The State Key Specialized Scientific Projects bring the unprecedented opportunity for the development of variety disciplines and provide the critical timing for the improvement of science and technology of university. Meanwhile, it presents new challenges to develop the frontier of sciences and to promote cooperation and cross of different disciplines. Through the process of the programs, we will expect to train and find team leaders and outstanding scientists. This paper presented the brief outline how the researchers from the Departments of Infectious Disease and School of Pharmacy in Fudan University collaborated in a cross-discipline manner and integrated the research resources based on the objectives of the research programs. During the application, they reorganized research teams, combined the overlapping research fields to focus the direction of research fields according to the national and research needs. In the process of their application, they finally promoted the capacities for their competition and innovation which were undoubted to help us to establish headship/main forces in the fields of infectious disease precaution and devolvement of new clinical medicine in the future.

CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
Biomedical Research ; standards ; China ; Clinical Trials as Topic ; standards ; Data Collection ; standards

Objective:To summarize the experiences of the surgical treatment of tumors in the posterior part of the third ventricle and pineal region. Methods: Twenty-seven patients with tumors in this region treated microsurgically from 1990 to 2000 were analyzed. The surgical indications, approaches, and operative key points were discussed. The prognostic factors were also analyzed. Results:Tumors were removed totally in 11 patients, removed subtotally in 7 and removed partially in 5. Biopsy and ventriculo-peritoneal shunt was performed in 4 patients. Of 17 patients in follow-up, 13 patients survived longer than 5 years. Conclusions: Most tumors in the posterior part of the third ventricle and pineal region can be surgically removed.Sufficient specimen obtained in the operation can confirm pathologic property of the tumor,guiding next chemotherapy and radiotherapy.

Objective To investigate whether the monthly distribution of birth was associated with congenital heart disease(CHD).Methods The monthly distribution of birth of 5 070 patients with CHD who accepted examination or treatment from Jan.2003 to Dec.2006 was investigated and compared with that of 6 627 healthy newborn children born in 2001-2006.The statistic analysis was accomplished with SPSS 12.0 software for ?2 test.Results Four hundred and forty-four of the 5 070 patients with CHD were born in January(8.8%),432 cases in February(8.5%),384 cases in March(7.6%),339 cases in April(6.7%),390 cases in May(7.7%),393 cases in June(7.8%),414 cases in July(8.2%),489 cases in August(9.6%),498 cases in September(9.8%),492 cases in October(9.7%),396 cases in November(7.8%),and 399 cases in December(7.8%).The structural ratio of the number of CHD patients were the highest for those who were born in August,September,October,and the lowest among those who were born of February and March,April.The number of CHD patients who were born in the autumnal months of August,September and October was 1 479(29.1%),much higher than those who were born in February,March and April(1 155 cases,22.8%)(P

In order to construct a prokaryotic expression vector of human receptor syt II N-fragment and to express recombinant MBP-Syt fusion protein in E.coli and to purify and identify its activity. According to codon preference of E.coli, a DNA fragment encoding human syt II N-fragment was synthesized, and then cloned into prokaryotic vector pMAL-c2x for sequencing. Then the recombinant plasmid pMAL-Syt was introduced into E.coli ER2566 by transformation for expression and the obtained engineered bacteria were induced by IPTG. The fusion protein was purified by amylose resin affinity chromatography and identified by SDS-PAGE and Western blot. The binding activity of the protein was determined by ELISA. It is concluded that MBP-Syt protein is of good binding activity.

Objective:To express the B subunit of Shiga-like toxin type Ⅱ,and analyze its expression form and receptor-binding activity.Methods:The slt2b gene was obtained from EHEC O157∶H7 by PCR,and cloned to the expression vector pET22b(+).The genetically engineered bacteria pET22b(+)-stx2B/BL21 expressed the recombinant StxB after induced with IPTG.The renatured inclusion bodies were purified by ion exchange chromatography.The expression form of rStx2B was investigated by denaturing and native electrophoresis.The receptor-binding activity was confirmed by fluorescence detection and flow cytometer.Result:The constructed genetically engineered bacteria expressed the rStx2B at a high level.The purified protein was obtained after denaturation,renaturation and ion exchange chromatography.According to the denaturing and native electrophoresis,the rStx2B was expressed in a dimmer form,which consists of two monomers cross linked with disulfide bridge.The rStx2B showed good receptor-binding activity by Hela-binding assay.Conclusion:The genetically engineered bacteria were constructed successfully.The receptor-binding activity of rStx2B was independent of the pentamers.

SW872 preadipocytes were cultured and induced to differentiate by oleic acid in vitro.The levels of adiponectin and its receptors (AdipoR1 and AdipoR2) mRNA were measured by semiquantitative RT- PCR.The concentration of adiponectin in the culture medium was assayed by ELISA.The results showed that rhIL- 6 could inhibit adiponectin,AdipoR1 mRNA expressions and adiponectin secretion in SW872 adipocytes in a time- and dose-dependent manner,but did not influence adipoR2 mRNA expression.

Objective To investigate the feasibility of ~1H-MR spectroscopy(~1H-MRS)imaging to quantitatively detect fatty liver.Methods Twenty patients with fatty liver and 11 healthy volunteers underwent plain CT scan,conventional MR imaging and ~1H-MRS analysis.The blood lipid and liver function were tested on the same day as the MR examination.~1H-MRS sequence measured the peaks of H_2O and lipid,and the areas under the peaks.The relative contents of the lipid compound were calculated,and compared with the results of CT scan and liver function tests.Results The CT values of the normal group and the fatty liver group were(59?9)HU and(24?11)HU respectively.On ~1H-MRS a protruding high H_2O peak and a flat low lipid peak were observed in the normal group,while the protruding high H_2O peak and a high lipid peak appeared in the fatty liver group.The values of lipid peak in the normal group and the fatty liver group were(0.05?0.01)?10~5,(0.70?0.24)?10~5 respectively(t=4.32,P0.05),the areas under the lipid peak were(1.36?0.73)?10~9、(2.35?1.15)?10~9 respectively(t=5.21,P0.05).Conclusion ~1 H-MRS imaging is feasible to quantitatively detect liver fat and is a non-invasive method for detecting early fatty liver.

Purpose To analyze the correlation of right subclavian artery ultrasound and individual blood lipid level with coronary atherosclerosis (CA) using carotid ultrasound as control so as to explore the clinical value of them in predicting CA.Materials and Methods Coronary CT angiography (CCTA) and right subclavian artery/neck vessel ultrasound in 55 patients were retrospectively analyzed.Gensini score was used to calculate the degree of coronary artery lesions.According to the result of CCTA,patients were divided into normal group,mild coronary atherosclerosis group,severe coronary artery stenosis group.The intina-media thickness (IMT) at the origin of right subclavian artery and carotid artery bifurcation on ultrasound was measured to evaluate carotid lesions.The correlation between the IMT and Gensini score of coronary artery was analyzed.The blood lipid levels of the 3 groups were analyzed,and the efficacy of right subclavian artery,carotid artery ultrasound and blood lipid in predicting CA was evaluated.Results ① The IMT at right subclavian artery and carotid artery bifurcation were positively correlated with Gensini score,and the former had higher correlation than the latter (r=0.636,r=0.462,P＜0.01);the prediction efficacy of the IMT at right subclavian artery was slightly higher than that at carotid artery bifurcation (with sensitivity and specificity of 78.3％,64.5％,and 77.5％,60.0％ respectively).② Compared with normal control group,the levels of low-density lipoprotein cholesterol,triglycerides,total cholesterol were higher,but the level of highdensity lipoprotein cholesterol (HDL-C) was lower in mild coronary atherosclerosis and severe coronary artery stenosis group,and the difference between the severe coronary artery stenosis group and normal groups was bigger,among which the level of triglycerides had the largest difference among the three groups with no statistical significance (P＞0.05).The HDL-C had a more significant correlation with Gensini score than other index of blood lipid (r=-0.151).③ The combination of IMT and HDL-C had a sensitivity of 81.0％ and specificity of 66.7％ in predicting CA,which were higher than that of each individual index (with sensitivity of 78.3％,64.5％ and specificity of 64.3％,55.5％respectively).Conclusion The IMT at right subclavian artery has a better predictive value in determining the degree of coronary artery lesions than that at carotid artery bifurcation.The combined application of blood lipid levels and the IMT at right subclavian artery can improve the sensitivity and specificity of predicting CA.

OBJECTIVETo explore clinical efficacy of Yiguanjian Decoction (YD) combined Adefovir Dipivoxil Tablet (ADT) in treating HBeAg negative chronic viral hepatitis B (CVHB) active compensated liver cirrhosis (LC) patients.

METHODSTotally 68 HBeAg negative CVHB active compensated LC patients initially treated were assigned to the treatment group and the control group using random digit table, 34 in each group. Patients in the control group took ADT alone, 10 mg each time, once per day. Those in the treatment group additionally took YD, one dose per day. The therapeutic course for all was 48 weeks. Levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil) were detected once in every two weeks. Hepatitis B virus (HBV)-DNA and four items of serum liver fibrosis [procollagen type I (PCN), hyaluronidase (HA), procollagen III peptide (PCIII), laminin (LN)] were detected once per every 4 weeks. Abdominal ultrasound B was performed before and after treatment. The inner diameter of the portal vein and the size of spleen were recorded. The fibrosis degree of liver was evaluated using Fibroscan. Efficacy of Chinese medicine (CM) was evaluated between the two groups before and after treatment using CM syndrome integrals. Efficacy of Western medicine (WM) was also evaluated between the two groups using Child-Pugh grading. Results Compared with before treatment in the same group, ALT and AST levels restored to normal levels, HBV-DNA turned negative (HBV-DNA < or = 1 x 10(2)) in the two groups after 48-week treatment. Besides, levels of TBil, ALB, PCIV, HA, PCIII, and LN obviously decreased (P < 0.05, P < 0.01). Results of ultrasound B showed the inner diameter of the portal vein and the size of spleen decreased. Fibroscan results showed that the elasticity value of the liver obviously decreased (P < 0.05). Besides, post-treatment levels of PCIV, HA, PCEJ, and LN, and the elasticity value of the liver decreased more obviously in the treatment group than in the control group (P < 0.01). There was no statistical difference in post-treatment levels of ALT, AST, TBil, ALB, inner diameter of the portal vein, or the size of spleen between the two groups (P > 0.05). Compared with before treatment in the same group, scores of Chinese medical syndrome and Child-Pugh scores decreased in the two groups after treatment (P < 0.05, P < 0.01). Besides, scores of Chinese medical syndrome decreased more obviously in the treatment group than in the control group (P < 0.05). The effective rate was 8824% (30/34) in the treatment group, higher than that of the control group [67.65% (23/34)] with statistical difference (P <0.05). Conclusion Combined treatment of YD and ADT could significantly improve symptoms of CM and fibrosis degree of liver of HBeAg negative CVHB active compensated LC patients.

Adenine ; analogs & derivatives ; therapeutic use ; Alanine Transaminase ; blood ; Antiviral Agents ; therapeutic use ; Aspartate Aminotransferases ; blood ; Bilirubin ; blood ; DNA, Viral ; blood ; Drugs, Chinese Herbal ; therapeutic use ; Hepatitis B e Antigens ; blood ; Hepatitis B, Chronic ; drug therapy ; Humans ; Liver Cirrhosis ; drug therapy ; virology ; Organophosphonates ; therapeutic use ; Tablets