Blind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group. Database auditing, listing data reviewing and reconciliation should become a good clinical data management practice. Statisticians, on the other hand, will focus on quality findings related to protocol deviations or protocol violations. To investigate the protocol deviations and/or violations and relevant impacts on data outcomes, it is important to provide the essential basis of data quality through the blind review, and to assess the reliability of study outcomes.
Biostatistics ; Clinical Trials as Topic ; Data Accuracy ; Databases, Factual ; Reproducibility of Results

ObjectiveTo explore the factorial structure of Chinese revision of connor-davidson resilience scale (CD-RISC) in Chinese college students.MethodsA total of 1534 college students were recruited for this study.After item analysis,half of the sample was used for exploratory factor analysis and the other for confirmatory factor analysis.ResultsThe Chinese revision of CD-RISC contained 19 items.Exploratory factor analysis showed that three factors were better:adaptability,tenacity and autonomy.And the results of confirmatory factor analysis ( x2/df =3.83,RMSEA =0.06,GFI =0.92,AGFI =0.90,CFI =0.92,NFI =0.89) indicated that this model provided a reasonable good fit for Chinese college students.ConclusionThis study indicate that the three-factor model of CD-RISC is adaptable to Chinese college students.

Hip ; diagnostic imaging ; Histiocytosis, Sinus ; diagnostic imaging ; physiopathology ; surgery ; Humans ; Male ; Middle Aged ; Tomography, X-Ray Computed

Ethics committee in hospitals aims to protect the rights of human subjects and patients,and provide ethical evaluation and justification for guaranteeing the quality of medical research and treatment.Based on experiences in recent years,this paper suggests the following methods in order to manage the activities of ethics committees and push its further development,such as to draft the ethics system,establish the criteria of ethics,implement the process administration and provide ethics training.

Long non-coding RNA (lncRNA)is a non-coding RNA which lacks a complete open reading frame (ORF)and plays an important role in biological processes such as cell proliferation,differentiation and apoptosis. At present,expression of lncRNA has been found to be abnormal in inflammatory reaction and inflammatory diseases. It might be involved in the development and progression of inflammatory diseases via regulating the expression of multiple genes and activation of signaling pathways. This article reviewed the progress in study on relationship between lncRNA and inflammatory diseases.

Rhesus retinal vascular endothelial cell line RF/6A cells were treated with human insulin. Cell proliferation, migration, and lumen formation, as well as the expressions of vascular endothelial growth factor-A ( VEGF-A ), VEGF-A receptors, and phosphorylated receptors were measured. Insulin promoted RF/6A cell proliferation, migration, and lumen formation ( all P＜0. 01 ). Insulin increased the expression of VEGF-A mRNA and improved its protein activity ( all P＜0. 05 ), and promoted the expression of VEGFR2 mRNA and its phosphorylation ( both P＜0. 01 ). There was no significant difference in the expression of VEGFR1 mRNA among the groups ( P＞0. 05 ).

Objective To examine the reliability and validity of Chinese revision of connor-davidson resilience scale(CD-RISC) in Chinese college students.Methods 1610 college students were tested with CD-RISC.783 of them took a more test by BFI and SCL-90 at the same time.After three weeks,83 students were retested by CD-RISC.Results (1) The results of confirmatory factor analysis (x2/df =6.632,RMSEA =0.059,GFI =0.934,AGFI =0.915,CFI =0.927,NFI =0.915) indicated that the three-factor model reasonably fitted Chinese college students.(2) The Cronabach α coefficients of the CD-RISC and three factors called adaptability,tenacity and autonomy were 0.914,0.865,0.784,0.767 respectively; the mean inter-item correlation coefficients of them were 0.364,0.417,0.425,0.398 respectively; the Guttman split-half coefficients were 0.888,0.843,0.707,0.650 respectively; the retest-reliability coefficients were 0.856,0.742,0.777,0.747.(3) The scores of the total scale of CDRISC and three factors were significantly correlated to BFI and SCL-90(P＜0.01).There were significant differences between the low-resilient group and the high-resilient group in every index of BFI and SCL-90.(4) There were significant differences between male and female students in CD-RISC and factor tenacity and autonomy(male:2.77±0.60,2.70-±0.74,2.65±0.68;female:Z70±0.53,2.62±0.67,2.54±0.62; P＜0.05).Conclusion The Chinese version of CD-RISC is a reliable and valid method for assessing resilience in Chinese college students.

Objective: To examine the effect of early comprehensive interventions on the physical growth and nerve development among premature infants, so as to provide insights into the follow-up management of premature infants after discharge from hospital. Methods: A total of 130 premature infants delivered in Shaoxing Municipal Maternal and Child Health Care Hospital from 2019 to 2021 were selected and divided into high- and low-risk groups according to gestational age and birth weight, while 306 full-term normal infants in the same hospital during the study period served as controls. All premature infants were given early comprehensive interventions until age of 12 months, including nutritional support and parental guidance of children's feeding and development, and all normal infants received periodical health checkup according to the basic public health service program. All infants received periodical measurements of height, weight and head circumference, and the 12-month intellectual and motor development ability was measured using the Bayley Scales of Infant Development revised in Chinese cities was used to assess. Infants' physical growth, mental development index (MDI) and motor development index (PDI) were compared among groups. Results: There were 130 premature infants with gestational ages of 28 to 36 weeks and birth weight of 1 200 to 3 440 g, including 79 male infants, and there were 80 infants in the low-risk group and 50 infants in the high-risk group. The full-term infants had a gestational age of 37 to 42 weeks, and birth weights of 2 500 to 4 000 g, including 162 male infants. There were significant differences in height (Wald χ2=28.664, P<0.001) and head circumference growth (Wald χ2=19.312, P=0.013) among the three groups as revealed by the generalized estimating equation; however, no significant differences were seen in the 12-month weight (F=0.639, P=0.528), height (F=1.051, P=0.350) or head circumference (F=0.318, P=0.728) among the three groups. The percentages of abnormal MDI were 2.00%, 0 and 1.31% among the high-risk premature infants, low-risk premature infants and full-term infants at ages of 12 months (χ2=1.319, P=0.517), while the percentages of abnormal PDI were 20.00%, 7.50% and 5.56% among the three groups at ages of 12 months (χ2=12.818, P=0.002). Conclusions Following implementation of early comprehensive interventions, the premature infants have favorable physical growth and comparable MDI with full-term infants; however, a high percentage of abnormal PDI is seen in high-risk premature infants. An improvement in the motor development among high-risk premature infants is recommended to be emphasized during the management of premature infants.

Objective:To evaluate the role of nuclear factor erythroid 2-related factor/ heme oxygenase-1 (Nrf2/HO-1) signaling pathway in dexmedetomidine-induced reduction of oxygen-glucose deprivation and restoration (OGD/R) injury to microglia.Methods:BV-2 microglia were cultured in high-glucose DMEM culture medium supplemented with 10% fetal bovine serum in an normal culture incubator at 37 ℃ (5%CO 2-21%O 2-74 %N 2). The cells were seeded in 96-well plates at a density of 1.5×10 4 cells/ml (200 μl/well) or 6-well plates at a density of 2×10 5 cells/ml (2 ml/well) and divided into 5 groups ( n=30 each) using a random number table method: control group (group C), dexmedetomidine group (group D), group OGD/R, OGD/R+ dexmedetomidine group (group OGD/R+ D) and OGD/R+ dexmedetomidine+ ML385 group (group OGD/R+ D+ ML). The cells in group C were continuously cultured in a normal culture incubator for 26 h. In group D, dexmedetomidine at the final concentration of 10 μmol/L was added, cells were incubated for 2 h, and then were continuously incubated in a normal culture incubator for 26 h. In OGD/R, OGD/R+ D and OGD/R+ D+ ML groups, the culture medium was replaced with glucose-free DMEM culture medium, cells were cultured for 2 h in an incubator at 37 ℃ (5%CO 2-1%O 2-94 %N 2), the culture medium was replaced with high-glucose DMEM culture medium containing 10% fetal bovine serum and then the cells were cultured for 24 h in a normal incubator.Dexmedetomidine at the final concentration of 10 μmol/L was added at 2 h before OGD in OGD/R+ D and OGD/R+ D+ ML groups.Nrf-2 inhibitor ML385 at the final concentration of 4 μmol/L was added at 30 min before dexmedetomidine was added in group OGD/R+ D+ ML.Cells in 6 wells in each group were selected randomly for assessment of cell viability (by methyl thiazolyl tetrazolium assay) and apoptosis (using flow cytometry), and for determination of the concentrations of tumor necrosis factor (TNF)-α, interleukin (IL)-6, and IL-10 in the supernatant (using enzyme-linked immunosorbent assay), the expression of Nrf2 in nucleus, Nrf2 and HO-1(by Western blot ) and the expression of HO-1 mRNA (by real-time polymerase chain reaction). Results:Compared with group C, the cell viability was significantly decreased, cell apoptosis rate and concentrations of TNF-α, IL-6 and IL-10 in the supernatant were increased, and the expression of Nrf2 in nucleus, Nrf2, HO-1 and its mRNA was up-regulated in OGD/R and OGD/R+ D groups ( P<0.05), and no significant change was found in each parameter mentioned above in group D ( P>0.05). Compared with group OGD/R, the cell viability and IL-10 in the supernatant concentration were significantly increased, cell apoptosis rate and concentrations of TNF-α and IL-6 in the supernatant were decreased and the expression of Nrf2 in nucleus, Nrf2, HO-1 and its mRNA was up-regulated in group OGD/R+ D ( P<0.05), and no significant changes were found in the parameters mentioned above in group OGD/R+ D+ ML ( P>0.05). Compared with group OGD/R+ D, the cell viability and concentration of IL-10 in the supernatant were significantly decreased, cell apoptosis rate and concentrations of TNF-α and IL-6 in the supernatant were increased and the expression of Nrf2 in nucleus, Nrf2, HO-1 and its mRNA was down-regulated in group OGD/R+ D+ ML ( P<0.05). Conclusion:The mechanism by which dexmedetomidine alleviates OGD/R injury to microglia may be related to promoting the activation of Nrf2/HO-1 signaling pathway and inhibition of inflammatory responses.

Objective To observe the therapeutic effect of electroacupuncture combined with rehabilitation exercises on swallowing function and cerebral perfusion in dysphagic stroke patients.Methods Sixty-two stroke pa- tients with dysphagia were randomly divided into a treatment group(n=32)and a control group(n=30).The treat- ment group received electroacupunture,rehabilitation exercise and conventional medical treatment,while the control group received only rehabilitation exercise and conventional medical treatment.They were treated once a day,6 times a week for 4 weeks.Water drinking test,stethocatharsis scores and swallowing fluorography were used to assess the swallowing function before and after treatment.Single photon emission computed tomography(SPECT)was also em- ployed to observe the status of cerebral perfusion before and after treatment.Results It was shown that the swallo- wing function and cerebral perfusion in the treatment group were significantly better than the control group after treat- ment.The effective rate in the treatment group was 96.88% while that of the control group was 66.67%.Conclu- sion Electroacupuncture combined with rehabilitation exercises is effective in treating the dysphagic stroke patients, and can significantly improve the brain perfusion of these patients.