Objective To observe changes of procalcitonin (PCT) level in cirrhosis patients complicated with hepatorenal syn?drome (HRS). Methods Cirrhosis without HRS (Non-HRS group, n=115), cirrhosis with HRS (HRS group, n=28) and control group (40 cases) were enrolled. Levels of serum PCT, C-reactive protein (CRP), Cystatin-C (Cys-C), white blood count, percentage of neutro?phils, serum creatinine and urine creatinine were examined in all participants. Correlation between serum PCT levels and incidence of HRS was analyzed. Correlations between serum PCT levels with CRP, Cys-C, 24 h-Creatinine clearance (24 h-Ccr) were analyzed. Re?sults Among cirrhosis patients, those with increased PCT had higher chance of complication with HRS than those with normal PCT (P=0.026). Levels of serum PCT, CRP and Cys-C are higher in HRS Group than those in Non-HRS group,both which are higher than those incontrol group (P<0.05);Level of 24 h-Ccr is lower in HRS Group than that in non-HRS group, both of which are lower than that in control group (P<0.05). Levels of serum PCT positively correlated to levels of serum CRP and Cys-C but, negatively correlated to levels of 24 h-Ccr. Conclusion Serum PCT level contribute to early infection and renal damage in cirrhosis and might play an im?portant role in development of HRS. It is valuable in giving early information of cirrhosis complicated with HRS.

Objective The therapeutic efficacy comparison of the ulcerative colitis(UC) disease between the enema treatment combined by Chinese and Western Medicine and purely regular western medicine oraltaking,and infusion treatment.Methods There were 30 cases of treatment group,and we used selfplanned herb medicine and western to conduct enema treatment altemative.And there were 30 cases of control group which adopted purely western medicine took orally,intramuscular,and intravenous driping treatment. Results The total effective rate treatment group was 98%,and control group was 68%.The difference of two sets had statistical significance(P＜0.05).The recurrence rate:treatment enema group Was 10%,and control group was 40%(P＜0.05);The adverse reaction enema group didn't show conspicuous adverse reaction,and in the control group there were headache,nausea,full-moon-shaped face etc to different extent. Conclusions Using the interchanging of Chinese medicine and Western medicine to conduct enema treatment towards ulcerative colitis conservatively,the curative effect of clinical observation is conspicuous,and there is rarely adverse reaction.

Objective To explore the effect of surgical treatment of low back pain patients with Modic change or high intensity zone(HIZ) on MRI of the lumbar spine .Methods 32 cases with intervertebral disc herniation underwent posterior lumbar inter-body fusion and 17 cases with lumbar discogenic pain underwent radiofrequency ablation from March 2011 to July 2012 were retro-spectively reviewed .For intervertebral disc herniation patients ,all patients were divided into two groups :groupⅠ (no with Modic changes group)and groupⅡ(with Modic changes group) ,according to the Admission MRI .GroupⅡ was sub-divided intoⅡa(Mod-ic type Ⅰgroup) andⅡb(Modic type Ⅱgroup) .For lumbar discogenic pain patients ,all patients were divided into group A (without HIZ group) and group B(with HIZ group) .The VAS and ODI scales at the preoperative and follow-up were recorded and analyzed . Results The postoperative scores of VAS and ODI of all the patients were improved ,and the difference was statistically significant (P<0 .05) .For intervertebral disc herniation patients ,three groups have no statistically significant difference (P>0 .05) .For lum-bar discogenic pain patients ,the improvement rate of VAS (low backpain) of A was better than that of B ,and the difference was sta-tistically significant(P<0 .05) ,but the differences of VAS (leg pain) and ODI scores weren′t statistically significant (P>0 .05) . Conclusion Posterior lumbar interbody fusion is effective for lumbar disc herniation patients with Modic changes ,and can obtain good clinical effect .For lumbar discogenic pain patients with high intensity zone on MRI ,radiofrequency ablation can cause clinical symptoms get some relief ,but the effect is poor .

Objective: To compare the myocardial protection effect between off-pump coronary artery bypass(OPCAB)and on-pump coronary artery bypass. Methods: 70 patients were divided into 2 groups:off-pump coronary artery bypass(beating group,n=35), and cold blood cardioplegia solution group(cold group,n=35). There was no statistical difference in heart function, sex, age and weight before operation. Blood samples were taken for determine the serum concentration of creatine kinase MB isoenzyme (CK-MB) and troponin-T(cTnT) peri-operatively. Myocardial ultrastructure was also observed. Results: CK-MB, cTnT release in beating group during bypass and post-bypass was lower than that in cold group (P

For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Clinical Trials as Topic ; standards ; Data Accuracy ; Data Collection ; standards ; Databases, Factual ; Quality Control ; Reproducibility of Results

Adult ; Female ; Glioma ; pathology ; surgery ; Humans ; Neoplasms, Multiple Primary ; pathology ; surgery ; Ovarian Neoplasms ; pathology ; surgery ; Peritoneal Neoplasms ; pathology ; surgery ; Teratoma ; pathology ; surgery

To investigate the neurobiological mechanism of depression pathogenesis and reveal the mechanism of acupuncture treatment of depression. Methods: Wistar rats were selected for subjects. A rat model of depression was made by individually housing with unpredicted chronic moderate stimuli. Changes in behavior and hypothalamus-pituitary-adrenocortical axis were examined in rat models of stress-induced depression. Meanwhile, the intervening effect of acupuncture was evaluated and the curative effects of different acupuncture methods compared. Results: CORT and ACTH contents of serum were significantly higher in the model and normal saline groups than in the control group (P＜0.05), significantly lower in the hand acupuncture and electroacupuncture groups than in the model group (P＜0.05) and significantly lower in the medication group than in the normal saline group (P＜0.05). There were no significant differences between the hand acupuncture, electroacupuncture and medication groups. Conclusion: Acupuncture of Baihui(GV 20) and Taichong (LR 3) has a marked antidepressant effect. Its mechanism may be related to the regulation of HPA axis by acupuncture.

Objective To explore the clinical value of 18F-FDG PET/CT in the diagnosis of cardiac neoplasm.Methods Between January 2007 and December 2011,18F-FDG PET/CT was performed in 8649 patients in our hospital,and 14 (0.16％ ; 11 males,3 females,average age 46.9 (35-68) years) patients were diagnosed with cardiac neoplasm.18F-FDG PET/CT data of those 14 patients were retrospectively analyzed.Final diagnoses were confirmed by either histopathology (n =5) or follow-up (n =9).Results Accurate tumor localization and diagnoses were made by 18 F-FDG PET/CT in all 14 patients.Among them,13 were malignant (2(14.3％,2/14) primary and 11(78.6％,11/14) metastatic tumors (8 HCC,2 lung cancer,1 esophageal cancer) ; SUVmax 3.2-10.7) and 1 (7.1％,1/14) was benign (myxoma).Conclusion 18F-FDG PET/CT is useful for the detection and staging of primary malignant and metastatic cardiac neoplasms.

ICH GCP requires that all information of clinical trial should be recorded, processed, and stored in a way that allows the accurate reporting, interpretation and verification. A trial master file (TMF) contains all paper or electronic records/documentations related to a clinical trial. As a tool of the retrospective analysis, the TMF profile should be able to reproduce the full procedure of the trial completely. As a part of TMF profiles, both the accuracy and completeness of clinical data management documentation are important in data integrity. It is helpful to learn the workflow of clinical data management in different stage of a clinical trial, to understand which documents are essential, and why the documentation of clinical data management is important for data integrity. This paper elaborates how to perform the good documentation practice of clinical data management, and suggests that both the precise and efficient document management and regular quality control may ensure the high quality of clinical data documentation management on the basis of an intensive awareness of the overall process of clinical data management.
Clinical Trials as Topic ; Data Curation ; standards ; Information Storage and Retrieval ; methods ; standards

BACKGROUND: Under certain condition, circulating endothelial progenitor cells (EPCs) can differentiate into endothelial cells, and further participate in angiogenesis.OBJECTIVE: The goal of this study was to investigate the feasibility and efficacy of peripheral blood-derived EPCs in promoting angiogenesis in the ischemic myocardium, in order to provide a new cell implanting method for the treatment of coronary heart disease.DESIGN: A randomized controlled experiment.MATERIALS: Sixty male Sprague-Dawley (SD) rats, of clean grade, weighing (340±20) g, were provided by Qingdao Laboratory Animal Center. These animals were randomly divided into 2 groups with 30 rats in each: experimental group and control group. In each group, ten rats were separately observed 2, 4 and 8 weeks after EPCs being injected. The protocol was conducted in accordance with animal ethics guidelines for the use and care of animals.METHODS: This study was carried out in the Qingdao Key Laboratory of Medical Biological Technology between May 2003 and September 2004. After SD rats in the experimental group were anesthetized, peripheral blood was taken.Mononuclear cells were harvested by density gradient centrifugation. CD31, CD34, Flk-1 and von Willebrand disease factor immunofluorescence staining positive EPCs were harvested by adding the defined media of vascular endothelial growth factors and basic fibroblast growth factor. Myocardial ischemia was induced by ligation of murine left anterior descending coronary artery. Autologous EPCs isolated from the peripheral blood of each animal were infused to ischemic myocardium. In the control groups,cell culture media were infused, and the other procedures were the same as those in the experimental group. Two, four and eight weeks after ligation, all animals were sacrificed by overdose anesthesia, and heart tissue sections were made.MAIN OUTCOME MEASURES: ①After haematoxylin-eosin staining, myocardial structure changes were observed under an optical microscope. ②Cells positive for factor Ⅷ were numbered and then to calculate the total number of cells in each visual field for evaluating microvessel density with a German ZEISS Axiotron image analyzer.RESULTS: All the 60 SD rats were involved in the final analysis, without deletion. ①Myocardial structure was relatively disarrayed in the control groups, with collagens and fibroblasts substituted for cardiomyocytes. In the marginal infarct areas, cardiomyocytes were irregular and partial cells were significantly hypertrophied. As compared with control group, myocardial collagen fibers fused less, and tissue structure got more disarranged in the experimental group. Microvessel density in the implanted area was obviously increased. ②In the 2nd, 4th and 8th weeks after EPC infusion, microvessel density at the ischemic myocardium was significantly higher than that at the corresponding time point in the control group (P ＜ 0.01). In the EPCs groups, microvessel density tended to statistically increase with time going (P ＜ 0.05). No prominent difference was observed in the three control groups (P＞ 0.05).CONCLUSION: Relatively purified EPCs can be obtained by certain procedure of isolation and culture from rat peripheral blood. Intramyocardial implantation of autologous EPCs promotes microangiogenesis and has a protective effect on ischemic myocardial tissue.