Two-stage designs for the assessment of bioequivalence have been recently accepted in various regulatory authorities.However controlling type Ⅰ error rates around 5％ at targeted power is still a great challenge for applying two-stage method.This paper reviewed the feature of present designs of the two-stage bioequivalence.The decision tree,nominal significance level,and sample size recalculation in previously published methods were also introduced in detail,which would be referential for domestic sponsors in the study of two-stage design bioequivalence.

Problem-based learning (PBL) is a teaching method which is tutor-guided,student-centered,learning in the procedure of solving problem and solving problem in the procedure of learning.Compared with traditional teaching methods,PBL has advantages in culturing the ability of the students,improving the ability of analyzing and solving problem and combining multiple disciplines and it plays an important role in culturing applicable and innovative talents.Attention should be paid to teacher training,learner supervision,strict selection of curriculum and supplement of extra relevant courses.Furthermore,the characteristics of traditional Chinese medicine must be highlighted so as to achieve the best teaching effects.

Objective To evaluate the effect about medication compliance for patients with chronic heart failure in outpatients using nursing intervention model based on Omaha system.Methods 100 patients were randomly divided into observation group(50 patients)and control group(50 patients).The two groups of patients were given routine nursing intervention,the observation group also used the Omaha system to develop care programs on this basis, and was given the implementation about continuity of care.Results On the point of the two or three months after the patients were discharged,the AHFKT -V2 questionnaire scores in the observation group[(17.690 ±1.892)points, (20.900 ±2.052)points]were significantly higher than the control group[(14.080 ±2.374)points,(18.450 ± 1.781)points],the differences were statistically significant (t =-8.488,-6.442,all P <0.05).However,the same as the points after the patients were discharged,Morisky questionnaire scores in the observation group[(1.036 ± 0.780)points,(0.487 ±0.260)points]were significantly lower than the control group[(1.54 ±1.182)points, (0.920 ±0.804)points],the differences were statistically significant(t =3.420,4.965,all P <0.05).Conclusion The use of Omaha system to develop the targeted continuity of care,can improve the patients medication compliance.

0.05).EBV-specific IgM was detected more frequently in patients than that in controls(P

Objective:To study the effects of Tongxinluo,a traditional Chinese medicine,on the proliferation of peripheral blood-derived endothelial progenitor cells(EPCs)in vitro.Methods:The Tongxinluo solution was prepared through ultrasonication according to the pervious literature.The mononuclear cells(MNCs)were isolated from the peripheral blood with Ficoll by density gradient centrifugation.MNCs were suspended in Medium 199 containing 20% fetal blood serum(FBS)and vascular endothelial growth factor(VEGF).After cultured for 7 d,the attached cells were characterized by Di-LDL uptaking and FITC-lectin binding by laser confocal microscope,and further identified through detection of CD34 and CD133 expression by flow cytometry.Then the cultured EPCs were incubated with Tongxinluo at a series of concentrations(0,50,100,200,500, 750,1000?g/ml)for different durations(0,6,12,24 and 36 h).The cell morphology was observed and cell proliferation was determined by MTT assay.Results:Incubation with different concentrations of Tongxinluo increased the proliferative ability of EPCs.Tongxinluo at 500?g/ml had the most prominent effect on proliferation and the effect increased as time went by and reached peak at 36 h(growth rate 54.18%,P

Objective: To chine and express the recombinant human endothelial monocyte-activating polypeptide-Ⅱ(EMAP-Ⅱ)and identify its anti-tumor biological activities.Methods: EMAP-Ⅱ_(147-312)was expressed by the expression vector pMAL-p2x and E.coli BL-21 and the product was purified.The production of tissue factor(TF)in human umbili- cal vein endothelial cell ECV-304 mediated by the recombinant EMAP-Ⅱwas determined by chemiluminescence sub- strate.The promoting effect of recombinant EMAP-Ⅱon TNF?-induced ECV-304 cell.Apoptosis was determined by flow cytometry.Its inhibitory effect on human pancreaic cancer cell SW1990 proliferation was determined by MTT method. Results:DNA sequencing verified that EMAP-Ⅱwas correctly cloned.The molecular mass of the protein identified by SDS-PAGE was consistent with the theoretic value.The productivity of recombinant EMAP-Ⅱwas 500?g per 1 g bacteria (wet mass).The purified product induced expression of tissue factor(TF)in ECV-304 cells;it also enhanced the sensi- tivity of ECV-304 cells to the apoptotic effect of TNF?([16.6?2.5]% vs[25.6?2.3]%,P

Macrolactins are 24-membered macrolides produced by unidentified marine bacterium, Actinomadura sp. and Bacillus sp., which exhibit both antibacterial and antitumor activities in vitro. The environmental strain X-2 which was isolated from the sediment of the East China Sea produce Macrolatin A, B and O. In this study, a set of degenerate oligonucleotide primers, designed for amplification ketosynthase(KS) domains, had been employed to identify KS gene fragments of the X-2 DNA samples. One 645 bp KS fragment(GenBank accession no. EF486351)had been cloned and used as a probe to screen the genome DNA fosmid library of X-2. Three positive clones were selected and sequenced, Homologous analysis and the function prediction of the obtained PKS gene fragments suggested that macrolactin is the Polyketide Biosynthesis Product of the gene cluster obtained in the environmental strain X-2.

Objective:To express Tumstatin_(183-230)-TRAIL fusion protein and to observe its biological functions.Methods: SOE-ing PCR was employed to amplify the recombinant sequence of Tumstatin_(183-230)and TNF-related apoptosis-inducing ligand (TRAIL_(114-281)).An expression vector pMAL-Tu-T was constructed by inserting Tu-T sequence into pMAL-c_2;the vector was used to transfect E.coli BL21(DE3)and expression of MBP-Tu-T fusion protein was induced by IPTG.Amylose Resin columns were employed to purify the fusion protein.The biological functions of MBP-Tu-T protein was examined by inhibitory test of endothelial cell proliferation,standard tumor cell cytotoxic assay,in vitro tube formation inhibition,and electron microscopic observation(apoptosis).Results:The expression rate of MBP-Tu-T fusion protein in E.coli was about 20%. Purified recombinant protein obviously inhibited endothelial cell proliferation(IC_(50)12.5?g/ml),induced apoptosis of pancreatic cancer cells,and inhibited tube formation.Conclusion:Constructed MBP-Tu-T fusion protein is bifunctional,which lays a solid foundation for further investigation of antitumor effect of Tumstatin_(183-230)-TRAIL in vivo.

Objective To describe the genetic epidemiologic features of alopecia areata (AA) patients in China and to presume the possible genetic mo del of AA.Methods A case-controlled study of 1032 AA patients was performed to analyze the effect of genetic factors on the liability to AA.Complex segreg ation and heritability analysis were performed using Falconer's method and SAGE-REGTL programs.Results The mean age of onset was 28.98 ? 13.43 years.The d ifference in the mean age of onset was not significant between males and females.A total of 82.6 percent of patients experienced their first episode of AA befo re the fourth decades of life.A positive family history of AA was obtained in 8 7 patients (8.43%).The prevalences of AA were 1.58%,0.19% and 0.03% in the firs t-,second-and third-degree relatives of the probands respectively,which were significantly higher than those in the controls(P

Asbestos ; adverse effects ; Humans ; Lung Neoplasms ; chemically induced ; Mesothelioma ; chemically induced ; Peritoneal Neoplasms ; chemically induced