This article from the clinical trials of the drug inspection agency review practice of view,summarize the key elements of drug clinical trials review examination,the status of agency offices of the daily management and analysis of the problems,the agency's Office to review how the inspection standards as a guide to clinical trial program files,personnel and other standardized management were discussed,with a view of other drugs in clinical trials and routine inspection agency review management to bring new inspiration,clinical trials of drugs for hospitals and fast construction and development agencies to provide a reference.

Objective To investigate the brain metabolic changes and evaluate their spatial distributions after traumatic axonal injury (TAI)in rats by using proton magnetic resonance spectroscopy(1H-MRS).Methods The TAI model was made by subjecting the head of the rats to the linear and angular accelerations.The multi-voxel MRS was employed to detect the tissue metabolic state at the levels of hippocampus-caudate and pons prior to injury and at 24 hours after injury.The alterations of NAA/Cr,NAA/Cho and Cho/Cr values as well as the spatial distribution of NAA/Cr reduction were accessed. Immunohistochemical staining for β-APP was used to observe the injured axons. Results A siguificantdecrease in NAA/Cr and NAA/Cho(P<0.05)and subtle increase in Cho/Cr(P>0.05)were observed in rats at 24 hours after TAI in comparison to the pre-injury levels.Notable decrease in NAA/Cr value was observed in the areas including the brain stem,hippocampus,internal capsule,corpus callosum and thalamus,where axonal injuries were confirmed by the histological examination. Conclusion Metabolic imbalances Occur in the brains of rats with TAI.with notable changes in the brain stem and the hippocampus.

Objective To explore and identify the role of scientific research management departmentin the construction of biobank,discuss problems encountered and possible strategies.Methods Our hospital scientific research management department actively involved,and played an important role in the coordination work for hardware and software construction during the setting up of Infectious disease biorepository.A series of institutional policies and procedures were developed,such as organizational structure of the biobank,sample collection rules at the clinic and research achievementtransformation guidelines.Results A total of 500-case samples were collected,involving different kinds of infectious diseases,like HBV,HCV and HIV.The biobank undertook the Science and Technology Resources Platform Construction Projectof Tianjin health and Family Planning Commission,also established collaboration relationships with domestic and foreign scientific research institutions andhospitals like Memorial University of Newfoundland.Conclusions Scientific research management department should play an important role in the construction of biobank and lay a solid foundation for the development of the biobank.

Objective To estimate the value of clinical parameters (such as patients' age,longitudinal melanonychia width and location) for the differential diagnosis of malignant and benign longitudinal melanonychia as well as for the evaluation of the necessity for invasive management.Methods A retrospective study was performed on 28 cases of subungual malignant melanoma collected from 2000 to 2010 as well as on 62 cases of benign longitudinal melanonychia from 2005 to 2010.Clinical analysis was carried out to compare the differences in clinical parameters such as.patients' age,longitudinal melanonychia width and lesional location,between the malignant melanoma and benign longitudinal melanonychia cases.Logistic regression analysis and ROC method were used to determine valuable clinical parameters for the differential diagnosis of malignant and benign longitudinal melanonychia.Results Significant differences were observed in the median age at diagnosis (23.0 years vs.52.5 years,Z =5.44,P ＜ 0.01 ),age at onset (21.0 years vs.48.0 years,Z =4.70,P ＜ 0.01 ),and longitudinal melanonychia width (3.0 mm vs.15.0 mm,Z =5.69,P ＜ 0.01 ) between the patients with malignant melanoma and benign longitudinal melanonychia.The involvement of thumb and hallux was observed in 77.8％ of the subungual melanoma cases,and 48.3％ of the benign cases (x2 =6.57,P ＜ 0.05).ROC method and Logistic regression analysis indicated that the age at onset and diagnosis as well as width of longitudinal melanonychia were of diagnostic value for the differential diagnosis of malignant and benign longitudinal melanonychia.Conclusions Not all longitudinal melanonychia cases need an invasive management at the time of awareness.The age at onset and diagnosis,width of melanonychia and site of the onset appear to be valuable in the differential diagnosis of malignant and benign longitudinal melanonychia,and there is a possibility to guide clinical diagnosis and treatment by establishing a mathematical model with these parameters.

Objective To explore and establish a method for quantitative evaluation of facial skin pores based on dermoscopy,and to evaluate the scientificity and practicability of this method.Methods Totally,30 patients with enlarged facial skin pores were enrolled from Department of Dermatology,Peking University Third Hospital between June 2017 and December 2017,and treated with 2 940 nm Er pixel laser.Photographs were taken,and dermoscopic images were collected before and after treatment.According to the standard photographs of facial pores,the improvement of enlarged facial pores was evaluated by comparing the photos before and after the treatment.A dermoscope-based pore detection system was established,and quantified indices for pore area and color difference before and after the treatment were evaluated by using this system.A pre-post self-contrast study was conducted,and statistical analysis was carried out by using paired t test for the comparison of measurement data and paired non-parametric test (Wilcoxon signed-rank test) for the comparison of ranked data.Results After the treatment,the standard photograph method for the assessment of facial pores showed score reduction by 3 grades in 1 of the 30 patients (3.3％),by 2 grades in 7(23.3％),by 1 grade in 21(70％),and no changes of grades in 1 (3.3％).Additionally,the differences between pre-and post-treatment grades were significant (Z =-4.94,P ＜ 0.01).The detection rate of skin pores by using the detection system was (70.59 ± 3)％.After the treatment,the quantified values of pore area and color difference both significantly decreased compared with those before the treatment (pore area:712.95 ± 87.45 vs.831.45 ± 88.92,t =5.70,P ＜ 0.05;color difference:23.82 ± 9.43 vs.28.92 ± 9.91,t =2.76,P ＜ 0.05).Conclusion The dermoscopy-based method for quantitative evaluation of skin pores after the treatment with 2 940 nm Er pixel laser showed highly consistent results with the standard photograph method,which can be further verified and popularized in the evaluation of enlarged skin pores.

Medical ethics education in clinical practice stage is especially critical to improve medical students' humanistic, medical ethics and professional accomplishment. Compared with other clinical disciplines, dermatology and venereology has many characteristics. To strengthen medical ethics education in dermatology and venereology clinical practice, we should persist in promoting and cultivating core values of Chinese socialism, accurately grasp the characteristics of various skin diseases, educate and guide students to flexibly apply the basic principles of ethics and improve their ethical decision-making ability. In the process of teaching implementation, we should pay attention to the coordination of education, enrich teaching means and strengthen practical teaching, so as to improve the quality of education.

Objective To explore the effect of right median nerve stimulation ( RMNS) on brain function in healthy subjects . Methods Twenty-eight healthy volunteers were selected as the study′s subjects. RMNS was admin-istered as a task stimulation in a wake-up therapy mode. The subjects were given 30 seconds of stimulation followed by 30 seconds of rest, repeated for 6 times as the block experiment designed, and functional magnetic resonance imaging (fMRI) was performed simultaneously with the task stimulation . The brain activation was analyzed using SPM 12 soft-ware. Results The fMRI showed that RMNS activated primarily the left M1, the premotor cortex (PMC), the bilater-al primary and secondary somatosensory cortexes (S1 and S2), and the left insular lobe. Compared with the resting state, the intensity of BOLD signal in the above activated brain areas changed significantly in RMNS wake-up stimula-tion mode. Conclusion Stimulation of the right median nerve can stimulate the local cerebral cortex and produce a certain wake-up effect by activating the right brain areas related to the motor and sensory functioning of the hand.

Strengthening medical ethics education for medical students is the need for the healthy development of human medical health, the cultivation of medical students’ professional ethics and the integration of medical ethics spirit and medical ethics practice. Through in-depth discussion of the new mode of the integration of medical ethics education and medical ethics practice, stimulating the new impetus of the integration of medical students’ self-cultivation into practice, and the new ways to cultivate the growth of medical students in the new era, this paper put forward specific measures to create an education suitable for each student’s development by selecting the medical ethics education team, learning ethics and humanistic education, taking medical students as the center, and creating a suitable learning environment for students, with a view to cultivating medical students to grow into guardians who can cope with the challenges of public health emergencies.

Objective To investigate the value of 3D pseudo-continuous arterial spin labeling (3D-pCASL) magnetic resonance perfusion technique in evaluating posterior circulation ischemia (PCI) of the elderly beyond 80 years old and to offer the evidence of PCI of the elderly for clinical diagnosis. Methods Totally 53 male subjects older than 80 years were recruited in this study,including 20 subjects with clinically diagnosed PCI and 33 normal subjects. All the subjects underwent routine brain magnetic resonance imaging and 3D-pCASL sequence on a 3.0T magnetic resonance imaging system with 8 channel brain coil. Two post-labeling delay (PLD) time (PLD=1525 ms and PLD=2525 ms) of 3D-pCASL were used in this study to increase the accuracy of cerebral blood flow (CBF) change of posterior circulation region. We used SPM12 software to measure mean CBF values of bilateral occipital lobes and bilateral cerebellums. Independent sample t-test and rank-sum test were performed to evaluate the difference of CBF changes of anterior circulation and posterior circulation in two groups at two PLD time,the difference of CBF changes of bilateral occipital lobes and bilateral cerebellums in two groups of two PLD time,and the difference of increment of CBF between two PLD interval between two groups. Results In case group,the CBF value of the anterior circulation was significantly higher than that of posterior circulation at both two PLD time points (PLD=1525 ms and PLD=2525 ms)(P=0.000,P=0.000);in control group,the CBF value of the anterior circulation was significantly higher than that of the posterior circulation only at PLD=1525ms (P=0.025). The CBF values at bilateral occipital lobes and bilateral cerebellums at two PLD time points (PLD=1525 ms and PLD=2525 ms) were significantly higher in case group than in control group(P=0.003,P=0.002,P=0.000,P=0.001,P=0.000,P=0.001,P=0.002,P=0.014,respectively). Compared with the control group,the difference was statistically significant in bilateral occipital lobes and cerebellums with a smaller △CBF between two PLD interval in case group (P=0.004,P=0.001,P=0.001,P=0.025). Conclusion Multiple PLD time points need to be used in 3D-pCASL in diagnosing PCI of the elderly because the posterior circulation is slow in these patients. 3D-pCASL technique is sensitive in detecting decreased CBF in posterior circulation and therefore can be used to predict posterior circulation stroke in the elderly.

School-age children are in a specific development stage corresponding to juvenility, when the white matter of the brain experiences ongoing maturation. Diffusion-weighted magnetic resonance imaging (DWI), especially diffusion tensor imaging (DTI), is extensively used to characterize the maturation by assessing white matter properties in vivo. In the analysis of DWI data, spatial normalization is crucial for conducting inter-subject analyses or linking the individual space with the reference space. Using tensor-based registration with an appropriate diffusion tensor template presents high accuracy regarding spatial normalization. However, there is a lack of a standardized diffusion tensor template dedicated to school-age children with ongoing brain development. Here, we established the school-age children diffusion tensor (SACT) template by optimizing tensor reorientation on high-quality DTI data from a large sample of cognitively normal participants aged 6-12 years. With an age-balanced design, the SACT template represented the entire age range well by showing high similarity to the age-specific templates. Compared with the tensor template of adults, the SACT template revealed significantly higher spatial normalization accuracy and inter-subject coherence upon evaluation of subjects in two different datasets of school-age children. A practical application regarding the age associations with the normalized DTI-derived data was conducted to further compare the SACT template and the adult template. Although similar spatial patterns were found, the SACT template showed significant effects on the distributions of the statistical results, which may be related to the performance of spatial normalization. Looking forward, the SACT template could contribute to future studies of white matter development in both healthy and clinical populations. The SACT template is publicly available now ( https://figshare.com/articles/dataset/SACT_template/14071283 ).