AIM:To test the efficacy and safety of Profermin in inducing remission in patients with active ulcerative colitis(UC).METHODS:The study included 39 patients with mild to moderate UC defined as a Simple Clinical Coliti...AIM:To test the efficacy and safety of Profermin in inducing remission in patients with active ulcerative colitis(UC).METHODS:The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index(SCCAI)>4 and<12(median:7.5),who were treated open-label with Profermintwice daily for 24 wk.Daily SCCAI was reported observer blinded via the Internet.RESULTS:In an intention to treat(ITT)analysis,the mean reduction in SCCAI score was 56.5%.Of the 39 patients,24(62%)reached the primary endpoint,which was proportion of patients with≥50%reduction in SCCAI.Our secondary endpoint,the proportion of patients in remission defined as SCCAI≤2.5,was in ITT analysis reached in 18 of the 39 patients(46%).In a repeated-measure regression analysis,the estimated mean reduction in score was 5.0 points(95%CI:4.1-5.9,P<0.001)and the estimated mean time taken to obtain half the reduction in score was 28 d(95%CI:26-30).There were no serious adverse events(AEs)or withdrawals due to AEs.Profermin was generally well tolerated.CONCLUSION:Profermin is safe and may be effective in inducing remission of active UC.展开更多
In order to improve the accuracy for quantitating the bovine foamy virus (BFV) in vitro,we developed a baby hamster kidney cell (BHK)-21-derived indicator cell line containing a plasmid that encodes the firefly lucife...In order to improve the accuracy for quantitating the bovine foamy virus (BFV) in vitro,we developed a baby hamster kidney cell (BHK)-21-derived indicator cell line containing a plasmid that encodes the firefly luciferase driven by the BFV long terminal repeat promoter (LTR,from-7 to 1012).The BFV titer could be determined by detecting the luciferase expression since the viral trans-activator BTas protein activates the promoter activity of the LTR.One clone,designated BFVL,was selected from ten neomycin-resistant clones.BFVL showed a specific and inducible dose-and time-dependent luciferase activity in response to BFV infection.Although the changes in luciferase activity of BFVL peaked at 84 h post infection,it was possible to differentiate infected and uninfected cells at 48 h post infection.A linear relationship was established between the multiplicity of infection (MOI) of BFV and the activated ratio of luciferase expression in BFVL.Moreover,the sensitivity of the BFVL-based assay for detecting infectious BFV was 10,000 times higher than the conventional CPE-based assay at 48 h post infection.These findings suggest that the BFVL-based assay is rapid,easy,sensitive,quantitative and specific for detection of BFV infection.展开更多
基金Supported by Danish Innovation Law Grant,J.nr.3414-06-01530from the Danish Food Industry Agency under the Ministry of Food,Agriculture and FisheriesNordisk Rebalance,who developed and manufactured Profermin,and partly financed the study
文摘AIM:To test the efficacy and safety of Profermin in inducing remission in patients with active ulcerative colitis(UC).METHODS:The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index(SCCAI)>4 and<12(median:7.5),who were treated open-label with Profermintwice daily for 24 wk.Daily SCCAI was reported observer blinded via the Internet.RESULTS:In an intention to treat(ITT)analysis,the mean reduction in SCCAI score was 56.5%.Of the 39 patients,24(62%)reached the primary endpoint,which was proportion of patients with≥50%reduction in SCCAI.Our secondary endpoint,the proportion of patients in remission defined as SCCAI≤2.5,was in ITT analysis reached in 18 of the 39 patients(46%).In a repeated-measure regression analysis,the estimated mean reduction in score was 5.0 points(95%CI:4.1-5.9,P<0.001)and the estimated mean time taken to obtain half the reduction in score was 28 d(95%CI:26-30).There were no serious adverse events(AEs)or withdrawals due to AEs.Profermin was generally well tolerated.CONCLUSION:Profermin is safe and may be effective in inducing remission of active UC.
基金National Natural Science Foundation of China(31070135,81071343)
文摘In order to improve the accuracy for quantitating the bovine foamy virus (BFV) in vitro,we developed a baby hamster kidney cell (BHK)-21-derived indicator cell line containing a plasmid that encodes the firefly luciferase driven by the BFV long terminal repeat promoter (LTR,from-7 to 1012).The BFV titer could be determined by detecting the luciferase expression since the viral trans-activator BTas protein activates the promoter activity of the LTR.One clone,designated BFVL,was selected from ten neomycin-resistant clones.BFVL showed a specific and inducible dose-and time-dependent luciferase activity in response to BFV infection.Although the changes in luciferase activity of BFVL peaked at 84 h post infection,it was possible to differentiate infected and uninfected cells at 48 h post infection.A linear relationship was established between the multiplicity of infection (MOI) of BFV and the activated ratio of luciferase expression in BFVL.Moreover,the sensitivity of the BFVL-based assay for detecting infectious BFV was 10,000 times higher than the conventional CPE-based assay at 48 h post infection.These findings suggest that the BFVL-based assay is rapid,easy,sensitive,quantitative and specific for detection of BFV infection.
