OBJECTIVE:To ensure the stability of electronic data capture(EDC)system in drug clinical trials and to improve the quality of drug clinical trials. METHODS:The quality control system for EDC system was established and introduced from the formulation of quality control process,establishment of data standard,trial project management,daily management,trial project design,system operation,system function,etc. RESULTS & CONCLUSIONS:Data standard have been achieved through estab-lishing EDC quality control system by our hospital based on attributable,legible,contemporaneous,original and accurate principle. The management of trial project and daily management are conducted through data registration,staff training,the formulation of da-ta management plan,fault emergency treatment,database backup;multiple verification of support data,data lock and export,trial report autogeneration and other functions have been realized by formulating related standard operation instruction,program file,op-eration manual and quality record. Those aspects improve facticity,accuracy and integrality of data in clinical trials,and lay a foun-dation for further data mining.

OBJECTIVE:To promote the supervision and management of clinical trial by institution. METHODS:The structure and function of clinical trial management system(CTMS)developed by our hospital and other enterprise together were analyzed to evaluate the application and operation result of CTMS. RESULTS & CONCLUSIONS:CTMS of our hospital is made up of foun-dation,efficiency and strategy. It is equipped with role allocation,information exchange and report,information warning,drug tracking,clinical trial process control,quality control of electronic record,electronic signature and integration and connection with other system,etc. Relevant operation procedure is established to promote standardization and institutionalization of CTMS. Due to the application of CTMS,the cooperation among departments become smoother,and management level have been enhanced in dai-ly management,pharmacy management,subjects and document administration. It also simplifies the work of researcher and reduc-es the human error by the autogeneration of trial records and tables with the system. Consequently,the monitor coveraged through-out all the trial process.

Animals ; Burns ; physiopathology ; Female ; Glycoproteins ; genetics ; metabolism ; Hydrogen Peroxide ; metabolism ; Male ; Mice ; RNA, Messenger ; genetics ; metabolism ; Skin ; injuries ; metabolism ; Wound Healing ; physiology

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

Animals ; Antineoplastic Agents ; administration & dosage ; Delayed-Action Preparations ; administration & dosage ; Drug Carriers ; chemistry ; Drug Delivery Systems ; Growth Hormone-Releasing Hormone ; administration & dosage ; Nanotechnology ; Research

Objective To investigate the clinical effect of mild hypothermia on neonatal bilirubin encephalopathy, and the value of 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/CT and amplitude integrated electroencephalogram (aEEG) for diagnosis and evaluation of curative effect. Methods From May, 2013 to December, 2014, 29 newborns with bilirubin encephalopathy were divided into conventional group (n=15) and mild hypothermia group (n=14). The conventional group received conventional therapy, and the other group received mild hypothermia in addition. The aEEG and neuron-specific enolase (NSE) were measured before and after treatment, as well as the glucose metabolism rate with 18F-FDG PET/CT after treatment. Results The NSE was lower after treatment in both groups (t>9.670, P<0.001), and was lower in the mild hypothermia group than in the conventional group (F=46.146, P<0.001). After treatment, sleep-wake cycle (SWC), epileptiform activity and the degree of abnormality were obviously improved (P<0.05), and were better in the mild hypothermia group than in the conventional group (P<0.05). The cerebral glucose metabolism rate was significantly better in the mild hypo-thermia group than in the conventional group (t>2.943, P<0.01). The cerebral glucose metabolism rate was negatively correlated with aEEG and NSE (r>0.640, P<0.05). Conclusion Mild hypothermia therapy could further promote the energy metabolism of brain cells in neonatal bilirubin encephalopathy. 18F-FDG PET/CT and aEEG can be used for early diagnosis and therapeutic evaluation.

OBJECTIVETo compare the changes of nucleus pulposus after in vitro culture of rabbit whole intervertebral disc and spinal motion segment.

METHODSTwenty-one New Zealand white rabbits which were randomly divided into organ group with 8 rabbits and segment group with 13 rabbits. Fifty intervertebral discs and 50 spinal motion segments were harvested respectively under aseptic conditions from two groups. These specimens were maintained in organ culture with hyperosmotic media (410 mOsm/kg), then 10 discs of the two groups were observed respectively by HE staining, immunohistochemistry of collagen type III, proteoglycan content and cells viability of nucleus pulposus before culture and at 3, 7, 14, 21 days after culture.

RESULTSHE staining showed the intervertebral disc tissue structure remained intact after culture of 21 days organ group and 14 days segment group,but there was severely degenerated of 21 days segment group. The intensity value of type II collagen immunohistochemical staining in the nucleus pulposus were not changed significantly between 21 days organ group and 14 days segment group (P > 0.05), but the staining of segment group at 21 days became shallower, there was significant difference compared with before each time points and organ group at 21 days (P < 0.05). PAS/AB staining of proteoglycan of nucleus pulposus showed that there were not decrease of tinting strength of two groups within 7 days, but the strength weakened slightly of two groups at 14 days, and the tinting strength became weaker at 21 days segment group, the change is more obvious than the organ group. The intensity value of fluorescence staining of nucleus pulposus cells was not changed significantly within 7 days of two groups (P > 0.05), the intensity value decreased slightly at 21 days organ group and 14 days segment group, but there were no significant difference compared with before time points (P > 0.05) however at 21 days segment group the intensity decreased as cells viability of nucleus pulposus decreased,and there was a significant difference compared with before each time points and organ group at 21 days (P < 0.05).

CONCLUSIONIt is not obviously degenerated of the discs of organ group cultured within 21 days and segment group cultured within 14 days, but there was significant degeneration of the intervertebral disc of segment group after cultured 21 days, so the rabbit spinal motion segment can be used on research about the biomechanics of intervertebral disc as a vitro experimental model within 14 days.

Animals ; Collagen Type II ; analysis ; Female ; Immunohistochemistry ; Intervertebral Disc ; chemistry ; pathology ; Male ; Organ Culture Techniques ; Rabbits

Objective: To explore the influencing factors of slow blood flow phenomenon after emergency percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). Methods: Clinical and PCI angiographic data of 488 patients, who were diagnosed as AMI and received primary PCI in our hospital from Jan 2010 to Jun 2011, were retrospectively analyzed. Patients were divided into slow blood flow group (n=51, TIMI flow ≤ grade 2) and normal flow group (n=437, TIMI flow= grade 3). Their clinical characteristics between two groups were compared. Results: Compared with normal flow group, there were significant reductions in percentages of thrombus aspiration (75.3% vs. 60.8%) and application of platelet glycoprotein IIb/IIIa receptor antagonist (81.7% vs. 68.6%) during PCI, and significant rise in total length of implanted stents [(31.8±12.2) mm vs. (35.7±12.0) mm] in slow blood flow group, P<0.05 all. Multi-factor Logistic regression analysis indicated that percentages of thrombus aspiration during PCI and total length of stents were independent influencing factors for slow blood flow (P<0.05 both). Conclusion: Percentages of thrombus aspiration and total length of stents during PCI are independent influencing factors for slow blood flow.

Objective To investigate the correlation of T cell subgroups and natural killer (NK) cell's activity level of peripheral blood of the patients with refractory lymphoma. Methods Flow cytometry was applied to detect T cell subgroups' level and NK cell's activity of peripheral blood in 60 early cure lymphoma patients with chemotherapy before and 20 normal controls , after chemotherapy follow-up they were divided into 30 cases of difficult cure group and 30 cases of effective group. Results Compared with the normal controls, CD+4, CD+4/CD+8 and NK cell in lymphoma patients with chemotherapy before decreased (30.17±8.63 vs 46.52±1.39, t =12.218, P ＜0.05; 0.86±0.45 vs 1.64±0.05, t =11.225, P ＜0.05; 12.39±7.08 vs 19.29±0.84,t =6.365, P＜0.05), while CD+3 and CD+8 cell increased (76.14±10.71 vs 70.48±1.44, t =-3.439, P＜0.05;40.28±14.03 vs 28.35±0.73, t =-5.625, P ＜0.05). Compared with effective group, CD+4 CD+4/CD+8 and NK cell in difficult response group with chemotherapy before decreased (27.70±7.81 vs 33.13±8.82, t =2.163, P =0.036;0.67±0.27 vs 1.10±0.52, t =3.272, P =0.003; 9.87±6.60 vs 15.40±6.58, t =2.771, P =0.008), while CD+3 and CD+8 cell increased (79.67±8.18 vs 71.91±12.00, t =-2.540, P =0.015; 44.70±13.99 vs 34.98±12.41, t =-2.416,P =0.020). Conclusion The detection of T cell subgroups' level and NK cell' s activity in early lymphoma patients before chemotherapy may play a role to diagnose and predict the outcome of refractory lymphoma patients.

Objective:To synthesize the mental resilience of Chinese children tested with the Resilience Scale for Chinese Adolescents (RSCA)to evaluate its status as well as the research status. Methods:Four Chinese elec-tronic databases including China Biology Medicine disc (CBM),VIP Database,China National Knowledge Infra-structure (CNKI)and WangFang Database were searched from database established to December 2014. Literatures that reported the mental resilience status of Chinese children tested with RSCA were included. A statistical formula was used to synthesize means and standard deviations to get a total score;the standard mean difference (SMD)and 95% confidence interval (95%CI)of scores measured with RSCA scale were used to conduct meta-analyses usingthe software of Review Manager 5. 2 for comparison between different subgroups. Results:Thirty-nine studies with 16 493 children were included for the final analysis. Quantitative synthesis results showed that the average total score of Chinese children was (3. 3 0. 6 ). The status of psychological resilience was at a good level. The average psychological resilience scores of girls,not left-behind children,urban children,Han children and not-only-child were higher than those of boys [SMD (95%CI):-0. 09 (-0. 14--0. 05 )],left-behind children [SMD (95%CI):-0. 37(-0. 56--0. 19)],rural children [SMD (95%CI):0. 26(0. 13 -0. 38)],minority children [SMD (95%CI):0. 12(0. 04-0. 21)]and only-children [SMD (95%CI):0. 30(0. 16-0. 44)]respectively. Conclusion:The mental resilience of Chinese children is modest with internal diversity.