Bronchi ; cytology ; Cell Culture Techniques ; Cells, Cultured ; Humans ; Myocytes, Smooth Muscle ; cytology

Alkanes ; toxicity ; Animals ; Chromosome Aberrations ; Mice ; Mice, Inbred ICR ; Micronucleus Tests ; Mutagenicity Tests ; Mutagens ; Rats ; Rats, Sprague-Dawley ; Teratogens

CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.
Biomedical Research ; standards ; China ; Clinical Trials as Topic ; standards ; Data Collection ; standards

Animals ; Brain Edema ; prevention & control ; Brain Ischemia ; physiopathology ; Erythropoietin ; pharmacology ; Female ; Hippocampus ; metabolism ; pathology ; Male ; Nitric Oxide ; metabolism ; Protective Agents ; pharmacology ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; prevention & control ; Superoxide Dismutase ; metabolism

Objective To observe the lecithin's effect on membrane of African green monkey kidney cells (Vero) exposed to sodium arsenite(NaAsO2). Methods Vero cells cultured in vitro were divided into 4 groups:control group (saline), model group (2.20 mg/L NaAsO2), high eoncentration of lecithin and arsenic group (53.33mg/L lecithin + 2.20 mg/L NaAsO2), low eoncentration of lecithin and arsenic group( 13.32 mg/L lecithin + 2.20 mg/L NaAsO2), 6 bottles of cells in each group, medium was changed every 2 days, cultured for 120 h. Na+ ,K+-ATPase activities of membrane were measured by spectrophotometry, and membrane phospholipids composition including phosphatidylserine (PS), phosphatidylethano-lamine (PE), phosphatidylcholine (PC) and sphingmyelin (SM) were measured by high performance liquid chromatography (HPLC). Results The Na~, K+-ATPase activities of membrane of control group, model group, high concentration of lecithin and arsenic group, low concentration of lecithin and arsenic group were (0.962 ± 0.081) × 106, (0.544 ± 0.037) × 106, (0.647 ± 0.043) x 106, (0.550±Compared with control group, the Na+ ,K+-ATPase activities of other 3 groups were significantly reduced (all P < 0.05). Compared with model group, the Na+ ,K+-ATPase activity in high concentration of lecithin and arsenic group was significantly higher (P < 0.05),but in low concentration of lecithin and arsenic group did not change significantly (P > 0.05). Compared with control group[(0.087 ± 0.003), (0.127 ± 0.053), (0.588 ± 0.105),(0.071 ± 0.029)g/L], PS, PE, PC, SM levels in model group[(0.051 ± 0.018), (0.073 + 0.030), (0.240 ±0.038), (0.047 ± 0.121 )g/L] were significantly lower(all P < 0.05) ;PS, PE, PC in high concentration of lecithin and arsenic group[(0.084 ± 0.011), (0.109 ± 0.363), (0.591 ± 0.476)g/L] did not change significantly(all P > 0.05), but SM[(0.057 ± 0.004)g/L] significantly decreased(P < 0.05) ;PS, PE, SM levels of low concentration of lecithin and arsenic group[(0.058 ± 0.020), (0.086 ± 0.177), (0.048 ± 0.103)g/L] significantly reduced (all P < 0.05), the PC did not change significantly [(0.521±0.098 )g/L, P > 0.05]. Compared with model group,the levels of PS, PE, PC, SM in high concentration of lecithin and arsenic group were significantly higher(all P <0.05);PS, PE, SM levels in low concentration of lecithin and arsenic group did not change significantly(all P > 0.05), and PC was significantly higher(P < 0.05). Conclusions High concentration lecithin has certain protective effect on Vero cell membrane exposured to sodium arsenite.

Objective: To observe the effects of acupoint thread-embedding therapy and low-carbohydrate diet therapy on obese patients with food addiction. Methods: Sixty-five eligible patients were randomized into a thread-embedding group of 33 cases and a diet group of 32 cases to respectively receive 12-week treatment. Before treatment, after treatment and at 6-month follow-up, the two groups were observed and compared in terms of body mass (BM), waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WHR), body mass index (BMI), body fat rate (BFR), basal metabolic rate (BMR) and Yale food addiction scale version 2.0 (YFAS 2.0). Results: At the end of treatment, there were no significant differences in the general efficacy, and the improvements in BM, BMI, WC, HC, WHR and BFR between the thread-embedding group and diet group (all P>0.05). At follow-up, the thread-embedding group showed more significant improvements in all the aforementioned indicators compared with the diet group except HC (all P<0.05). At the end of treatment and follow-up, BMR and YFSA 2.0 had more significant improvements in the thread-embedding group than in the diet group (all P<0.05). Conclusion: Acupoint thread-embedding therapy can produce significant efficacy in treating obese patients with food addiction; it can improve the food addiction state and work better in maintaining the efficacy compared with low-carbohydrate diet therapy.

The effects of two different sample labeling methods on background signal intensities for high-density 60mer oligonucleotide microarray were investigated. Peripheral blood samples from five disease and five control subjects were collected. Total RNA targets from peripheral blood mononuclear cells were extracted and labeled with RD-PCR protocol, which were hybridized to Agilent Human 1B oligonucleotide microarrays in a two-color comparative format. The positive control targets were labeled with the directly incorporated fluorescently-labeled dNTP labeling. The SPSS program was performed to test normality of the dataset, variance homogeneity between the groups, coefficients of variation (CV) and analysis of variance. The results showed that the background signal intensities of Cy3 channel were higher than those of Cy5 channel. The differences of background signal intensities between the RD-PCR approach and the directly incorporated fluorescently-labeled dNTP labeling were extremely significant (P- Cy3

OBJECTIVETo investigate the diagnostic value of serum islet autoantibody-glutamic acid decarboxylase antibody (GADA) and islet cell antibody (ICA) in patients with hepatogenic diabetes.

METHODSSerum GADA and ICA were measured with enzyme-linked immunosorbent assay (ELISA) in 217 patients with chronic hepatitis B (CH) or liver cirrhosis (LC). The positivity rate of GADA and ICA in different phases of CH and LC and their relations with diabetes mellitus were analyzed.

RESULTSThe positivity rate of the islet autoantibody in the circulation was 72% in CH and LC patients with diabetes mellitus and 30% in patients with normal glucose level, showing significant difference between the two patient groups (Chi2=36.620, P=0.000). CH patients with diabetes had much higher positivity rate for the antibody [52% than type 2 diabetic patients with liver dysfunction [8%, P<0.05]. The positivity rate was also much higher in CH and LC patients with lowered C peptide level [70%] than in those with normal C peptide level [40%, P<0.005].

CONCLUSIONBoth GADA and ICA have important value in the diagnosis of hepatogenic diabetes and may serve as indexed in laboratory test for distinguishing hepatogenic diabetes from type 2 diabetes.

Adult ; Autoantibodies ; blood ; Diabetes Mellitus, Type 1 ; complications ; diagnosis ; immunology ; Diabetes Mellitus, Type 2 ; complications ; diagnosis ; immunology ; Diagnosis, Differential ; Female ; Glutamate Decarboxylase ; immunology ; Hepatitis B, Chronic ; complications ; Humans ; Islets of Langerhans ; immunology ; Liver Cirrhosis ; complications ; Male ; Middle Aged ; Predictive Value of Tests

OBJECTIVETo investigate the relationship between lamivudine-resistant mutants of hepatitis B virus (HBV) and serum HBV DNA loading before antiviral therapy.

METHODSThis study involved 106 patients with hepatitis B receiving lamivudine treatment for an average of 32 months (rang 12-48 months). Serum HBV DNA loadings were measured with PCR before and every 4 to 6 months during lamivudine therapy. HBV YMDD mutants were detected using mismatched PCR-restriction fragment length polymorphism (PCR-RFLP) during lamivudine treatment.

RESULTSHBV DNA loading was significantly higher in patients infected with HBV YMDD mutants during lamivudine therapy than those infected with HBV without YMDD mutation.

CONCLUSIONHigh viral loading in hepatitis B patients before treatment is associated with high likeliness of HBV YMDD mutation during lamivudine treatment. HBV DNA loading may be indicative for the occurrence of YMDD mutation during lamivudine therapy.

Antiviral Agents ; pharmacology ; DNA, Viral ; blood ; Drug Resistance, Viral ; genetics ; Female ; Hepatitis B ; blood ; Hepatitis B virus ; drug effects ; genetics ; physiology ; Humans ; Lamivudine ; pharmacology ; Male ; Middle Aged ; Mutation ; Viral Load ; genetics

OBJECTIVETo predict part of medicinal properties of traditional Chinese medicine components and traditional Chinese medicine decoction pieces by using the traditional Chinese medicinal property data prediction platform, in order to establish the relationship between properties of traditional Chinese medicine components and traditional Chinese medicine decoction pieces.

METHODThe properties of traditional Chinese medicine components were predicted by using the medicinal property data prediction platform based on the pharmacological effects of the components.

RESULTThe total sum of identical or similar results of the prediction for the properties of traditional Chinese medicine components and traditional Chinese medicine decoction pieces accounted for over 75%.

CONCLUSIONThe self-similarity exists between properties of traditional Chinese medicine components and traditional Chinese medicine decoction pieces, which reflects the inheritance, additivity and emergence among different properties of traditional Chinese medicines.

Drug Combinations ; Drug Prescriptions ; Drug Therapy ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; Humans ; Medicine, Chinese Traditional