从科学与法律的角度试析药品检验若干问题

目的明确药品检验机构的地位和作用,增强药品检验工作者的法律意识。方法运用史学、法学、管理学的研究思路,对药品检验工作涉及的法律问题进行研究分析。结果与结论药品检验机构是履行公共管理职能的机构,应当确保检验报告书的真实性,并认识到药品检验工作存在的局限性。     

Development of Impact-Echo Multitransducer Device for Automated Concrete Homogeneity Assessment

A combination of multiple nondestructive testing (NDT) methods speeds up the assessment of concrete and increases the precision. This is why the UIR-Scanner was developed at Warsaw University of Technology. The scanner uses an Impact-Echo (IE) method with a unique arrangement of multiple transducers. This paper presents the development of the IE module using numerical models validated with experimental testing. It was found that rectangular arrangement of four transducers with the impactor in the middle is optimal for quick scanning of area for faults and discontinuities, changing the method from punctual to volumetric. A numerical study of void detectability depending on its position with respect to the IE module is discussed as well. After confirmation of the findings of models using experimental tests, the module was implemented into the scanner.     

2011-2013年长沙空港口岸入境传染病疑似病例分析

目的通过分析2011-2013年长沙空港口岸入境传染病疑似病例流行病学调查资料,指导口岸传染病防控。方法对相关资料进行归纳分析,计算出地区分布、时间分布、主要症状分布、性别分布、发现方式分布。结果传染病疑似病例主要来自中国台湾、中国香港和泰国,时间上主要分布在第一、三季度及十月份,多以呼吸道和消化道症状为主,男性多于女性,以体温监测为主要发现方式。结论长沙空港口岸旅检工作应加强来自中国台湾、中国香港、泰国的入境旅客的体温监测、医学巡查,加强第一季度、第三季度、十月的旅客查验工作,重点关注呼吸道症状旅客、消化道症状旅客。     

输血质量管理暨输血资质评审辅导在输血质量管理中的应用研究

目的探讨输血质量管理暨输血资质评审辅导工作对临床输血质量管理情况的影响程度。方法按照《柳州市医院输血质量管理暨输血资质评审标准》对医院输血质量管理及输血资质评审辅导前、后各用血医院的硬件配置、管理文件、关键纪录、人力资源以及库房设施等指标进行综合评价。结果输血质量管理暨输血资质评审辅导前后医院硬件配置、配血方法、管理文件、关键记录、人力资源配置及库房配置等21项指标的综合考察表明,不同级别医院分别统计,输血质量管理及资质评审辅导前、后,各项指标满足标准情况差异有统计学意义（均P〈0．01）,输血质量管理及资质评审辅导前、后医院综合评价符合情况比较差异有统计学意义。结论输血质量管理及资质评审辅导工作对输血质量管理水平提高有促进作用;卫生管理部门周期性对医院输血资质组织评审并执行行业准入制度对输血质量管理将起到关键的推动作用。     

大连市2013年公共场所游泳池水质卫生抽检结果分析

目的通过分析大连市公用场所卫生抽检结果,为加强当地公共场所卫生监督管理提供科学依据。方法对大连市2013年33家游泳馆类场所69份游泳池水卫生质量监测结果进行分析。结果大连市2013年抽检69份游泳池水总合格率为78.26%,其中pH和尿素的合格率为94.20%,浑浊度的合格率为100.00%,游离性余氯的合格率为85.51%,细菌总数和大肠菌群的合格率为97.10%,两类场所游泳池水质结果比较差异无统计学意义（P〉0.05）。结论 2013年大连市的游泳池水质抽检结果不如上年,卫生部门应继续加强监督管理。     

Comparing methods for clinical investigator site inspection selection: a comparison of site selection methods of investigators in clinical trials

ABSTRACT

Background During the past two decades, the number and complexity of clinical trials have risen dramatically increasing the difficulty of choosing sites for inspection. FDA’s resources are limited and so sites should be chosen with care.

Purpose To determine if data mining techniques and/or unsupervised statistical monitoring can assist with the process of identifying potential clinical sites for inspection.

Methods Five summary-level clinical site datasets from four new drug applications (NDA) and one biologics license application (BLA), where the FDA had performed or had planned site inspections, were used. The number of sites inspected and the results of the inspections were blinded to the researchers. Five supervised learning models from the previous two years (2016–2017) of an on-going research project were used to predict site inspections results, i.e., No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI). Statistical Monitoring Applied to Research Trials (SMART^TM) software for unsupervised statistical monitoring software developed by CluePoints (Mont-Saint-Guibert, Belgium) was utilized to identify atypical centers (via a p-value approach) within a study.Finally, Clinical Investigator Site Selection Tool (CISST), developed by the Center for Drug Evaluation and Research (CDER), was used to calculate the total risk of each site thereby providing a framework for site selection. The agreement between the predictions of these methods was compared. The overall accuracy and sensitivity of the methods were graphically compared.

Results Spearman’s rank order correlation was used to examine the agreement between the SMART^TM analysis (CluePoints’ software) and the CISST analysis. The average aggregated correlation between the p-values (SMART^TM) and total risk scores (CISST) for all five studies was 0.21, and range from ?0.41 to 0.50. The Random Forest models for 2016 and 2017 showed the highest aggregated mean agreement (65.1%) amongst outcomes (NAI, VAI, OAI) for the three available studies. While there does not appear to be a single most accurate approach, the performance of methods under certain circumstances is discussed later in this paper.

Limitations Classifier models based on data mining techniques require historical data (i.e., training data) to develop the model. There is a possibility that sites in the five-summary level datasets were included in the training datasets for the models from the previous year’s research which could result in spurious confirmation of predictive ability. Additionally, the CISST was utilized in three of the five site selection processes, possibly biasing the data.

Conclusion The agreement between methods was lower than expected and no single method emerged as the most accurate.     

浅谈小医院临床检验分析前质控

我们检验科每次更换新的批号的试裁都会及时的做质控,质控的结果也很好,由于我们的标本量少,患者来得时间不统一,检验的结果有时候会和大医院有差距,我们分析7原因,我们应当注意检验分析前的质控。     

3种方式处理下颌骨对舌鳞癌患者手术预后的影响

目的：探讨舌癌病人下颌骨的不同处理方法与手术远期预后的关系,为舌癌患者的手术选择提供参考。方法：随访71例接受手术治疗的舌癌患者5年,分析术后影响预后因素,评价3种不同的下颌骨处理方式与患者预后的关系。结果：下颌骨处理方式对于舌鳞癌患者生存率有直接影响,其中未处理下颌骨患者5年总体生存率56.3%,边缘性去骨截骨患者的5年总体生存率为53.6%,而节段性截骨患者的仅为51.7%。结论：舌癌的预后不完全由下颌骨的切除方式决定的,而是由其侵袭性决定的,因此对于舌癌患者要根据不同情况选择不同方式处理下颌骨,在提高患者生存率的情况下,尽量保存下颌骨的完整性。     

Deterioration Mechanisms and Advanced Inspection Technologies of Aluminum Windows

Aluminum windows are crucial components of building envelopes since they connect the indoor space to the external environment. Various external causes degrade or harm the functioning of aluminum windows. In this regard, inspecting the performance of aluminum windows is a necessary task to keep buildings healthy. This review illustrates the deterioration mechanisms of aluminum windows under various environmental conditions with an intention to provide comprehensive information for developing damage protection and inspection technologies. The illustrations reveal that moisture and chloride ions have the most detrimental effect on deteriorating aluminum windows in the long run, while mechanical loads can damage aluminum windows in a sudden manner. In addition, multiple advanced inspection techniques potential to benefit assessing aluminum window health state are discussed in order to help tackle the efficiency problem of traditional visual inspection. The comparison among those techniques demonstrates that infrared thermography can help acquire a preliminary defect profile of inspected windows, whereas ultrasonic phased arrays technology demonstrates a high level of competency in analyzing comprehensive defect information. This review also discusses the challenges in the scarcity of nanoscale corrosion information for insightful understandings of aluminum window corrosion and reliable window inspection tools for lifespan prediction. In this regard, molecular dynamics simulation and artificial intelligence technology are recommended as promising tools for better revealing the deterioration mechanisms and advancing inspection techniques, respectively, for future directions. It is envisioned that this paper will help upgrade the aluminum window inspection scheme and contribute to driving the construction of intelligent and safe cities.     

探讨引入JCI标准理念提升药品检验机构留样管理质量

目的:引入美国医疗机构评审联合委员会国际部(JCI)标准理念,促进药品检验机构改进留样管理.方法:借鉴JCI标准理念,从管理制度和操作规程、工作目标与计划、人员管理与培训、留样出入库和库存管理、留样管理信息化和质控工作以及留样库房安全管理等方面,探讨加强药品检验机构留样管理的方法.结果 与结论:药品检验机构引入JCI标...