目前临床研究协调员（CRC）在完成高质量的临床试验中所扮演的角色越来越受到国内药物临床试验机构及药物申办者的广泛关注。作为临床试验过程中重要的一员，CRC承担着协调及管理临床试验项目的任务，具有“项目管理助手、后勤保障支持”的特点。四川大学华西医院国家药物临床试验机构在中医专业新药临床试验过程中，尝试配备CRC并在实际工作中取得了一定成效，同时也积累了实践经验。现就该机构中医专业新药临床试验过程中，CRC的运行机制和具体工作职责进行简要介绍，为各药物临床试验机构的建设和管理、药物临床试验的质量和整体水平的提高提供参考。
ObjectiveIn order to provide guidance for early interference of diabetic retinopathy (DR) in patients with diabetes mellitus (DM), we surveyed the prevalence and analysis the related factors of DR in Shanghai Songnan community. MethodsBased on an established resident health database, an epidemiology study was performed on the residents with DM in Shanghai Songnan community.1177 patients completed questionnaire survey, and received physical examination and laboratory tests. The diagnosis and grading of DR were established based on the ocular fundus images acquired by digital non-mydriasis fundus camera. Patients with incomplete questionnaires were excluded. ResultsThere were 1120 DM patients with valid questionnaires. DR was found in 264 (23.57%) patients. The prevalence of mild, moderate, severe non-proliferative DR and proliferative DR was 17.05%, 5.09%, 1.16% and 0.27% respectively. There was significant differences in age, disease course, systolic blood pressure, insulin usage between the DR group and NDR group(t=-2.647, 2.688, 2.204, 2.291;χ2=12.527;P=0.008, 0.007, 0.028, 0.022, 0.000). There was significant differences in fasting blood-glucose and insulin usage between the mild, the moderate and the severe DR group(t=21.964, χ2=14.996;P=0.000, 0.001). Stepwise logistic analysis identified that age, DM course, and insulin usage were the related factors of DR (OR=0.769, 1.239, 1.100, 1.071, 1.682;P=0.001, 0.043, 0.176, 0.097, 0.005). ConclusionThe age, DM course, and insulin usage were the related factors of DR. The high prevalence of DR indicated the importance of the management of diabetic patients.
ObjectiveTo study the expressions of Ras trapping to Golgi (RasTG) genes in pancreatic carcinoma tissues and to observe the growth, proliferation and the impact of tumors formation of human pancreatic cancer cells (PANC-1), and to explore its mechanism. MethodsMade PANC1 as a target to research, transfected RasTG genes into PANC-1, used RNAi technology and observed the growth, proliferation and the impact of tumors formation of the cells. Meantime, contrasted the RasTG expressions between pancreatic ductal cancer and adjacent tissue by tissue microarray technology. Results①The expression of RasTG gene in tissues was not very differential， which was higher in the brain, liver, and adrenal gland. ②The expression of RasTG protein in pancreatic ductal carcinoma was significantly higher than that in adjacent tissues （Plt;0.05）. ③After RasTG RNAi in PANC-1 cells, the ability of growth and proliferation were decreased. ④The ability of tumors formation in PANC-1 cells after RNAi was decreased, carcinoma’s volume of transfected group was significantly smaller than that in the nontransfected group (Plt;0.05). ConclusionsRasTG gene is widely distributed in animals. RasTG protein in pancreatic carcinoma tissues is higher than that in adjacent tissues. The ability of proliferation, transformation and tumors formation in PANC-1 cells after RNAi of RasTG gene are restrained, RasTG gene is a positive regulatory factor.