OBJECTIVE:To provide reference for improving the data integrity management system of pharmaceutical produc-tion enterprises. METHODS:According to related reports in US Food and Drug Administration(FDA)and China Food and Drug Administration(CFDA),the source of data integrity problems was analyzed,its reasons were summarized and solutions were put forward. RESULTS&CONCLUSIONS:The reasons why there were data integrity problems in enterprises can be attributed to 3 as-pects(staff,hardware/software system and quality management),and the 3 aspects showed large gap with current standards. It is suggested that enterprises evaluate the existing system by adopting the gap analysis,establish a data integrity management project team,strengthen personnel training,upgrade hardware/software system to ensure its safety,stability and effectiveness;and opti-mize the quality management system by developing good ducument specification,special regulation system of data integrity. In addi-tion,the enterprise should establish quality culture,pay attention to industry and regulatory trends in real time to guarantee the data integrity effectively.

Retrograde HRP technique was used to study the somatotopical organization of the raphe—spinal projection of the rat. HRP or wheat germ agglutinin conjugated HRP was injected into unilateral gray matter or dorsal horn of the cervical cord or lumbar cord. The following conclusions have been reached.The caudal part of NRM projects to areas ventral to the dorsal horn. Projection to the dorsal horn was found to originate from the rostral part of NRM, which is somatotopically localized. Cells projecting to the cervical dorsal horn are distributed more rostrally than those to the lumbar dorsal horn, although an extensive overlapping of these two parts is evident. Somatotopical localization in the form of "gap" as suggested by Watkins et al. could not been verified in our experiment.The functional significance of the sornatotopical organization of NRM is discussed.

Objective To study the prevalence and distribution of dental trauma in children and adolescents. Method A total of 347 patients with the permanent anterior teeth injured aged from 6 to 25 years were treated and selected from July 2008 to June 2009. Data of gender, age, site of accident occurred, number of teeth injured, and location and type of injury were taken from the dental records. Results Of them, there were male 219, female 128, and the ratio of male/female was 1.7:1.0, The highest incidence of tooth injuries occurred a-mong children of 10 to 13 years old. The common site of dental trauma was school. The majority of dental casualties had one tooth (38.0%) and two teeth (38.0%) injured. Of all types of dental injury, subloxation (19.8%), and enamel and dentin fractures without pulpa involvement (18.7%) were the most seen ones. Con-clusions The dental trauma in children and adolescents is a major problem that can not be ignored, and should be given persistent attention to prevent.

Objective To compare the ability of auditory verbal learning,memory and retention between each side of thalamus and basal ganglia after stroke.Methods 63 patients with single lesion in thalamus or basal ganglia after stroke,34 patients with amnestic mild cognitive impairment (aMCI)and 34 healthy control subjects received auditory verbal learning test.Results There was an overall decline of immediate and delayed recall,retention ability in patients with single lesion of stroke as compared with the healthy control group(P＜0.05).Both the left thalamic stroke group [(19.0± 3.1)scores]and aMCI group[(17.6 ±3.3)scores]showed similar pattern in damaged recognition ability,while this ability still existed in the other three stroke groups.The ability of auditory verbal learning in the left thalamic stroke group[(2.2 ± 2.0)scores]and right thalamic stroke group[(2.1 ± 1.9)scores]were lower than in the healthy control group[(3.6 ± 1.8)scores](P ＜0.05).The retention ability in the left thalamus stroke group[(2.8±1.7)scores]and the right basal ganglia stroke group[(2.7 ± 1.9)scores]was decreased than in the healthy control group[(1.7±1.4)scores](P＜0.05).Conclusions There is decline of AVLT-learning,memory and retention ability in patients with single lesion stroke,especially in the left thalamus stroke patients.Moreover,the pattern of impairment in the left thalamus stroke is similar to aMCI but different from the other three stroke groups.

Autonomic nerve dysfunction is common after onset of ischemic stroke.Heart rate variability (HRV) has been used widely because of the regulation effect of heart rate by the quantitative analysis of the autonomic nervous system.This article reviews the evaluation method of HRV and its clinical significance in ischemic stroke.

Objective:To evaluate iron metabolism disorders in sepsis patients and explore the effect of iron deficiency on mortality.Methods:Patients ( n=130) who were admitted to the emergency intensive care unit (ICU) of the First Affiliated Hospital of Dalian Medical University from September 2016 to July 2018 and met the diagnostic criteria of Sepsis 3.0 were selected, and sex- and age-matched healthy volunteers ( n=20) were enrolled as a control group. Peripheral venous blood samples were collected in sepsis patients on day 1, 3 and 7 after admission, or in the healthy volunteers upon enrollment, to detect iron metabolism-related indicators and interleukin-6 (IL-6); the Sequential Organ Failure Assessment (SOFA) score was calculated upon hospital admission. Iron metabolism-related indicators were compared between the groups; the correlation of plasma iron with hemoglobin, hepcidin, ferritin, IL-6, sTFR/log ferritin and the ability of plasma iron to predict 28-day death of sepsis patients were analyzed. Results:Sepsis patients developed significant anemia on day 3 after admission; plasma iron, transferrin, iron saturation, total iron binding capacity and unsaturated iron binding capacity in the first week of admission were significantly lower than those in the control group; distribution width of red blood cells, ferritin, IL-6, hepcidin and soluble transferrin receptor were significantly higher than those in the control group. Distribution width of red blood cells, ferritin and hepcidin on day 3 and 7 after admission, and plasma iron and iron saturation on day 7 after admission were significantly higher than those on day 1. However, total iron binding capacity and unsaturated iron binding power on day 7, and sTFR/log ferritin on day 3 were significantly lower than those on day 1. Patients in the survival and non-survivor groups in the first week of admission had significant anemia on day 3 and 7, but the anemia was worse in the non-survivor group. Transferrin, total iron binding capacity, and unsaturated iron binding capacity in the non-survivor group in the first week of admission, and plasma iron in the non-survivor group on day 3 and 7, were significantly lower than those in the survival group. Ferritin, IL-6 and hepcidin in the non-survivor group in the first week of admission, and iron saturation on day 7 were significantly higher than those in the survival group. Spearman correlation analysis showed that plasma iron was negatively correlated with IL-6 ( r=-0.391, P<0.01), ferritin ( r=-0.293, P=0.001) and hepcidin ( r=-0.209, P=0.017), but not with hemoglobin ( r=0.005, P=0.958). The area under the operation curve (AUC) for plasma iron for predicting 28-day mortality in sepsis patients was 0.524 (95% CI: 0.416-0.631, P=0.656). Conclusions:Sepsis patients have significant anemia and iron metabolism disorders in the early stage, while non-survival patients are more severe. Reduced plasma iron level has no capacity to predict 28-day mortality of sepsis patients. In addition, decreased plasma iron level is not related to decreased hemoglobin, and thus iron supplementation should be cautious in sepsis patients.

Objective To observe the protective and repairing effects of bone mesenchymal stem cells(BMSCs) transplantation on cerebral infarction in rats and to study the different effect of transplantation at different time points. Methods Middle cerebral artery occlusion(MCAO) models were set up,and the rats were divided into a control group,a group with PBS transplantation and five groups with BMSCs transplantation 3,6,12,24 and 72 h after MCAO,respectively.The volume of infarction area and the neurological severity score(NSS) in all the groups were compared. Results Twenty-eight days after MCAO,the TTC staining indicated that the volume of infarction area in the groups with BMSCs transplantation decreased remarkably compared with the control group and the group with PBS transplantation(P

Objective To observe the effects of comprehensive rehabilitation program on severe traumatic brain injury young patients when the time from injury to admission was delayed. Methods Eleven severe traumatic brain injury young patients received comprehensive rehabilitation program, including the neurodevelopmental techniques. They were evaluated with Functional Independence Measure (FIM) and Berg Balance Scale. One Way ANOVA was used to assess the functional status of patients during the course of treatment. Results After 6 to 12 months' treatment, the motor, cognitive and total scores of FIM and the Berg scores of all patients increased significantly ( P

Objective To construct pSUPER-ARPC2 vector and to obtain its expression in eukaryotic cell, in order to down-regulate the expression of ARPC2. Methods Oligonucleotide sequences specific for ARPC2 were designed for RNAi, and cloned into pSUPER.basic vector after annealing by restriction enzyme digestion and ligation. After identification by restriction enzyme digestion and sequencing, the plasmid of positive clones was transfected into HEK 293 cells for three times. The expression of ARPC2 was detected by RT-PCR and Western blot. Results It was found that the expression of ARPC2 was definitely knocked down by transfection with pSUPER-ARPC2. Conclusions The RNAi expression vector of ARPC2 was constructed successfully, which was showed to possess the ability to knockdown the expression of ARPC2 by different methods. So, pSUPER-ARPC2 should be a powerful tool in the study of function of ARPC2.