药物信息化管理系统在临床试验中的应用

探讨我院临床试验用药物信息化管理平台建设及其在药物临床试验中的应用。我院《药物临床试验项目管理系统》与医院原有的HIS、LIS、RIS等系统对接,对临床试验用药物进行电子信息化管理。成立我院机构临床研究药物专用药库和药房,试验用药物管理采用药物临床试验（good clinical practice, GCP）系统药物管理模块,执行药品保管制度,药剂科专业人员负责试验用药品的验收、发放、回收、保管等。     

浅析Ⅰ期药物临床试验仪器设备管理的措施

目的：通过对机构药物临床试验仪器设备管理工作的现状分析，探讨规范化药物临床试验仪器设备管理的各项措施。方法：通过文献检索并结合自身实际工作经验，分析目前仪器设备管理存在的问题，从而建立完善的仪器设备管理制度，细化仪器设备使用标准操作规程，推进大数据模式下的管理方法，加强专业管理队伍的建设。结果：实施仪器设备的专人管理能够保障仪器设备管理工作的全面落实，降低仪器设备管理问题的发生频率，提高仪器设备管理人员的专业水平。结论：规范化仪器设备管理体系是药物临床试验开展的前提，这有助于提高药物临床试验的准确性和可靠性，有效保证药物临床试验的质量，为后续临床试验打下坚实基础。     

浅谈伊柯夫BEIS系统在我院Ⅰ期临床研究中的应用和体会

自2015年7月22日国家食品药品监督管理总局（CFDA）发布《关于开展药物临床试验数据自查核查工作的公告》后,临床试验数据的完整性和真实性越发地引起了药品注册申请人、临床试验机构、合同研究组织（CRO）的重视。我院为了进一步提高Ⅰ期临床试验的规范化和管理效率,保证各项数据资料的清晰准确可靠,于2017年开始推动和加强了药物临床试验信息化平台的建设并逐步应用于新药Ⅰ期临床研究中,通过伊柯夫的BEIS系统与医院信息管理系统（HIS）和实验室信息管理系统（LIS）等第三方系统进行对接,可有效实现试验的全流程实时信息化管理,大大提高了临床试验的质量和研究效率。     

论接受药品医疗器械境外临床试验数据的四个维度

我国已经启动了药品医疗器械境外临床试验数据的接受工作,符合要求的境外数据可用于国内注册。要做好该工作,应该从数据接受原则性、数据质量可靠性、数据评价可用性和数据国际差异性等四个关键维度来加以考察。其中,数据的真实性、完整性、准确性以及可溯源性是决定数据质量可靠性的主要因素。接受药品医疗器械境外临床试验数据,将有利于临床试验数据国际互认制度的建立,并提升国内临床试验数据管理的重视程度,推动临床试验数据质量管理体系的形成。     

基于CDASH标准的肿瘤临床试验病例报告表设计

目的：探讨基于临床数据获取协调标准（clinical data acquisition standards harmonization, CDASH）的肿瘤临床试验病例报告表（case report form, CRF）的设计意义、方法及内容。方法：对照CDASH v 2.2,分析肿瘤临床试验数据特点,设计符合肿瘤临床试验实际需求的标准化CRF。结果：将CDASH标准应用到肿瘤临床试验CRF的设计中,规范肿瘤临床试验数据采集,以使肿瘤临床试验CRF设计相对标准化,提升数据质量。结论：执行基于CDASH标准的肿瘤CRF设计,能够促进肿瘤临床研究数据交换、共享,有利于提升肿瘤临床研究结果可靠性。     

药物临床试验不良事件监管问题分析

目的: 研究药物临床试验不良事件监管过程中存在的问题。方法: 通过查阅机构临床试验相关资料,分析2011年至2016年承担的完成临床部分的Ⅱ-Ⅳ期及上市后再评价药物临床试验中不良事件的监管质量。结果: 对165项药物临床试验的所有不良事件及其中的39人次严重不良事件整理后,获得实验室检查类不良事件有无漏记、原始病历和病例报告表的不良事件记录一致性、不良事件跟踪及复查情况、不良事件记录的及时率、严重不良事件是否按规定时间上报5个监控问题影响因素的相关数据。结论: 现有药物临床试验安全性评价体系尚存在一定问题,要解决这些问题,必须加强研究者的培训和全方位的过程管理。     

EpiData 用于数据管理逻辑核查功能的实现

目的:探讨借助EpiData 软件实现药物临床试验数据管理逻辑核查以保证数据正确性的有效手段。方法:应用EpiData 提供的CHECK 命令和WRITENOTE 命令, 产生变量核查法和记录核查法两种逻辑核查方法, 对数据库中的数据进行可靠性检验。变量核查法是以数据库中的变量为单位进行逻辑核查, 记录核查法是以数据库中的记录为单位进行逻辑核查。结果:两种逻辑核查方法均能核查出逻辑错误的数据, 有效地实现了对数据库中数据的逻辑核查。结论:EpiData 用于药物临床试验数据的逻辑核查, 方法简便、有效、可靠。     

过程计算机系统在钢管生产中的应用

介绍了天津钢管有限责任公司过程计算机系统的总体布局、网络结构,各过程计算机系统的主要功能以及功能的完善工作,并对过程计算机系统未来的发展和设备选型、体系结构的选择提出了看法,对钢铁企业或短流程生产制造业有一定的借鉴作用。     

径轴向数控轧环机计算机管理系统

介绍了中国重型机械研究院有限公司研制的径轴向数控轧环机的工作原理和计算机管理系统的组成,该系统分为轧制管理计算机系统和轧制操作计算机系统,轧制管理计算机系统在轧环机控制系统中的通信功能,以及轧制操作计算机系统的人机界面功能。     

标准化数据采集平台构建及在临床试验数据质量控制的应用

规范、完整的试验数据是临床试验统计分析的先决条件,也是临床试验结果真实可信的有力保障。当前电子数据采集系统（EDC）以其能够优化试验设计、保障数据真实可靠、控制试验成本和风险等优势得到了国内临床试验数据管理行业的极大重视,但也存在数据采集规范化、标准化不足的问题。本文以基于ClinCapture二次开发的药物临床试验数据采集平台eClinicaXY为例,阐述了标准化数据采集平台的架构设计、遵循标准以及在临床试验数据质量管控方面的优势特点。     

Potential and current distributions of one-dimensional galvanic corrosion systems

Many practical galvanic corrosion problems can be simplified into a one-dimensional mathematical equation. In this study, theoretical expressions for galvanic potentials and currents of one-dimensional systems are deduced and some critical parameters involved in the potential and current equations are systematically discussed. The developed analytical approach is then applied to some practical galvanic corrosion cases, such as a steel-Al joint exposed to bio-fuel E85, a galvanic couple separated by a passive spacer and a scratched organic coating. It is demonstrated that the analytical approach can examine the reliability of a computer modeled galvanic corrosion process and help understand the mechanism behind the computer modeled galvanic corrosion behavior.     

铜熔炼过程中伴生元素分配行为的计算机模型

本文提出了伴生元素Ｎｉ，Ｃｏ，Ｓｎ，Ｐｂ，Ｚｎ，Ａｓ，Ｓｂ，Ｂｉ，Ａｕ和Ａｇ在铜熔炼过程中分配行为的计算机模型。     

Thermodynamic database development-modeling and phase diagram calculations in oxide systems

The databases of the FactSage thermodynamic computer system have been under development for 30 years. These databases contain critically evaluated and opthnized data for thousands of compounds and hundreds of multicomponent solutions of solid and liquid metals, oxides, salts, sulfides, etc. The databases are automatically accessed by user-friendly software that calculates complex multiphase equilibria in large multicomponent systems for a wide variety of possible input/output constraints. The databases for solutions have been developed by critical evaluation/optimization of all available phase equilibrium and thermodynamic data. The databases contain parameters of models specifically developed for different types of solutions involving sublattices, ordering, etc. Through the optimization process, model parameters are found which reproduce all thermodynamic and phase equilibrium data within experimental error limits and permit extrapolation into regions of tempea＇ature and composition where data are unavailable. The present article focuses on the databases for solid and liquid oxide phases involving 25 elements. A short review of the available databases is presented along with the models used for the molten slag and the solid solutions such as spinel, pyroxene, olivine, monoxide, corundum, etc. The critical evaluation/optimization procedure is outlined using examples from the Al203-SiO2-CaO-FeO-Fe2O3 system. Sample calculations are presented in which the oxide databases are used in conjunction with the FactSage databases for metallic and other phases. In particular, the use of the FactSage module for the calculation of multicomponent phase diagrams is illustrated.     

摩擦焊机液压、转速测控系统串行通信设计

介绍的摩擦焊机测控系统是以工业PC为主控机，液压，转速测控单元用2个单片机系统实现，文中讨论了工业PC机与2个单片机系统通信的硬件连接，通信原理及协议，并用VisualC^ 6.0实现了在Windows平台上的多机串行通信。     

基于Modbus协议的工业现场快速组网方案

设计了一款基于IPORT-1模块与STM32微处理器的工业现场数据采集器,通过485总线以及Modbus通信协议读取工业现场各种数据与信息,并与计算机通过以太网相连。建立了完整的通信机制,包括计算机与数据收集器之间及数据收集器和工业现场各种设备之间的通信机制。计算机的任务是对数据采集器进行初始化,包括串口初始化和通信内容设定,以及从数据收集器内读取所有数据信息,并完成界面显示任务;数据采集器的任务是从工业现场各个设备上读取所需数据,并将这些数据传递给计算机,所读的内容是由计算机指定的。实际测试证明:该方案能够实现基本的工业组网要求,同时具有可靠性高、使用方便、成本低廉等优点。     

全位置管焊机控制系统的研制

采用ＰＣ机对全位置管焊机进行控制,从而实现了焊接过程的实时控制,保证了焊接电流的反馈调节及电弧电压的自动调节。并能够实现焊接小车机头的横向摆动及焊接参数的顺序调整。经过实验验证,焊接过程稳定、焊缝质量较好,具有一定的实用价值。     

Evaluation of defects in aluminum piston castings by using ultrasonics and computer tomography

Pistons used in automobile engines are made of aluminum alloy; and endurance of high pressure and high temperature is required. Recently, high strength pistons are needed to cope with the increase of pressure and temperature in the engine cylinder. A high strength piston is possible when the piston casting has little or no casting defects, such as micro-pores and cracks. Generally the defects can be evaluated by non-destructive testing (NDT), and the most efficient ways for evaluation are using ultrasonics and computer tomography. In the present study, two NDT methods were compared and evaluated to investigate the defects in the aluminum piston castings. Artificial defects were machined by using very small drill bits with diameters 1, 0.5, 0.3, 0.2 and 0.1 mm. The defects were investigated by using an ultrasonic tester and a computer tomography system. Defects smaller than 0.3 mm may not be found by using the ultrasonic test, but the defects may be found by using the computer tomography system. The investigation conditions for detecting small defects and the scanning time for in-line defect analysis are discussed in the present study.     

Hidden logistic potentials of working systems

Nowadays, the companies operate in a turbulent environment caused by various effects of global market, quick expansion of new products and production processes, fastidious customers and increased competition.In these circumstances only those companies are successful which can respond to market changes as fast as possible—i.e. they have the shortest response time regarding fulfilment of customer requirements (short delivery time and reliable delivery in addition to price and quality).Consequently, a reduction of mean inventory, range and lead time of working systems in the company is an ever increasing strategy that ensures an increase of growth and profit of the company.The article shows how the tools for modelling the flow of orders through working systems can be used in order to discover the hidden logistic potentials of working systems in a company.Presented are the results of finding hidden logistic potentials of working systems in the tool-production department of "ETI d.d." company from Izlake, Slovenia.     

The computer—an aid for analyzing and processing creep-rupture data

Several systems are described in which the computer is used as an aid for analyzing creep-rupture data. In the CADCAPS system the basic test parameters are measured as electronic signals that can be used as input information for a small on-line computer. The data can be displayed as creep (strain vs time) curves or in numerous other forms.In our present systems data collection and data processing are performed separately. The data-collection systems include (1) manually collected data that are keypunched onto cards and (2) electronic transducer signals that are fed through a multichannel recorder to an analog-to-digital converter, punched on paper tape, and transferred to magnetic tape. In both cases large central computers are used to process the data to obtain tabulations and plots of strain versus time for each test. Several methods for storing and sorting the creep test data are described.     

Theoretical calculation of the mixing enthalpies of 21 IIIB-IVB, IIIB-VB and IVB-VB binary alloy systems

The calculation of the formation/mixing enthalpies of binary alloys is an important problem. There have been no systematic theoretical calculations of the mixing enthalpies for group B alloy systems using the famous Miedema theory or from the theoretical methods of first principle. Therefore such calculations for the 21 binary group IIIB-IVB, IIIB-VB and IVB-VB metal alloy systems are performed systematically for the first time using a subregular model. The results show that the agreement between the calculations and experimental data is pretty good and could be accepted from the theoretical or experimental points of view. From the present results and those in other two papers by the authors, it also can be concluded that the subregular model can be used for calculating the mixing enthalpies for all the 36 alloy systems combined with the 9 group B metals of Zn, Cd, Ga, In, Tl, Sn, Pb, Sb and Bi.