Although the importance of clinical data is drawing more attention in drug development in China, the clinical data management is not good enough in the clinical trials right now. With the development of internet and progress of information technology, especially with the setup of the state innovation strategy for drug development, it is necessary and urgent to improve the clinical data quality. Good data quality is the primary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation of CFDA has made some endeavors to enhance data management in the clinical trials in recent years. This article is focused on these aspects of data managment.
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Although the importance of clinical data is drawing more attention in drug development in China, the clinical data management is not good enough in the clinical trials right now. With the development of internet and progress of information technology, especially with the setup of the state innovation strategy for drug development, it is necessary and urgent to improve the clinical data quality. Good data quality is the primary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation of CFDA has made some endeavors to enhance data management in the clinical trials in recent years. This article is focused on these aspects of data managment.

AIM: To investigate the role of Src tyrosine kinase (Src)/signal transducer and activator of transcription 3 (Stat3) signaling pathway in high glucose (HG)-induced vascular smooth muscle cell (VSMC) proliferation and migration.METHODS: VSMCs were incubated with HG (10~40 mmol/L) for 24 h.The cell proliferation was detected by MTT assay and EdU staining, while the migration ability of VSMCs was measured by Transwell assay.The protein levels of p-Src, Src, p-Stat3, Stat3 and GAPDH were determined by Western blot.The mRNA expression levels of cyclin D1, Myc, matrix metalloproteinase 2 (MMP2) and matrix metalloproteinase 9 (MMP9) were detected by qPCR.To further confirm the role of Src in HG-induced VSMC proliferation, the VSMCs were exposed to HG (40 mmol/L) and co-treated with Src inhibitor saracatinib (100 nmol/L) for 24 h, and then the proliferation ability and the Stat3 activity of the cells were analyzed.RESULTS: Treatment with HG dose-dependently enhanced the cell viability, increased the ratio of EdU-positive cells, and raised the migration cell number, the protein levels of p-Src and p-Stat3 and the mRNA levels of cyclin D1, Myc, MMP2 and MMP9.Inhibition of Src inhibited HG-induced VSMC proliferation and migration, and suppressed Stat3 activation and the expression of Stat3 target genes cyclin D1, Myc, MMP2 and MMP9.CONCLUSION: Src/Stat3 signaling pathway might play an important role in HG-induced VSMC proliferation and migration.

Objective: To screen for seasickness behavior parameters in rats with simulated seasickness, so as to investigate the rule of seasickness adaptation in rats. Methods: SD rats were stimulated daily by Crampton model. Urine volume (UV) and amount of fecal particle (FP) were observed during stimulation, and the spontaneous activity (SA) was also determined immediately after stimulation. Interventional experiments were performed using anti-motion sickness drugs to examine the specificity of the indices. Results: On the first day of stimulation, the FP of stimulating group increased significantly compared with the normal control group (P<0.05), while SA decreased significantly (P<0.01). FP and SA of stimulating group gradually recovered with the increase of stimulation period; there was a significant correlation between FP, SA with stimulation times (P<0.01). FP and SA recovered to the normal levels on the 9th, 7th day, respectively. The experimental group received gastric perfusion of scopolamine (0.5, 1 mg/kg) and was then subjected to rotation stimulation. The indices had no significant difference between the experimental group and the normal control group. Conclusion: It is indicated that FP during stimulation and SA after stimulation can be used for effective judgment of seasickness in rats. The rats become adapted to seasickness after 9 days' continuous stimulation.

OBJECTIVEThis work lays the foundation for establishing a digital model database with normal occlusion. A digital dental cast is acquired through grating projection, and model features are measured through reverse engineering.

METHODSThe grating projection system controlled by a computer was projected onto the surface of a normal dental model. Three-dimensional contour data were obtained through multi-angle shooting. A three-dimensional model was constructed, and the model features were analyzed by using reverse engineering. The digital model was compared with the plaster model to determine the accuracy of the measurement system.

RESULTSThe structure of three-dimensional reconstruction model was clear. The digital models of two measurements exhibited no significant difference (P > 0.05). When digital and plaster models were measured, we found that the crown length and arch width were not statistically different (P > 0.05), whereas the difference between the crown width and arch length was statistically significant (P < 0.05).

CONCLUSIONThe reconstruction of a digital model by using the grating projection technique and reverse engineering can be used for dental model measurement in clinic al and scientific research and can provide a scientific method for establishing a digital model database with normal occlusion.

Objective To discuss the clinical manifestations, diagnosis and treatment of solidpseudopapillary tumor of the pancreas (SPTP) in children. Methods Clinical data of 12 cases of SPTP admitted to Beijing Children's Hospital from Mar 2001 to Mar 2007 were collected and analyzed retrospectively. Result There were 7 females and 5 males among the patients. The mean age was 13.6 years. The main symptoms were abdominal pain and mass. Tumors located in the head in 4 cases, in the body and tail of the pancreas in 8 cases. Five cases underwent tumor enucleations, one case underwent body resection of the pancreas, two cases underwent Whippple's procedure including one recurrent case, five cases underwent body and tail resection of the pancreas plus splenectomy. All these 12 cases were followed up for 6 months to 6 years. One case lost follow-up 6 months after body and tail resection of the pancreas plus spleneetomy. Another one suffered from live tumor one year after operation and refused surgical exploration and lost follow-up. The other 10 cases were still alive. Conclusion SPTP are predominantly seen in adolescent females. For its benign clinical behavior and relatively good prognosis, surgical resection is the main choice of therapy.

Objective To analyze the clinical and pathological characteristics of thyroid nodules.Methods A retrospective analysis of the clinical data of 2843 Han patients with thyroid nodules from January 2009 to June 2011 in Henan province was performed.Results The most high-risk of thyroid nodule resided in the group aged 45-54.The main pathological manifestation was simple nodular goiter.The rate of preoperative misdiagnosis was 2.4％.22.1％ of the patients with thyroid nodules showed abnormal thyroid function,which was mainly as subclinical thyroid dysfunction.The positive rate of thyroid peroxidase antibody (TPOAb) in patients with thyroid nodule was 19.8％ while that of thyroid globulin antibody (TgAb) was 20.0％.Among all 2843 subjects,the prevalence of differentiated thyroid carcinoma (DTC) was 28.8％,and the incidence of DTC was accompanied by raised TSH levels.The prevalence of DTC exceeded 40％ in patients aged between 25 to 34 as well as more than 74 years old.The prevalence of DTC was up to 33.8％ in TgAb positive patients.There was no difference in TPOAb levels between DTC patients and non DTC patients (P =0.406),but the TgAb level in patients with DTC was significantly higher than that of non DTC patients (P =0.033).Conclusion Thyroid nodule patients aged 25-34 or older than 74 formed high-risk groups of DTC.The serum TSH level and TgAb level were positively correlated with the risk of DTC.

Objective To explore the effectiveness of the home-community-hospital network management (HCHNM) on the prevention and treatment of stroke.Methods From June to December 2011,HCHNM was implenented in Qingdao of Shandong Province to prevent and treat stroke patients.According to community residents healthcare records,A total of 80 stroke patients were randomly selected from Badahu and Fushanhou communities (study group) and another 80 patients from Zhongshan Road and Liaoning Road communities (control group).A household questionnaire survey was then conducted among these participants.Chi-square test and t test were used for data analysis.Results The overall effective rate of the study group was 86.25％ (69/80),which was significantly higher than that of the control group (67.5％) (x2=221.807,P＜0.05).The study group also showed largely improved quality of life (total score:t=4.593;physical fitness,family activities,movement,mood,self-care ability,social activities,upper limb function and work ability scores:t values were 7.775,2.244,5.329,3.832,5.463,2.979,5.924 and 3.555,respectively; all P＜0.05),although language,character,thinking and vision abilities had no statistically significant difference from the control group (t values were 0.561,1.466,0.831 and 1.000,respectively; all P＞0.05).The scores of daily activities and life satisfaction of the study group were higher than those of the control group,while per capita medical cost was much lower (t values were 12.998,20.760 and-29.777,respectively; all P＜0.05).Conclusions As an effective,safe and economy therapy model,HCHNM could improve rehabilitation,self-care ability,quality of life,and life satisfaction of community stroke patients.In addition,it greatly mitigates medical burden.

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