中药临床试验是中医药研究中发展较快的一个领域，临床研究协调员（CRC）在中药临床试验中有重要作用，其工作范围涉及到中药临床试验的各个方面。由于中药临床试验有着不同于西药临床试验的特点，CRC在中药临床试验中的作用也有其特殊性，对提高临床试验的安全性、科学性及试验数据的可信度方面起重要作用。
Objective To investigate the effect of the 8-bromum-cyclic adenosine monophosphate (8-Br-cAMP) on the telomerase activity and changes of cell cycle in retinoblastoma （RB） cells. Methods The cultured RB cells were divided into the experimental group (8-Br-cAMP) and control group. After cultured for 24, 48 and 72 hours in vitro, the telomerase activity of RB cells was detected by polymerase chain reaction enzyme-linked immunosorbent assay (PCR-ELISA) and the changes of cell cycle were detected by flow-cytometry. Results The difference of telomerase activity was significant between the experimental groups and control group (Plt;0.01). There was a negative correlation between the A value of absorbance and the time in the experimental groups (r=-0.778 9, F=33.936, Plt;0.01). The changes of the cell cycle were that the percentages increased in G1 phase and decreased in S phases. Conclusion 8-Br-cAMP may weaken telomerase activity, affect the cell cycle, and inhibit the proliferation of RB cells. (Chin J Ocul Fundus Dis，2004，20：358-360)
Objective To know the abnormal expression of the cell cycle-regulated proteins in pancreatic adenocarcinoma and their effect on tumor cell growth. Methods The expression of p16, p21, Rb and p53 protein in 47 cases were investigated by immunohistochemistry with wet autoclave pretreatment for antigen retriaval. Furthermore, tumor growth index were assessed by a novel anti-ki-67 antibody (ki-s5). Results All the expression of p53, p16, p21 and Rb protein were the nuclear stainning. The positive rates of p53, p16, p21 and Rb protein were 55%, 53%, 74% and 98% respectively. There was negative correlation between of p16, p21 or Rb protein expression and ki-67 growth index. No relation of p53 protein stainning and the expression of p21 protein was found. Conclusion In pancreatic adenocarcinoma, the negative expression of p16 protein and p21 protein may play an important role in tumor cell growth, but tumor proliferation caused by abnormality of Rb protein is rare. The expression of p21 protein was not associated with the expression of p53 protein.
摘要:目的：评价围手术期预防性应用抗菌药物现状及合理性。方法：采用回顾性调查的方法，随机抽查2009年度Ⅰ类切口手术围手术期病案500份，设计外科围手术期预防性应用抗生素调查表，对预防用药的适应证、用药种类、联合用药、给药时机及持续时间进行统计分析。结果：未使用抗生素5例，预防性使用抗生素495例，其中不合理80例（16.00％）。预防性使用抗生素总品规数为540，其中头孢菌素类453例（83.89%），青霉素类（包括加酶抑制剂）26例（4.81%），喹诺酮类44例（8.15%）。选用头孢唑啉钠178例（32.96%）居第一位，头孢替唑钠第二，151例（2796%）。结论：Ⅰ类切口手术患者围手术期预防性使用抗菌药物较为合理，但仍存在用药指征把握不严，抗菌药物的选择、抗菌药物使用时间较长等问题，有待进一步规范化管理。Abstract: Objective: To understand the current application of perioperative preventive antibiotics, and their rationality. Methods: Five hundred perioperative records of patients with incision Ⅰ were randomly chosen and surveyed in 2009. A questionnaire for prophylactic use of antimicrobial was designed. The indication of antimicrobial use, the species, combination, timing and drug duration were analyzed. Results: Our of 500, 495 used antimicrobial and 80 were unreasonable; 540 kinds of antimicrobial were used, included cephalosporin 453 cases (83.89%), penicillin class (including plus enzyme inhibitors) in 26 cases (4.81%), quinolone 44 cases (8.15%). Cefazolin sodium (178 patients, 32.96%) ranked first, second was cefazolin sodium (151, 27.96%). Conclusion: Perioperative use of antimicrobial prophylaxis in patients with incision Ⅰ is reasonable, but standardization management should be strengthened in the indication, species, and duration.
Establishing and improving the quality control system of drug clinical trial institutions is the key to ensure the quality of clinical trial. In recent years, the number of drug clinical trial has been continuously improved, and the quality control requirements have been continuously improved. However, in clinical work, the workload of medical staff is heavy, and the energy devoted to clinical trial is limited. Clinical research coordinator (CRC), as a participant and coordinator of clinical trial, has carried out transactional work related to non-medical judgment under the authorization and guidance of researchers, and has undertaken any specific work in clinical trial. Based on the quality control management experience of nosocomial CRC and hospital drug clinical trial institutions in West China Hospital of Sichuan University, this paper discusses the mode of nosocomial CRC participating in clinical trial quality control. By participating in the quality control of clinical trial, the nosocomial CRC has improved the quality control efficiency, enriched the quality control team and improved the overall level of CRC. This model enriches the quality control system of drug clinical trial.
摘要:目的:优化药品单剂量调剂,加强信息化管理,优化操作流程。 方法:采用东华软件:住院药房管理系统(DTCISIP)和住院药品调剂系统(DTCISID) 实施。结果:东华软件成功实现了我院4300病床的药品单剂量调剂及各部门管理联网,优化了操作系统及流程,且系统运行稳定。结论:东华软件进行药品单剂量调剂,加强了药品的出入管理,优化了药品单剂量调剂的操作流程。Abstract: Objective: To improve united dose dispension, enhance the utilization of information technology in management of united dose dispension and optimize clinical human resource. Methods: DONG HUA software, which included DTCISIP system(system for management of medicine for inpatients) and DTCISID system(system for dispension of medicine for in-patients), was used to carry out united dose dispension. Results: United dose dispension of 4300 beds were easy to achieve by using DONG HUA software. The system worked smoothly and received lots of praise. Conclusion: The management of medicine is enhanced and clinical human resource is optimized by using DONG HUA software to carry out united dose dispension
Objective To investigate the effects of ulinastatin on Treg/Th17 and immune status in patients with severe sepsis.Methods A total of 80 patients with severe sepsis, who were hospitalized in ICU during October 2011 to July 2012, were randomly divided into a routine group and a ulinastatin group. The patients in the ulinastatin group were intravenously administered 30mg ulinastatin three times per day for 5 days in addition to routine bundle treatment. The expression of Treg, Th17 and HLA-DR were detected on the first day in ICU and 5 days after treatment. 20 healthy individuals served as controls. Results Compared with the control group, the severe sepsis group had overexpression of Treg and Th17 ( P lt;0. 01) , higher ratio of Treg/Th17( P lt;0. 01) , and decreased HLA-DR expression of CD14 monocyte ( P lt; 0. 01) . In the severe sepsis patients, ulinastatin injection reduced the abnormal expression of Treg and Th17 ( P lt; 0. 01) , decreased the ratio of Treg/Th17( P lt; 0. 01) , and improved the expression of HLA-DR ( P lt; 0. 01) more effectively compared with the routine treatment. Ulinastatin also lowered 28-day mortality of the patients with sepsis, but the difference between the ulinastatin group and the routine group was not significant. Conclusions In severe sepsis patients, there were abnormal overexpression of Treg and Th17, imbalance of Treg/Th17, and underexpression of HLA-DR which imply an immune suppression. Ulinastatin can decrease the expression of Treg and Th17, inverses the ratio of Treg/Th17, and improve the expression of HLA-DR, so as to improve the prognosis of severe sepsis patients.
Objective To summarize the traits of calcium-binding tyrosine phosphorylation regulate gene and the significance in tumor incidence. Methods The domestic and foreign literatures about calcium-binding tyrosine phosphorylation regulate gene involved in the regulation of signaling pathways and research status in a variety of tumors were reviewed. Results Calcium-binding tyrosine phosphorylation regulate gene induced the abnormal proliferation of cells through multiple mechanisms. There was closely relation between the occurrence of many tumors and abnormal expression of calcium-binding tyrosine phosphorylation regulate gene. In the distribution of different epithelial tumors， the pathway of calcium-binding tyrosine phosphorylation regulate gene involved in the regulation was same， and the effect target was similar. Conclusion Further study of the calcium-binding tyrosine phosphorylation regulate gene is expected to provide a new way for clarify the occurrence and development mechanisms of tumors， and can serve as important means of early diagnosis and adjuvant therapy.