ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials， promote clinical trial progress， and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials， analyzing the advantages and challenges of decentralized drug clinical trials， and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review， and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility， applicability， and rationality， the adequacy of informed consent， the protection of rights and interests and privacy of subjects， as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties， pay attention to the rights and interests of subjects， and gradually promote the implementation of decentralized drug clinical trials.

Mutations in the IARS1 gene are rare in clinical practice， and up to now， only ten cases with detailed clinical and genetic data have been recorded in the literature. This article reports a case of growth retardation， intellectual developmental disorder， hypotonia， and hepatopathy （GRIDHH） associated with single heterozygous mutations in the IARS1 gene and summarizes the clinical and genetic features of GRIDHH， thereby expanding the genetic spectrum of GRIDHH.

Objective:To explore the predictive value of hepatitis B surface antibody (HBsAb) quantitative level for achieving hepatitis B surface antigen (HBsAg) seroclearance and serological conversion in patients with chronic hepatitis B (CHB) treated with nucleos(t)ide analogs (NAs) or interferon (IFN).Methods:A two-center prospective cohort study was conducted, including CHB patients from Nanfang Hospital Southern Medical University and Eastern Theater General Hospital treated with NAs and IFN. All patients were followed up once every three to six months. Basic clinical information and test results were collected at each follow-up. The presence or absence of HBsAg seroclearance and serological conversion rate was evaluated. HBsAg serological conversion was defined as HBsAg quantification continuously below the detection limit (<0.05 IU/mL) at two detection time points at least six months apart. HBsAg serological conversion was defined as HBsAb positivity (≥10 IU/L) at the same time as the first HBsAg seroclearance. The Kruskal-Wallis test was used to compare the quantitative data of multiple groups, and the Wilcoxon rank-sum test was used to compare the data between groups. The chi-square test was used for the count data, and the Fisher exact test was used when the chi-square test was not met. Univariate and multivariate Cox analysis was used to determine the predictors of the study endpoints, and stepwise regression was used for variable screening.Results:A total of 2 266 CHB cases were included, of which 86.5% (1 959/2 266) were NA antiviral-received population. The median treatment duration before baseline was 10.5 (2.5, 37.6) months, and the baseline HBsAg quantification was 3.1 (2.6, 3.5) log 10 IU/mL. A total of 68 cases (3.0%) had HBsAg seroclearance, and 44 cases (1.9%) achieved serological conversion after 85.0 (62.7, 97.3) months of prospective follow-up. The level and positivity rate of HBsAb showed a progressive increase 36 months before and significantly after HBsAg seroclearance. Cox regression analysis results showed that baseline HBsAb level was an independent predictor of HBsAg serological conversion ( HR=2.26, P=0.002) in the overall population, especially in the subgroup with HBsAg between 100 and 1 000 IU/mL, suggesting HBsAb level had important predictive value. In addition, the serological conversion development rate was significantly higher in the GOLDEN model favourable patients than in the unfavourable patients (11.5% vs. 0, P<0.001). Conclusion:The baseline HBsAb quantitative level can predict HBsAg seroclearance and serological conversion for patients with CHB receiving antiviral treatment, which is of significant value in long-term treatment monitoring.

Objective:To investigate the prevalence and risk factors of overweight and obesity among Chinese children aged 3-18 years from 11 provinces, antonomous regions, or municipalities.Methods:This national cross-sectional community health survey utilized a multistage stratified cluster-random sampling method to recruit 193 997 nationally representative participants from 11 provinces, autonomous regions, or municipalities between January 2017 and December 2019. All participants underwent physical examinations, and their caregivers completed questionnaires assessing participants′ dietary, lifestyle, familial, and perinatal information. Multilevel multinomial logistic regression models were employed to identify the potential risk factors.Results:The cohort comprised 193 997 children (102 178 boys, 91 819 girls),aged (10±4) years. Overall prevalence rates were 30 574(15.8%)overweight children and 17 217(8.9%) obesity children. Boys exhibited higher overweight and obesity rates than girls (17.0% (17 368/102 178) vs. 14.4% (13 206/102 178), 11.3% (11 553/91 819) vs. 6.2% (5 664/91 819), χ2=249.12,1 578.69,both P<0.001). The detection rates of obesity in Tanner stage 2 and 3 were the highest in boys and girls, with 13.4%(2 231/16 665) and 8.6%(880/10 221) respectively. Risk factors for obesity included parental overweight (paternal OR=2.34 and maternal OR=2.29), annual household income of 100 000-200 000 yuan (compared with<100 000 yuan, OR=1.04), higher paternal education (compared with below high school,high school and a college education OR=1.09,1.14), birth weight >4.0 kg (≤5 and>5 years old OR=1.74, 1.44,respectively), and western food consumption≥1 time/month (compared with<1, 1-2, 3-4,>4 times/month OR=1.36, 1.30, 1.67(≤5 years), 1.19, 1.16, 1.15 (>5 years), respectively) (all P<0.05). Conversely, coarse grain intake≥1 times/week (compared with<1 times/week, every day, 3-4, 1-2 times/week OR=0.74, 0.80, 0.71 (≤5 years), 0.75, 0.87, 0.90(>5 years), respectively, all P<0.05) was associated with reduced obesity risk. Conclusions:Obesity epidemiology in children demonstrates significant heterogeneity across age, gender, geographic regions, and pubertal stages. It is necessary to establish a personalized prevention and control strategy.

Objective:To investigate the prevalence and risk factors of overweight and obesity among Chinese children aged 3-18 years from 11 provinces, antonomous regions, or municipalities.Methods:This national cross-sectional community health survey utilized a multistage stratified cluster-random sampling method to recruit 193 997 nationally representative participants from 11 provinces, autonomous regions, or municipalities between January 2017 and December 2019. All participants underwent physical examinations, and their caregivers completed questionnaires assessing participants′ dietary, lifestyle, familial, and perinatal information. Multilevel multinomial logistic regression models were employed to identify the potential risk factors.Results:The cohort comprised 193 997 children (102 178 boys, 91 819 girls),aged (10±4) years. Overall prevalence rates were 30 574(15.8%)overweight children and 17 217(8.9%) obesity children. Boys exhibited higher overweight and obesity rates than girls (17.0% (17 368/102 178) vs. 14.4% (13 206/102 178), 11.3% (11 553/91 819) vs. 6.2% (5 664/91 819), χ2=249.12,1 578.69,both P<0.001). The detection rates of obesity in Tanner stage 2 and 3 were the highest in boys and girls, with 13.4%(2 231/16 665) and 8.6%(880/10 221) respectively. Risk factors for obesity included parental overweight (paternal OR=2.34 and maternal OR=2.29), annual household income of 100 000-200 000 yuan (compared with<100 000 yuan, OR=1.04), higher paternal education (compared with below high school,high school and a college education OR=1.09,1.14), birth weight >4.0 kg (≤5 and>5 years old OR=1.74, 1.44,respectively), and western food consumption≥1 time/month (compared with<1, 1-2, 3-4,>4 times/month OR=1.36, 1.30, 1.67(≤5 years), 1.19, 1.16, 1.15 (>5 years), respectively) (all P<0.05). Conversely, coarse grain intake≥1 times/week (compared with<1 times/week, every day, 3-4, 1-2 times/week OR=0.74, 0.80, 0.71 (≤5 years), 0.75, 0.87, 0.90(>5 years), respectively, all P<0.05) was associated with reduced obesity risk. Conclusions:Obesity epidemiology in children demonstrates significant heterogeneity across age, gender, geographic regions, and pubertal stages. It is necessary to establish a personalized prevention and control strategy.

Objective:To explore the predictive value of hepatitis B surface antibody (HBsAb) quantitative level for achieving hepatitis B surface antigen (HBsAg) seroclearance and serological conversion in patients with chronic hepatitis B (CHB) treated with nucleos(t)ide analogs (NAs) or interferon (IFN).Methods:A two-center prospective cohort study was conducted, including CHB patients from Nanfang Hospital Southern Medical University and Eastern Theater General Hospital treated with NAs and IFN. All patients were followed up once every three to six months. Basic clinical information and test results were collected at each follow-up. The presence or absence of HBsAg seroclearance and serological conversion rate was evaluated. HBsAg serological conversion was defined as HBsAg quantification continuously below the detection limit (<0.05 IU/mL) at two detection time points at least six months apart. HBsAg serological conversion was defined as HBsAb positivity (≥10 IU/L) at the same time as the first HBsAg seroclearance. The Kruskal-Wallis test was used to compare the quantitative data of multiple groups, and the Wilcoxon rank-sum test was used to compare the data between groups. The chi-square test was used for the count data, and the Fisher exact test was used when the chi-square test was not met. Univariate and multivariate Cox analysis was used to determine the predictors of the study endpoints, and stepwise regression was used for variable screening.Results:A total of 2 266 CHB cases were included, of which 86.5% (1 959/2 266) were NA antiviral-received population. The median treatment duration before baseline was 10.5 (2.5, 37.6) months, and the baseline HBsAg quantification was 3.1 (2.6, 3.5) log 10 IU/mL. A total of 68 cases (3.0%) had HBsAg seroclearance, and 44 cases (1.9%) achieved serological conversion after 85.0 (62.7, 97.3) months of prospective follow-up. The level and positivity rate of HBsAb showed a progressive increase 36 months before and significantly after HBsAg seroclearance. Cox regression analysis results showed that baseline HBsAb level was an independent predictor of HBsAg serological conversion ( HR=2.26, P=0.002) in the overall population, especially in the subgroup with HBsAg between 100 and 1 000 IU/mL, suggesting HBsAb level had important predictive value. In addition, the serological conversion development rate was significantly higher in the GOLDEN model favourable patients than in the unfavourable patients (11.5% vs. 0, P<0.001). Conclusion:The baseline HBsAb quantitative level can predict HBsAg seroclearance and serological conversion for patients with CHB receiving antiviral treatment, which is of significant value in long-term treatment monitoring.

Objective To investigate current status in knowledge,attitude and practice(KAP)of transitional care among the nurses in Shaanxi province,identify the influencing factors that hinder the transitional care and carry out training of transitional care for the nurses in different specialties in order to provide a theoretical basis for establishing a transitional care model for discharged patients.Methods A total of 2 288 nurses were selected to participate the survey from 41 hospitals in Shaanxi province by the stratified two-stage random sampling method.A self-designed questionnaire for general information,an obstacle factor scale,and a KAP of transitional care questionnaire were used as the survey instruments.The data acquired from the survey were processed by Cluster analysis to identify potential categories and the influencing factors.Results Totally 2085 nurses finished the study.Total score of KAP of transitional care among the nurses in Shaanxi province was found at(134.96±23.75),which was at a medium level.The scores of knowledge,attitude and practice were 77.24%,80.64%and 76.98%respectively.Cluster analysis showed that all the nurses could be categorised into either a lower scored group(n=1 596,76.5%)or a higher scored group(489,23.5%),with a best potential category number of 2 for the 2 085 nurses who participated the survey.There were statistically significant differences between the groups in terms of care training,telephone follow-up,network platform,outpatient service of nursing experts,family visits,patient club and hospital categories(all P＜0.05).Logistic regression analysis on even factors above showed that care training,telephone follow-up,network platform and patient club could significantly affect the potential categorisation of KAP of the nurses in transitional care(all P＜0.05).The main factors that hindered the transitional care included insufficient human resources(93.81%),insufficient supply of community services(93.57%)and lack of a standardised flowchart for transitional care(93.09%).Conclusions Levels of KAP about the transitional care are at a medium level among the nurses of 41 hospitals in Shaanxi province,which indicates that the nurses are active in attitude,but the knowledge and practice are required to be further improved and standardised.The results of cluster analysis indicate that it is necessary for nursing managers to carry out targeted trainings in transitional care for the nurses in different categories.This study provides a theoretical basis to establish a diversified transitional care mode for discharged patients in Shaanxi province.

Graves′ disease (GD) is the most prevalent cause of hyperthyroidism in children, posing a significant threat to their normal growth and development.The incidence of GD is increasing year by year.Antithyroid drugs are the preferred treatment for GD in children, which can alleviate immune disorders and normalize thyroid function in a short period of time.However, there are still numerous unsolved problems and controversies surrounding this treatment, and the challenges that need to be overcome include the low remission rate, high recurrence rate and high incidence of adverse reactions.The key challenges facing antithyroid drug therapy are how to normalize thyroid function quickly, maintain therapeutic efficacy and reduce recurrence rate, and further studies are needed to improve the effectiveness and safety of the therapy.This article summarizes and reviews the therapeutic strategies, controversies and adverse reactions of antithyroid drugs for GD in children and adolescents.

Objective:The classification model of prognosis of elderly cancer patients in rural areas of Shaanxi province was constructed based on machine learning algorithm, and its effectiveness was verified, providing reference for early prognosis recognition and intervention treatment.Methods:Using a multicenter, cross-sectional survey method and convenience sampling method, 597 elderly cancer patients in rural areas hospitalized in 9 different medical institutions (Shaanxi Cancer Hospital and its member units of specialty alliance) in Shaanxi Province from July to August 2022 were selected as the research objects, and a variable database of "basic information", "self-care ability", "symptoms", "comprehensive needs" and "quality of life" of elderly cancer patients in rural areas was established. Machine learning and statistical analysis were carried out to explore the important prognostic characteristics of elderly cancer patients in rural areas, and a prognostic classification model for elderly cancer patients in rural areas was constructed and verified.Results:The 597 valid questionnaires were ultimately collected.Among the 597 elderly cancer patients in rural areas, 207 were males and 390 were females, aged (69.56 ± 8.84) years. The results of cluster exploration showed that the prognosis of elderly cancer patients in rural areas was divided into three categories: good, medium and poor. The areas under the working characteristic curves of the subjects in good, medium and poor were 0.84, 0.79 and 0.69, respectively. The results of characteristic exploration showed that 10 indicators of "whether accompanied by metastasis", "distress", "sadness", "numbness", "eating", "walking", "fatigue", "forgetfulness", "fun of life" and "relationship with others" were important characteristic indicators of prognosis evaluation of elderly cancer patients in rural areas. There were statistically significant differences among the 10 important characteristic indicators in the three categories of prognosis of rural elderly cancer patients ( χ2=21.07, H values were 18.51-144.38, all P<0.01). There were statistically significant differences in the three categories of "comprehensive needs", "quality of life", "self-care ability" and "symptoms" ( H values were 519.40, 40.80, 103.69, all P<0.01). Conclusions:The construction and verification of a prognostic classification model for elderly cancer patients in rural areas based on machine learning algorithm can effectively explore the important characteristic indicators and prognostic classification of elderly cancer patients in rural areas, and provide basis and guidance for clinical medical staff to make individualized plans.

Objective:To investigate the effects of abdominal Tuina(Chinese therapeutic massage)on behavioral function,5-hydroxytryptamine 1A receptor(5-HT1AR),and synapsin-1(Syn1)in neonatal rats with hypoxic-ischemic brain injuries(HIBI). Methods:Forty healthy neonatal rats,born of 5 specific pathogen-free healthy pregnant rats,were randomly divided into a group for modeling(n=28)and a sham operation group(n=12)on the 7th day of birth.In the group for modeling,24 neonatal rats with HIBI successfully established by the Rice method were randomly divided into a model group(n=12)and an abdominal Tuina group(n=12).The abdominal Tuina group was given abdominal Tuina for 28 d from 24 h after modeling,and the other groups were put under the same conditions but without any treatments.Rats in each group were subjected to suspension tests on the 7th,14th,21st,and 28th days of intervention.After the intervention,the rat hippocampal tissue was collected and stained with hematoxylin-eosin to observe the pathological changes in the rat hippocampal CA1 region.The 5-HT1AR expression in rat hippocampal CA1 region was detected by immune-histochemistry.The Syn1 expression in rat hippocampus was measured by Western blotting method. Results:The cells were disordered,and edema and necrosis appeared in the hippocampal CA1 region of the model group.Cell arrangement was clear,and edema was improved obviously in the hippocampal CA1 region of the abdominal Tuina group.Compared with the sham operation group,the suspension test scores,the number of 5-HT1AR positive cells,and Syn1 protein expression in the hippocampus decreased significantly in the model group after 21 d and 28 d of interventions(P<0.05).Compared with the model group,the suspension test scores,the number of 5-HT1AR positive cells,and Syn1 protein expression increased significantly in the abdominal Tuina group after 21 d and 28 d of interventions(P<0.05). Conclusion:Abdominal Tuina improves the behavioral function of upper limbs and up-regulates the expression levels of 5-HT1AR and Syn1 in the hippocampus of neonatal HIBI rats.