OBJECTIVE:To put forward the ideas on construction of a new drug GMP certification inspection management information system to meet work needs in the new situation.METHODS:The purpose,overall frame,structure and database of new system were analyzed,considering the goal and task of drug GMP certification inspection.RESULTS&CONCLUSIONS:With the rapid development of information technology and drug administration,it is urgent to realize scientific supervision through establishing a new drug GMP certification inspection management information system and ensuring efficiency and quality of drug inspection.

OBJECTIVE:To pose the overall concept for the construction of drug authentication system and to promote its scientific development. METHODS: With an emphasis on the target and task,the author analyzed preliminarily and studied the objective and significance,the basic principle,the objective and the content of the construction of drug authentication system. RESULTS & CONCLUSIONS: The construction of drug authentication system is an important part of drug authentication work and it has become an urgent affair,meanwhile it is an important means to promote and ensure impartiality,fairness and publicity of drug authentication and facilitate its scientific and sound development.

Objective To observe and study the application and effect of antimicrobial agents in type Ⅰ general surgery, in order to rationalize the use of drugs.Methods 228 patients with type Ⅰgeneral surgery from May 2014 to September 2016 were selected as the observation group.The patients in the type Ⅰ general surgery group from February 2012 to April 2014 were selected as the control group.The observation group were retrospectively monitored, and the control group were prospectively monitored.The application of antimicrobial agents in the two groups of patients, the rational application and the application rate of antimicrobial agents in type Ⅰ general surgery and outcome were compared.Results The application rate of the first generation cephalosporins in the observation group was significantly higher than that in the control group ( P<0.05 ).There was no significant difference in application rate of macrolides compared with the control group.The application rates of the second generation and third generation cephalosporins, quinolones, aminoglycosides and nitroimidazoles were lower than those of the control group ( P<0.05 ).And the rational use of antimicrobial agents, reasonable choice of time, rational combination of drugs, reasonable dose, reasonable frequency of administration and reasonable volume of solvent were higher than those of the control group, the differences were statistically significant (P<0.05).The antibiotic application rates of abdominal hernia surgery, thyroid surgery and breast surgery were lower than those of the control group, the differences were statistically significant (P<0.05).There was no infective case in the two groups.And the average length of stay in the observation group was (8.50 ±1.20) days, which was lower than (15.00 ±2.30) days in the control group, the difference was statistically significant (P<0.05).Conclusion Accordance with the principles of antibiotics in type Ⅰ general surgery, it could rationalize medication and reduce the drug resistance.

Objective Measure the cytokines including hIFN-?、hIL-12 and hTNF-? which secreted by PBMC stimulated with recombinant BCG, and research how recombinant BCG influence the expression of cytokines and improve the immunologic response. Methods In the experiment, Recombinant hIFN-?-2b-BCG group and wild-type BCG group stimulate peripheral blood monocytes(PBMC) with different density in vitro, which is 0.1 OD and 0.01 OD (1 OD=2.7?107CFU). In third group, we put IFN-?-2b into wild-type BCG so that we can compare it with recombinant BCG. All these components foster with PBMC(4?106/ml), then collect the supernatant in 12 hours, 24 hours, 48hours, 72 hours, 5 day, 7day, and detect hIFN-?、hTNF-?, hIL-12 by an enzyme-linked immynosorbent assay(ELISA), compare the results. Results We can learn from the result, compared with the other groups, recombinant BCG can induce higher density cytokines than wild-type BCG’s and combination group’s(P

Nonalcoholic fatty liver disease(NAFLD) is the most common liver disorder in the world.A significant,albeit relative small,proportion of NAFLD patients can advance from steatohepatitis to liver cirrhosis and hepatocellular carcinoma.Moreover,NAFLD is associated independently with an increased incidence of type 2 diabetes and cardiovascular disease.The mortality of patients with NAFLD is significantly higher than that among the general population and cardiovascular risk may compete with liver-related risk in dictating the final outcome.From a clinical point of view,it has become mandatory to evaluate the metabolic risk factors in NAFLD patients and to consider careful surveillance and aggressive treatment of both hepatic and cardiovascular outcomes.Nowadays,there are substantial advances in the ability to make the diagnosis of NAFLD as well as both grade and stage the disease,however,liver biopsy remains the gold standard.Lifestyle changes are the first line and mainstay of management of NAFLD,weight loss and treatment of insulin resistant remain central to the therapeutic process.Specific pharmacological treatment is currently not recommended for routine clinical practice.

Age-related macular degeneration (AMD) is the mainirreversible blinding eye disease in the elderly.Its main pathogenic factors include age, genetic variation and lifestyle, but the specific pathogenesis has not been fully elucidated.As an emerging research method, proteomics technology has been gradually applied in the field of ophthalmology in recent years.A large number of studies about proteomic analysis of blood, tears, aqueous humor, vitreous humor, retina and choroid, drusen and RPE cell samples from AMD patients have been carried out to screen AMD biomarkers and explore the mechanism of AMD.These results can not only help us to make a more accurate diagnosis of AMD, but also play a guiding role in the selection of treatment targets and prognosis.

Objective To compare the efficacy of intralesional glucocorticoid injection with a needle-free injector versus an ordinary injector for the treatment of keloid. Methods A total of 60 patients with keloid were enrolled and randomly divided into two groups by using a random number table to receive intralesional injection of compound betamethasone with a needle-free injector(n=31)or an ordinary injector(n=29). The injection was given at a dose of 0.2 ml/cm3 once every 3 weeks for 3 sessions. Parameters for therapeutic efficacy were assessed, adverse reactions were recorded, and clinical pictures were taken before and after each treatment. Statistical analysis was carried out by the Mann-Whitney U test and chi-square test with the SPSS 19.0 software. Results Compared with the ordinary injector group, the needle-free injector group showed significantly different injection time during the first and second treatment (U=299.000, 773.500, respectively, both P=0.000), as well as duration of pain after the first injection(U=730.000, P=0.003). After three sessions of treatment, there was a significant difference in the volume, height, hardness of keloid, scores for pain, itching and appearance, and number of injection points between the needle-free injector group and ordinary injector group (U=295.000, 336.500, 264.000, 464.000, 451.500, 308.000, 233.500, P=0.001, 0.007, 0.000, 0.041, 0.043, 0.003, 0.001, respectively). No significant differences were observed in the incidence of adverse reactions between the two groups(all P>0.05). Moreover, the interval for lesion recurrence was significantly shorter in the needle-free injector group(11.8 days, 95%CI:10.96-12.6 days)than in the ordinary injector group(21.2 days, 95%CI:13.96-28.45 days). Conclusion Compared with the ordinary injector, the needle-free injector shows better efficiency for the treatment of keloid with decreased difficulty in injection and improved compliance in patients.

Itraconazole has potent anticancer activity at the standard therapeutic doses,which is proved in vitro and in vivo preclinical studies,even in active clinical trials.The precise mode of action of itraconazole for its anticancer activity has not been elucidated,however multiple putative mechanisms are proposed,such as anti-angiogenesis,inhibition of Hedgehog pathway,autophagy induction and reversal of multi-drug resistance.Its high efficacy,known toxicity and well-estabhshed pharmacokinetics make this generic drug a strong candidate for repurposing as an oncological treatment.

Objective:To study the mechanism of effect of miR-21 via Wnt/β-catenin signaling pathway in human A549 lung cancer cells and Lewis lung carcinoma in mice. Methods:The effect of miR-21 on A549 cells were detected by MTT method. MiR-21 expression levels were overexpressed or inhibited in A549 cells by transfecting with miR-21 mimics or inhibitors. Correlation among key molecules (Wnt1,β-catenin, CyclinD1 and miR-21) of mRNA and protein levels in Wnt/β-catenin signaling pathway were studied by Real-time PCR and Western blot hybridization assay. Invasive ability of A549 cells was determined via Transwell chamber cell invasion assay;the role of miR-21 in A549 cells was explored via the Wnt/β-catenin signaling pathway. A Lewis lung carcinoma animal model was established to detect miR-21 expressions in tumor animals and controlled animal tissues, and verify expression changes of the above moleculesin the Wnt/ β-catenin signaling pathway was determined in the animal level. Results:MTT assay results showed that miR-21 overexpression could markedly enhance cell absorbance value;that is, miR-21 could increase the ability proliferation of A549 cells.β-catenin and CyclinD1 expression levels were significantly higher in miR-21 mimic transfected cells (P<0.05), and Wnt1 gene had no significant change. Wnt1,β-catenin and CyclinD1 gene expression showed no significant change when miR-21 expression was suppressed, compared with controls. After cells were transfected with miR-21 mimics, cell invasion assay revealed that the perforated cells was significantly higher than the perforated cells in the control group (P<0.01). Lewis lung assay revealed that miR-21 expression levels in the Lewis lung carcinoma were significantly higher;and at the same time, Wnt1,β-catenin and CyclinD1 gene expression levels were significantly increased, compared to controls. Conclusions: In A549 human lung cancer cells and Lewis lung carcinoma in mice, key moleculesβ-catenin and CyclinD1of miR-21 expressions and the Wnt/β-catenin signaling pathway are positively correlated.

Objective To investigate the association between diabetes mellitus and risks of kidney cancer.Methods The cohort and case-control studies on the association between diabetes mellitus and risk of kidney cancer were analyzed by searching PubMed database within the time limit of Jan.1990 to Oct.2011.Data were selected according to the inclusion and exclusion criteria,and the meta-analysis was performed by using the Cochrane Collaboration's RevMan 5.0 software.Results A total of 14 studies(8 cohort studies and 6 case-control studies) involving 6,645,516 participants met the inclusion criteria.Meta analysis showed that patients with diabetes had a higher risk of kidney cancer compared with the control group without diabetes(OR =1.28,95％ CI 1.10 ～ 1.48,P ＜ 0.05).Stratification study showed that diabetes was associated with an increased risk of kidney cancer in cohort studies(OR =1.32,95％ CI 1.14-1.53,P ＜0.05),but this association was not found in casecontrol studies (OR =1.21,95 ％ CI 0.79-1.84,P ＞ 0.05).Conclusion This meta-analysis indicates a positive association between diabetes and risk of kidney cancer,however,future researches are needed to identify whether diabetes mellitus is an independent risk factor for kidney cancer.