This article introduces the definition and sample size estimation of three special tests (namely, non-inferiority test, equivalence test and superiority test) for qualitative data with the design of one factor with two levels having a binary response variable. Non-inferiority test refers to the research design of which the objective is to verify that the efficacy of the experimental drug is not clinically inferior to that of the positive control drug. Equivalence test refers to the research design of which the objective is to verify that the experimental drug and the control drug have clinically equivalent efficacy. Superiority test refers to the research design of which the objective is to verify that the efficacy of the experimental drug is clinically superior to that of the control drug. By specific examples, this article introduces formulas of sample size estimation for the three special tests, and their SAS realization in detail.

Sample size estimation is necessary for any experimental or survey research. An appropriate estimation of sample size based on known information and statistical knowledge is of great significance. This article introduces methods of sample size estimation of difference test for data with the design of one factor with two levels, including sample size estimation formulas and realization based on the formulas and the POWER procedure of SAS software for quantitative data and qualitative data with the design of one factor with two levels. In addition, this article presents examples for analysis, which will play a leading role for researchers to implement the repetition principle during the research design phase.

ABSTRACT: Estimation of sample size and testing power is an important component of research design. This article introduced methods for sample size and testing power estimation of difference test for quantitative and qualitative data with the single-group design, the paired design or the crossover design. To be specific, this article introduced formulas for sample size and testing power estimation of difference test for quantitative and qualitative data with the above three designs, the realization based on the formulas and the POWER procedure of SAS software and elaborated it with examples, which will benefit researchers for implementing the repetition principle.

This article introduces the general concepts and methods of sample size estimation and testing power analysis. It focuses on parametric methods of sample size estimation, including sample size estimation of estimating the population mean and the population probability. It also provides estimation formulas and introduces how to realize sample size estimation manually and by SAS software.

This article introduces definitions of three special tests, namely, non-inferiority test (to verify that the efficacy of the experimental drug is clinically not inferior to that of the positive control drug), equivalence test (to verify that the efficacy of the experimental drug is equivalent to that of the control drug) and superiority test (to verify that the efficacy of the experimental drug is superior to that of the control drug), and methods of sample size estimation under the three different conditions. By specific examples, the article introduces formulas of sample size estimation for the three special tests, and their SAS realization in detail.

The design of one factor with k levels (k≥3) refers to the research that only involves one experimental factor with k levels (k≥3), and there is no arrangement for other important non-experimental factors. This paper introduces the estimation of sample size and testing power for quantitative data and qualitative data having a binary response variable with the design of one factor with k levels (k≥3).

Hematopoietic Stem Cell Transplantation ; Humans ; Leukemia, Lymphocytic, Chronic, B-Cell ; surgery ; Transplantation, Homologous

Transcranial Doppler can be used for diagnosing,monitoring,identifying the site of arterial occlusion,selecting appropriate cases for thrombolysis,and monitoring arterial recanalization during intravenous thrombolysis,and intra-arterial and intravenous thrombolysis with recombinant tissue plasminogen activator,The continuous monitoring of low frequency transcranial ultrasound has the effect of assisted thrombolysis;however,there are still controversies on the frequencies used in clinical practice.Transcranial Doppler assisted with microbubble contrast agent may further enhance the effect of thrombolysis.

Objective:To explore the application value of problem-based learning (PBL) controlled by closed-loop feedback in the teaching of respiratory medicine.Methods:In PBL teaching, after students' open inquiry, discussion and PBL self-study, closed-loop feedback was given by organizing PPT report, written summary and mechanism diagram display of medical students. The participation of teachers and students, teaching quality, the degree of students' identification of key knowledge points, the breadth and depth of mastering the characteristics of key symptoms and the satisfaction of PBL teaching work were investigated, and the differences were compared before and after the closed-loop feedback. GraphPad Prism 5.01 was used in the analysis.Results:It was found that closed-loop feedback could improve the self-evaluation of tutor's teaching participation [(7.97±0.91) vs. (8.77±0.64), P < 0.001] and students' evaluation on teaching participation of tutor [(8.09±0.79) vs. (8.74±0.45), P < 0.001]. At the same time, students' evaluation on the teaching quality of tutors was also improved [(88.61±6.53) vs. (92.59±5.44), P < 0.001]. After closed-loop feedback, the students' identification of the required knowledge points in the syllabus was significantly increased [(84.00±21.75) vs. (90.22±16.18), P = 0.017]. The overall satisfaction with PBL teaching was also improved obviously [(8.93±0.67) vs. (9.37±0.64), P < 0.001]. Conclusion:Practice has proved that the closed-loop controlled PBL teaching approach has a good effect on the teaching of respiratory medicine, and it's worth popularizing in clinical teaching.

Fibrolase is a non-hemorrhagic zinc metalloproteinase isolated from southern copperhead snake venom (Agkistrodon contortrix contortrix) and is capable of degrading fibrin clots resulting from purified fibrinogen or from blood plasma. Alfimeprase, a truncated form of fibrolase, as a clinical agent was successfully completed PhaseII clinical trials.The cDNA of alfimeprase was amplified by recursive PCR, digested with BamHI and HindII, and cloned into pET43.1a, pMALp2X and pMALc2X vectors to generate fusions with NusA, MBP and sMBP(with signal peptide), respectively. Nus/alfimeprase was expressed in soluble form by co-expressing with chaperone FkpA and inducing with1mmol/L IPTG. The fusion protein accounted for about 25 % of total protein following cell lysis. Alfimeprase was successfully purifiesd by Ni-NTA affinity chromatography and cleaved by enterokinase. The results demonstrate the fibrinolytic activity of recombinant alfimeprase using fibrin plate assays and fibrinogen hydrolysis.