With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
Clinical Trials as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Outsourced Services ; Quality Control

Differences in their pharmacognostic features, microscopic appearance of their powders and UV spectrums, can be used to differentiate Artemisia rupestris from its confusable Achillea millefolium. It is of value to identify them in actual practice.

AIM: To quantitatively detect the expression level of transforming growth factor-β1 (TGF-β1) and transforming growth factor-β2 (TGF-β2) genes in the retina of normal rat in order to determine the expression difference of TGF-β1 and TGF-β2 in retina.METHODS: The total RNA was isolated from which the first strand of cDNA was prepared. The mRNA levels of TGF-β1 and TGF-β2 were detected quantitatively by real time polymerase chain reaction (PCR).RESULTS: The mRNA levels of TGF-β1 and TGF-β2 were 0.0008±0.0003 and 0.0378±0.009, respectively. Expression of TGF-β2 was obviously higher than that of TGF-β1 in rat retina with statistical significance (t=12.37, P<0.001). The ratio of TGF-β2/TG-β1 was 55.00±26.61.CONCLUSION: QRT-PCR could specifically and accurately detect gene expression level in rat retina. In retina the TGF-β2 gene was expressed more abundantly than TGF-β1. It is suggested that TGF-β2 play an important role in retina diseases.

AIM: To quantitatively investigate transforming growth factor-β type Ⅰ receptor (TβRⅠ) and transforming growth factor-β type Ⅱ receptor (TβRⅡ) gene expressions in rat retina.METHODS: Sprague-Dawley rats were chosen in this research. Gene expression was detected quantitatively by reverse transcription polymerase chain reaction (RT-PCR) analysis. RESULTS: The expression level of TβRⅠ and TβRⅡ were 0.00034±0.00013 and 0.0001±0.00005, respectively. The expression level of TβRⅠ was obviously higher than that of TβRⅡ in the rat retina with statistical significance (P<0.01). The ratio of TβRⅠ/TβRⅡ was 3.9±1.7.CONCLUSION: Real time quantitative RT-PCR is an effective method to detect differential expression genes in retina. The change of TβRⅠ/TβRⅡ expression may play an important role in the pathogenesis of retinopathy, which could be further investigated in its significance in the development of proliferation retinopathy.

AIM: To detect the gene expression of TGF-β2 in retinas of diabetic rats at different stages, to observe and analyze the effect of TGF-β2 on the retinas of diabetic rats, to explore the role of TGF-β2 in pathogenesis of diabetic retinopathy (DR), and to provide experiment data and experience for further clinic studies.METHODS: Sprague-Dawley (SD) rats were used and retinas were dissected. The total RNA was isolated from which the first strand of cDNA was prepared. Diabetes mellitus was induced by a single intraperitoneal injection of 60mg/kg streptozotocin (STZ) and the rats were held without insulin treatment until sacrifice. Besides, agematched rats treated with saline were used as controls. Tail vein blood glucose was measured after 2 days and rats were considered hyperglycemic if blood glucose reading>16.7mmol/L. Animals with blood glucose level<16.7mmol/L were excluded from the study. The rats were killed at the 4th, 8th, 12th, 16th, 20th and 24th week respectively after hyperglycemic models were established. The retinas were separated and preserved in liquid nitrogen. The expressions of TGF-β2 gene mRNA were detected by reverse transcription PCR (RT-PCR).RESULTS: The RNA of rat retina was integrative enough to be used to further carry out PCR analysis. Compared with control groups, the expression of TGF-β2 mRNA in retinas of diabetic rats was up-regulated at the 4th week, but there was no statistical difference (P>0.05); it was down-regulated at the 8th week, and there was statistical difference (P<0.05); it was also down-regulated at the 12th week, and there was statistical difference (P<0.05); at the 16th week there was no statistical difference (P>0.05); it was up-regulated at the 20th week, but there was no statistical difference (P>0.05); it continued to be up-regulated at the 24th week, and there was statistical difference (P<0.05).CONCLUSION: Since the expression of TGF-β2 mRNA in retinas of diabetic rats was down-regulated at the 8th week and 12th week statistically, up-regulated at the 24th week statistically, it has obviously shown that TGF-β2 was down-and up-regulated through the period of DR. That is, its changes are diphasic with time. It may confirm that TGF-β2, with the characteristic of diphasic regulation, played an important role in DR. It is necessary to study it furthermore.

Objective To investigate the clinical values of loop electrosurgical excision procedure (LEEP) in diagnosis and treatment of cervical intraepithelial neoplasia(CIN). Methods Fifty-two patients with cervical intraepithelial neoplasia underwent LEEP following cytology, colposcopy and multiple biopsies, were treated by LEEP. The cure rate, the operative time, bleeding volume and patients reaction of LEEP to the cervical intraepithelial neoplasia were investigated during the follow-up. Results The effective rate was 98.07 % in the patients treated by LEEP. The effective rate was 100 % in the patients in grade CIN Ⅰ or CIN Ⅱ by LEEP. No patients in grade CIN Ⅰ and Ⅱ had recurrence during the follow-up 1 year. The mean operative time was 7.8 minutes. The mean bleeding volume was 10 ml. No secondary bleeding and post-operative infection occurred. All these surgical specimens were checked successfully for pathology diagnosis. Conclusion The advantages to use the LEEP to manage cervical intraepithelial neoplasia include its simpleness to handle, short operative time,less bleeding, less vaginal discharge, safety, and high cure rate. LEEP can offer intact sample for pathological diagnosis. LEEP electrotome is a very ideal therapy for the cervical intraepithelial neoplasia, and can block the development of precancerosis to infiltrating carcinoma effectively.

Objective To study the mechanism of toxicity of hexane. Methods SD rats inhaled 15 g/ma n-hexane statically for 8 hours. Results The levels of GSH in whole blood of rats declined significantly (t-test,P＜0. 01). The levels of MDA in serum of rats revealed increasing trend but without statistical significance (t-test,P＞0. 05). The activities of SOD and GSH-Px in liver of rats decreased significantly (t-test,P＜0.01). Conclusion n-Hexane could induce or enhance the reaction of oxygen free radical in organism,and result in damages of lipid peroxidation,which might be one of the mechanisms of the toxicity of alkane.

Despite a combination of all available treatment, the mortality of liver failure is very high,especially in children patients. Artificial liver support methods have been tested for over 50 years. Standard techniques of blood purification like hemodialysis, adsorption, hemo or plasma filtration as well as bioreactorbased approaches using liver cells or tissues have been used. It' s believed that the damaged liver has the ability to return to normal. Artificial liver support systems are expected to be useful for temporary support of liver function. If the liver does not regenerate to normal functions, an artificial liver support system may be useful as a bridge to liver transplantation. In conclusion, artificial liver support method appears to be a reliable therapy for advanced liver diseases and has significantly decreased the mortality of liver failure. Artificial liver support system has been used in children patients as well, but it still needs more researches.

OBJECTIVE To evaluate the effect of air disinfection methods to improve air quality in dental clinic.METHODS Electrostatic attraction method was used to disinfect air in dental clinic.Air samples here collected before,during and after daily and treatments compared.Bacterial colonies were counted. The air effect of disinfection was compared with undisinfected control group in terms of total number of germs.RESULTS Bacterial count of disinfected group was lower than that of undisinfected group(P

BACKGROUND: Basic fibroblast growth factor (BFGF) widely in human tissue participates in trauma repair of various tissues and is one of wound healing factors in the body. OBJECTIVE: To summarize the progress of BFGF in the fracture healing. RETRIEVAL STRATEGY: A computer-based online search of Pubmed Database was undertaken to identify the relevant articles on BFGF in the fracture healing published from January 2000 to December 2007 with the Keywords of "fibroblast growth factor 2 (basic fibroblast growth factor), fracture healing, regulation, signal transduction" in English. At the same time, Chinese relevant articles were searched in China Journal Full-text Database (CJFD) and Wanfang Database published between January 2000 and December 2007 with the same key words in Chinese. Exclusive criteria included articles with repetitive research and non-original study. LITERATURE EVALUATION: A total of 33 articles were collected about the distribution (3 articles), biological characteristics (3 articles) and the effect on the healing of bone fracture (27 articles) of BFGF. DATA SYNTHESIS: Bone healing is the process of regeneration after bone injury and the process of bone formation. BFGF can promote the cell migration by its chemotaxis and accelerate the healing by aggregating mesenchymal stem cells, macrophage and fibroblasts towards trauma region. Present animal studies on BFGF are deep and reports on clinical application are a few. Thus, the effect of BFGF is available. BGFG can affect bone formation by adjusting cell prolifeation and differentiation and changing the synthesis of cell products. BGFG not only can promote the bone growth, but also enhance the adhesion of osteoblasts and scaffold. CONCLUSION: The distribution and biological characteristics of BGFG have been recognized primarily. The further study on modulatory mechanism in the fracture healing of BFGF is carrying through. The bone restoration compounded by BFGF and its carriers is in the experiment and needs to be studied further.