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

The volatile components of roots and stems of Zanthoxylum nitidum were investigated by supercritical fluid carbon dioxide extraction (SFE-CO2) and gas chromatography-mass spectrometry(GC-MS). Thirty-one and fifty-one compounds were identified in the supercritical extracts from roots and stems of Z. nitidum, respectively, and total twenty-seven compounds were the common constituents. Among them, the major constituents in root and stem supercritical extracts were spathulenol (18.49 and 26.18%), n-hexadecanoic acid (14.24% and 12.79%), ar-tumerone (6.95% and 8.88%), oleic acid (8.39% and 5.71%) and hexanoic acid (4.39% and 7.78%). The in-vitro MTT assay showed that the volatile components of roots and stems of Z. nitidum did not exhibited any cytotoxic activity against human cancer Huh-7 and normal IEC-6 cells. These results indicated the same nature of the volatile constituents in the root and stem of Z. nitidum. This investigation may provide further evidence for expansion of medicinal parts of Z. nitidum.
Animals ; Cell Line, Tumor ; Cell Survival ; drug effects ; Chromatography, Supercritical Fluid ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; toxicity ; Gas Chromatography-Mass Spectrometry ; methods ; Humans ; Mice ; Plant Roots ; chemistry ; Plant Stems ; chemistry ; Zanthoxylum ; chemistry

OBJECTIVETo investigate performance of a biotinylated imaging probe 3a for targeted imaging of breast cancer cells.

METHODSUltraviolet absorption spectrum and fluorescence spectrum were employed to analyze the spectral characteristics of 3a. The fluorescence spectrums of 3a treated with different concentrations of glutathione (GSH) were obtained to determine the sensibility of 3a to GSH. Flow cytometry was used to determine the cellular uptake of 3a by MCF-7 cells, MDA-MB-231 cells and Hs 578Bst cells in the presence or absence of biotin, and the imaging performance of 3a in the 3 cell lines was assessed under an inverted fluorescent microscope. The toxicity of 3a to the cells was evaluated using MTT method.

RESULTS3a showed the strongest absorption peak at 510 nm, and its fluorescence emission signal was the strongest at 544 nm. As the concentration of GSH increased (0-6 mmol/L), 3a exhibited an increasing fluorescence signal at 544 nm. The cellular uptake of 3a was markedly higher in MDA-MB-231 cells and MCF-7 cells than in Hs 578Bst cells. The imaging studies showed that 3a had a good breast cancer cell-targeting property and produced clear images under fluorescent microscope. MTT assay demonstrated no obvious toxicity of 3a in Hs 578Bst cells even at the concentration of 20 µmol/L, but MCF-7 cells and MDA-MB-231 cells exposed to 2-20 µmol/L 3a showed a lowered cell viability.

CONCLUSION3a is capable of targeted imaging of breast cancer cells mediated by biotin. 3a at the concentration of 2-20 µmol/L has minimal cytotoxicity to normal breast cells but can lower the viability of breast cancer cells.

Emerging data indicated that HCV subverts the antiviral activity of interferon (IF); however,whether HCV core protein contributes to the process remains controversial. In the present study, we examined the effect of HCV core protein on interferon-induced antiviral gene expression and whether the effect is involved in the activation and negative regulation of the Jak/STAT signaling pathway. Our results showed that, following treatment with IFN-α, the transcription of PKR, MxA and 2'-5'OAS were down-regulated in HepG2 cells expressing the core protein. In the presence of HCV core protein,ISRE-dependent luciferase activity also decreased. Further study indicated that the core protein could inhibit the tyrosine phosphorylation of STAT1, whereas the level of STAT1 expression was unchanged.Accordingly, SOCS3, the negative regulator of the Jak/STAT pathway, was induced by HCV core protein. These results suggests that HCV core protein may interfere with the expression of some interferon-induced antiviral genes by inhibiting STAT1 phosphorylation and induction of SOCS3.

Cardiomyopathy, Hypertrophic/diagnostic imaging* ; Endocarditis/diagnosis* ; Endocarditis, Bacterial/drug therapy* ; Humans

OBJECTIVETo establish the national quantity standard of hepatitis B surface antigen according to the world health organization' s standard material and prepare the national liner reference panel for hepatitis B surface antigen.

METHODSSera from hepatitis B patients and health blood donors in different areas were collected and detected by domastic HBsAg kits, anti-HBs kits, HBeAg kits, anti-HBe kits, anti-HBc kits and anti-HCV, and then confirmed by the kits produced by Abbott, which was approved by WHO. One serum with high concentration of HBsAg was calibrated with the standard sample of WHO. And then it was diluted by 1.5 fold as the liner HBsAg reference panel.

RESULTSThe HBsAg concentration of one serum was 1226 IU/ml calibrated by 21 independent standardization measurements with 7 kinds of kits. The coefficient of variation of each calibration were less then 15%. A panel contained 8 serial dilutions was established as the national liner HBsAg reference panel. The permitted range of every dilution was stipulated and the stability of the panel was detected by accelerated test.

CONCLUSIONSThe national quantity standard of hepatitis B surface antigen was established and the national quantitative reference panel for HBsAg which contains eight liner serum was developed.

China ; Hepatitis B ; virology ; Hepatitis B Surface Antigens ; blood ; Humans ; Immunoenzyme Techniques ; methods ; standards ; Reagent Kits, Diagnostic ; standards ; Reference Standards

Functional magnetic resonance imaging (fMRI) has been widely used in the research of acupuncture mechanism in recent years. This article analyzes the effect of four main influencing factors, i.e., research subject, selection of acupoints, manipulation of acupuncture and evaluation of Deqi, and examples are given to explain research application of these four aspects. Based on those mentioned above, the authors presumed that removing ex terior and interior factors of research subject, optimizing compatibility of acupoints and manipulations of acupuncture and making use of correct evaluation scale of Deqi can improve the scientificity and objectivity of fMRI for evaluation of acupuncture mechanism research.
Acupuncture Points ; Acupuncture Therapy ; Humans ; Magnetic Resonance Imaging

In order to study the value of sequential and quantitative analysis of chimerism in determination of optional time of donor lymphocyte infusion (DLI) and prediction of efficacy of DLI, six patients with leukemias who relapsed or failed of engraftment were treated with DLI. Serial and quantitative analyses of donor chimerism (DC) both prior to and following DLI were performed by multiplex PCR amplification of STR markers (STR-PCR) and capillary electrophoresis with fluorescence detection. The results showed that at the time of relapse or graft rejection, STR-PCR indicated the decreasing donor chimerism in all six patients, at levels ranging from 27.3% to 85.7%. The declining value of DC (<90%) was detected in four patients at 26 days before relapse or graft rejection diagnosed clinically. Therefore the decrease of value of DC can be identified the high risk of relapse or graft failure and can be used to guide DLI implementation at early stage. In this study the clinical response were seen in two patients, the value of DC in these patients increased with convertion to a predominant donor profile (>90%) or converted to stable FDC shortly after DLI, while in the patients without clinical response, the level of DC decreased persistently or declined after transient increase. Three patients without response received second DLI. It is concluded that the monitoring of chimerism is proved to be a valuable to determine the optional time point of DLI and to early evaluate the efficacy of DLI. Furthermore, it can present a rational basis for treatment of intensification in the patients who did not respond to first-line DLI treatment.
Adolescent ; Adult ; Hematopoietic Stem Cell Transplantation ; Humans ; Lymphocyte Transfusion ; Recurrence ; Tissue Donors ; Transplantation Chimera

This study was purposed to explore the apoptotic effect of gambogic acid on Raji cells and the role of death inducer-obliterator 1 (DIO-1) in this process. Annexin V-fluorescein-isothiocyanate/propidium iodide was used to detect apoptosis of Raji cells. Western blot was used to determine the expressions of DIO-1, Bcl-xL, pro-caspase 3 and 2 activated subunits: P17 and P20. The subcellular localization of DIO-1 in untreated and treated Raji cells was checked by immunofluorescence and Hoechst 33258 double staining. The results showed that the Gambogic acid dose-dependently induced the apoptosis of Raji cells, downregulated the expression of Bcl-xL, upregulated the expressions of DIO-1 and pro-caspase 3, induced the cleavage of pro-caspase 3 and DIO nuclear translocation. It is concluded that gambogic acid induces the apoptosis of Raji cells through DIO-1 upregulation, nuclear translocation, Bcl-xL downregulation and caspase 3 activation.
Apoptosis ; drug effects ; Caspase 3 ; genetics ; metabolism ; Cell Line, Tumor ; DNA-Binding Proteins ; genetics ; metabolism ; Humans ; Xanthones ; pharmacology ; bcl-X Protein ; genetics ; metabolism

OBJECTIVETo explore the possible mechanism of apoptosis induced by photodynamic therapy (PDT) in human pancreatic cancer cells Capan-1 with 2-butylamino-2-demethoxy-hypocrellin B (BAHB) as photosensitizer.

METHODSThe localization of BAHB in Capan-1 cells was studied, apoptosis was determined by DNA gel electrophoresis after PDT. The mitochondria membrane potential (DYm) and cytochrome C release were observed by laser scan confocal microscopy and Western blotting.

RESULTSThe low concentration photosensitizer was mainly localized in mitochondria and also in lysosomes when the concentration is high. DNA ladder analysis showed characteristic of apoptosis. The mitochondria membrane potential (DYm) showed a loss of 30% around, after 6 hours by PDT under laser scan confocal microscopy, which is caused by a sudden increase in the permeability of mitochondria membrane accompanied with apoptosis. In Western blotting, cytochrome C release was observed from the mitochondria into the cytoplasm during BAHB-induced apoptosis.

CONCLUSIONThe research suggests that BAHB-induced apoptosis is related to photosensitization of mitochondria.

Apoptosis ; drug effects ; Dose-Response Relationship, Drug ; Humans ; Membrane Potentials ; drug effects ; Mitochondria ; drug effects ; physiology ; Pancreatic Neoplasms ; drug therapy ; pathology ; Perylene ; administration & dosage ; analogs & derivatives ; pharmacology ; Photochemotherapy ; Photosensitizing Agents ; administration & dosage ; pharmacology ; Quinones ; administration & dosage ; pharmacology ; Tumor Cells, Cultured