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 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.

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

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

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

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.

Objective:To investigate the clinical characteristics of elderly patients with coronavirus disease 2019(COVID-19), in order to provide scientific evidence for the diagnosis and treatment of COVID-19 in elderly patients.Methods:Clinical data of 102 patients with COVID-19 admitted to the B11 East Ward of the Zhongfaxincheng campus and the E1-3 ward of the Guanggu Campus of Tongji Hospital affiliated to Huazhong University of Science and Technology in Wuhan from 1 February 2020 to 28 February 2020 were retrospectively collected and analyzed.Patients were categorized into 2 groups: the elderly group(≥60 years old)and the young and middle-aged group(<60 years old). Differences in epidemiological features, demographics, clinical symptoms, laboratory results and imaging findings between the two groups were retrospectively analyzed.Results:Among 102 patients with COVID-19, 58 were in the elderly group(≥60 years old), with a median age of 67.0(63.8, 71.0)years old, and 44 in the young and middle-aged group(<60 years old), with a median age of 47.5(38.0, 51.8)years old.There was no significant difference in gender ratio between the two groups( χ2=0.033, P=0.855). Of 102 patients, 42.0%(21/50)had close contact with an infected person, 14.0%(7/50)were from infection clusters, and 18.0%(9/50)had suspected hospital-acquired infections.Fever and cough remained the most common symptoms, but gastrointestinal symptoms such as nausea, poor appetite, diarrhea and muscle cramps were also warning signs.Fatigue and cough were the most common presenting symptoms in elderly male patients.Bilateral patchy infiltrates(57.9%, 22/38)and ground-glass opacities(42.1%, 16/38)were the main imaging features and 42.1%(16/38)patients had multiple areas of the lungs involved.Over 50% patients had increased levels of blood glucose, D-dimer, fibrinogen, C-reactive protein, procalcitonin, multiple cytokines and neutrophil-to-lymphocyte ratio, as well as decreased levels of albumin, hemoglobin, hematocrit, lymphocytes and serum calcium.Compared with the young and middle-aged group, the elderly group had higher rates of abnormality in levels of D-dimer and serum calcium( χ2=7.067 and 4.166, P=0.008 and 0.041). Conclusions:Fever and cough are the most common symptoms in elderly patients with COVID-19.Elderly patients with COVID-19 have multiple abnormalities in clinical laboratory test results, which show a certain level of specificity compared with young and middle-aged patients.

Objective:To investigate the risk factors for death in children with acute necrotizing encephalopathy (ANE) in pediatric intensive care unit (PICU).Methods:This was a multicenter retrospective study. Thirty-nine children with ANE were from PICUs in 4 centers from December 1, 2014 to December 1, 2020. The 4 participating centers were Beijing Children′s Hospital, Shengjing Hospital of China Medical University, Hebei Children′s Hospital, and Bao′an Maternity & Child Health Hospital. Patients were divided into survival and non-survival groups by the outcome at discharge, and the differences in clinical data between the two groups were compared. Risk factors for death in children with ANE and the odds ratios ( OR) were analyzed by univariable Logistic regression. Results:Thirty-nine children with ANE were included. There were 18 males and 21 females. The median onset age was 30 months. The mortality at discharge was 41% (16/39). The onset age of most patients (74%, 29/39) was younger than 4 years old. Influenza virus was the most common precursor infection (80%, 20/25). Patients with shock at PICU admission were more common in the non-survival group (12/16 vs. 17% (4/23), P=0.001). Glasgow coma score (GCS) at PICU admission was significantly lower in the non-survival group than survival group (3 (3, 6) vs. 6 (5, 7), Z=-2.598, P=0.009). The optimal cut-off value was 4. The proportion of patients with GCS ≤ 4 at PICU admission was higher in the non-survival group (10/16 vs. 22% (5/23), P=0.018). ANE severity score (ANE-SS) at PICU admission was significantly higher in the non-survival group (5 (2, 6) vs. 2 (1, 4), Z=-2.436, P=0.015). The proportion of patients with high risk ANE-SS was higher in non-survival group than the survival group (9/16 vs. 22% (5/23), P=0.043). The proportion of application of high-dose methylprednisolone (20 mg/(kg·d)) was significantly higher in survival group than non-survival group (43% (10/23) vs. 1/13, P=0.031). Univariable Logistic regression indicated that risk factors for death in children with ANE were shock ( OR=14.250, 95% CI 2.985-68.018, P=0.001), GCS≤4 ( OR=6.000, 95% CI 1.456-24.733, P=0.013) and high risk ANE-SS ( OR=4.629, 95% CI 1.142-18.752, P=0.032) at PICU admission. Conclusions:ANE usually occurs in children under 4 years old after influenza infection. Shock, GCS≤4 and high risk ANE-SS at PICU admission were risk factors for death in children with ANE. High-dose methylprednisolone may improve the prognosis of children with ANE.