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

With the deployment of electronic medical records systems, more and more routine clinical data are recorded electronically, which become a potential data source for new drug clinical trials. In this paper, we summarized the opportunities, challenges, obstacles and the latest development in this field.
Clinical Trials as Topic ; Data Collection ; methods ; Drug Evaluation ; Electronic Health Records

OBJECTIVELong time exhaled oxygen will induced oxygen toxicity. Some studies had found that different pathology may exised in normobaric and hyperbaric pulmonary oxygen toxicity, and nitric oxide synthase (NOS) may play a role. In this study, we discussed the change of NOS in normobaric and hyperbaric pulmonary oxygen toxicity.

METHODSSixty male SD rats were randomly divided into 6 groups (n = 10), exposed to 1 ATA (atmosphere absolute), 1.5 ATA, 2 ATA, 2.5 ATA and 3 ATA, 100% oxygen for 56, 20, 10, 8, 6 hours respectively. Rats were exposed to air as control. After exposure, the protein in bronchoalveolar lavage fluid (BALF), the wet/dry weight of lung and the expression of eNOS, nNOS in lung were defined.

RESULTSAs compared to air group, the protein in BALF, the wet/dry of lung were significantly elevated in 1.0 ATA group, while these changes were not so obviously in the other groups, and these changes in hyperbaric oxygen group (approximately 1.0 ATA) were significantly decreased as compared with nonnrmobaric oxygen group (1.0 ATA). The expression of nNOS were not changed in normobaric and hyperbaric pulmonary oxygen toxicity, while the expression of eNOS was significantly decreased in 2 ATA group, and significantly elevated in 2.5 ATA and 3 ATA group.

CONCLUSIONThe expression of eNOS can change when exposed to different pressures of oxygen.

Animals ; Disease Models, Animal ; Lung ; metabolism ; Male ; Nitric Oxide Synthase Type I ; metabolism ; Nitric Oxide Synthase Type III ; metabolism ; Oxygen ; poisoning ; Pressure ; Rats ; Rats, Sprague-Dawley

Base Sequence ; Conjugation, Genetic ; Drug Resistance, Bacterial ; Electrophoresis, Gel, Pulsed-Field ; Escherichia coli ; drug effects ; enzymology ; Humans ; Klebsiella pneumoniae ; drug effects ; enzymology ; Microbial Sensitivity Tests ; Molecular Sequence Data ; Polymerase Chain Reaction ; Transformation, Bacterial ; beta-Lactamases ; genetics

OBJECTIVETo investigate the hemodynamic changes of primary hepatocellular carcinoma (HCC) evolved from hepatic cirrhosis using CT perfusion imaging.

METHODSThirty-two patients with primary hepatocellular carcinoma evolved from virus-induced fibrosis or cirrhosis underwent dynamic CT scanning of the target slices for 60 min. The perfusion parameters of the hepatic parenchyma and HCC including the blood flow (BF), blood volume (BV), mean transit time (MTT), permeability-surface area product (PS), hepatic arterial fraction (HAF), IRF time of arrival (IRF TO) were obtained. Paired-sample t test was used to determine the differences in the perfusion parameters between the hepatic parenchyma and the primary HCC mass.

RESULTSCompared with hepatic BF (117.13-/+31.05 ml/100 mg/min), BV (14.73-/+3.91 ml/100 mg), PS (31.93-/+5.91 ml/100 mg/min), HAF (25.02-/+8.19%), MTT (12.79-/+3.31 s), IRF TO (3.14-/+1.09 s), the primary HCC mass showed significant increments in the BF (239.69-/+96.07 ml/100 mg/min), BV (20.26-/+6.73 ml/100 mg), PS (37.50-/+9.50 ml/100 mg/min), HAF (68.97-/+15.22%) with decreased MTT (7.17-/+1.38 s) and IRF TO (2.42-/+0.94 s). Significant differences were found in all the perfusion parameters between the hepatic parenchyma and HCC (P<0.05).

CONCLUSIONLiver perfusion parameters can represent the hemodynamic changes in the HCC derived from hepatic cirrhosis.

Adult ; Aged ; Carcinoma, Hepatocellular ; diagnostic imaging ; etiology ; physiopathology ; Female ; Hemodynamics ; Hepatitis ; complications ; Humans ; Image Interpretation, Computer-Assisted ; methods ; Liver Cirrhosis ; complications ; Liver Neoplasms ; diagnostic imaging ; etiology ; physiopathology ; Male ; Middle Aged ; Perfusion ; methods ; Radiographic Image Enhancement ; instrumentation ; methods ; Tomography, X-Ray Computed

Objective:To observe the effect of tuina exercise on simple obesity in college students.Methods:Fifty-seven college students with simple obesity were divided into two groups according to the stratified randomization method.Twenty-eight in the tuina exercise group were trained in tuina exercise;while 29 in the auricular acupoint sticking group were treated with acuricular acupoint sticking.The tuina exercise group was trained once every other day,and 10 times made one course.The auricular acupoint sticking was replaced once every 4 d,and 5 times made one course.After 2-course treatment,the total therapeutic effect,weight,body mass index (BMI),waist and hip circumferences,serum total cholesterol (TC),triglyceride (TG),high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) were assessed.Results:The total therapeutic effect was 86.2％ in the auricular acupoint sticking group and 85.7％ in the tuina exercise group.There was no significant difference between the two groups (P＞0.05).After treatment,the weight,BMI,waist and hip circumferences were decreased and the differences were statistically significant (all P＜0.05).The waist and hip circumferences in the tuina exercise group were lower than those in the auricular acupoint sticking group,showing statistically significant differences (all P＜0.05).After treatment,there were no significant intra-group differences in TC,TG,HDL-C and LDL-C in the two groups (all P＞0.05),and the between-group differences were not significant (all P＞0.05).Conclusion:Tuina exercise has reliable effect in treating obesity.It can produce more significant improvements in waist and hip circumferences than auricular acupoint sticking.But no obvious effect is shown in blood lipid indicators.

OBJECTIVETo study optimum planting density and sowing depth of Tulipa edulis.

METHODThe effects of different planting densities, sowing depth and thin plastic film cover were studied on yield, rate of increase, bulb weight increased multiples, and proliferation rate of bulb.

RESULT AND CONCLUSIONUnder 30-200 bulbs per squremeter density range, the yield increased with the density increasing, and reached significance level. In 5-20 centimeter depth range, the yield and the number of harvested bulbs enhanced along with the sowing depth increasing, and the best sowing depth was 20 cm. Thin plastic film cover showed no effect on the growth.

Agriculture ; methods ; Crops, Agricultural ; growth & development ; Tulipa ; growth & development

We established a fluorescent quantitative PCR (qPCR)method for the detection of Chlamydophila abortus (C. abortus),and replaced the method of smear staining which has subjective influence on the detection of C.abortus inactivated vaccine titer.According to the conserved sequence of the large cysteine-rich periplasmic protein(envB)of C.abortus,a specific primer was designed and the EnvB-PMD19T positive plasmid was used as the reference standard,optimization condition,sensi-tivity assay,specificity assay,repeatability assay and the bacteria loads of organs from mouse have been done.The results showed that the standard curve established with positive plasmid had a liner response from 1×102copies/μL to 1×106copies/μL with the correlation coefficient of 97%,sensitive for detecting C.abortus with the detection limit of 10 copies/μL,and re-peatable and stable with the coefficients of variation less than 2%.According to the result,the established method can detect the bacteria loads in organ of mouse,which provide a reliable method for evaluation of inactivated C.abortus vaccine.

OBJECTIVETo observe the effects of Stragalus membranaceus injection on nitric oxide and endothelin levels of intestinal mucosa in reperfusion injury after hemorrhage shock.

METHOD32 SD rats were randomly divided into four groups: normal group, model group, low dosage group, (treated with Astragalus membranaceus 10 g x kg(-1)); high dosage group (treated with Astragalus membranaceus 20 g x kg(-1)). Models of hemorrhagic shock for 60 minutes and reperfusion for 90 minutes were created. The animals were administrated 3 mL therapeutic solution before reperfusion. At the end of study, intestinal pathology was observed, and the concentration of lactic acid (LD), nitric oxide (NO), endothelin (ET) of intestinal mucosa were detected.

RESULTThe intestinal pathology showed that intestinal mucosa epithelial cells damage in model group was severe, in low dosage group was medium, in high dosage group was slight, and no obvious damage was found in normal group. The concentration of LD and NO of small intestine mucous membrane in model group and low dosage group were significantly higher than those in high dosage group and normal group (P < 0.05), but there were no significant differences between high dosage group and normal group (P > 0.05). The concentration of ET of small intestine mucous membrane in model group was the highest of the four groups (P < 0.05). The concentration of ET in low dosage group was significantly higher than that in high dosage group and normal group (P < 0.05), but there were no significant differences between high dosage group and normal group (P > 0.05).

CONCLUSIONStragalus membranaceus injection can reduce small intestine mucous damage by protecting endothelium function in injury after hemorrhage shock-reperfusion.

Animals ; Astragalus membranaceus ; chemistry ; Drugs, Chinese Herbal ; administration & dosage ; isolation & purification ; pharmacology ; Endothelins ; metabolism ; Ileum ; metabolism ; pathology ; Injections, Intravenous ; Intestinal Mucosa ; metabolism ; pathology ; Lactic Acid ; metabolism ; Male ; Nitric Oxide ; metabolism ; Plants, Medicinal ; chemistry ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; etiology ; metabolism ; pathology ; Shock, Hemorrhagic ; complications

OBJECTIVETo investigate the polymorphism of Kell blood group system in Chinese and to find a suitable method for large scale screening.

METHODSAn analysis method of polymerase chain reaction-restriction fragment-single strand conformation polymorphism (PCR-RF-SSCP) combined with heteroduplex was established to detect abnormal sample in KEL exon 7-9 area, then sequencing was used to find out the mutation site.

RESULTSTwo mutations were found from 500 samples: 966G > A mutation in exon 9 and C > A mutation in 67th site of intron 7, both with no amino acid change. The mutation rate was 4/1000. No mutation was found as missed in using PCR-RF-SSCP combined with heteroduplex.

CONCLUSIONPCR-RF-SSCP combined with heteroduplex is confirmed as an effective, economical and simple method, it is quite suitable for large scale population screening study with unclear gene background and unavailable positive controls. Since there is special polymorphism for Kell blood group system in Chinese, further study is needed.

Asian Continental Ancestry Group ; genetics ; China ; Heteroduplex Analysis ; methods ; Humans ; Kell Blood-Group System ; genetics ; Polymerase Chain Reaction ; methods ; Polymorphism, Restriction Fragment Length ; Polymorphism, Single-Stranded Conformational