Generic drug products (test products: drug A, B...) are bioequivalent to an innovator product (reference product) when their bioavailabilities in the same molar dose are similar. Bioavailability is usually expressed by following pharmacokinetic parameters: the area under plasma concentration-time curve (AUC), the maximum plasma concentration (Cmax) and the time of maximum plasma concentration (tmax). This paper used a two period crossover bioequivalence study to develop convenient, friendly user interface software, BA&BE Analysis to statistically process data in clinical pharmacology studies and other areas. The method involves user input of data for analysis into a grid format, setting variables and parameters, followed by one-way analysis of variance (ANOVA), bioavailability and bioequivalence analysis of the data. The software developed in the present study should help scientists to carry out data analysis of bioavailability and bioequivalence testing quickly and easily.

Objective To explore the changes and clinical significance of regulatory T cell/T help cell 17 (Th17) in the peripheral blood from patients with dermatomyositis (DM).Methods Thirty-six patients with DM were recruited and thirty-six healthy individuals were enrolled as normal controls.The percentage of regulatory T cell/Th17 cell was assessed by flow cytometry and the mRNA levels of Foxp3/RORγt were detected by real-time quantitative reverse wanscription polymerase chain reaction (RT-PCR).The plasma levels of TGF-β1/IL-17 were measured by enzyme linked immunosorbent assay (ELISA).T-test was used for statistical analysis and Pearson's linear analysis were used for correlation analysis.Results The percentage of CD4+ Foxp3+ T cell,the mRNA expression of Foxp3 and the plasma levels of TGF-β1 decreased significantly in patients with DM than in normal controls [(7.2±2.3)％ vs (9.1±3.2)％,(0.44±0.19) vs (0.62±0.25),(37 400±4814) pg/ml vs (41 200±6348) pg/ml,P＜0.05].The percentage of Th17 cell,the mRNA expression of RORγt and the plasma levels of IL-17 increased in patients with DM compared with normal controls [(1.22±0.41)％ vs (0.83±0.14)％,(0.85±0.34) vs (0.61±0.21),(77±32) pg/ml vs (58±20) pg/ml,P＜0.05].There was negative correlation between the percentage of regulatory T cell,the mRNA levels of Foxp3,the plasma levels of TGF-β1 and the serum levels of CK in patients with DM (r=-0.573,-0.593,-0.618,P＜0.05).There was positive correhtion between the percentage of Thl7 cell,the mRNA levels of RORγt,the plasma levels of IL-17 and the serum levels of CK in patients with DM (r=0.582,0.609,0.623,P＜0.05).Conclusion The imbalance of regulatory T cell/Th17 cell may exist in the peripheral blood of patients with DM.Regulatory T cell/Th17 cell may be associated with the pathology of DM.

Objective To investigate the value of prenatal ultrasound in diagnosis and treatment of twin reverse arterial perfusion (TRAP) syndrome. Methods A retrospective study was performed in 5 TRAP cases, including ultrasound images, clinical data and pregnancy outcomes. The sonographic characteristics were summarized. Results Five TRAP cases were diagnosed during 13 to 28 weeks' gestation and confirmed after birth. Color Doppler unltrasonography revealed retrograde umbilical artery perfusion towards acardiac twin. Two of 5 cases ended up in induced abortion, 1 in spontaneous abortion, 1 was delivered at 37 weeks' gestation after ultrasound-guided feticide of the acardiac twin and 1 was monitored closely with ultrasound and delivered alive at 32~(+4) weeks' gestation. Conclusion Prenatal ultrasonography has great applicative value for TRAP syndrome in early diagnosis, choosing optimal treatment and prognosis assessment.

Student evaluation is an important part of the teaching process.The Children's Hos-pital of Chongqing Medical University focused on the characteristics of individual child's growth and overall development according to the own condition and integrated formative assessment and summa-tive evaluation in the classroom teaching and clinical internship process. All the measures mentioned above not only help promote students' learning interests,master of knowledge and clinical skills but also exert positive effect on the improvement of teaching level.

Objective To study the academic level of randomized control trials(RCTs)published from 2004 to 2009 in Chinese Journal of Hepatobiliary Surgery.Methods Published work about RCTs in 72 issues of Chinese Journal of Hepatobiliary Surgery was searched by finding relevant articles published during 2004-2009.Correlated indexes including literature received time, literature publishing time, the total number of citations, number of citations in Chinese, number of citations in English, research funding situations, the number of authors, article affiliations in all RCTs, together with single(or multiple)center study situation, positive conclusions, the starting time, the end time,and number of patients recruited in clinical RCTs were extracted for aggregate analysis.Results During the past six years, a total of 135 articles of RCT were published in Chinese Journal of Hepatobiliary Surgery, accounting for 8.7% in all clinical studies.The average number of RCTs in each issue was 1.88.The average time for publishing time delay was 450 days.The total number of citations in RCTs was 1252 and the average number of RCTs for citations was 9.3.53 RCT studies were financed, accounting for 39% of the total number of research papers.Beijing Friendship Hospital attached to the Capital University of Medical Sciences had published 8 papers of RCT and it is the institution of publishing the largest number of such papers in the journal.The number of multi-center study for RCTs was one and all RCT studies had significant conclusions.The average research duraton in RCTs was 45 months.The total number of patients in 33 clinical RCTs was 2705 and the average number of patients recruited in each RCT was 82.Conclusion Chinese Journal of Hepatobiliary Surgery put emphasis on the strongest evidence and the most valuable RCT researches that have great significance in the field of domestic hepatobiliary surgery for clinical treatment and experimental research.

Objective To prepare and study the immunogenicity of hepatitis B virus surface anti-gen (HBsAg)-tetanus toxoid (TT) conjugate vaccine. Methods Tr was activated by cyangen bromide and reacted with adipic acid dihydrazide, then HBsAg-TT conjugate was prepared by carbediimide. Conjugate, HBsAg or hepatitis B vaccine was injected subcutaneously into mice. Anti-HBsAg and HBsAg-specific T cell response elicited by these immunogens were assayed. Results New HBsAg-TT conjugate elicited higher levels of anti-HBsAg and HBsAg positive conversion rates after the immunization than did HBsAg alone or hepatitis B vaccine. Conjugate induced mesdy antibodies of the IgG2a subclass, while HBsAg alone or hepa-titis B vaccine mainly elicited anti-HBsAg in the IgG1 subclass. The number of IFN-γand IL-2 secreting T cells induced by conjugate was also significantly higher than that did by HBsAg or hepatitis B vaccine. Con-clusion This study indicated new HBsAg-TT conjugate can induce both stronger humoral and TH1 type of cellular immune response.

OBJECTIVE: To explore serological and molecular characteristics of a family trio with weak B phenotype. METHODS: ABO blood type of the family was determined with a serological method. Genotypes of the ABO gene were determined with PCR-sequence specific primer (PCR-SSP). Sequences of exons 6 and 7 of the ABO gene were analyzed by PCR sequence-based testing. RESULTS: Serologically, the proband and her father were determined as B subtype (Bw), while her mother was of O group. The genotypes of the proband and her father were Bw12/O, while her mother was O01/O01. Sequencing of exons 6 and 7 of the ABO gene confirmed that the proband and her father were Bw12/O01. Compared with B101/O01, the Bw12 subtype carried a missense mutation (278C>T) in exon 6 of the ABO gene. CONCLUSION The 278C>T mutation probably underlies the Bw phenotype and can be transmitted stably.
ABO Blood-Group System ; genetics ; Alleles ; Base Sequence ; Exons ; Female ; Genotype ; Humans ; Male ; Mutation, Missense ; Phenotype ; Sequence Analysis, DNA

OBJECTIVETo investigate the hemodynamics evidence of the descending branch of lateral circumflex femoral artery in a reversed way. To explore the clinical result of using the reversed descending branch of the lateral circumflex femoral artery as the receipt artery for free flaps for reconstruction of the leg soft-tissue defect.

METHODSFrom October 2005 to February 2012, 38 patients with severe leg soft-tissue defects were treated. The proximal antegrade and retrograde mean artery pressure of the descending branch of the lateral circumflex femoral artery in 16 of 38 patients were recorded during operation. All wounds had osteomyelitis, bone and tendon exposure requiring coverage reconstruction. And there was no recipient artery in the injured lower leg for free flaps in all 38 patients. Reversed descending branches of lateral femoral circumflex arteries were used as recipient arteries for free flaps (free latissimus dorsi flap, free thoracoumbilical flap, and free anterolateral thigh flap) in all patients. The flap donor site was closed directly or with the skin graft.

RESULTSThe proximal antegrade mean artery pressure of the descending branch of lateral circumflex femoral artery was(81.6 +/- 12.4) mmHg. The proximal retrograde pressure was(48.2 +/- 10.7) mmHg. The proximal retrograde mean artery pressure was 59.07 percent of the proximal antegrade pressure. The donor skin graft survived and wound healed primarily. After operation, 2 flaps had distal partial necrosis and healing was achieved after dressing change. All the other flaps survived completely without vascular problems. All the patients were followed up for 11 months to 2.5 years (mean, 1.6 years). The flap appearance was satisfactory. The texture and color of flaps in all cases were good.

CONCLUSIONSThe reverse descending branch of lateral circumflex femoral artery is a reliable recipient artery for the free flaps. It is an easy and simple technique that can be used for reconstruction of the defects in the lower leg, with the reversed descending branch of lateral circumflex femoral artery as recipient artery.

Adolescent ; Adult ; Blood Pressure ; Female ; Femoral Artery ; physiopathology ; surgery ; Free Tissue Flaps ; blood supply ; Hemodynamics ; Humans ; Lower Extremity ; injuries ; Male ; Middle Aged ; Soft Tissue Injuries ; surgery ; Young Adult

Apolipoprotein M (apoM), a member of apolipoprotein family, is primarily combined to high density lipoprotein (HDL) in plasma. The study of apoM developed into a new period since it was discovered as the major carrier of Sphingosine-1-phosphate (S1P) in circulation. apoM-S1P regulates diverse downstream signaling pathways mainly by binding to and activating specific cell-surface receptors. Being aware of the functions of apoM-S1P in different diseases helps us to explore the pathogenesis of diseases and casts new lights on its precaution and treatment. The relationship between apoM-S1P axis and diseases is reviewed below.

OBJECTIVE: To study the correlation of genome-wide distribution of 6-methyladenine (6mA) of DNA in chorionic tissues from abortuses with monosomy 21. METHODS: Genomic DNA was extracted from chorionic samples from four abortuses with monosomy 21 and four without. After quality and purity test, partial DNA was subjected to chromatin immunoprecipitation with anti-6mA antibody, and then identified by sequencing. The sequencing data was analyzed by using bioinformatic software for the difference in 6mA between the two groups. RESULTS: Analysis of read peaks suggested that the control group have much more 6mA genes (n=4607) compared with the experiment group (n=1059). For chromosome 21, this difference is even more pronounced (8032 vs. 1769). Above results suggested that the level of 6mA modification in monosomy 21 is low. Gene ontology enrichment analysis and KEGG pathway enrichment analysis indicated that the absence of 6mA genes in monosomy 21 is closely related to the growth and development of embryo. CONCLUSION The 6mA modification of human genes may play a similar role to 5-methylcytosine (5mC) modification during the growth and development of embryos.