Data acquisition is one of the key links that influencing the quality of clinical research.Electronic data capture system (EDC) embodies the advantages of saving time,manpower and material resources and improving efficiency and reliability by data acquisition.CDISC has established worldwide industry standards to support the electronic acquisition,exchange,submission and archiving of clinical research data.The application of CDISC standards to EDC system is favorable in ensuring the validity and standardization of clinical data.This paper takes the Oracle's OC/ RDC (Oracle Clinical / Oracle Remote Data Capture) system as an example to discuss the application of CDISC standard to EDC system from the two aspects:direct application and indirect application.We suggest that data collection should be taken into account during the design phase of a clinical trial,and the CDISC standard be applied at the CRF design stage.A design for eCRF takes time and effort by the combination of EDC system and CDISC standard,while thoughtless design may collect the wrong data.Therefore,it is suggested that a specialized personnel should be put in charge of eCRF design and maintenance during the operation of EDC system,and a set of standardized eCRFs based on CDISC standard and standard operating procedures should be built in one organization.

OBJECTIVE:To understand the status quo adverse drug reactions(ADR) occurred in our hospital and to promote clinical use of drugs.METHODS:By retrospective analysis,study 73 ADR cases collected from our hospital in 2009 were analyzed in respect of gender and age of patient,route of administration,category of drugs,organs and systems involved in ADR and its clinical manifestation.RESULTS:Of total 73 ADR cases,35.6% of cases were induced by anti-infective agents and 9.6% traditional Chinese medicines.Most of cases were caused by intravenous administration.Main clinical manifestations were lesion of skin and its appendents.CONCLUSION:Rational use of anti-infective agents and traditional Chinese medicine(TCM) should be strengthened.Quality control and standard application of TCM injection should be enhanced to reduced or avoid the incidence of ADR.

Background:Medical treatment and surgery are the two main therapeutic approaches for esophageal variceal bleeding ( EVB),but studies showed that the efficacy of medical treatment was poor,and surgery was invasive and could lead to serious complications. Aims:To investigate the efficacy and safety of endoscopic variceal ligation combined with sclerotherapy for treatment of EVB. Methods:A total of 150 cirrhotic patients with EVB admitted from May 2011 to May 2012 at Wenling Oriental Hospital were enrolled and assigned into observation group and control group by random digital table. Patients in observation group were treated with endoscopic variceal ligation combined with sclerotherapy,and patients in control group were treated with somatostatin and pantoprazole. Overall clinical efficacy,recurrence and adverse effect were compared between the two groups. Results:In observation group,the overall clinical efficacy was 94. 7%(72/76), the recurrence rate was 3. 9%(3/76),and the adverse effect rate was 13. 2%(10/76);in control group,the overall clinical efficacy was 79. 7%(59/74),the recurrence rate was 14. 9%(11/74),and the adverse effect rate was 28. 4%(21/74). Overall clinical efficacy in observation group was significantly higher than that in control group(P<0. 05), while recurrence rate and adverse effect rate were significantly lower than those in control group( P all < 0. 05 ). Conclusions:Compared with medical treatment,endoscopic variceal ligation combined with sclerotherapy is effective in improving the clinical efficacy and reducing the recurrence and adverse effect for treatment of EVB. It is worthy of being used in clinical practice.

Objective To explore clinical significance of muhidetector(64-row)computed tomography carotid atherosclerosis angiography(MDCTA)in detecting carotid atherosclerotic plaque.Methods Data of 116 patients with carotid atherosclerosis undergone with MDCTA stayed at Huashan Hospital,Shanghai from January to August,2008 were analyzed retrospectively.Results Three hundred and seventy-seven plaques were identified among all the 116 patients in the study,with an incidence of calcified plaque of 63.40 percent,and more detected at the common carotid artery(27.85%).the carotid bifurcation(39.78%)and the internal carotid artery (21.48%).There was significantly statistical difference in plaque types between those with mild,moderate and severe carotid stenosis(P=0.000)and between those aged equal to or lower than 50 years and equal to or greater than 70 years(P=0.005).Plaque types at the common carotid artery were significantly difierent from those at the carotid bifurcation(P=0.000)and at the internal carotid artery(P=0.000).Results of regression analysis showed a positive and significant association between carotid occlusion and clinical symptomatology(with a coefficient of correlation of 1.080.P=0.023)and inverse association between calcified plaque and clinical symptomatology(with a coefficient of correlation of 0.688,P=0.006).Conclusions Not only imaging characteristics of carotid atherosclerotic plaque can be accurately assessed by MDCTA,but also measurement of its stenosis degree.Assessment of plaque type,degree of stenosis and distribution of plaque in different Vascular segments with MDCTA can be used to predict clinical occurrence of cerebevaseular events in patients with carotid atherosclerosis.

Objectives To examine the clinical usefulness of magnetic resonance spectroscopy (MRS) on assessment of vascular dementia (VD) in patients with stroke; the relationships between metabolic changes of brain and clinical symptom improvements after giving rivastigmine in these patients.Methods 20 stroke patients without VD, male 17, female 3, with a mean age of (71.7?4.7) years old; 23 stroke patients with VD, male 20, female 3, a mean age of (72.9?5.1) years old; 20 normal volunteers were studied, a mean age of (70.9?4.8) years old. MRS was performed in all these patients. The patients with VD were prescribed rivastigmine hydrogen tartrate ("Exelon", Norvatis), and given MRS assessment half a year later.Results The patients with VD had a significantly lower N-acetyl aspartate/Creatine (NAA/Cr) ratio (mean?SD: left: 0.57?0.30; right: 0.66?0.29) and higher Choline/Creatine (Cho/Cr) ratio (mean?SD: left: 1.79?0.52; right: 1.97?0.44) in bilateral temporal hippocampus area, compared to those without VD (mean?SD: NAA/Cr: left, 0.91?0.31; right, 0.87?0.27, P

Objective To parse the concept of self-management in the context of coronary heart disease based on the content analysis,to clarify the connotation of the concept of self-management.Methods Thirty-four references were recruited through the databases of CNKI,VIP journals knowledge service platform,Wanfang Data Services Platform and Pubmed.We broke the concept of self-management in the context of coronary heart disease into such three aspects as implementing body,major behavior,and facilitators.Results The most common indicators were symptom management(which was mentioned by 78.57％ of domestic literature and 66.67％ of foreign literature),and protect and promote healthcame second,the person with the chronic diseasewas 42.85％,other indicators' frequency existed differences.The major body of coronary artery disease self-management was the patient itself,with the help of assist staff and using lifestyle management,symptom management,rehabilitation and exercise,environmental control,emotional awareness behavior management and medication to maintain patients' satisfactory functional status.Conclusions To parse the concept of self-management in the context of coronary heart disease can be applied as the basis for clinical nursing research and build an effective reference and guidance for future coronary heart disease self-management model building.

Objective To investigate the carboprost ammonia butyl alcohol three plus motherwort injection on prevention of high risk maternal postpartum hemorrhage effect .Methods 120 cases of cesarean section operation and potential bleeding symptom of women were selected as the research object ,and randomly divided into two groups , the observation group of 60 cases using carboprost ammonia butyl alcohol three joint of leonurus heterophyllus injec -tion for prevention and treatment ,the control group of 60 cases used oxytocin for prevention and treatment ,prevention and treatment effects were compared between the two groups .Results After treatment,the observation group 2h,24h postpartum hemorrhage were (422.41 ±213.49)mL,(35.29 ±16.44)mL,were significantly less than those in the control group (589.64 ±345.21)mL,(69.31 ±29.47)mL(t=6.732,8.915,all P<0.05);the observation group 1 cases without production after bleeding ,control group 5 cases of postpartum hemorrhage ,statistically significant differ-ences between the two groups (χ2 =4.973,P<0.05).Conclusion Carboprost ammonia butyl alcohol three plus motherwort injection on prevention of high risk maternal postpartum hemorrhage has a significant effect ,which can re-duce the cesarean section uterine bleeding and reduce the amount of bleeding ,promote uterine involution ,conducive to maternal rehabilitation .

OBJECTIVE: To explore the prophylactic effect of Budesonide on the expression of IL-4,IL-5 in nasal mucosa in model of minimal persistent inflammation of allergic rhinitis in rats. METHOD: Eighty SD rats were randomly divided into allergic rhinitis group (A group), experimental (B group), control group (C group) and negative control group (D group). A group was made for model of allergic rhinitis. B and C group were made for model of the lightest persistent inflammatory response. After the models were established, half of rats in the A group, B group, C group and D group were executed, and EOS infiltration and the expression of IL-4, IL-5, ICAM-1 were observed in nasal mucosa. The remaining rats of B group were given budesonide (64 microg/side/time, twice/day) treatment for 2 weeks. A, C, D group were given nasal spray with normal saline for 2 weeks. After that A, B, and C groups were stimulated with 1% OVA daily for one week, D group were given nasal spray with normal saline. All rats were executed after excitation, EOS infiltration and IL-4, IL-5 expression were observed. RESULT: After the drug treatment, B group only had a small amount of mucous EOS infiltration and had no significant difference with D group, but in A and C group EOS had heavy infiltration. Gray value of the IL-4 positive areas in B group were significantly different compared with A and C group (P < 0.05), A group and C group had no significant difference (P > 0.05). Distribution of IL-5 positive signals was similar with that of IL-4. CONCLUSION Budesonide MPI application could significantly inhibit the allergic.
Animals ; Budesonide ; therapeutic use ; Disease Models, Animal ; Female ; Interleukin-4 ; metabolism ; Interleukin-5 ; metabolism ; Male ; Rats ; Rats, Sprague-Dawley ; Rhinitis, Allergic ; metabolism ; prevention & control

ObjectiveTo explore the correlation between white matter hyperintensities(WMH) and the clinical features of Parkinson's disease(PD) when examined by magnetic resonance imaging(MRI).MethodsThe correlation between WMH,periventricular hyperintensities(PVH),deep white matter hyperintense signals(DWMH) in MRI and age,disease duration,distribution in 64 patients with PD and 45 age-matched healthy controls was studied.ResultsThe frequency of WMH was higher in patients with PD,but no significant difference compared with controls(P>0.05).The patients with WMH were significantly older(P<0.01) and more severity(P<0.01) than those without WMH,but disease duration was no significant difference(P>0.05).The frequency of DWMH was higher in patients with PD,but no significant difference compared with controls(P>0.05).The patients with DWMH were significantly older(P<0.01) than those without DWMH,but disease duration and severity were no significant difference(P>0.05).The frequency of PVH was higher in patients with PD and having a significant difference compared with controls(P<0.05).The patients with PVH were significantly older(P<0.01) and more severity than those without PVH,but disease duration was no significant difference(P>0.05).The distribution of DWMH was not significantly different between patients with PD and controls (P>0.05),but distribution of PVH was significantly different between patients with PD and controls(P<(0.05)).ConclusionPVH may influence some clinical features of PD characterized by a greater disease severity.

BACKGROUND: It is demonstrated in modern pharmacologic study that total paeony glycoside (TPG) provides extensive pharmacologic activities,such as inhibiting aggregation of platelets and erythrocytes, anticoagulation,antithrombsis, anti-arterial sclerosis, protecting heart and liver, anti-tumor,etc.OBJECTIVE: Neonatal rat cardiomyocytes were cultured in vitro and by the changes of superoxide dismutase (SOD) activity, malondialdehyde (MDA) and nitric oxide (NO) contents in cell culture solution, the protection of TPG on injured cardiomyocytes was analyzed.DESIGN: Controlled observation was designed.SETTING: Bioengineering Department in School of Life Science and Technology of Xi 'an Jiaotong University and Institute of Bone Diseases in Medical School of Xi'an Jiaotong University.MATERIALS: The experiment was performed in Bioengineering Department in School of Life Science and Technology of Xi 'an Jiaotong University from February to June in 2003, in which, 44 SD neonatal rats aged 1-3 days were employed. The 48-hour-cultured cardioryocytes were prepared in 42 bottles and randomized into 6 groups, named normal control (normal group), medicated-injury group (injury group), TPG 0.625 mg/L group,TPG 3.125 mg/L group, TPG 15.625 mg/L group and positive control, 7 bottles in each group.METHODS: Cardiomyocytic primary culture was performed under aseptic condition. No any drug was used in normal group, isoprenaline was added in injury group to terminate the concentration at 100 mg/L, in TPG 0.625, 3.125 and 15.625 mg/L groups, 30 minutes after isoprenaline added, RGP at dosages of 0.625, 3.125 and 15.625 mg/L were added respectively; in positive control, 30 minutes after isoprenaline added, coenzyme Q10 was used to terminate the concentration as 100 mg/L.Afterwards, the assay of every index was performed. Xanthine oxidase (XOD) method was used to assay SOD activity, thiobarbituric acid (TBA)method was to assay MDA content and nitrate reductase (NR) method was to assay NO content.cell culture solution in each group.Compared with normal group, the levels of total SOD, CuZn-SOD and MnSOD were reduced remarkably in injury group (P ＜ 0.05 or P ＜ 0.01).The above-indexes in every TPG group and positive control were improved to different extents (P ＜ 0.05 or ＜ 0.01), in which, the protection of TPG 15.625 mg/L group was near to or superior to positive control [(79.50±10.67), (80.30±13.50); (48.24±13.26), (49.73±10.23); (31.26±10.22),in cell culture solution in each group: Those in injury group were higher remarkably than normal group (P ＜ 0.01). MDA and NO contents were all reduced in every TPG group and positive control and dose dependence presented in TPG protection, the higher the dose was, the stronger the action of TPG on protection was, in which, in high-dose group, MDA content was near to normal group [(5.41±1.81), (4.48±0.94) μmol/L, P ＞ 0.05] and NO content was similar to positive control [(81.83± 9.08), (82.41±12.37) mol/L,P ＞ 0.05].CONCLUSION: TPG protects myocardial injury induced by isoprenaline,indicating dose-dependence relationship, which is probably associated with enhanced anti-oxidation of cell, reduced injury of cellular membrane induced by free radical and lipid oxidant.