新形势下医学院校学籍管理工作的实践与思考

学籍管理工作在高校教学管理工作中具有重要的、特殊的作用。本文结合自身工作实践就如何提高学籍管理工作效率和水平进行了初步探讨。提出学籍管理制度建设是根本；执行力度是保障；转变管理理念、加快信息化进程是动力，尤其提出要建立教务管理服务平台，切实解决学生的具体问题；作为管理人员要树立“科研型”管理理念，深入研究学籍管理的特点和规律，加速科学管理的进程。     

Elevated risk of death and major cardiovascular events in subjects with newly diagnosed diabetes: Findings from an administrative database

AimsTo investigate the incidence of major cardiovascular complications and mortality in the first years of follow-up in patients with newly diagnosed diabetes.Methods and resultsWe examined incidence rates of hospitalization for cardiovascular reasons and death among new patients with diabetes using the administrative health database of the nine million inhabitants of Lombardy followed from 2002 to 2007. Age and sex-adjusted rates were calculated and hazard ratios (HR) were estimated with a matched population without diabetes of the same sex, age (±1 year) and general practitioner.There were 158,426 patients with newly diagnosed diabetes and 314,115 subjects without diabetes. Mean follow-up was 33.0 months (SD ± 17.5). 9.7% of patients with diabetes were hospitalized for cardiovascular events vs. 5.4% of subjects without diabetes; mortality rate was higher in patients with diabetes (7.7% vs. 4.4%). The estimated probability of hospitalization during the follow up was higher in patients with diabetes than in subjects without for coronary heart disease (HR 1.4, 95% CI 1.3–1.4), cerebrovascular disease (HR 1.3.95% CI 1.2–1.3), heart failure (HR 1.4, 95% CI 1.3–1.4) as was mortality (HR 1.4, 95% CI 1.4–1.4).Younger patients with diabetes had a risk of death or hospital admission for cardio-cerebrovascular events similar to subjects without diabetes ten years older.ConclusionsThe elevated morbidity and mortality risks were clear since the onset of diabetes and rose over time. These data highlight the importance of prompt and comprehensive patients care in addition to anti-diabetic therapy in patients with newly diagnosed diabetes.     

18F-FDG符合显像与同机定位CT图像融合对肿瘤诊断的价值

目的评价18氟-脱氧葡萄糖(18F-FDG)符合显像与同机定位CT图像融合在肿瘤诊断中的应用价值.方法对临床怀疑为恶性肿瘤或肿瘤转移复发的107例患者,在GE HAWKEYE符合线路双探头单光子发射型计算机断层显像装置上进行X-CT穿透扫描和18F-FDG发射断层扫描,并获得发射与穿透融合图像,将分析结果与最后诊断进行对比.结果 107例患者显像阳性75例,其中假阳性6例,真阳性69例;阴性32例,其中假阴性3例,真阴性29例.107例患者共检出病灶167个,其中淋巴结和远处转移灶82个.18F-FDG符合显像结合同机定位CT图像融合对肿瘤或其转移灶诊断的灵敏度为95.8%(69/72),特异性为82.9%(29/35),阳性预测值92.0%(69/75),阴性预测值90.6%(29/32),诊断准确率91.6%(98/107);167个病灶在同机定位CT上均能正确定位.结论 18F-FDG符合显像是临床诊断肿瘤的有效无创手段;与同机定位CT图像融合有助于区别恶性病灶与生理摄取,并能对病灶精确定位.     

Comparison of performance between rigid and non-rigid software registering CT to FDG-PET

Object: This retrospective study compares the anatomical accuracy of automated rigid and non-rigid registration software for aligning data from separately performed X-ray computed tomography (CT) and positron emission tomography with F-18-deoxyglucose (PET). Materials and methods: Analyses were performed on independently acquired PET and CT data from 40 tumor patients. Rigid as well as non-rigid automated fusion was carried out using the commercially available Mirada 7D platform (MIR and MINR, respectively) as well as a second automated non-rigid registration based on a variational image registration approach (VIR). Distances between lesion representation on PET and CT of 105 malignant lesions were measured in X-, Y-, and Z-directions. Statistical evaluation was performed using mixed effect analysis, comparing separately MIR with MINR and VIR with MINR. Results: The percentage of lesions misregistered by less than 15 mm varied from 70% for MIR and MINR in Z-direction to 93% for VIR in X-direction. The average X-, Y- and Z-distances ranged between 5.9 ± 5.7 mm for VIR in X-direction and 12.8±9.7 mm for MIR in Z-direction. MINR was significantly more accurate than MIR in Y-direction. Furthermore, VIR aligned thoracic lesions in the X- direction significantly better than MINR. Conclusion: The accuracy of rigid and non-rigid automated image registration can be expected to be better than 15 mm for the majority of lesions. Alignment tended to be more accurate with non-rigid registration. This work was supported by the ELAN-Fonds of the Clinical Faculty of the University of Erlangen-Nürnberg (AZ: 04.03.10.1) as well as by the Deutsche Forschungsgemeinschaft (DFG), Sonderforschungsbereich 603, Teilprojekt C10.     

临床试验注册制度与循证医学

本文介绍了当前新药临床试验、院内制剂、上市后药物临床试验及其他类型临床试验的管理情况,世界卫生组织临床试验注册平台(WHO ICTRP)的结构和运作机制和全球临床试验注册制度建立概况,中国临床试验注册中心和中国临床试验注册与发表协作网及其运作机制;提出用循证医学基本哲学思想作为临床试验研究者的思想和行为准则,是临床试验真实性的内部保障系统。     

US-MRI图像配准融合技术在高强度聚焦超声消融子宫肌瘤中的应用价值

目的 探讨超声和MRI图像（US-MRI）配准融合技术在高强度聚焦超声（HIFU）消融子宫肌瘤中的价值。方法 评估78例子宫肌瘤患者的80组US-MRI图像的配准与融合效果;记录并分析用于指导不同配准融合操作的解剖标记部位和效果。结果 以子宫的边界为标志配准同一子宫平面,与配准前比较,图像清晰度评分显著增加（P=0.004）;以子宫肌瘤的边界为标志配准同一子宫肌瘤平面,与配准前比较,图像清晰度评分显著增加（P<0.001）;以耻骨边界为标志能配准同一耻骨平面;以骶岬为标志点能配准骶尾骨。结论 US-MRI配准技术可有效提高HIFU消融子宫肌瘤的可视化空间。     

Report from the EPAA workshop: In vitro ADME in safety testing used by EPAA industry sectors

There are now numerous in vitro and in silico ADME alternatives to in vivo assays but how do different industries incorporate them into their decision tree approaches for risk assessment, bearing in mind that the chemicals tested are intended for widely varying purposes? The extent of the use of animal tests is mainly driven by regulations or by the lack of a suitable in vitro model. Therefore, what considerations are needed for alternative models and how can they be improved so that they can be used as part of the risk assessment process? To address these issues, the European Partnership for Alternative Approaches to Animal Testing (EPAA) working group on prioritisation, promotion and implementation of the 3Rs research held a workshop in November, 2008 in Duesseldorf, Germany. Participants included different industry sectors such as pharmaceuticals, cosmetics, industrial- and agro-chemicals. This report describes the outcome of the discussions and recommendations (a) to reduce the number of animals used for determining the ADME properties of chemicals and (b) for considerations and actions regarding in vitro and in silico assays. These included: standardisation and promotion of in vitro assays so that they may become accepted by regulators; increased availability of industry in vivo kinetic data for a central database to increase the power of in silico predictions; expansion of the applicability domains of in vitro and in silico tools (which are not necessarily more applicable or even exclusive to one particular sector) and continued collaborations between regulators, academia and industry. A recommended immediate course of action was to establish an expert panel of users, developers and regulators to define the testing scope of models for different chemical classes. It was agreed by all participants that improvement and harmonization of alternative approaches is needed for all sectors and this will most effectively be achieved by stakeholders from different sectors sharing data.     

美国临床试验数据库的信息建设及检索服务的研究

目的:探寻美国临床试验数据库的信息资源建立机制,为我国相关数据库的发展提供借鉴。方法:综述国外文献,研究数据库的组织结构,从信息数据建设和检索服务两方面对ClinicalTrials.gov进行研究。结果:该数据库具有较为独特和方便的组织结构和检索系统。结论:ClinicalTrial.gov作为世界上最有影响力的临床试验数据库,为患者、家庭成员、卫生保健专家以及社会公众的每一成员提供了获取各种疾病的临床试验信息的便捷途径,同时也对我国发展此类数据库有着重要的借鉴意义。     

全面实施预约挂号方便患者就医

2011年是深化医药卫生体制改革的关键年,首都医科大学附属北京朝阳医院按照北京市公立医院改革要求,结合医院门诊量快速增长所致医生工作强度大、患者挂号难、就医时间成本大等实际问题,通过增加预约号源、提高医生出诊率、拓宽门诊预约挂号渠道等多项措施方便患者就医,我院全面实施预约挂号以来取得了明显成效。     

Assessment of reproductive toxicity under REACH

The European REACH regulation requires the evaluation of reproductive toxicity in screening tests according to OECD TG 421 and 422 for substances above the tonnage level of 10 tons/year. The overall aim of this paper is to increase flexibility in combination with a reduced number of experimental animals. Therefore, in contrast to the existing approach the registrant should have the possibility to file a dossier for a substance at the level of 10 tons/year and above also on the basis of data from a developmental toxicity study (OECD TG 414) plus a full-scale subacute toxicity study (OECD TG 407 according to the 1995 protocol). The proposed new test strategy takes into account overall considerations of duty of care and animal welfare. It enables an assessment of developmental toxicity on a definitive instead of a screening level. Registrants should be allowed to select between these two options, either the existing approach (OECD TG 421/407 and alternatively TG 422) or the approach proposed in this paper (OECD TG 407 plus TG 414).