length (FL). The differences between Shenzhen charts and published charts were quantified by calculating the Z -score. The impact of applying these published charts was quantified by calculating the proportions of fetuses with biometric measurements below the 3rd centile of these charts. The sensitivity and area under the receiver operating characteristic curves of published charts to predict neonatal SGA (birthweight <10th centile) were assessed. RESULTS: Following selection, 169,980 scans of fetal biometry contributed by 41,032 pregnancies with reliable gestational age were analyzed. When using Hadlock references (<3rd centile), the proportions of small heads and short femurs were as high as 8.9% and 6.6% in late gestation, respectively. The INTERGROWTH-21st standards matched those of our observed curves better than other charts, in particular for fat-free biometry (HC and FL). When using AC<10th centile, all of these references were poor at predicting neonatal SGA. CONCLUSIONS Applying long-standing Hadlock references could misclassify a large proportion of fetuses as SGA. INTERGROWTH-21st standard appears to be a safe option in China. For fat-based biometry, AC, a reference based on the Chinese population is needed. In addition, when applying published charts, particular care should be taken due to the discrepancy of measurement methods.
Infant, Newborn ; Child ; Female ; Pregnancy ; Humans ; Growth Charts ; Prenatal Care ; Ultrasonography, Prenatal/methods* ; Fetal Development ; Fetal Growth Retardation ; Gestational Age ; Fetus ; China ; Infant, Newborn, Diseases ; Observational Studies as Topic

Objective:To establish a cytokine release syndrome (CRS) mouse model related to CAR-T cell therapy and provide a research model for the clinical phenomena.Methods:CAR-T cells targeting human CD19 molecule were constructed by molecular cloning and lentiviral transfection. Flow cytometry (FACS) was used to detect the transfection efficiency of CAR-T cells. The tumor-killing efficiency of CAR-T cells was detected by ELISA and flow cytometry. The CAR-T cells were injected into the tumor-bearing SCID/Beige mice through tail vein, and divided into phosphate buffered solution (PBS) group, low-burden group (1×10 5 Raji-Luc2 cells) and high-burden group (5×10 5 Raji-Luc2 cells). The tumor treatment effect was detected by animal in vivo imaging. Serum levels of cytokines including human IFN-γ, human IL-2, mouse IL-6, and mouse GM-CSF were measured by ELISA. The health status of the mice was evaluated by pathological examination. Results:The health scores of T cell group and T cell+ OKT-3 group were (1.15±0.08) and (2.90±0.15), respectively, after the injection of human T cell and T cell + OKT-3 antibody through tail vein, and the difference was statistically significant ( P<0.001). The serum levels of human IL-2, human IFN-γ, human IL-15, mouse IL-6 and mouse GM-CSF in T cell+ OKT-3 group were (1 064.00±50.14), (1 285.00±193.90), (202.4±18.76), (1 478.00±289.20) and (350.70±42.27) pg/ml, respectively, higher than (22.67±6.36), (23.67±3.71), (44.33±14.45), (147.30±36.20), (138.00±22.74) pg/ml in T cell group ( P<0.05). OKT-3 combined with human T cells caused a rapid increase in serum levels of human IL-2, human IFN-γ, mouse IL-6 and mouse GM-CSF, accompanied by an increase in body temperature and weight loss. CD19-targeting CAR-T cells were successfully constructed, and the positive rate of CAR-T cells was >30% detected by flow cytometry. ELISA results showed that in the presence of CD19 antigen, IL-2 and IFN-γ secreted by CAR-T19 cells co-incubated with Raji and Nalm were (561.00±37.07), (680.30±71.27), (369±25.71) and (523.00±26.31) pg/ml, respectively, higher than (55.00±20.53) and (64.00±7.55) pg/ml in the co-incubated with K562 group ( P<0.001). Activated CAR-T19 cells were reinjected through the tail vein on the seventh day after tumor formation. Imaging experiments in mice showed that on the thirteenth day after tumor formation, the fluorescence intensities of tumors in the low-burden and high-burden groups were lower than on the seventh day of tumor inoculation, and the fluorescence intensity of tumors in the high-burden group decreased from 144.00±24.69 to 5.02±2.35 ( P=0.005). The fluorescence intensity of low burden group decreased from 58.47±9.36 to 3.48±1.67 ( P=0.004). The serum levels of T cell activation related cytokines IL-2, IL-15 and IFN-γ increased rapidly, and the secretion of monocyte related cytokines IL-16 and GM-CSF increased, accompanied by the typical characteristics of CRS such as increased body temperature and weight loss at 72 hours after injection of CAR-T19 cells. Conclusions:CAR-T cells targeting CD19 molecule are successfully constructed, and CRS phenomenon is verified in tumor-bearing mice by CAR-T cell re-infusion, providing an animal model for the mechanism of CAR-T treatment-related CRS and CRS prevention strategies.