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 obtain the specific human scFv basic fibroblast growth factor(bFGF)using phage antibody library technology. Methods The library was panned with human recombinant bFGF for 4 rounds. The antigen binding activities of random clones were tested by ELISA in order to select specific antibodies, which were then examined by DNA sequence analysis. Results The positive clone selected from the 104 random clones was able to bind bFGF specifically, while not able to bind other growth factors,such as aFGF, VEGF(vascular endothelial growth factor). By competition ELISA assay we found one clone 44 could inhibit bFGF binding to FGFR1. Conclusion Seven specific human phage antibody against bFGF was obtained by phage display technique, one clone could inhibit bFGF binding to its high affinity receptor FGFR1.

OBJECTIVE To compare the clinical efficacy between adenoidectomy combined with auripuncture (AT+A) and adenoidectomy combined with tympanostomy tubes (AT+T) in children wiht otitis media with effusion. METHODS 92 cases of children with otitis media with effusion were selected from September 2010 to September 2014 in our hospital which was divided into AT+T group and AT+A group, depending on therapy methods.There were 48 in AT+T group and 44 in AT+A group. Retrospective analysis were made on a series of clinical data ,including the therapeutic effect, hearing threshold before and after treatment, infection rate and recurrence rate. RESULTS The hearing threshold has been significantly reduced within one year of follow-up after treatment,however,there was no significant difference (P>0.05). Total efficiency rate was 97.9% in AT+T group and 95.4% in AT+A group, no significant difference was found (P>0.05). The average middle ear fluid duration, infection and recurrence rate of children in AT+T group and AT+A group was (7.3±0.8) days, 6.3%, 4.2% and (11.7±0.4) days, 15.9%, 11.4% respectively, there was significant differences (P<0.05). CONCLUSION Both AT+T and AT +A have a good therapeutic effect for children with otitis media with effusion, which can significantly improve the hearing. Compared to AT+A, AT+T have a higher recovery rate,significantly reduce the recurrence and infection rate,and may be more suitable for clinical treatment of children with otitis media with effusion.

Objective To explore the change of serum sIL-2R and IL-6 levels in patients with Kawasaki disease (KD) and its role in the pathogenesis. Methods The serum slL-2R and IL-6 were detected by sandwich ELISA. The serum hs-CRP level was measured by DADE BEHRING BN ProSpec. Results The serum levels of sIL-2R and hs-CRP in KD before and after high-dose intravenous gama globulin(IVIg) were significantly higher than in healthy controls (P

Animals ; Antigens, CD34 ; metabolism ; Cell Culture Techniques ; methods ; Cells, Cultured ; Endothelial Cells ; cytology ; metabolism ; Female ; Kidney Glomerulus ; cytology ; metabolism ; Male ; Rats ; Rats, Sprague-Dawley ; Vimentin ; metabolism

Objective Comparison of three different molecular assays for the detection and molecular characterization of circulating tumor cells in breast cancer .Methods The retrospective study compared three different molecular assays to detect CTC in the peripheral blood of 30 healthy individuals and 71 benign breast disease patients and 83 early and 84 metastatic breast cancer patients .All samples were collected at the outpatient , inpatient and physical examination department of Sichuan Provincial People ′s Hospital from January 2011 to June 2014.The same cDNAs were analyzed by:singleplex RT-qPCR assay for BCL-2, multiplex RT-qPCR for BCL-2, HER-2, HMAM, and a commercially available molecular assay (AdnaTest BreastCancer ) for GA733-2, MUC-1, HER-2.The positive of CTC were compared among healthy individuals and benign breast disease patients and breast cancer patients .Chi square test was used to compare the expression of gene markers among the three groups , and the agreement of Kappa test was used to evaluate the method.Results (1) Detection rates of early breast cancer by single RT-qPCR, Adna kits and multiple RT-qPCR were 13.3%, 16.9% and 18.1%, respectively , and the detection of metastatic breast cancer were 31.0%, 42.9%and 35.7%, respectively.There were significant differences in the positive of CTC by three molecular assays between healthy individuals and benign breast disease patients and early breast cancer patients ( The test values were 4.235 and 4.301, 5.367 and 5.474, 5.894 and 6.023 respectively, P<0.05).There were no differences between benign breast disease patients and early breast cancer patients (The test values were 0.891,0.748 and 0.701 respectively,P >0.05) .There were significant differences between metastasis breast cancer patients and healthy individuals and benign breast disease patients and early breast cancer patients ( The test values were 8.429,7.553 and 7.061;10.24, 9.025 and 8.745; 9.658, 8.417 and 8.201 respectively,P<0.05).(2) In early breast cancer: The concordance between AdnaTest and single RT-qPCR was 79.5%while between AdnaTest and multiplex RT-qPCR was 77.1%.No agreement was found among them ( The test values were 1.065 and 1.871, P were 0.371 and 0.258 ) .The concordance between single RT-qPCR and multiplex RT-qPCR was 80.7%.No agreement was found between them (The test values was 2.814, P was 0.156).(3) In patients with overt metastasis:The concordance between AdnaTest and single RT-qPCR was 78.6%( The test values was 10.986).While between AdnaTest and multiplex RT-qPCR was 80.9%( The test values was 9.251 ) . Agreements were found among them ( P was 0.002 and 0.005 respectively ) .The concordance between single and multiplex RT-qPCR was 88.1%( The test values was 12.364 ) .Agreement was found between them (P was 0.001).Conclusions No correlations were found among different molecular methods to detect CTC in the early primary breast cancer , but correlations were found in the metastatic breast cancer , suggesting that different rate of CTC caused by the number of CTC and its heterogeneity should be considered to the clinical diagnosis and treatment of breast cancer while molecular method is used .

Butyric acid can be used to produce cellulose butyrate fiber and ester derivatives,and to be applied in foodstuffs and perfume industries.Recent researches have found that butyric acid is a preferred carbon source for colonic epithelial cells,and can inhibit histone deacetylase,showing great anticancer potentials.With more and more functions of butyric acid being found and applied in bio-related fields,and with consumer's growing preference to bioproducts,biotechnological production of butyric acid will receive more competence than petroleum-based chemical synthesis.Low product concentration and poor selectivity are presently the main restricting factors.Workers have made considerable progress on more cheep carbon sources,optimization of fermentation process,simplifying downstream processing,and genetic engineering of producing strains.Any achievement on these aspects in the future can contribute to put fermentation of butyric acid into industry.

Objective:To study the enhancing effect of bFGF-targeted antisense phosphorothioate oligonucleotide (APO)on the chemosensitivity of human laryngeal squamous carcinoma cell line Hep2 to Doxorubicin,5-Fluorouracil, and Cisplatin.Methods:bFGF-specific APO was designed,constructed and transfected into Hep2 cells with jetPEI (polyethyleneimine).Expression of bFGF mRNA was evaluated by semi-quantitative RT-PCR after transfection;immuno- cytochemical method was used to examine the expression of bEGF expression before and after transfection of Hep2;the in- duction of cell apoptosis was analyzed by flow cytometry;cell proliferation was then analYzed by MTT assay after treatment with bFGF-specific APO or chemotherapeutic drugs,or a combination of both.Results:bFGF-specific APO inhibited the growth of Hep2 cells in a dose-and time-dependent manner,with the peak inhibitory rate being 25.5%.The expression of bFGF mRNA and protein decreased by 52.0% and 41.1%,respectively.The apoptosis rate of Hep2 cells was 20.5% after transfection,bFGF-specifie APO reduced the 50% inhibitory concentration of Doxorubicin,5-Fluorouracil,and Cis- platin in Hep2 cells by 75.5%,83.5% and 65.4%,respectively.Conclusion:bFGF-specific APO can enhance the chemosensitivity of Hep2 cells,which paves a new way for potential biologic chemotherapy of laryngeal squamous carcino- ma.

Objective To investigate the apoptosis of cultured normal human hepatocyte HL-7702 cells induced by glycodeoxycholate(GCDC)and to explore its possible mechanism.Methods HL-7702 cells were incubated with various concentrations(100,150,200 and 250 ?mol/L)of GCDC.The changes of cellular morphology were observed under optical microscope.The apoptosis rate of HL-7702 was determined by Annexin V-FITC/PI double staining.The changes of HL-7702 cell intracelluar \[Ca2+\]i were determined with Fluo-3/AM load technique.The mRNA expression levels of Bcl-2/Bax in HL-7702 cells were analyzed by RT-PCR.Results Typical apoptotic morphological changes were observed after HL-7702 cells had been treated with 150 ?mol/L GCDC for 24 h;HL-7702 cells could be induced to undergo apoptosis in a concentration-dependent manner after 100,150,200,and 250 ?mol/L GCDC treatment for 24 hours.The apoptosis rates were(13.16?2.9)%,(20.3?3.0)%,(25.02?2.1)% and(45.02?3.5)%,which were markedly higher(P

Objective To compare clinical outcomes in eyes with macula-off rhegmatogenous retinal detachments (RRD) with peripheral breaks managed by surgical protocols that result in either complete (CSFD) or partial subretinal fluid drainage (PSFD).Methods Following the clinical detection of a maculaoff RRD with peripheral retinal breaks,patients were offered the opportunity to enroll in the study,and those patients who signed the consent were evaluated for eligibility based upon the inclusion and exclusion criteria for this clinical study,and if fully eligible they were assigned prospectively to one of the two surgical designs (PSFD or CSFD,1∶ 1) using a random number table.Seventy-two eyes of 72 patients were enrolled and studied.Patients were treated with 25G plus vitrectomy,endolaser or transscleral cryopexy,either complete (n=36),or partial (n=36) subretinal fluid drainage,and 14％C3F8 (PFO) was used for intraocular tamponade.After surgery,all patients were kept in a supine position for 24 hours,and then in a clinically optimal position for 6-10 days.The study patients were examined at 1,3 and 6 months after surgery with thorough ophthalmic examinations.Macular optical coherence tomography (OCT) imaging was acquired in 1 month.Anatomical and visual outcomes as well as intra-operative and postoperative complications of the two groups were compared.Furthermore,the persistence of subfoveal fluid in OCT images and the symptoms of distortion at 3 months were measured and recorded.The primary study endpoint of anatomic retinal reattachment for each group was based upon the 6-month time-point.Results The preoperative baseline characteristics between the two groups were not significantly different.The single-operation success rates were 88.9％ and 91.6％ respectively for the CSFD and the PSFD groups (x2 =0.158,P＞0.05).The mean best corrected visual acuity (BCVA) at 6 month endpoint were 0.99± 0.52 minimum resoluation angle in logarithmic (logMAR) for the CSFD group and 1.07±0.34 logMAR for the PSFD group(t=0.580,P=0.564).The mean operative time was longer in the CSFD group (62.25± 4.32) minutes than that in the PSFD group (47.9 ± 5.0) minutes (t =0.580,P=0.564).seven of 29 (24.1％) phakic eyes in the CSFD group had lens injury during SRF drainage,and none of the 31-phakic eyes in the PSFD group sustained lens damage.Residual PFO was present in 6 of 36 CSFD cases (16.7％).Successful retinal reattachment after primary surgery was achieved in 33) PSFD eyes and in 32 CSFD eyes based upon OCT imaging at 1 month demonstrated reattached foveae with no residual subfoveal fluid.Among these patients,22 patients (62.5％) in the CSFD group and 23(69.7％) patients in the PSFD group reported distortion in the operated eye or/and a difference in image size between the two eyes at the 6 month visit (P=1.00).Conclusions Partial subretinal fluid drainage during pars plana vitrectomy for the repair of macula-off RRD with peripheral breaks is effective.The success rates are not statistically different.Additionally,PSFD procedures can simplify the surgery procedure,shorten operative time and,and to some extent,reduce the incidence of complications relevant to the CSFD approach.