Implementation of information technology in clinical research has resulted in revolutionary changes in drug development. Based on the good clinical practice (GCP) requirements on data, processes and documentations, and the era of fast growth in clinical studies using up-to-date information technology, we explore an integrated e-clinical solution in clinical studies in China.

Objective To investigate the expression of CXCR4 and CXCL12 in the labial gland of patients with primary Sj?gren's syndrome (pSS), and to explore their role in the pathogenesis of pSS. Methods The expression of CXCR4 and CXCL12 in labial gland tissues was detected by immunohistochemistry in 32 cases of newly diagnosed pSS and 30 cases of oral mucosa cysts or trauma patients. The expression level, intensity and location were analyzed and compared statistically. χ2 test and Spearman correlation analysis were used for statistical analysis. Results The positive rate of CXCR4 in the test group was 91%(n=29), which was significantly higher than that in the control group (33%, n=10, χ2=21.77, P=0.001). The positive rate of CXCL12 in the test group was 97%(n=31), which was significantly higher than that in the control group 40%(n=12), and the difference was statistically significant ( χ2=23.57, P=0.001). Conclusion CXCR4 and CXCL12 are highly expressed in labial gland of pSS patients, this suggests that they participate in the pathological process of pSS local inflammatory response and play an important role in pSS pathogenesis.

Objective To study the feasibility and clinical effect of percutaneous C2 pedicle lag screw in treatment of Hangman's fracture and define the indications of the technique. Methods There were 9 patients including 5 males and 4 females at average age of 36 years (26-68 years). According to a Levine and Edwards System, there were 5 patients with type Ⅰ hangman' s fracture, 3 with type Ⅱ hangman' s fracture and 1 with type Ⅱ A hangman' s fracture. According to American spinal injury association (ASIA) system, the spinal cord function was ranked at Type D in 2 patients and Type E in 7. All patients achieved anatomic reduction by skull traction. Under general anesthesia, 9 patients were fixed with percutaneons C2 pedicle lag screw. The whole procedure was done under monitoring of "C"-arm fluoroscopy for safety and accuracy. Results All patients obtained bony fusion within 2-3 months, with no infection, neurological deficits, vertebra artery injury or other complications. CondusionsThe percutaneous C2 pedicle lag screw fixation is minimally invasive and effective for treatment of Hangman's fracture. During the course of treatment, the function of upper cervical spine remains unaffected.

Objective To discuss the clinical characteristics and treatment of upper cervical spine injuries in the elderly. Methods A retrospective study was done on clinical data of 28 elderly patients ( > 60 years old) with upper cervical spine injuries treated from January 2003 to December 2007. There were 20 males and 8 females, at age range of 60-86 years (mean 68.1 years). Injury causes included slip in 16 patients, traffic injury in eight and fall from height in four. Atlas fractures occurred in five patients and axis ones in 15,of which there were eight patients with odontoid fractures, six with C2 vertebral arch fractures and one with C2 body fractures. Upper cervical spine injury was combined with lower cervical spine injuries in five patients. There were combined atlantoaxial injuries including odontoid fractures combined with lateral atlas fracture in one and edontoid fractures combined with anterior atlas arch fracture in one. Atlantoaxial dislocation occurred in one patient and combined spinal injury in four. Of all, eight patients were treated conservatively, eight with open surgical operation and 12 with minimally invasive surgery. Results The average hospital stay was 16.5 days, with no statistical difference be-tween conservative treatment group and open surgical operation group ( P > 0.05 ). While the average hos-pital stay in minimally invasive surgery group was shorter than that in conservative treatment and open sur-gical operation groups ( P < 0.05 ). Of all, two patients in conservative treatment group and one in open surgical operation group died and the other 25 patients were followed up for average 16.8 months (9-56 months). The satisfaction rate was 50% in conservative treatment group, 72% in open surgical operation group and 75% in minimally invasive surgery group. Complications occurred in four patients in conserva-tive treatment group, three in open surgical operation group and two in minimally invasive surgery group. Conclusions With odontoid fracture the most common injury type, upper cervical spine injuries arema-inly caused by low-energy force and characterized by low mobidity of spinal cord injuries and high possi-bility of missed diagnosis in the elderly patients. The surgical treatment especially minimally invasive surgery can bring good results compared with conservative methods.

Objective To explore different treatment choices for unilateral cervical facet locking. Methods The study involved 32 patients with cervical unilateral facet locking. Successful reduction by the skull traction was done in eight patients, of whom three were fixated by the head and neck chest plas-ter after a month of traction. Five patients were treated with anterior decompression and internal fusion fixation. The other 23 patients resulted in failure of traction and then were treated with anterior reduction, discectomy and internal fusion fixation in 14 patients, subtotal vertebral decompression and bone graft fix-ation in three, posterior open reduction and anterior bone graft fixation in one, posterior reduction, fixation and internal fusion fixation in three and posterior reduction and decompression plus anterior discectomy decompression and bone graft fixation in two. Due to misdiagnosis, one patient was treated with anterior decompression and fusion eight months after injury. Results A follow-up for average 18 months showed cervical instability in two patients who were treated with only traction, without fusion. The patients treated with anterior cervical fusion obtained bone union after 12 weeks, with satisfactory cervical physiological curvature and vertebral height. There were no internal fixation complications or neurological complications. Conclusions The treatment of lower cervical unilateral facet locking needs a compre-hensive considerations on whether there associates with disc injury, posterior column fractures or spinal cord injuries. As for patients with lower cervical unilateral facet locking combined with traumatic cervical disc herniation, the anterior reduction and decompression is the choice of treatment. While for those with-out disc herniation, traction or posterior open reduction and fixation can be carried out directly.

OBJECTIVE:To study the relative bioavailability,pharmacokinetics and bioequivalence of domestic nisoldipine tablets in healthy volunteers.METHODS:A single oral dose of 10 mg test and reference nisoldipine tablets were given to 24 male healthy volunteers in an open randomized 2?2 latin square design.The plasma concentrations of nisoldipine at different time points were determined by LC-MS and the pharmacokinetic parameters of the two kinds of tablets were computed and their bioequiavailability was evaluated.RESULTS:The main pharmacokinetic parameters of the test vs.reference formulations of nisoldipine in 24 healthy volunteers were as follows:Cmax(2.94?2.78)ng?mL-1 vs.(3.22?2.16)ng?mL-1,tmax(1.70?1.00)h vs.(1.40?1.00)h,t1/2(6.81?4.11)h vs.(5.55?2.35)h,AUC0～24(10.60?7.70)ng?h?mL-1 vs.(9.90?6.76)ng?h?mL-1,AUC0～∞(11.30?7.90)ng?h?mL-1 vs.(10.20?7.00)ng?h?mL-1.The relative bioavailability of domestic nisoldipine tablets was(110.3?30.8)%.CONCLUSION:The reference preparation and the test preparation of nisoldipine tablets were proved to be bioequivalent.

This study was aimed to observe the antipyresis and cholagogue effect of theFructus Gardeniae-Fructus Forsythiaeherb couple in order to explore the possible pharmacodynamic mechanism. Dry yeast suspension was subcutaneously injected into the back of rat to establish the fever model. The freeze-dried powders ofF. Gardeniae,F. Forsythiae, andF. Gardeniae-F. Forsythiaeherb couple were prepared. They were dissolved in the water for intragastric administration. SD rats were randomly divided into the normal group, model group, positive control group and Chinese medicine group. The Chinese medicine group was subdivided into the group ofF. Gardeniae,F. Forsythiae, andF. Gardeniae-F. Forsythiaeherb couple. The concentration of herbal water extract was 10 mL·kg-1 (which equaled to 3 g·kg-1 of a single crude herb). The concentration of positive control was 10 mL·kg-1. Intragastric administration of equal amount of normal saline was given to the blank group and the model group. Except rats in the normal group, rats in other groups were subcutaneously injected with 10 mL·kg-1 of 15% dry yeast suspension on the back of to establish the fever model. Electronic thermometer was used to record the body temperature of rats at 0, 1, 4, 5, 6, 7 and 8 h after the injection, respectively. Meanwhile, bile was collected from 1-1, 1-2, 2-4, 4-6, 6-8, 8-12, 12-24 h, respectively. Observation was given on changes of body temperature and bile amount of rat. The results showed thatF. Gardeniae,F. Forsythiae, andF. Gardeniae- F. Forsythiaeherb couple had certain effect to reduce the body temperature of rats. The temperature-reducing effect of the combination of both herbs was better than a single herb. TheF. Gardeniae -F. Forsythiae herb couple can reduce the body temperature of fever rat (P < 0.05, orP < 0.01). It had a little effect on the body temperature of normal rat. TheF. Gardeniae - F. Forsythiaeherb couple can promote the bile secretion, which was better than the single using of F. Gardeniae (P < 0.05). It was concluded that theF. Gardeniae - F. Forsythiaeherb couple had better temperature-reducing effect than the using of a single herb; however, there was no significant difference. But it had obvious effect on the promotion of bile secretion, which indicated the strengthening of cholagogue effect.

BACKGROUND:Many types of mammalian cells aggregate and display three-dimensional multicellular spheroids when they are in normal physiological conditions. In order to observe and explore cellular natural states, many researchers try to use spherical cellculture in vitro, a common three-dimensional culture pattern.
OBJECTIVE:To use three different methods for spherical culture in vitro of adipose-derived stem cells and to observe their biological features.
METHODS:Adipose-derived stem cells were confirmed by the analysis of the markers for cellphenotypes as wel as adipogenic and osteogenic differentiation potential assays. Three different methods of sphere cultures were used as fol ows:(1) ultra low attachment culture;(2) hanging-drop culture and (3) Eppendorf tube culture. The sphere formation was compared among above three methods. We used Imagej to calculate mean areas of these spheres. And we used Viability/Cytotoxicity Assay Kit for Animal Live&Dead cells to detect their vitality.
RESULTS AND CONCLUSION:(1) Adipose-derived stem cells were confirmed by the analysis of the markers for cellphenotypes, CD29, CD44, CD59 were positive, as wel as adipogenic and osteogenic differentiation potential assays were positive. The conventional monolayer cultures of adipose-derived stem cells showed spindle and cloning growth within three passages. (2) Ultra low attachment culture, hanging-drop culture, Eppendorf tube culture al could elicit adipose-derived stem cells spherical growth. However, spherical size, shape and uniformity differed depending on cellnumbers, culture time and spherical culture methods. The ultra low attachment culture was comparatively difficult to control spherical shape and uniformity of adipose-derived stem cells. But hanging-drop culture and Eppendorf tube culture were able to form even cellspheres. (3) Spherical formation of adipose-derived stem cells using our three methods displayed good cellvitality.

Background The construction of tissue-engineered corneal endothelium and corneal endothelial cells (CECs) therapy need abundant seed cells,so how to culture a large amount of CECs with high viability and original cell properties is an urgent issue to be solved.Objective This study was to establish three-dimensional spheroid culture of CECs and explore the cellular biological characteristics.Methods Primary rabbit CECs were isolated with trypsin and subcultured.Low attachment and shaking culture was applied to form CECs spheres.Cultured cells were identified under the inverted microscope.The surface features of the cells were examined under the scanning electron microscope.The viability of the cells were assayed by acridine orange (AO) staining and CCK-8 kit.Then CECs spheres were incubated to 6-well plate for 1 week,and immunofluorescence staining was used to identify the expression of zonula occludens-1 (ZO-1) and Na+/K+-ATPase in the cells.The cell proliferation value of spheroid culture method was compared with that of regular culture method.Results CECs grew into aggregation after cultured with the hexagonal or polygonal shape and tight connection among the cells.The cells converged into single layer and slabstone-like arrangement 1 week later.Cells migrated out of the CECs sphere and formed an uneven spherical surface.The living cells showed green fluorescence for AO with the survival rate 90％.The absorbance (A450) of the cells was 1.524±0.013 and 1.265 ±0.021 in the spherical culture group and conventional culture group,respectively,showing a significant difference between them (t =-3.436,P=0.010).The positive cells of ZO-1 and Na+/K+-ATPase showed the green fluorescence for FITC on cell membrane and blue fluorescence for DAPI on cell nucleus.Conclusions Spherical culture method maintains a high viability and proliferation ability of the cells and remains phenotype of CECs,which is superior to conventional culture method.This culture method provides better seeding CECs for the establishment of tissue engineering cornea endothelial layer and CECs therapy.

Objective To explore possible associations between host polymorphism of HLA classⅡgenotypes and advanced hepatosplenic schistosomiasis japonica.Methods 45 advanced schistosomiasis patients(experimental group) and 44 age,and sex,matched patients with chronic schistosomiasis(control group) from the same area were investigated for their HLA class II gene DRB genotypes by genotyping the alleles using microarray DNA chip.The correlation of allele frequencies to advanced hepatosplenic schistosomiasis was compared for the two groups.Results HLA,DRB1*04x exhibited markedly higher frequency in advanced patients than that in control group(P