OBJECTIVE:To strengthen the inspection for qualification of new drugs when introduced in order to guarantee the quality of new drugs and the safety of drug use.METHODS:The problems existing in the inspection for qualification of new drugs were exemplified and classified.RESULTS&CONCLUSION:There existed the problems in the respect of validity,authenticity,effectiveness,and integrality.The good maintainance of the database of SFDA plays a important role in in-specting the new drugs when introduced,while on the other hand such issues as establishment and use of credibility file in medical agencies are worth discussing.

OBJECTIVE:To facilitate the in-depth implementation of Prescription Administrative Policy("New Method" in short).METHODS:The change of the Prescription Administrative Policy and its problems were analyzed through comparison between the "New Method" and the trial edition.RESULTS & CONCLUSIONS:Improvements of Prescription Administrative Policy such as the introduction of prescription comment system,clarifying supervising subjects and strengthening requirement on prescription dispensing rights etc play a role in tightening comprehensive management on prescriptions and promoting rational drug use.However,the defects of Prescription Administrative Policy such as the absence of the regulations unsuitable for medical orders in retail pharmacy and endemic areas and the unidentified prescription forms need to be improved step by step in the practice.

Amino Acid Metabolism, Inborn Errors ; blood ; diagnosis ; Humans ; Infant, Newborn ; Male

Armillariella tabescens EJLY2098 was induced to produce ?-mannanase with konjac fine flour (Amorphopallus rivieri) as single carbon source. This induced enzyme was then purified using DEAE ion exchange chromatography and named atMAN47. Zymologic analysis showed that the molecular weight of this ?-mannanase was approximately 47 kD. The enzyme was stable when pH ranged from 5.0 to 6.5 and could be activated by Na+ and Ba2+. With an optimal temperature of 50?C. Action mode analysis of TLC revealed that the enzyme belonged to the endo-?-mannanase family. Being a meta-acid endo-?-mannanase, it was suitable to be applied to feed industry with a promising future as an enzyme preparation.

OBJECTIVE:To systematically review the efficacy of agomelatine in the treatment of depression in acute phase, and provide evidence-based reference for the clinical treatment. METHODS:Retrieved from Cochrane Library,Medline,EMBase, CJFD,VIP,CBM,Wanfang Database,WHO Clinical Trials Registry Platform and American Clinical Trials Registry Platform, the randomized controlled trials (RCT) about agomelatine versus placebo in the depression patients in acute phase. After quality evaluation and data extraction,Meta-analysis was conducted by using Rev Man 5.2 statistics software. RESULTS:A total of 7 RCT were included,involving 2 378 patients. Results of Meta-analysis showed the effective rate in agomelatine group was obviously bet-ter than placebo group [RR=1.43 ,95%CI(1.29 ,1.59),P<0.001] ,remission rate was obviously better than placebo group [RR=1.27 ,95%CI(1.03 ,1.57),P=0.02] ,and the endpoint score of depression scales was obviously lower than placebo group [MD=-2.92,95%CI(-3.65,-2.20),P<0.001],there was statistically significance. CONCLUSIONS:Agomelatine is effective in the treatment of depression patients in acute phase. However,due to the limit of methodological quality and sample size,it remains to be further verified with more rigorously designed and long-term follow-up of large-scale RCT.

Objective To explore the effect of leg massage during operation on deep venous thrombosis(DVT)in patients of vascular surgery department.Methods Ninety-four DVT patients were randomized into experiment group and control group according to the computer-generated numbers ,46 cases in the latter and 48 in the former.The routine care measures were applied in the control group, while intraoperative leg massage was used in the observation group.The two groups were compared in terms of curative effect and the incidence of DVT.Result The incidences of DVT in the experiment group and the control one were 2.08%(1/48)and 15.22%(7/46)respectively, showing significant difference between them(P<0.05).Conclusion The intraoperative lag massage are significant in the reduction of DVT incidences after operation.

Objectives To evaluate the lung function in patients of severe secondary hyperparathyroidism caused by uremia and to analyze related factors.Methods The pulmonary function of 70 patients with uremia ( 40 patients with severe secondary hyperparathyroidism, 30 MHD patients without SHPT) and 30 healthy people was determined.Correlative analysis was performed between parameters such as pulmonary function indexes and clinical or laboratory parameters. Results Lung function was significantly different between patients with uremia and healthy subjects(P<0.05, respectively). A number of lung function indicators were negatively correlated with iPTH,C reactive protein( CRP) ,dialysis age but were positively correlated with hemoglobin (Hb) and albumin(Alb) (P <0.05).Conclusion Patients with SHPT show impaired lung function.IPTH, dialysis age, Hb, Alb and CRP can be used as important indicators of lung function.

To develop a recombinant lentivirus co-expressing structural protein of hepatitis C virus (HCV) and secreted Gaussia Luciferase (Gluc), we first constructed an expression vector that encoded HCV structural protein (C, E1, E2) and GLuc named pCSGluc2aCE1E2. The expression of HCV proteins and Gluc was confirmed by an immunofluorescence assay (IFA) and the detection of luciferase activity. Recombinant lentivirus (VSVpp-HCV) was developed by the co-transfection of pCSGluc2aCE1E2 into 293T cells with pHR'CMVA8.2 and pVSVG. The infectivity of VSVpp-HCV was confirmed by luciferase activity detection, IFA and western blotting. Virus-like particles were identified using electron microscopy after concentration. The results showed that the level of luciferase activity correlated with the expression of HCV protein after the infection of cells with lentivirus VSVpp-HCV. Therefore, the expression level of HCV proteins could be evaluated by detecting the luciferase activity of Gluc. In conclusion, this research pave a way for the development of transgenic mice that express HCV proteins and Gluc, which enable the evaluation of anti-HCV therapy and vaccine in vivo.
Animals ; Copepoda ; Genes, Reporter ; Genetic Vectors ; genetics ; metabolism ; Hepacivirus ; genetics ; metabolism ; Hepatitis C ; virology ; Humans ; Lentivirus ; genetics ; metabolism ; Luciferases ; genetics ; metabolism ; Recombinant Fusion Proteins ; genetics ; metabolism ; Viral Structural Proteins ; genetics ; metabolism

Objective To detect the immune effect of FbaAmAb2 against the surface protein of group A Straptococcus (GAS),and explore the pathogenesis and therapy of GAS infections.Methods By subclonal and bacterial ELISA,the positive hybridoma cells were screened that can produce better titers of FbaAmAb2 against GAS-surface FbaA protein,and were injected into the peritoneal cavities of BALB/c mice to produce ascites.The collected ascites were performed to dilute,as follows,original ascite,1:2,1:4,1:8,and 1:16 to test tube agglutination.Based on the results,we selected appropriate dilution to passively immunize mice,and then challenged the mice with GAS,evaluating FbaAmAb2 neutralizing ability with GAS in mice by the survival rate of the immunized mice.Whether FbaAmAb2 could inhibit the binding of factor H to GAS was confirmed by the invasive inhibition assay.Results The IgG titer of bacteria solution ELISA is 1:160 and the titer of tube agglutination is 1∶8.The protect rates of FbaAmAb2 on preventing mice with GAS infections are as follows:66.67％ in original ascite and 1:2 diluted groups,and 50％ in 1:4 diluted group.Mice in each experimental group were evoked significantly protective immune responses compared with the PBS control by SPSS analysis.FbaAmAb2 can competitively inhibit factor H binding to the surface proteins FbaA of GAS,which decreased the entry of GAS into the cytoplasm of human epithelial cells through the binding of factor H.Conclusion FbaAmAb2 is promising to be used in emergent prevention or the clinical therapy for GAS infection and it is promising starting points for pharmacologic targeting and further development of new therapeutic agents for GAS.

BACKGROUND: The association of genetic variation in the IRAK-1 gene with sepsis outcome has been proved. However, few studies have addressed the impact of the IRAK-4 gene variants on sepsis risk. This study aimed to determine whether the polymorphisms in the IRAK-4 gene are associated with susceptibility to and prognosis of severe sepsis in the Chinese Han ethnic population.METHODS: In this case-control study, 192 patients with severe sepsis hospitalized in the emergency department of Zhongshan Hospital from February 2006 to December 2009 and 192 healthy volunteers were enrolled. Exclusion criteria included metastatic tumors, autoimmune diseases, AIDS or treatment with immunosuppressive drugs. This study was approved by the ethical committee of Zhongshan Hospital, Fudan University. Sepsis patients were divided into a survival group (n=124) and a non-survival group (n=68) according to the 30-day mortality. Primer 3 software was used to design PCR and sequencing primers. Genomic DNA was extracted from peripheral blood mononuclear cells. Seven tagSNPs in IRAK-4 were selected according to the data of the Chinese Han population in Beijing from the Hapmap project and genotyped by direct sequencing. The chi-square test was used to evaluate the differences in genotype and allele frequencies between the two groups.RESULTS: The distributions of all tagSNPs were consistent with Hardy-Weinberg equilibrium. The allele and genotype frequencies of rs4251545 (G/A) were significantly different between the severe sepsis and healthy control groups (P=0.015, P=0.035, respectively). Carriers of the rs4251545A had a higher risk for severe sepsis compared with carriers of the rs4251545G (OR=1.69, 95％ CI: 1.10-2.58). The allele and genotype frequencies of all SNPs were not significantly different between the survival group and non-survival group.CONCLUSION: These findings indicate that the variants in IRAK-4 are significantly associated with susceptibility to severe sepsis in the Chinese Han ethnic population.