Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
Adverse Drug Reaction Reporting Systems ; standards ; statistics & numerical data ; Databases, Pharmaceutical ; standards ; Humans

Animals ; Cardiovascular System ; metabolism ; GTPase-Activating Proteins ; metabolism ; Humans ; Nerve Tissue Proteins ; metabolism ; Signal Transduction

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 study the antioxidant activity in vitro of neutral polysaccharides and its graded component from 3samples of white ginseng and red ginseng. METHODS:The decoction method was used to extract the crude polysaccharides fromwhite ginseng,100 ℃ and 120 ℃ processed red ginseng;the crude polysaccharides were further separated through ion exchangecolumn to extract neutral polysaccharides;Sephadex G-75 gels filter column was used to grade the neutral polysaccharides accordingto the molecular weight,antioxidant activity in vitro of 9 samples in 3 neutral polysaccharides and were detected by DPPH andOH free radical scavenging test and reduction capacity test(FRAP value),and vitamin C was used as positive control. RESULTS:The 3 neutral polysaccharides all obtained component Ⅰ and component Ⅱ after grading. Neutral polysaccharides and its gradedcomponent showed certain antioxidant activity in vitro in a certain concentration range,and increased by concentration increasing.The activity of neutral polysaccharides and component Ⅱ from 120 ℃ processed red ginseng was the strongest,of which 50% inhibitoryconcentration(IC50)on DPPH free radical was 0.258 g/L and 0.253 g/L,on OH free radical was 7.157 g/L and 6.845g/L,FRAP values were 2.8 and 3.0 mmol/L(when concentration was 1.2 g/L),respectively. CONCLUSIONS:The antioxidant activityin vitro from 120 ℃ processed red ginseng is higher than that of 100 ℃ processed red ginseng and white ginseng,in whichcomponent Ⅱ makes important contribution to the antioxidant activity.

0.05).92.7%of the objects knew that passive smoking was harmful.71.9%knew that passive smoking made people suffering from cardiopathy more possibly.74.9%knew that the wife whose husband smoked were easier to catch lung cancer.And 84.4%knew that the child whose parent s smoked more possibly took asthma or respiration disease. The correct rates of the four knowledge points were different among different gender and the degree of education,which was higher in female than in male,and higher in high education degree than in the other(P

Objective To investigate the effects of osteopontin (OPN) antisense oligodeoxynucleotide (AS-ODN)on OPN mRNA expressions and adherence to collagen gel of rat renal mesangial cell line (1097). Methods One AS-ODN complementary chain to rat OPN cDNA sequences was designed and synthesized. All nucleotides of different kinds of oligodeoxynucleotide (including antisense, sense and mismatch sense) were modified with phosphrothioate. All the ODNs were mixed with cationic liposome(DOTAP) respectively. The cultured 1097 cells were incubated with different concentration of ODN at 37t for 48 hours, then total RNA was extracted from cultured cell line with Trizol reagent. OPN mRNA expression was detected with RNA dot blot and RT-PCR. The cell adhesion ability was measured with collagen gel attachment lest. Results OPN mRNA expression of mesangial cells was higherly upregulated in the medium with calf serum compare to that in the medium without serum. AS-ODN could suppress the expression of OPN mRNA in mesangial cells with dose-dependent and its lowest inhibitory concentration was 2. 5 ?mol/L, but mismatch ODN or sense ODN have no inhibitory effects on the OPN mRNA expression of mesangial cells even if at a high ODN concentration of 30 ?mmol/L. AS-ODN-treated cells weakly adhered to the collagen gel and could be easily detached off. The mesangial cells treated with mismatch ODN or sense ODN still had a good adherent ability to collagen gel. Conclusions Calf serum can induce rat renal mesangial cells higherly expressing OPN mRNA. Osteopontin antisense oligodeoxynucleotide can specifically suppress mesangial cells OPN mRNA expression and adhension to collagen gel.

In order to affirm the cardioactive components in Fuzi, we identified a group of aminoalcohol- diterpenoid alkaloids in Fuzi using ultra high-performance liquid chromatography coupled with electrospray ionization mass spectrometer (UPLC-ESI-MS) method. Among a total of forty-one isolated ingredients, thirteen major aminoalcohol-diterpenoid alkaloids were identified by comparing their retention times and MS spectra with those of the reference substances. Moreover, Fuzi samples from different places of origin and with different processing methods were examined and their components displayed a pattern of high similarity, though the relative abundance varies probably due to their different processing methods. Furthermore, the cardiac effect of each identified alkaloid was individually evaluated using the isolated bullfrog heart perfusion experiment. Among the thirteen aminoalcohol diterpenoid alkaloids tested, six of them significantly enhanced the amplitude rates. Taken together, we affirm that the cardioactive components in Fuzi are aminoalcohol-diterpenoid alkaloids, shedding light on future studies of the mechanisms and development of these cardioactive compounds.
Aconitum ; chemistry ; Alkaloids ; chemistry ; Amino Alcohols ; chemistry ; Animals ; Cardiotonic Agents ; chemistry ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; chemistry ; Heart ; drug effects ; In Vitro Techniques ; Plant Extracts ; chemistry ; Rana catesbeiana ; Spectrometry, Mass, Electrospray Ionization

Objective: Study the morphology and kinetics characters in breast diseases by using helical CT,to assess the value of differential diagnosis in benign and malignant breast diseases.Methods: Forty-three focuses in thirty-eight patients were detected by using double row detector CT with histopathologic correlation.Analyzed the characters of morphology,the time-density curve and the enhancement rate of all focuses.Results: Of the 43 focuses,breast cancers were twenty-eight and benign diseases were fifteen. There were eleven pieces and thirty-two masses.Lobulation signs and spicule signs were twelve respectively,among twenty-one malignant masses.One had spicule sign and two had lobulation sign among eleven benign mas-ses.Twenty breast cancers had Ⅲ type time-density curve,eleven benign diseases had Ⅰ type curve,and there were some overlaps on Ⅱ type curve.Enhancement rate(E) reflected the blood kinetics of breast diseases.E 1min and E 3min were better than E 3min in differentiating benign and malignant breast diseases.Conclusion:Lobulation signs and spicule signs are more often found in malignant lesions than in benign lesions.Early enhancement rate and time-density curve present some important information in differentiation.Synthesizing all these specialties can promote the diagnosis accuracy.

Objective To evaluate the influence of gestational diabetes mellitus (GDM) on maternal and perinatal outcomes in twin pregnancies. Methods We retrospectively analyzed the clinical features of both twin and singleton pregnancies, which delivered in Guangzhou Women and Children's Medical Center between January 1, 2012 and December 31, 2013. The twin pregnancies were divided into two groups:those with (GDM-T, n=51) and without GDM (non-GDM-T, n=130), which were matched by maternal age and delivery time (within one month) in a ratio of 1∶2 among singleton pregnancies with (GDM-S, n=102) and without GDM (non-GDM-S, n=102), respectively. The differences of adverse maternal and perinatal outcomes among these four groups were examined. The overall assessment of pregnancy outcomes was completed using Delphi method. Statistical analysis was performed with one-way analysis of variance, t test, Kruskal-Wallis test, rank test, Chi-square test or Fisher's exact test. Results (1) When compared to GDM-S and non-GDM-S group respectively, less women conceived with the help of assisted reproductive technology, higher proportion of women underwent and gestational age at delivery tend to be earlier in GDM-T and non-GDM-T group (all P<0.01). In oral glucose tolerance test,the fasting blood glucose level of GDM-T group was higher than the other three groups (F=21.716, P<0.01), the glucose levels at 1 and 2 h were higher than non-GDM-T and non-GDM-s respectively (both P<0.01), but no significant difference was found when compared with GDM-S group (P>0.01). Similarly, no significant difference was found in prenatal glycosylated hemoglobin value between GDM-T and GDM-S group (P>0.01). (2) There was no significant difference in the incidences of hypertensive disorders of pregnancy, anemia, premature rupture of membranes, oligohydramnios, placental abruption, postpartum hemorrhage, asphyxia neonatorum, small for gestational age, hypoglycemia of newborn, hyperbilirubinemia of newborn and perinatal death between GDM-T group and the other three groups(all P>0.01). Higher incidences of hypertensive disorders of pregnancy and postpartum hemorrhage were shown in the GDM-T group than in the GDM-S and non-GDM-S groups, respectively (both P<0.01). The incidences of preterm birth in GDM-T and non-GDM-T group were both higher than that in GDM-S and non-GDM-S, respectively [54.9%(66/102), 53.8%(140/260), 5.0%(10/102) and 3.0%(6/102), all P<0.01], while no significant difference was found between GDM-T and non-GDM-T group (P>0.01). (3) The overall assessment of pregnancy outcomes did not show any difference between GDM-T group and the other three groups (χ2=6.707, P>0.01). However, the score for fetal outcomes in the GDM-T group was higher than in the GDM-S and non-GDM-S group, but lower than in non-GDM-T group [M(Q)=1.0(2.3), 0.0(3.0), 0.0(0.0), 1.0(2.8) score, χ2=122.818, P<0.01]. Conclusions GDM does not increase the risk of adverse pregnant outcomes in twin pregnancies.

Objective To introduce extrapedicular infiltration anesthesia as an improved method of local anesthesia which applied to unipedicular percutaneous vertebroplasty or percutaneous kyphoplasty.Methods From March 2015 to March 2016,20 patients in our hospital received percutaneous vertebroplasty or percutaneous kyphoplasty with 1％ lidocaine local infiltration anesthesia and extrapedicular infiltration anesthesia.The visual analogue score of patients during the operation and whether they needed additional sedative anesthesia were evaluated.The anaesthetic effect of nerve root block was observed.Results The visual analogue score of all the patients ranged from 1 point to 3 point,averagely (2.5 ± 0.7) point.Among the 20 patients,there were 2 cases of 1 point,7 cases of 2 point and 11 cases of 3 point.No patients required additional sedative anesthesia,and no nerve root block effects were observed.Conclusion Extrapedicular infiltration anesthesia provides good local anesthetic effects without significant complications,which deserved further use in unipedicular percutaneous vertebroplasty and percutaneous kyphoplasty.