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.

0.05).CONCLUS_ION:The present study in rabbits showed no significant interaction between ciprofloxacin and tacrolimus after combined administration of these two drugs in a single dose.

Objective To explore the applied value of the super-short exposure time of the DR adjustable control in radiography of infant chest.Methods 100 chest radiographic films of infant in adjustable control group and fixed control group respectively were selected randomly.The quality of all films was evaluated by 4 technicians in charge in 4 grades(A,B,C and waste)and the detective rate of the tiny parts of the images was also evaluated.Results DR adjustable control:the rate of grade A,B,C and waste was 70%,20%,10% and 0% respectively.DR fixed control:the rate of grade A,B,C and waste was 42%,41%,15% and 2% respectively.The detective rate of tiny parts was 100% and 90% in DR adjustable control group and DR fixed control group respectively.Conclusion DR adjustable control chest film in infant is better than DR fixed control in image quality.DR adjustable control system is good for radiographic diagnosis.

Objective To analyze the clinical efficacy of endovenous laser treatment combined with transilluminated powered phlebectomy for great saphenous varicosity and summarize the experiencein order to achieve better results.Methods From January 2014 to June 2015,45 patients (52 limbs,including 17 males and 28 females,aged 36 to 68 years) diagnosed as great saphenous varicosity received endovenous laser treatment combined with transilluminated powered phlebectomy.Thirty-eight cases was unilateral great saphenous vafcose veins,7 cases was bilateral large saphenous varicose veins.The clinical efficacy was analyzed.Results All cases were performed successfully.The mean operation time was (68.4 ± 15.1) minutes,the average bleeding volume was (23.5 ± 10.7) ml,the number of mean operative incision quantity was (5.8 ± 1.9) and the average hospitalization time was (5.9 ± 1.6) days.All patients had no serious complications.During a mean follow-up time of 22 months (12 to 30 months),only one patient recurred.Conclusions Endovenous laser treatment combined with transilluminated powered phlebectomy for great saphenous varicosity is effective and safe.It also has the advantages of shorter operation time,less bleeding,shorter hospitalization time,small trauma and better cosmetic results.

OBJECTIVE:To prepare Idebenone solid dispersion,and to investigate its dissolution rate in vitro. METHODS:Us-ing Poloxamer 407(P407)as carrier,the influence of preparation methods(solvent method,melting method)and the ratio of the drug to P407(1∶1,1∶3,1∶8)on the dissolution of drug were investigated by single factor design. The state of idebenone in ma-trix of solid dispersion was further determined by using differential scanning calorimetry (DSC) and X-ray powder diffraction (XRD). RESULTS:Idebenone solid dispersion prepared by solvent method(the ratio of the drug to poloxamer was 1∶3)showed dissolution rate of 80%. The majority of idebenone existed in the solid dispersion at amorphous forms or molecular state. CONCLU-SIONS:Idebenone solid dispersions with high dissolution rate in vitro is prepared successfully.

Objective To enhance the oral bioavailability of breviscapine and investigate the feasibility of preparing the proliposome of breviscapine by fluidized bed coating method. Methods The fluidized bed coating method was used to prepare breviscapine proliposome and ultrafiltration-HPLC was applied to determination of the encapsulation efficiency. The influence factors on encapsulation efficiency including carriers, drug-lipid weight ratio, inlet air temperature, spray rate, and spray air volume were investigated. Results When the carrier was sorbitol and the drug-lipid weight ratio was under 1∶3, the encapsulation efficiency could be higher. Inlet air temperature, spray rate, and spray air volume had some effects on the encapsulation efficiency. By the method, the fluidity of the proliposome granules was well and the particle size distribution ratio of them was uniform; the mean particle size of liposomal formulation of breviscapine after rehydration was 98 nm, and the encapsulation efficiency was (63.1?2.8)% (n=3). Conclusion It is feasible to prepare the breviscapine proliposome with fluidized bed coating method.

Objective To compare the efficacy of endovenous laser treatment combined with transilluminated powered phlebectomy and traditional surgical treatment for great saphenous varicosity. Methods From January 2014 to January 2015,77 patients diagnosed as great saphenous varicosity were enrolled. They were randomly divided into two groups, 37 patients received endovenous laser treatment combined with transilluminated powered phlebectomy and the other 40 patients underwent traditional surgical treatment. The related indicators were compared.Results The mean operation time,average bleeding volume,operative incisionquantity and average hospitalization time of EVLT+ TIPP group were (66.1±14.7) min,(24.4±10.5) ml,5.7±1.7,(5.6±1.4) d respectively,of control group were (84.3±18.5) min,(59.0±15.6) ml,8.0±1.8,(10.1±3.1) d respectively,there were significant differences between the two groups(t =-4.749,-11.460,-5.714;P<0.001) .There were no significant complications in the two groups.In the EVLT+ TIPP group,6 patientsoccurred patsubcutaneous induration, 5 patients occurred subcutaneous hematoma and 7 patients had skinparesthesias.In the traditional operation group,2 cases occurred patsubcutaneous induration,3 cases occurredsubcutaneous hematoma and 2 cases had skin paresthesias.The EVLT+ TIPP group was slightly higher than thetraditional operation group in the complications, but there were no significant differences between them ( P>0.05).During a mean follow?up time of (18±7) months(12 months to 24 months),1 patient recurrence in theEVLT+ TIPP group,2 cases recurrence in the traditional operation group.The recurrence rates of the two groupswere similar,the difference was not significant between them(P=1.000) .Conclusion Endovenous lasertreatment combined with transilluminated powered phlebectomy for great saphenous varicosity is effective andsafe.It also has the advanta and better cosmetic results.

OBJECTIVETo construct a lentiviral expression vector of has-miR-338-3p and verify its target gene.

METHODSThe pre-miR-338-3p was synthesized and inserted into pLV-THM, and the recombinant plasmid pLV-THM-miR-338-3p was confirmed by restriction endonuclease analysis and DNA sequencing. 293T cells were co-transfected with the lentiviral vector pLV-THM-miR-338-3p, psPAX2 and pMD2.G, and the supernatant containing the lentivirus particles was harvested to determine the virus titer and used to infect SW-620 cells. Flow cytometry was employed for sorting the GFP-positive cells. The expression of miR-338-3p was determined using real-time RT-PCR and the expression of SMO protein was detected with Western blotting in the infected SW-620 cells. The invasiveness of the infected SW-620 cells was assessed using Transwell assay.

RESULTSRestriction enzyme digestion and DNA sequencing demonstrated successful construction of the lentiviral vector pLV-THM-miR-338-3p. SW-620 cells infected with pLV-THM-miR-338-3p showed a significantly increased expression of miR-338-3p, and the overexpression of miR-338-3p suppressed the expression of SMO protein and the invasiveness of the cells.

CONCLUSIONThe successful construction of the lentiviral vector pLV-THM-miR-338-3p and the establishment of a SW-620 cell line with miR-338-3p overexpression provide the basis for further study of the molecular function of miR-338-3p in colorectal carcinoma. MiR-338-3p can suppress SMO gene expression to inhibit the invasiveness of colorectal carcinoma cells.

Cell Line, Tumor ; Gene Expression ; Genetic Vectors ; Green Fluorescent Proteins ; genetics ; Humans ; Lentivirus ; genetics ; MicroRNAs ; genetics

Objective:To understand the clinical significance and mutation characteristics in the basic core promoters and pre-C region (BCP/PC) of different hepatitis B virus genotypes samples of infected children.Methods:A total of 294 children and 92 adults with CHB infection who were treated at four hospitals in Chongqing from 2011 to 2018 were collected. The BCP / PC region of HBV was amplified by PCR and sequenced directly to comparatively analyze the gene mutation conditions in this region. The two sample means were compared by the t-test, and the nonparametric data was compared by Wilcoxon-Mann-Whitney test. χ2 test or Fisher's exact test was used to compare the data rates of the two groups.Results:Children and adult patients were dominated by genotype B; accounting for 76.9% and 71.7%, respectively, and genotype C accounted for 23.1% and 28.3%, respectively. In the children group, the mutation rates of ten nucleotide sites containing nt 1679, 1721, 1753, 1757, 1758, 1762, 1764, 1775, 1856 and 1858 of the genotype C samples was significantly higher than that of genotype B samples. The mutation rates of G1721a, C1856t and T1858c of genotype C samples were 30.9%, 16.2% and 30.9%, respectively, while the mutation rates of genotype B samples were 0.4%, 0, 0, P < 0.001, respectively. In the adult group, the only three sites containing nt 1679, 1758, and 1775 of the genotype C sample had a higher mutation rate than the genotype B samples. The combined mutations pattern were only detected in children with genotype C samples, but not in children and adult with genotype B samples. Further analysis showed that the age of G1721A/A1775G/T1858C containing combined mutation group was significantly lower than that of the non-mutation group [(4.58 ± 2.53) years vs. (6.53 ± 4.02) years, P = 0.012]. Serum HBV DNA titer was significantly higher in combined mutation group than that of the non-mutation group [(7.57 ± 2.03) log10 copies / ml vs. (6.61 ± 2.11) log10 copies / ml, P = 0.045]. Conclusion:The frequencies of mutations in the BCP/PC region of HBV-infected children in genotype C samples were significantly higher than that of genotype B samples. Genotype-related combined site mutations were only found in children with genotype C samples, and were also associated with younger patients and high HBV-DNA titers.

OBJECTIVETo investigate the effect of knocking-down microRNA-221 (miR-221) expression on the radiosensitivity of human colorectal carcinoma cells.

METHODSHuman colorectal carcinoma-derived cell line Caco2 was transfected with miR-221 antisense oligonucleotides (anti-miR-221) via Lipofectamine 2000. Real-time quantitative PCR was performed to detect the expression of miR-221 and PTEN mRNA in Caco2 cells. The changes in the protein expression of PTEN in the transfected cells were detected by Western blotting. The cell death after transfection and irradiation was detected by flow cytometry.

RESULTSTransfection with anti-miR-221 caused a significant reduction in miR-221 expression (P<0.05) and up-regulated PTEN protein expression (P<0.05) in Caco2 cells. The percentage of cell death was significantly increased in anti-miR-221 group and anti-miR-221 with irradiation group (P<0.01). Anti-miR-221 significantly enhanced the radiosensitivity of Caco2 cells, which was partially reversed by PTEN-siRNA.

CONCLUSIONAnti-miR-221 can enhance the radiosensitivity of colorectal carcinoma cells by up-regulating the expression of PTEN.

Caco-2 Cells ; radiation effects ; Colorectal Neoplasms ; genetics ; metabolism ; Humans ; MicroRNAs ; genetics ; metabolism ; PTEN Phosphohydrolase ; metabolism ; RNA, Messenger ; genetics ; Radiation Tolerance ; Transfection ; Up-Regulation