There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.
China ; Clinical Trials as Topic ; standards ; Data Collection ; standards ; Information Storage and Retrieval ; standards

Objective To optimize the sulfated modification conditions for Rhizoma Smilacis Glabrae polysaccharides (RSGP),and to investigate the possibility of enhancing the activity of RSGP after sulfating modification.Methods RSGP was modified by cholorosulfonic acid-pyridine.With the yield,carbohydrate content and sulphate substitution degree as the observation indexes,L9 (34)orthogonal design was used to optimize reaction time,reaction temperature and reagent ratio.The degree of sulphate substitution was determined by barium chloride turbitimetry,and the carbohydrate content was detected by sulfuric acid-phenol method.Then the structures of the sulfated modified products were analyzed by infrared radiation (IR) spectrum.Methyl thiazolyl tetrazolim(MTT)assay was used to determine the anti-tumor activity of sulfated RSGP on HepG2 and MCF-7 cell lines.Results The optimized modification conditions of RSGP were sulfating RSGP with cholorosulfonic acid-pyridine in the ratio of 1:6 for 4.5 hours at 60 ℃.The MTT assay results showed that the sulfated RSGP could inhibit the growth and proliferation of human liver cancer HepG2 cell line and human mammary cancer MCF-7 cell line in concentrationdepending manner.Conclusion It is feasible for sulfating modification of RSGP with cholorosulfonic acid-pyridine,and sulfating modification can enhance the anti-tumor activitv of RSGP.

Objective To examine the changes in the expression of voltage-gated sodium channel?subunit mRNA in the dorsal root ganglion(DRG)and the role it plays in the neuropathie pain.Methods Thirty- two male SD rats weighing 250-400g were randomly divided into 2 groups:groupⅠneuropathic pain(SNL,n= 20)and groupⅡsham operation(n=12).Neuropathic pain was produced by ligation of right sciatic nerve according to Seltzer.Paw withdrawal latency to noxious thermal(PWHL)and mechanical(PWML)stimulation were measured before(baseline)and 1,2,3,5,8,11,14,28 day after sciatic nerve ligation(SNL).DRG at L_(4,5) was isolated on the 14th day after SNL in 8 SNL and 4 sham-operated animals for determination of sodium channel?subunit mRNA expression(by in-situ hybridization).Results PWHL and PWML were significantly decreased on the 2nd-28th day after SNL as compared to the baseline in SNL group.There was no significant difference in?_1 subunit mRNA expression between the 2 groups.The?_2 subunit mRNA expression in DRG was hardly detectable.The?_3 subunit mRNA expression in DRG on the operated side was significantly higher in SNL group than in sham-operation group.Conclusion The up-regulation of sodium channel?_3 subunit mRNA expression in DRG may play an important role in neuropathic pain.

Objective To put forward reasonable and feasible recommendations against the procedure with relative high risk during the high dose rate (HDR) afterloading radiotherapy,so as to enhance its clinical application safety,through studying the human reliability in the process of carrying out the HDR afterloading radiotherapy.Methods Basic data were collected by on-site investigation and process analysis as well as expert evaluation.Failure mode,effect and criticality analysis (FMECA) employed to study the human reliability in the execution of HDR afierloading radiotherapy.Results The FMECA model of human reliability for HDR afterloading radiotherapy was established,through which 25 procedures with relative high risk index were found,accounting for 14.1％ of total 177 procedures.Conclusions FMECA method in human reliability study for HDR afterloading radiotherapy is feasible.The countermeasures are put forward to reduce the human error,so as to provide important basis for enhancing clinical application safety of HDR afterloading radiotherapy.

Objective To put forward reasonable and feasible recommendations aiming at enhancing the application safety of afterloading unit, through studying the human reliability in the emergency response against the source blockage of afterloading unit.Methods Based on the human cognition reliability model, ten operation errors during the emergency response against the source blockage of afterloading unit were analyzed and permissible time widow of emergency response operation were determined.The human error probability was calculated with the execution time of emergency response operation obtained through simulation, observation and recording.Results The operation action, relevant permissible time window and execution time were obtained with the corresponding human error probabilities in the range 0.04 - 0.27.Conclusions The human error model in emergency response against the source blockage of afterloading unit based on HCRmodel is feasible, and provides important reference basis to reduce the occurrence of potential exposure and mitigate the consequence of potential exposure.

Objective To investigate the causes and managements of capsular perforation in transurethral resection of prostate(TURP) for benign prostatic hyperplasia (BPH). Methods Clinical data of 893 cases who received TURP from February 2002 to February 2011 were analyzed retrospectively.Results In 893 cases, capsular perforation in 16 cases, among them, tissue covered perforation in 10 cases, dissociative perforation in 3 cases, perforation under bladder trignne in 3 cases. Six cases occurred with obviously extravasation, 10 cases with transurethral resection syndrome (TURS) or omen of TURS. Two cases were ceased operation and received TURP again after 2 weeks, 2 cases transferred to open surgery suprapubic prostatectomy, 12 cases kept up operation with lower bladder douche pressure. Two cases with postoperatire bleeding underwent open surgery hemostasis cured. All cases were discharged from hospital after recovery. Conclusions The type and extent of capsule perforation must be judged correctly,corresponding treatment must be given, prevention and treatment of TURS must be taken notice of, if capsule perforation occurs when TURP operation in progress. Less haematoma, clearview and normal anatomic structures can decrease the incidence of perforation.

OBJECTIVETo analyze the status and characteristics of dental manpower in the center for disease controls (CDC) in Sichuan Province and to provide more evidence for strengthening the oral healthcare workforce in the CDC system.

METHODSA mass survey on dental manpower was made in CDCs in Sichuan Province through questionnaire investigation. Data were collected and entered with the Epidemiological Dynamic Data Collection (EDDC) platform and analyzed with SPSS 13.0 software.

RESULTSSichuan Province had 0.15 hospitals providing oral health services and 0.38 dentists on average per 10,000 people. About 65.53% (135/206) of the CDCs had one department responsible for the oral health service. However, oral health care personnel comprised only 2.23% (237/10,624) of the personnel of the whole CDC system. About 64.67% (119/184) of county CDCs and 47.62% (10/21) of city CDCs knew well the dental health status of local residents. Less than 5% of the CDCs used the data and assisted in the policy making of public health administrators.

CONCLUSIONThe dental care personal deficit exists in the CDC system in Sichuan Province. The distribution and composition of dental manpower are not reasonable. The oral health service ability of CDCs in Sichuan Province should be strengthened and improved.

China ; Dental Care ; statistics & numerical data ; Dentists ; Humans ; Oral Health ; Surveys and Questionnaires

OBJECTIVESTo understand the hepatic pathology, hepatitis B reactivation rates and serological changes in chronic HBV carriers.

METHODSA 5 year dynamic observation and survey of 220 chronic HBV carriers in Wuxi district was taken, analyzing their clinical symptoms, liver histopathology, virology and HBV immunological markers.

RESULTSThirty-five of the 220 (15.9%) patients, showed hepatitis B reactivation. The hepatitis B reactivation rate of patients with obvious hepatic tissue inflammation (> or = G2) was 27.0% (33/122) and the rate of the patients with mild hepatic tissue inflammation (G0-G1) was 2.0% (2/98), showing significant differences (x2=25.41, P less than 0.01). The reactivation rate of patients with high inflammation was clearly higher than those with mild inflammation. Twenty-seven of the 35 hepatitis B reactivation cases were older than 40 years, showing a significant association between the ages of the patients and hepatitis B reactivation rates (x2=6.72, P less than 0.01), moreover there was no relationship between sex and the hepatitis B reactivation rate. There were differences in the inflammation grades and fibrosis stages between HBeAg positive and anti-HBe positive group cases (Kruskal-Wallis Test, x2=8.68, P less than 0.01, x2=6.84, P less than 0.01), showing inflammation grades and fibrosis stages of the anti-HBe positive group were higher than those of the HBeAg positive group. There were no obvious differences about the inflammation grade between age less than 40 years old and > or = 40 years old group cases (x2=0.62, P more than 0.05), but there were significant statistical differences about the fibrosis stage (x2=7.37, P less than 0.01), showing fibrosis stage of more than 40 years old group cases was clearly higher than the less than 40 years old group cases. Fifty-six cases received a liver biopsy for a second time and 23 for a third time. We found those whose hepatic tissues were normal in their first liver biopsies, then their liver histology continued remaining stable for several years while those with abnormal ones hardly or only recovered slightly. The rate of HBsAg turning to negativity per year was 1.55% and for HBeAg was 5.4%.

CONCLUSIONThe hepatic tissue pathology for most chronic HBV carriers (55%) had significant abnormalities (inflammation grade > or = G2), and the rates of hepatitis B reactivation were highly relevant to the liver inflammation grades and the ages of the patients.

Adolescent ; Adult ; Carrier State ; virology ; Child ; Female ; Follow-Up Studies ; Hepatitis B virus ; physiology ; Hepatitis B, Chronic ; pathology ; virology ; Humans ; Inflammation ; Liver ; pathology ; virology ; Male ; Middle Aged ; Virus Activation ; Virus Replication ; Young Adult

Objective To investigate the role of hypoxia inducible factor-1α (HIF-1α) and von Hippel-Lindau (VHL) in murine endochondral ossification. Methods The knockout of HIF-1α or VHL gene in murine osteoblasts was accomplished by conditional knockout technique at 4th, 8th and 12th week, and the differences between wild-type group and knock-out group in endochondral ossification were detected by HE staining, micro-CT scanning, trabecular bone area measurement, calcium content measurement, tetracycline fluorescence labeling, Real-time PCR and Western blotting. Results After knockout of HIF-1α gene in osteoblasts, the expression of vascular endothelial growth factor ( VEGF) reduced, the rate of new bone formation stepped down, the content of calcium became less, and the trabecular bone volume decreased (P <0.05) . After knockout of VHL gene in osteoblasts, the expression of VEGF increased, the rate of new bone formation stepped up, the content of calcium became more, and the trabecular bone volume was promoted (P < 0.001). Conclusion During murine endochondral ossification, VHL/HIF-1α signal pathway promotes angiogenesis through the stimulation of VEGF expression, which subsequently accelerates osteogenesis.

Objective To assess the systolic function in left ventricular subendocardial myocardium , midmyocardium and subepicardial myocardium in patients with hypertrophic cardiomyopathy (HCM ) by two‐dimensional speckle tracking echocardiography .Methods A total of 32 patients with HCM and 32 healthy adults were included in the study .All standard measurements were obtained from the left ventricular short‐axis views at the levels of mitral annulus ,papillary muscle and apex ,and apical four‐chamber ,two‐chamber ,and long‐axis views .Two‐dimensional speckle tracking imaging was employed .The global peak systolic radial strain ,peak systolic longitudinal strain and circumferential strain of each layer of the left ventricle were measured .Results In patients with HCM and the control group ,the peak systolic longitudinal strain and circumferential strain reduced from subendocardial myocardium to subepicardial myocardium .The global peak systolic radial strain in patients with HCM was significant lower than that in the control group . And in patients with HCM ,peak systolic longitudinal strain in subendocardial myocardium ,midmyocardium and subepicardial myocardium was significant lower than those in the control group .Conclusions Peak systolic longitudinal strain and circumferential strain are reduced from subendocardial myocardium to subepicardial myocardium .Myocardial systolic function is impaired in patients with HCM .In patients with HCM ,longitudinal strain of each layer is lower ,but circumferential strain is mainly reduced in midmyocardium and subepicardial myocardium compared with that in the control group .