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.

OBJECTIVETo analyze the changes of patients with type 2 diabetes in different stages in glucagon (GC) and free fatty acid (FFA) in fasting, OGT and L-Arg experiments, and discusses the role of pancreatic alphabeta cells in diabetes pathogenesis by studying the relations among indexes such as glucagon (GC), free fatty acid (FFA) and blood glucose (BG), insulin, insulin homeostasis model (HOMA) and glucose metabolism hormone secretion curve, in order to provide theoretical basis for the treatment of diabetes.

METHODStudy objects were divided into the T2DM group (45 cases), the IGT group (28 cases) and the NGT group (30 cases) for an OGTT experiment and then an L-Arg experiment on the next day. Under the fasting state, their blood glucose (FBG), insulin (F), glucagon (FGC), free fatty acid (FFA) were detected to calculate HOMA-beta, insulin sensitivity index (ISI) and HOMA-IR of different groups. Meanwhile, efforts were made to calculate different time quantum detected in OGTT and L-Arg experiments and area under the curve AUC(BG), AUC(INS) and AUC(GC).

RESULTObvious overall differences were observed in FFA and FGC of the three groups. FGC of each group was negatively correlated with HOMA-beta and ISI. Among all of the 103 study objects, FGC was positively correlated with FBG and HOMA-IR and negatively correlated with HOMA-beta and ISI, with no correlation with FINS; FFA was positively correlated with FBG, HOMA-IR and negatively correlated with FINS, HOMA-beta, ISI. FGC and FFA were positively correlated in the T2DM group and the IGT group, but with no statistical correlation in the NGT group. The sequence of the three study objects was T2DM > IGR > NGT in AUC(GC) in the OGTT experiment and T2DM > IGR > NGT in in AUC(GC) in the L-Arg experiment, with the significant positive correlation between AUC(GC) and AUC(BG) and significant negative correlation with AUC(INS).

CONCLUSIONGlucagon and free fatty acid of T2DM and IGT patients increased, which was positively correlated with blood glucose and HOMA-IR and negatively correlated with INS, HOMA-beta and ISI. The increase in glucagons of T2DM and IGT patients indicated inappropriate secretion of pancreatic alphabeta cells among patients with type 2 diabetes.

Adult ; Blood Glucose ; metabolism ; Diabetes Mellitus, Type 2 ; metabolism ; Fatty Acids, Nonesterified ; metabolism ; Female ; Glucagon ; blood ; Humans ; Insulin ; secretion ; Islets of Langerhans ; secretion ; Male ; Middle Aged

OBJECTIVE:To systematic review the relationship between CYP4F2 gene polymorphism and warfarin maintenance dose in Chinese population,and to provide evidence-based reference for clinical treatment. METHODS:Retrieved from Cochrane library,PubMed,EMBase,CJFD,VIP and Wanfang database,studies about the relationship between CYP4F2 gene polymorphism and warfarin maintenance dose in Chinese population were collected,and Meta-analysis was performed by using Rev Man 5.0 statis-tics software. RESULTS:A total of 13 studies were included,involving 2 958 patients. The type of gene was type TT,type CT and type CC. Results of Meta-analysis showed the relationship between 3 gene polymorphism and warfarin maintenance dose was type TT>type CT>type CC,and there were significant differences among groups. CONCLUSIONS:CYP4F2 gene polymorphism in Chinese population has significant correlation with warfarin maintenance dose. However,due to the limit of methodological quali-ty,large-scale and high quality studies are required for further validation of the conclusions.

Objective: To study the relation of plasma Se to oxidative stress in the patients with primary glomerular diseases (PGS) and its clinical significance. Methods: Plasma Se concentration ,GSH-Px and SOD activities and contents of MDA in 45 patients with PGS and 20 normal control (NC)were measured by catalytic polarography and colorimetric assay. Serum creatinine, urea nitrogen and uric acid concentrations in these patients were determined simultaneously. Results: 1. Plasma Se contents of both PGS patients of normal(groupⅠ) and impaired renal function (groupⅡ) were significantly lower than those in NC;2. PGS patients of groupⅠandⅡhad significantly lower plasma GSH-Px and SOD activities than NC and their MDA contents were siginificantly higher. 3. Plasma GSH-Px and SOD activities and MDA contents between groupⅠand Ⅱ were not different; 4. Multiple logistic regression analysis showed that plasma Se content in patients with PGS was positively related to plasma GSH-Px , SOD activities and negatively correlated with MDA. Serum creatinine concentrations were negatively correlated significantly with plasma Se, GSH-Px, SOD and positively related to MDA. Conclusion: Plasma Se deficiency may be an important non-immune factor resulting in or worsening PGS through weakening body抯 antioxidative defence. It is suggested that sufficient Se supplementation in practice may be obviously beneficial to oxidative stress in the patients with PGS.

Objective To study the effect of lentinan on cisplatin’s inhibition on cervical cancer Hela cell line. Method Cervical cancer Hela cell line were divided into LEN group (only lentinan treatment), CIS group (only Cisplatin treatment), LEC group (Both Lentinan and Cisplatin treatment) and CON group (no Lentinan and Cisplatin treatment) according to their treatment methods. The differences of cell proliferation, cell cycle, PI and apoptosis were compared. Results The differences of absorbance between LEN group and CON group were not significant d1-d8 after treatment, but significant between CIS and LEC group (P<0.05). The absorbance in LEC group was significantly lower than in CIS group (P<0.05). The differences of PI and apoptosis rate in LEC and CIS group were significant (P<0.05), but not between LEN and group. The PI in LEC group was lower than in CIS group (P<0.05), while apoptosis rate was higher (P<0.05). Conclusion Lentinan could significantly promote Cisplatin’s inhibition effects on cervical cancer Hela cell line.

Objective To evaluate the role of SPECT cerebral perfusion imaging in assessing the stent implantation for cerebral artery stenosis.Methods A total of 35 patients (31 males,4 females,average age (63.9±10.8)years) with cerebral artery stenosis confirmed by DSA for cerebral artery stent implantation were retrospectively analyzed.99Tcm-ECD cerebral perfusion imaging was performed for all patients before and after stent implantation.The images were realigned and normalized by SPM 2.0 and then analyzed by Brain Search software for quantitative analysis.The brain was automatically separated to 210 functional areas according to Talarich map.The normalized averaged counts (NAC) of each area were calculated and compared with the data of 28 health controls (8 males,20 females,average age (35.8± 9.4) years).Less than 1.96s was defined as low perfusion lesions.The NAC values before and after stent implantation were compared for classifying improved from non-improved group.The mean number of lesions and Essen stroke risk score (ESRS) were analyzed between the two groups.The mean number of lesions and postoperative improvement rate of the internal carotid artery (ICA) occlusion and stenosis were compared.Paired rank sum test,two-sample t test,two-sample rank sum test and x2 test were used for statistical analysis.Results In 35 patients with low perfusion areas,20 were significantly improved after stent implantation.The mean number of lesions in the improved group (34.05± 14.41)was significantly higher than that in the non-improved group (22.93±17.24; t=2.067,P＜0.05).The mean ESRS of the improved patients (14.8)was significantly lower than that of the non-improved patients (22.3,Z=2.24,P＜0.05).The improvement rate of 28 cases with ICA stent implantation was (60.7％,17/28)higher than that of 7 cases with middle cerebral artery (MCA) stent implantation (3/7; P＞0.05).The mean number of the ICA occlusion lesions (34.36± 14.31)was higher than that of the ICA stenosis lesions(31.35± 16.37),but the difference was not statistically significant(t=0.498,P＞0.05).The improvement rate of the ICA occlusion was higher than that of the ICA stenosis (7/11 vs 10/17),but the difference was not statistically significant (P＞0.05).Conclusion SPECT cerebral perfusion imaging and its quantitative analysis can evaluate the low perfusion lesions before stent implantation and predict the perfusion improvement after stent implantation.

Objective:To observe the expression of miR-30c-5p and Toll-like receptor 4(TLR4) in colon cancer tissues and cells, and to explore their relationship with clinicopathological features.Methods:As a prospective study, 30 cases of colon cancer surgical specimens and matched normal tissue samples were selected from the Cancer Hospital of China Medical University from May 2016 to may 2017.The expression of miR-30c-5p mRNA was detected by quantitative real-time polymerase chain reaction(qRT-PCR), and the expression of TLR4 Protein was detected by western blot (WC). The expression differences of miR-30c-5p mRNA and TLR4 protein in different TNM stages, differentiation degrees and diameters were observed.The correlation between the expression of miR-30c-5p and TLR4 Protein was analyzed by Pearson Rank method.Results:The expression of miR-30c-5p was lower in colon cancer tissues(0.311±0.147) than in adjacent normal colon tissues(0.881±0.266)( t=10.613, P<0.001). TLR4 protein was higher in colon cancer tissues(0.729±0.274) than in adjacent normal colon tissues(0.361±0.168)( t=6.310, P<0.001). Expression of miR-30c-5p was lower in colon cancer cell lines(0.394±0.045, 0.435±0.098, 0.533±0.092, 0.272±0.069) than in normal colon epithelial cell line(1.371±0.101)( t value were 6.744, 6.432, 6.865 and 6.201, respectively; P<0.001). The expression of TLR4 protein was higher in colon cancer cell lines(1.108±0.169, 1.035±0.177, 1.114±0.253, 1.116±0.157) than in normal colon epithelial tissues(0.358±0.094)( t value were 5.789, 4.799, 5.311 and 5.292, respectively; P<0.001). Pearson rank correlation showed that miR-30c-5p was negatively correlated with TLR4 protein expression( r=-0.487, 95% CI: -0.721--0.154, P<0.01). MiR-30c-5p was decreased with TNM stage increasing( F=31.406, P<0.001), pathological differentiation degree decreasing( F=9.960, P<0.001), tumor diameter increasing( F=10.267, P<0.001). TLR4 was increasing with TNM stage increasing( F=37.634, P<0.001). TLR4 increased with the decrease of tumor differentiation( F=38.027.35, P<0.001). TLR4 increased with tumor diameter ( F=20.717, P<0.001). Conclusion:The low expression of mir-30c-5p and high expression of TLR4 in colon cancer were correlated with TNM stage and tumor volume.

Adult ; Female ; Humans ; Lymphoma, T-Cell ; pathology ; physiopathology ; Lymphoma, T-Cell, Cutaneous ; pathology ; physiopathology ; Myositis ; physiopathology

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.

OBJECTIVETo detect the expressions of receptor tyrosine kinases (RTKs) mRNA and protein and to explore potentially promising tumor markers and conceivable drug target in bladder cancer.

METHODSThe expressions of RTKs mRNA and protein in tissue from invasive urothelial carcinoma of the bladder were examined by real-time quantitative PCR array and cytokine antibody array, with normal bladder tissue as control. The Results were analyzed using bioinformatic approaches.

RESULTSThe expressions of TGFA, STAB1, SERPINE1, ANGPT2, SPINK5, ANGPTL1, PROK1, MDK, CXCL9, GRN, RUNX1, VEGFA, and TGFB1 were obviously upregulated in bladder cancer tissue, while those of EDIL3, PTN, CCL2, PDGFD, FGF13, KITLG, FGF2, SERPINF1, and TNF were downregulated. ALK, Btk, EphB2, ErbB4, PDGFR-α, ROS, Tie-2, Tyk2, and VEGFR3 were over-expressed in bladder cancer, while FRK, Fyn, IGF-IR, Insulin R, Itk, JAK1, JAK3, and LCK were low-expressed.

CONCLUSIONVascular endothelial growth factor/platelet-derived growth factor-targeted therapies may play an active role in treating carcinoma of bladder.

Carcinoma, Transitional Cell ; metabolism ; Humans ; RNA, Messenger ; genetics ; Receptor Protein-Tyrosine Kinases ; genetics ; metabolism ; Urinary Bladder Neoplasms ; metabolism