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 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.

Objective:To analyze the expression of CD44 in non-alcoholic fatty liver disease (NAFLD) accompanied with hepatitis B virus (HBV) infection and its clinical significance.Methods:Blood sample of hospitalized patients with NAFLD, chronic hepatitis B, cirrhosis, and healthy population (control) was collected. The study was approved by the hospital ethics committee. Serum CD44 level and clinopathological characteristics were analyzed quantitatively by enzyme-linked immunosorbent-assay. Flow cytometry was used to analyze the proportion of CD44 +T lymphocytes in patients with NAFLD and chronic hepatitis B. NAFLD model was prepared with high-fat diet to verify the abnormal expression of CD44. Results:Compared with the healthy control group, the expression of serum CD44 in the cirrhosis group, chronic hepatitis B group and NAFLD group was increased, and the difference between the groups were statistically significant ( P < 0.01). NAFLD patients graded as mild or severe group were equally accompanied by hepatocyte injury, abnormal blood glucose, lipid or CD44. In NAFLD patients accompanied with HBV infection, serum CD44 concentrations were significantly higher in HBsAg, HBeAg and HBV DNA positive group than HBsAg, HBeAg and HBV DNA negative group ( P < 0.01). The proportion of CD44 +T lymphocytes in peripheral blood of NAFLD and chronic hepatitis B group were 78.2% ± 16.3% and 68.5% ± 20.9%, respectively, and both groups (NAFLD and chronic hepatitis B) were significantly higher than the healthy control group (46.5% ± 20.5%) ( P < 0.05). The high-fat diet model confirmed that in rat liver tissues the CD44 was overexpressed with fat deposition accompanied with liver cell damage, especially remarkable in liver tissues containing carcinogens. Conclusion:The abnormal expression of CD44 in patients with NAFLD may be related to the malignant transformation of HBV-related liver disease.

Objective: To design the protection of peritoneal dialysis catheter and solve the problem of broken peritoneal dialysis catheter during clinical use. Methods: A total of 94 patients with end-stage renal disease who received newly opened peritoneal dialysis in the Department of Nephrology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from January 2016 to December 2017 were selected as research objects. In order of the time of tube opening, 47 patients with singular ordinal number receiving treatment were set as the control group, and 47 patients with even ordinal number receiving treatment were set as the observation group. The patients of control group, using the traditional peritoneal dialysis tube nursing; the patients of observation group, using anti - broken peritoneal dialysis tube for nursing. To observe and compare the incidence of dialysis catheter loosening and breakage during dialysis in the 2 groups of peritoneal dialysis patients, as well as the patient satisfaction. Results: The catheter crease deformation of the observation group(0 case) was significantly lower than that of the control group (12 cases), and the difference was statistically significant (χ²=13.610, P<0.05). The total satisfaction of patients in the observation group was 97.87% (46/47), while that of patients in the control group was 72.34% (30/47). The total satisfaction rate of observation group was significantly higher than that of control group (χ²=12.086, P<0.01). No leakage occurred in the observation group, which was also significantly lower than that in the control group. However, due to the limited observation time, the number of cases was small without statistical significance (P>0.05). Conclusions The improved peritoneal dialysis catheter is more convenient, safe and effective for long-term peritoneal dialysis patients, and it can reduce the incidence of peritonitis associated with peritoneal dialysis catheter, which is worthy of clinical application.

Objective To design the protection of peritoneal dialysis catheter and solve the problem of broken peritoneal dialysis catheter during clinical use. Methods A total of 94 patients with end-stage renal disease who received newly opened peritoneal dialysis in the Department of Nephrology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from January 2016 to December 2017 were selected as research objects. In order of the time of tube opening, 47 patients with singular ordinal number receiving treatment were set as the control group, and 47 patients with even ordinal number receiving treatment were set as the observation group. The patients of control group, using the traditional peritoneal dialysis tube nursing; the patients of observation group, using anti- broken peritoneal dialysis tube for nursing. To observe and compare the incidence of dialysis catheter loosening and breakage during dialysis in the 2 groups of peritoneal dialysis patients, as well as the patient satisfaction. Results The catheter crease deformation of the observation group(0 case) was significantly lower than that of the control group (12 cases), and the difference was statistically significant (χ2=13.610, P<0.05). The total satisfaction of patients in the observation group was 97.87％ (46/47), while that of patients in the control group was 72.34％ (30/47). The total satisfaction rate of observation group was significantly higher than that of control group (χ2=12.086, P<0.01). No leakage occurred in the observation group, which was also significantly lower than that in the control group. However, due to the limited observation time, the number of cases was small without statistical significance (P>0.05). Conclusions The improved peritoneal dialysis catheter is more convenient, safe and effective for long-term peritoneal dialysis patients, and it can reduce the incidence of peritonitis associated with peritoneal dialysis catheter, which is worthy of clinical application.

Objective To understand the gender selection and prognosis of children with 46,XY disorders of sex development (DSD) after surgery,and to provide reference for future clinical decision-making.Methods Data of 85 (80 males and 5 females) postoperative patients with 46,XY DSD with follow-up age of 6(4,11) years who were treated at the Department of Endocrinology,Genetics and Metabolism of Beijing Children's Hospital Affiliated to Capital Medical University during the period from September 2009 to April 2018 were retrospectively analyzed.The patients were grouped based on diagnosis.The basis of postoperative gender selection,patient satisfaction and related factors,gender characteristics,and adolescent development were analyzed.The Pre-school Activities Inventory or the Children's Sex Role Inventory were used in the analysis of gender tendency.Mann-Whitney U test was used to compare postoperative gender satisfaction of different factors.The Kruskal-Wallis method was used to compare the postoperative gender satisfaction of each group.Fisher's test was used to compare the follow-up status of male children over 11 years old in each group.Results Among the 85 patients,62 individuals were raised as girls after birth,9 were facultative and 14 as boys.According to the diagnosis,there were 31 individuals in group 1 (with 5α-reductase deficiency),11 individuals in group 2 (with androgen insensitivity syndrome),9 individuals in group 3 (with NR5A1 gene mutation),4 individuals in group 4 (with hypergonadotropic gonadal dysplasia),and 30 indiviudals in group 5 (with unclear diagnosis and normal human choionic gonadotophin test).Among the 71 children who were raised as girls or facultative children after birth,66 selected as boys,and 5 continued as girls (among them,3 individuals were female with passive selection,and 2 individuals of testicular dysplasia with uterus in group 4 and 5 were female with active selection).Among the 71 patients faced with gender selection,only one was unsatisfied,that was a postoperative female.There was no significant difference in postoperative gender satisfaction among different disease diagnoses,surgical age and penis length (x2(H)=6.007,P=0.199;Z=-0.860,P=0.390;Z=-0.438,P=0.661).Fifty-nine of the 85 cases completed the gender tendency scale test and 46 cases (78％) were consistent.In the male patients,45 cases were consistent.Thirteen inconsistent patients (22％) were female or facultative after birth who were 5 years old or older.There was no stigmatization noticed in the inconsistent patients' daily life and school social settings.There were 22 male patients aged 11 years and older.They were 13(12,16) years old.Fourteen (64％) individuals' penile length reached the normal minimum,15 (68％) individuals' testicular volume were equal or more than 4 ml,16 (73％) individuals' sex hormones entered puberty levels,12 (55％) individuals had been spermatorrhea,the age of first spermatorrhea was (13.3±2.4) years.They were satisfied and adaptable after surgery.There was no significant difference in the above indicators among the groups (x2 =2.999,P=0.694;x2 =7.278,P=0.086;x2 =5.597,P=0.358;x2 =6.904,P=0.127).Conclusions The appropriate gender of 46,XY DSD patients was selected according to gonadal status after diagnosis.Regardless the diagnosis,the age of operation and the length of the penis at the first diagnosis,male patients were satisfied with the gender after the operation.A few of patients were inconsistent with the results of gender tendency scale test who were raised as girls or facultative children after birth,and they required sustained special attention.Some of the children showed natural adolescent development in males,and the prognosis may be ideal.