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Background/Aims@#PF-00547659 is a monoclonal antibody against human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) that prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract with high affinity and selectivity, and is being developed for the treatment of Crohn’s disease (CD). @*Methods@#OPERA is a randomized, multicenter, double-blind, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of PF-00547659 following subcutaneous administration in subjects with active CD, a history of failure or intolerance to anti-tumor necrosis factor and/or immunosuppressants, high-sensitivity C-reactive protein > 3.0 mg/L, and ulcers on colonoscopy. The primary endpoint was Crohn’s Disease Activity Index-70 response at week 8 or 12. Subpopulation analyses for Asian subjects were performed as some differences are observed in genetics and clinical phenotypes in Asian CD patients compared with Western patients. @*Results@#In this study, 265 CD subjects were randomized, with a subpopulation of 21 subjects (8 Japanese and 13 Korean) defined as the Asian population. In the overall and Asian populations; PF-00547659 was pharmacologically active as evidenced by soluble MAdCAM and circulating β7+ central memory CD4+ T-lymphocytes, although no clear evidence of efficacy was observed in any clinical endpoints; pharmacokinetics of PF-00547659 in the Asian subpopulation was generally comparable to the overall population; and the safety profile of PF-00547659 appeared acceptable up to 12 weeks of treatment. @*Conclusions@#In the overall and Asian populations, efficacy of PF-00547659 could not be demonstrated using any clinical endpoints compared with placebo. Pharmacokinetics and safety of PF-00547659 were generally comparable. Further studies with larger numbers of patients are required to confirm our results. (Trial Registration Number: NCT01276509)
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Objective To study the imaging features and the diagnostic value of conventional and enhanced MRI,DWI and magnetic resonance cholangiopancreatography (MRCP)in primary duodenal adenocarcinoma.Methods 12 cases with duodenal adenocarcinoma confirmed by pathological results were analyzed by conventional and enhanced MRI,DWI (3.0T,b＝0 and 800 s/mm2 )and MRCP.Results 11 cases out of twelve cases of duodenal adenocarcinoma demonstrated uneven thickening of intestinal wall,while mass shadow was observed in 1 case.Slight hypointensity of T1 WI and slight hyperintensity of T2 WI were demonstrated in all the twelve cases .DWI demonstrated mild increase in signal in 3 cases,while hyperintensity was observed in 9 cases.On MRCP,ampullary obstructions were observed in 1 1 cases,of which 6 were accompanied with the dilatation of common bile duct (CBD),and 5 with dilatation of CBD and pancreatic duct, while no dilatation of CBD or pancreatic duct was observed in 1 case.The tumors showed moderate enhancement after intravenous administration of contrast material.No normal layered intestinal walls were observed.Conclusion Conventional and enhanced MRI combined with DWI can clearly demonstrate the features of duodenal adenocarcinoma.Additionally,MRCP is instrumental in assessing the lesions involved in the duodenal papilla.
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Objective:To evaluate the effect of epigallocatechin-3-gallate (EGCG) and epigallocatechin-3-O-(3-O-methyl)-gallate (EGCG-3Me) on the anti-bacterial effect and the stability of intraradicular dentin-adhesive interface.Methods:EGCG and EGCG3Me with the concentration of 400 μg/ml were incorporated into Single Bond 2 (SB2) respectively to obtain 2 modified adhesives E-SB2 and E3-SB2.Confocal laser scanning microscopy(CLSM) and ultraviolet spectrophotometry were used to evaluate the anti-bacterial effect of the modified adhesives.Micro-Raman spectrum was used to test the degree of conversion (DC) of the adhesives.Push-out bond strength test was conducted to examine the immediate bond strength and the bond strength after themocycling.Results:E-SB2 and E3-SB2 both showed inhibiting effect on the proliferation of E.faecalis,while E3-SB2 performed stronger inhibiting effect.DC and the immediate push-out bond strength of SB2 were not decreased with the incorporation of EGCG or EGCG-3Me(P ＞ 0.05).E-SB2 and E3-SB2 showed significantly higher push-out bond strengths than that of SB2 (P ＜ 0.05) after themocycling.Conclusion:EGCG and EGCG-3Me modified adhesives have anti-bacterial effect and can enhance the stability of bonding between intraradicular dentin and adhesive,EGCG-3Me may have stronger anti-bacterial effect.
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Objective To introduce inhaled inactivated-mycobacterium phlei on prevention and treatment of moderate bronchial asthma to observe the clinical effect. Method This study was a prospective and controlled study. The patients diagnosed with asthma in our out-patient from March 2009 to December 2010 were collected, who met the following conditions were included in the study: age≥ 14 years; met the criteria of moderate chronic persistent bronchial asthma in Global Initiative for Asthma (GINA) in 2008; suspended receiving systemic corticosteroids, Montelukast, ketotifen and other anti-inflammatory and anti-allergic drugs in one month; no significant respiratory tract infections; and other serious illnesses or abnormalities known.A total of 100 patients with asthma were selected, including 37 males and 63 females, age (32.11 ± 12.95 )years. The patients were randomly(random number) divided into two groups: A group(treatment group; 16males and 34 females, age 33.56 ± 14.23 years) and B group (control group; 21 males and 29 females,age 30.66 ± 11.50 years); 50 in each group. No significant difference was noted between the two groups on age and gender composition. The patients in A group were treated with inhaled inactivated-mycobacterium phlei F. U. 36 Injection 1.72 μg/mL × 2 that adding 3 mL normal saline, once a day for 5 days. The patients in B group were treated with salmeterol xinafoate and fluticasone propionate powder for inhalation (50/100 μg), twice daily for sustainable use. The patients in the two groups were observed for one month. During this course, the patients in the two groups could inhale the salbutamol sulphate aerosol as need to relieve symptoms. And the number of using was recorded. Pulmonary function test and asthma provocative test were carried out on the Day O, 6 and 31. ACT scores were measured before and after the treatment. Results On Day 6 and 31 after treatment, the negative conversion rates of asthma provocative test of the patients in A group were 82% and 78% respectively, B group were 84% and 90% respectively. Provocative test of the patients in the two groups were negative conversion significantly before and after treatment. There was no significant difference between the two groups by chi-square test (P ＞ 0. 05 ). Completely random designed data was analyzed by analysis of variance. The analysis showed that the accumulated doses of methacholine of the patients in the two group increased significantly ( P ＜ 0. 05 ), but no difference between the two groups.There was a improvement trend on forced expiratory volume in one second( FEV1 )of the patients in A group after treatment, but no difference. FEV1 of the patients in B group increased significantly higher ( P ＜0.05), which was significantly higher than A group on the 31th day (P ＜0. 05); Peak expiratory flow (PEF) of the patients in the two group increased significantly on Day 6 and 31 after treatment (P ＜0.05 ).On Day 31, B group was significantly higher than A group ( P ＜ 0. 05 ); Scores of asthma control test (ACT)of the patients in the two group were significantly increased, and the number of using of salbutamol sulfate aerosol was significantly reduced (P ＜0.01 ). B group was obvious than group A (P ＜0.05 ). During treatment, there were only two adverse reaction cases of transient low fever; most obvious was on the third day.Conclusions Inhaled inactivated-mycobacterium phlei would inhibit the airway hyperresponsiveness of the patients with moderate bronchial asthma in short time, improve the symptoms, reduce the acute exacerbation, and reduce the use of rescue medication, which has the roles of prevention and treatment of moderate asthma in a certain period of time.
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Objective To design a device sampling Korotkoff's sound signal and acquiring blood pressure based on Korotkoff theory.Methods The author sampled Korotkoff's sound signal via microphone,and then according the cuff pressure corresponding to signal appearance and disappearance,the author acquired SBP and DBP.At last,the author validated the creditability by contrasting with the results of auscultatory method.Results The difference of SBP and DBP is near nonexistence,the blood pressure data using this device is creditable.Conclusion The blood pressure can be measured using this device,and it can be used to further study the auto-measurement of blood pressure base on Korotkoff's sound theory.