Objective:To explore the impact of recent changes in domestic policies and regulations on the development and appli-cation of generic drugs. Methods:Through the collation of the recent regulatory documents, the policy changes for generic drugs were analyzed, and the corresponding development proposals were provided. Results and Conclusion:According to the possible impact of current policy changes on generic drug development, the relative solutions are proposed with the aim to provide certain reference for ge-neric pharmaceutical R & D institutions.

Objective To investigate the 64-slice spiral CT angiography combined with negative contrast CT cholangiography in the evaluation of resectability of hilar cholangiocarcinoma.Methods The clinical data of 46 patients with hilar cholangiocarcinoma were analyzed.The resectability was observed by the 64-slice spiral CT angiography combined with negative contrast CT cholangiography,and compared with the postoperative results.Results Preoperative CT Bismuth-Corlette classification and postoperative results showed no significant difference (x2 =0.00,0.53,1.96,0.59,2.63,all P ＞ 0.05).Preoperative CT assessed the resectability of 26 cases with hilar cholangiocarcinoma,The intraoperation evaluated resectable 22 cases,the difference was not significant (x2 =1.51,P ＞ 0.05).Conclusion 64-slice spiral CT angiography combined with negative contrast CT cholangiography can make a good evaluation of hilar cholangiocarcinoma involving the degree of blood vessels and bile ducts,provide an important basis for the selection of clinical protocols.

Objective:To observe oncosis in human peripheral blood T lymphocytes.Methods:Peripheral blood T lymphocytes of healthy adult was separated with Percoll(1.073 g/ml)and harvested by using nylon column.The cultured cells were divided into control and dexamethasone(DXM)group,and cell morphology was observed through light microscope,electron microscope and fluorescent microscope.And incidence rate of oncosis was analyzed by flow cytometry.Results:①Oncosis could be observed in cultured T lymphocyte after 96h.②In different concentrations of DXM group(1?10-6,1?10-5,1?10-4,1?10-3mol/L),The incidence of oncosis T lymphocytes was(3.49?0.42)%,(5.17?0.48)%,(8.44?0.72)%,(17.93?1.50)%.③During different cultured period(48,72,96,120h),The oncositic rate of T lymphocytes in DXM group was(0.53?0.10)%,(6.36?0.80)%,(20.60?1.59)%,(25.56?1.76)%.Conclusion:Oncosis can be seen in human peripheral blood T lymphocytes,and DXM could induce oncosis.

The effects of ginseng saponins on platelet aggregation, cyclic AMP and cyclic GMP level in platelets were studied. Ginseng saponins was found to be a potent inhibitor of platelet aggregation induced by arachidonic acid ( AA ) , ADP and thrombin in vitro and in vivo. The concentrations of ginseng saponins producing 50% inhibition of platelet aggregation induced by 0.55HM AA, 1.8-3.5uM ADP and 0.6-0.7 NIH u/ml of thrombin were 0.44, 1.20 and 1.32 mg/ml respectively. The inhibition % of aggregation induced by AA and ADP in vivo from 2-30min after iv administration of ginseng saponins ( 80 mg/kg) were 99-30.44 and 80.7-40.7, respectively. Also, cyclic AMP and cyclic GMP level in platelets were determined. It was observed that ginseng saponins significantly increased cyclic AMP level in platelets in a dose-dependent manner. But ginseng saponins did not affect cyclic GMP level in platelets. Our results indicate that the inhibition of ginseng saponins on platelet aggregation may be associated with an increase in cyclic AMP level.

Objective:To observe the GluR2 expression in rat inferior colliculus (IC) in different developmental stages , and to investigate its developmental change and relationship with the synapse development.Method: The expression of GluR2 and synaptophysin(SYP) in IC were detected by double immunofluorescence method.Result:①All sorts of neurons in IC expressed GluR2 in every postnatal groups, and the GluR2 expression in P6w groups was higher than that in other groups .②The expression of GluR2 were different in different subnucleus of IC.③All sorts of neurons in IC expressed SYP in every postnatal groups, and the SYP expression in P6w groups was higher than others. ④The expressions of GluR2 consistented with the expression of SYP in IC.Conclusion:The developmental changes of GluR2 and SYP expression in the rat IC may be involved in the development and plasticity of auditory center.

Objective To investigate the clinical efficacy of mind-regulating and kidney-reinforcing acupuncture in treating attention deficit hyperactivity disorder (ADHD).Methods Fifty-six patients with attention deficit hyperactivity disorder were randomly allocated to treatment and control groups, 28 cases each. The treatment group received mind-regulating and kidney-reinforcing acupuncture and the control group, conventional acupuncture, for a total of 28 days. The American Connell children’s ADHD behavior diagnostic scale and the Chinese version of ADHD SNAP-IV scale-parent form were used as evaluating indicators. The total efficacy rates were compared between the two groups of patients.Results The total efficacy rate was 96.4% in the treatment group and 71.4% in the control group; there was a statistically significant difference between the two groups (P<0.05). There were statistically significant pre-/post-treatment differences in the American Connell children’s ADHD behavior diagnostic scale score and the Chinese version of ADHD SNAP-IV scale-parent form score in the two groups (P<0.05). There were statistically significant post-treatment differences in the American Connell children’s ADHD behavior diagnostic scale score and the Chinese version of ADHD SNAP-IV scale-parent form score between the treatment and control groups (P<0.05). Conclusion Mind-regulating and kidney-reinforcing acupuncture is an effective way to treat attention deficit hyperactivity disorder.

Activating Transcription Factor 1 ; metabolism ; physiology ; Animals ; Humans ; Mitogen-Activated Protein Kinase Kinases ; metabolism ; Neoplasm Invasiveness ; Neoplasm Metastasis ; Neoplasms ; metabolism ; pathology ; Neovascularization, Pathologic ; Proto-Oncogene Proteins c-jun ; metabolism ; Proto-Oncogene Proteins c-raf ; metabolism ; Signal Transduction ; Smad4 Protein ; metabolism ; Stromal Cells ; metabolism ; Transforming Growth Factor beta1 ; metabolism

Objective To evaluate the diagnostic value of Human Epididymal Protein 4(HE4) and HE4/Cancer Antigen 125 (CA125) parallel detection for ovarian cancer by meta-analysis.Methods The databases,such as Pubmed,Embase and China National Knowledge Infrastructure (CNKI),were employed to search for the studies related to diagnostic value of HE4 and HE4/CA125 parallel detection for ovarian cancer.The screening,data extraction and quality assessment were conducted in accordance with the inclusion and exclusion criteria by two reviewers independently.The software Meta-disc 1.4 was used to perform meta-analysis and draw the forest plots and the Summary Receiver Operating Characteristic (SROC) curves.The AUCs of HE4,HE4/CA125 parallel detection were detected by Z test.The Egger's regression test was applied to evaluate the publication bias by Stata11.0.Results A total of 14 studies with benign control and/or healthy control were included.In the studies with healthy control.The AUCs of HE4,HE4/CA125 parallel detection were 0.9502 ± 0.0137 and 0.9588 ± 0.0113 respectively,but there was no significant difference between them (Z =0.484,P ＞ 0.05) ;In the studies with benign control.The value of cutoff was the most important cause of heterogeneity.The AUCs of HE4,HE4/CA125 parallel detection were 0.9153 ± 0.0095 and 0.9323 ± 0.0082 respectively,but with no significant difference (Z =1.350,P ＞ 0.05).In the subgroup with cut-off value divided by 150 pmoL/L,the AUCs of HE4,HE4/CA125 parallel detection were 0.9032±0.0174 and 0.9267 ±0.0176 respectively,but there was no significant difference between them (Z =0.950,P ＞ 0.05).Conclusions Both HE4 and HE4/CA125 parallel detection had meaningful values for the diagnosis of ovarian cancer.The detection of HE4 had a higher specificity,while the HE4/CA125 parallel detection had a higher sensitivity.But there was no statistical difference between them in diagnosis value of ovarian cancer.

Objective To explore the value of diffusion tensor tractography (DTT)in grading gliomas.Methods 27 patients with brain glioma(gradeⅠ-Ⅱ in 1 1 cases and grade Ⅲ-Ⅳ in 1 6 cases)confirmed by pathology were collected.Conventional MR and DTT were carried out and the bilateral corticospinal tracts(CST)were reconstructed before operation.The fiber density index (FDi)and relative FDi (rFDi= ipsilateral FDi/contralateral FDi)of CST was measured.Results The FDi of ipsilateral CST was lower than that of the contralateral CST in all patients(P <0.05).The bilateral FDi had no statistical difference in low-grade glioma (LGG)and high-grade glioma (HGG)(P >0.05).The rFDi of LGG was higher than that of HGG (P <0.05).Conclusion In com-bination with conventional MR,DTT can improve the accuracy of grading gliomas.

Objective To explore the efficient way to purify and to enrich umbilical cord mesenchymal stem cells which have abilities to differentiate into chondrocytes. Methods Umbilical cord was acquired from new born infants and chopped into 1 mm2 cubics, then they were pretreated with colleganase and trypsin so as to get the mixed cell suspension. CD45(-),CD90(+) cells were acquired from the mixed cell suspension via FCM sorting and were cultured in the medium as umbilical cord mesenchymal stem PO cells. The PO cells were detached and passaged by multiplex collagenase NB4 and the positive rate of CD90 and CD45 of the P1-P3 cells were observeed via FCM ; the P3 cells were induced to differentiated into chondrocytes. Results FCM results showed that the positive rate of CD90 on P1, P2, F3 was (80.86 ± 7.85)%,(95.86± 3.28)%,(97.15± 1.43)%, while the positive rate of CD45 on P1, P2, P3 cells was (2.53 ±0.28)% and (0.97 ± 0.48)% and (0.05 ± 0.01)% respectively; P3 cells had differenciated into chondrocytes. Conclusion FCM presorting and Multiplex collagenase detachment procedures can swiftly acquire highly purified human umbilical cord mesenchymal stem cells which have the ability to differentiate into chondroeytes.