Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
Adverse Drug Reaction Reporting Systems ; standards ; statistics & numerical data ; Databases, Pharmaceutical ; standards ; Humans

0.05). In captopril group MAP, HR and plasma ET concentration remained unchanged during intubation, but the plasma NO concentration was increased at intubation (T2) or (T3) and NO/ET ratio increased significantly at T2 as compared with the baseline (T1 ) . In control group MAP, HR and plasma ET concentration were increased significantly during intubation (P

Objective To study the role of transforming growth factor-β1 (TGF-β1),connective tissue growth factor (CTGF)and endothelin-1 (ET-1) in myocardial tissues of the mice with myocardial fibrosis induced by coxsachievirus B3 (CVB3) and the effect of Carvedilol intervention for it in acute stage and chronic phase of viral myocarditis.Methods Forty male BALB/c mice were randomly divided into 4 groups (10 cases in each group):control group,model group,Carvedilol acute phase intervention group,the chronic phase intervention group.Mice in model group and Carvedilol intervention groups were inoculated with CVB3 (100TCID50/0.1 mL) by peritoneal injection fortnightly.Mice in control group were given normal saline(NS) instead equivalently.Mice were poured Carvedilol (10 mg/kg per day for 2 weeks) from the second day in acute phase intervention group and from the fourth week in the chronic phase intervention group,while mice of control group and model group were poured with equivalent NS instead.At the end of 6 weeks,mice were sacrificed.Heart weight index (HWI) was determined.The collagen volume fraction (CVF) of left ventricular myocardial tissue were examined after Masson staining.Expressions of ET-1,TGF-β1 and CTGF were detected by enzyme linked immunosorbent assay and immunohistochemistry staining respectively; the mRNA expression was tested by reverse transcription-polymerase chain reaction.Results Compared with the control group,HWI and CVF of model group increased significantly(all P ＜ 0.01),those of the intervention groups decreased than those of the model group(all P ＜ 0.01),and in the acute phase those of the intervention group were significantly lower than those in chronic phase intervention group(all P ＜ 0.05).The expressions of TGF-β1,CTGF,ET-1 and their mRNA in model group were increased significantly than those in the control group(all P ＜0.01),and were decreased in acute and the chronic phase intervention group than those in model group(all P ＜0.01),while those were significantly lower in acute phase intervention group than those in chronic phase intervention group (all P ＜ 0.01).Conclusions TGF-β1,CTGF and ET-1 may be involved in myocardial fibrosis induced by CVB3.Compared with the chronic phase intervention,the acute phase intervention of Carvedilol can reduce myocardial fibrosis more efficiently by down-regulating the excessive expression of inflammatory factors.

Objective To observe the injury effect of ionizing radiation on bone marrow derived c-kit+ cells.Methods Via-bility of c-kit+ cells was measured by bioluminescence;the level of c-kit+ cells reactive oxygen species was measured by DCFH-DA, the ability of colony-forming units was reflected by CFU-GM;proliferation and apoptosis of c-kit+ cells were measured by flow cy-tometry;the variation of pathway was detected by arrays of gene chip.Results Compared to control group(0 Gy).It had a decrease of c-kit+ cells′cell viability and the ability of colony-forming units after the cells receipt irradiation with the dose of 1 Gy and 4 Gy;and the level of cell reactive oxygen species,ratio of apoptosis cells increased.After 1 Gy irradiation exposure,the ratio of prolifera-tion(S/G2/M phase)cells increased compared to control group.However,when the c-kit+ cells were receipt 4 Gy irradiation expo-sure,the ratio of proliferation(S/G2/M phase)cells decreased.After 4 Gy irradiation exposure,the up-regulate genes contained Srxn1,Psmb5,Cdkn1a,Smc1b,Bcl2l1,Lrdd and so on;the down-regulate genes contained Mpo,Mtf1,Chek1,Rcc1 Ebag9,Ciapin1 and so on.Conclusion There was injury effect of ionizing radiation on c-kit+ cells,and it could induce variation of many pathways.

Complex clinical situation requires healthcare providers to be able to perceive, un-derstand and predict the situation changes correctly, namely they need situation awareness. Good clin-ical situational awareness can help clinical decision-making and cooperation, which is critical to im-proving the quality of healthcare. Therefore this review aims to summarize the meaning, applications, status and influence factors, measurements and training of clinical situation awareness, to provide evidence for training and improving clinical situation awareness.

Objective To explore the sexual life quality of females at the reproductive ages after cervix cancer operation and supply evidence for establishment of correspondindg nursing measure. Methods We investigated the frequency of sexual life and satisfaction degree of sexual life in 40 females at the reproductive ages after cervix cancer operation by face-to-face investigations using questionnaires before and 4 months after operations. Then the difference of sexual life quality before and after operation were compared and analyzed. Results The frequency of sexual life (P＜0.01,P＜0.05) and satisfaction degree of sexual life (P＜0.01,P＜0.05) were evidently decreased. The sexual life quality was lower than that before operation. Conclusion The sexual life quality could be affected by many factors such as economic conditions, culture background, sexual conceptions and the attitude of their partners.

BACKGROUND:Previous studies have reported that rapamycin can affect the proliferation, migration and adhesion abilities of endothelial progenitor cels, but there is no report on the effect of autophagy, as wel as the interaction between autophagy and apoptosis. OBJECTIVE: To observe the effect of rapamycin activated autophagy activation on the proliferation, apoptosis, and cycle of endothelial progenitor cels. METHODS:Density gradient centrifugation was used to obtain mononuclear cels from bone marrow, and the mononuclear cels were inoculated on human fibronectin-coated culture plate.Then after cultured for 7 days the adherent cels colected were the endothelial progenitor cels. Different concentrations of rapamycin (0.01, 0.1, 1 and 10 μg/L) were added and cultured for 24 hours. Western blot was used to detect the LC3-II protein expression and monitor the induction of autophagy, flow cytometry was used to observe the cel cycle progression and apoptosis changes, and methylthiazolyldiphenyl-tetrazolium bromide colorimetric assay was used to observe the proliferation ability. Meanwhile, the ultrastructural changes were observed under transmission electron microscope. RESULTS AND CONCLUSION:Compared with the control group, there was no significant increasing of LC3-II protein expression of endothelial progenitor cels in 0.01 μg/L rapamycin group, and the LC3-II protein expression was in the high level. The LC3-IIprotein expression in the 1 μg/L and 10 μg/L rapamycin groups was higher than that in the control group, but lower than that in the 0.01 μg/L rapamycin group, which indicated that autophagywas particularly active when the concentration of rapamycin was 0.01 μg/L. The apoptosis of endothelial progenitor cels was increased with the increasing of concentration of rapamycin, and the proliferation rate was decreased with the increasing of concentration of rapamycin. The results indicate that activation of autophagy by bapamycin can promote the cel apoptosis, change the cel cycle significantly, and can inhibit the proliferation of endothelial progenitor cels.

Objective To investigate the probabilities of brain-derived stem cells from fetal rats differentiating into neurons and astrocytes by velvet antler polypeptide(VAP) in vitro. Methods Neural stem cells from E12-14d rats were cultured for 7 days until neural stem cells (NSCs) aggregations were formed into neurospheres. The neurospheres were cultured at different concentrations of VAP, and immunocytochemistry was used to detect the differentiation of neural stem cells. Results The differentiated cells in 50?g/L VAP group are more than that in control group; the number of NSE positive cells in 50?g/L,100?g/L and 200?g/L groups is more than that in control group.Conclusion Neural stem cells can be successfully induced into neurons by VAP in vitro, which could provide a basis for regeneration of nerve system.;

Objective:To extract the common factors for evaluating the teaching effect of the integrated curriculum of basic medicine in China, and to analyze and explain the practical significance of these common factors.Methods:A questionnaire survey was conducted among undergraduates of 15 medical colleges in China to evaluate the teaching effect of integrated curriculum of basic medicine, and exploratory factor analysis was conducted for screening and classification. SPSS 22.0 was used to conduct factor analysis.Results:The four major common factors evaluating the teaching effect of integrated curriculum were the effectiveness of teaching process, the rationality of teaching organization, the education of teaching content, and the innovation of teaching methods.Conclusion:The integrated curriculum reform of basic medicine should pay great attention to the simultaneous development of basic theory learning and practical ability training, the effective connection between theoretical teaching and experimental teaching, the educational role in comprehensive quality cultivation of students, and the flexible application of various teaching means and methods.

ObjectiveTo detect specific antigens of neural cells in amniotic epithelial cells(AECs) in rats. MethodsAECs were dissociated and purified from the amnion of pregnancy 12—14 d rats. The expression of specific markers of neural stem cells (Nestin, Musashi) and differentiated cells (MAP-2,NSE,GFAP) and ChAT, NT-3 in the AECs were detected by immunocytochemistry. ResultsThe cultured AECs displayed positive immunoreactivity to MAP-2, NSE, GFAP, Nestin and Musashi. In addition, the cells also demonstrated immunoreactivity to ChAT and NT-3. ConclusionAECs are similar with neural cells and it may be useful as a sustained source to improve outcome of neural stem cells transplantation.