Adenocarcinoma, Mucinous ; pathology ; Adult ; Breast Neoplasms ; metabolism ; pathology ; surgery ; Carcinoma ; pathology ; Carcinoma in Situ ; metabolism ; pathology ; surgery ; Carcinoma, Ductal, Breast ; metabolism ; pathology ; surgery ; Diagnosis, Differential ; Female ; Fibrocystic Breast Disease ; metabolism ; pathology ; surgery ; Humans ; Hyperplasia ; Lactalbumin ; metabolism ; S100 Proteins ; metabolism

Actins ; metabolism ; Breast ; cytology ; metabolism ; Breast Neoplasms ; metabolism ; pathology ; Cell Differentiation ; Female ; Humans ; Keratins ; metabolism ; Neoplastic Stem Cells ; metabolism ; pathology ; Signal Transduction ; Stem Cells ; cytology ; metabolism

Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.
China ; Data Collection ; standards ; Documentation ; standards ; Information Storage and Retrieval ; methods ; standards

Objective To compare the clinical efficacy of Rivaroxaban and Warfarin in the treatment of lower extremity deep vein thrombosis.Methods From January to December 2015,51 patients of deep vein thrombosis of the lower limb divided into.Warfarin group (21 cases) and Rivaroxaban group (30 cases).The time of each therapy lasted for 3 months or longer.The characteristics and the change of lower limb venous patency rate in two groups of patients were analyzed to evaluate the curative effect.Results Rivaroxaban group had shorter therapy time than Warfarin group.The lower limb venous patency rate in Rivaroxaban group were higher than that in Warfarin group (85.7％ vs.60％,P ＜0.05).Ultrasonography showed partial patency in 5 mixed thrombus patients of Warfarin group,while complete patency in 2 and partial patency in 3 of Rivaroxaban group.Normalized rate in peripheral venous thrombosis patients of Rivaroxaban group were higher than Warfarin group (84％ vs.25 ％ P ＜ 0.001).Conclusions Rivaraxaban is superior to Warfarin in the complete recanalization of DVT,while safe and reliable.

Ribavirin is a broad-spectrum antiviral agent and glycyrrhizin has activities of anti-inflammation, immunoregulation and anti-viral infections. To enhance antiviral efficacy and weaken side-effects of ribavirin, antiviral effects of the combination of glycyrrhizin and ribavirin were studied in the present study. Firstly, a mouse model of viral pneumonia was established by inoculation of influenza H1N1 virus. Protective effects of glycyrrhizin and ribavirin used alone or in combination against H1N1 virus infection in mice were evaluated based on the survival rate, lung index and virus titer in lungs of mice. Results showed that the combination of glycyrrhizin and ribavirin significantly inhibited the lung consolidation with a 36% inhibition ratio on the lung swell of infected mice. The combination of the two drugs exhibited synergetic effects on survival of infected mice. The combination of 50 mg · kg(-1) · d(-1) glycyrrhizin and 40 mg · kg(-1) · d(-1) ribavirin resulted a 100% protection for infected mice with a synergetic value of 36, which was significantly higher than the control group and each drug alone. This combination also resulted a significant drop of lung virus titer (P < 0.01), as well as inhibition on the production of proinflammatory cytokines IL-6 (P < 0.01), TNF-α (P < 0.01) and IL-1β (P < 0.05) induced by virus infection compared to the control. The treatment of ribavirin plus glycyrrhizin was more effective in influenza A infection in mice than either compound used alone, which suggested a potential clinical value of the combination of the two agents.
Animals ; Antiviral Agents ; pharmacology ; Disease Models, Animal ; Drug Synergism ; Drug Therapy, Combination ; Glycyrrhizic Acid ; pharmacology ; Inflammation ; immunology ; Influenza A Virus, H1N1 Subtype ; drug effects ; Interleukin-1beta ; immunology ; Interleukin-6 ; immunology ; Lung ; immunology ; virology ; Mice ; Orthomyxoviridae Infections ; drug therapy ; Pneumonia, Viral ; drug therapy ; Ribavirin ; pharmacology ; Tumor Necrosis Factor-alpha ; immunology

Objective To explore the maternal-fetal transmission patterns and interventional methods of syphilis during pregnancy.Methods A total of 847 cases of syphilis in pregnancy confirmed by rapid plasma reagin test(RPR)and treponema pallidum hemoagglutination test(TPHA)were treated with procaine benzylpenieillin intramuscular injection,and with erythrocin oral medication if hypersensitive to benzylpenicillin.Eight hundred forty seven cases of syphilis during pregnancy were followed up for pregnancy outcomes.And their newborn babies were tested using the RPR.The newborns with positive results were given intervention and followed up until 24 months after birth.Results(1)A total of 733 cases among the total 847 have given birth to living-babies,in which 626 cases were tested using RPR,and the positive rate was 55.1%(345/626).(2)The RPR positive rate,neonatal mortality,preterm birth rate and low birth rate in the newborn of mothers with an RPR titer higher than or at 1:8 were higher than those of mothers with an RPR titer lower than 1:8(P

AIM: To measure the anatomical character of nasolacrimal dust by spiral CT 3D reconstruction in children.METHODS: The length of nasolacrimal dust and the angles between nasolacrimal dust and vertical plane,horizontal plane and coronal plane in 27 children(54 eyes) and 15 adults(30 eyes) were surveyed using spiral CT 3D reconstruction. While the length of nasolacrimal dust in 7 dead children(14 eyes) body were surveyed as comparison by anatomical method. The RESULTS:were analyzed by software SPSS 13.0 statistically. RESULTS: The length of nasolacrimal dust was 10.06±0.29mm in children and 11.51±1.54mm in adults by spiral CT 3D reconstruction,as 9.95±0.31mm in dead children body by anatomical method,with significant statistical difference between that of children and adults. The angles between nasolacrimal dust and vertical plane,horizontal plane and coronal plane in children were 7.96°±1.62°,73.24°±6.75°,and 12.31°±2.03° respectively,while the corresponding angels in adults were 8.08°±0.63°,72.69°±3.85° and 12.09°±1.21°. The difference between them had no statistical meaning. CONCLUSION: The anatomical data of children nasolacrimal dust obtained from spiral CT 3D reconstruction have important guidance to the therapy of nasolacrimal dust diseases in children.

OBJECTIVETo investigate the relations between anti-myelin basic protein antibody (anti-MBP) variation and myelinoclasis in the brain stem following brain trauma.

METHODSIn rat models of brain trauma, MBP content and anti-MBP titer in the blood were measured using enzyme-linked immunosorbent assay (ELISA) at different time points after brain trauma, and the degree of myelinoclasis in the brain stem slices was assessed with osmic acid staining.

RESULTSEarly after brain trauma, MBP content in the blood increased followed by significant reduction 10 days later. Four days after the trauma, anti-MBP titer was markedly increased, accompanied by obvious exacerbation of myelinoclasis in the brain stem, both reaching the highest levels on day 10, at the point of which anti-MBP titer increased by 4 folds and the number of myelinoclasis by 10 folds compared with the control group. Anti-MBP titer and brain stem myelinolysis both lowered 30 days later. Correlation analysis showed an intimate positive correlation between anti-MBP titer and the degree of myelinoclasis.

CONCLUSIONAfter brain trauma, MBP is released as a specific antigen into the blood to stimulate the immune system for anti-MBP production, and the antibody is intimately related to the brain stem myelinoclasis.

Animals ; Antibodies ; metabolism ; Brain Injuries ; complications ; Brain Stem ; immunology ; pathology ; Demyelinating Autoimmune Diseases, CNS ; etiology ; immunology ; Female ; Male ; Myelin Basic Protein ; Nerve Tissue Proteins ; blood ; immunology ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Transcription Factors ; blood ; immunology

OBJECTIVETo assess the risk factors for vulvar dystrophy.

METHODSAn epidemiological study was carried out. Data on 100 cases with vulvar dystrophy was reviewed and face to face interviewed with a uniform questionnaire including the manner of work, environmental temperature, habit of eating, mood, underwear wearing, autoimmune diseases, marriage, menstrual age, the quantity of menses, orders of pregnancy, and labor trauma of vulvar during delivery, vulvitis and urethritis ect. Univariable analysis and multivariate logistic regression analysis were carried out with 1:1 case-control methodology.

RESULTSMultiple conditional logistic regression analysis showed that vulvar dystrophy was positively associated with hot food (OR = 2.55, 95% CI: 1.24 - 5.25), mood (OR = 4.27, 95% CI: 1.96 - 9.29), order of pregnancy (OR = 3.37, 95% CI: 2.11 - 5.40), vulvitis (OR = 6.74, 95% CI: 2.66 - 17.09) and urethritis (OR = 11.02, 95% CI: 1.01 - 120.19). Vulviitis or urethritis increased 6.74 or 11.02 times the incidence of vulva dystrophy. Anger or nervous state contributed to the incidence of vulva dystrophy (OR = 4.27). Addict to hot food and order of labor also increased risk ratio for 2.55 and 3.37 times, respectively.

CONCLUSIONThe risk factors of vulvar dystrophy were: addict to hot food, often holding a angry or nervous state, increase of labors, having vulvitis and urethritis.

Diet ; Emotions ; Female ; Humans ; Multivariate Analysis ; Parity ; Risk Factors ; Vulvar Lichen Sclerosus ; etiology

OBJECTIVETo understand the possibility of estimating the anti-inflammation effect of Liuwei Dihuang Wan (LWW) in rat by having developed HPLC-UV metabonomic technology.

METHODThe hydrophilic or lipophilic constituent group of LWW was extracted by distilled water or acetic ether respectively. The anti-inflammation effects of different LWW dosages and extractions were measured by traditional method respectively. Then, metabonomic analysis was performed.

RESULTThe high dosage of LWW extraction (16.5 g x kg(-1))could inhibit the swell of rat palm significantly, but there are not statistically significant effect of low dosage group. Nevertheless, the metabonomic study showed that LWW extraction could restore obviously the rat HPLC-UV urinary profiling disturbed by inflammation in low dosage, especially the hydrophilic constituent group.

CONCLUSIONOur study indicated that the developed metabonomic technology based on HPLC-UV might be used as a potentially powerful tool for estimating the anti-inflammation effect of LWW with sensitivity and integrity.

Animals ; Anti-Inflammatory Agents ; analysis ; metabolism ; pharmacology ; Chromatography, High Pressure Liquid ; methods ; Drugs, Chinese Herbal ; analysis ; metabolism ; pharmacology ; Male ; Metabolomics ; methods ; Rats ; Rats, Sprague-Dawley