按GB／T3359用随机样本检验数据判定医疗器械总体质量水平

计量抽样检验目前在中国医疗器械行业应用较少。本文结合两个国外医疗器械标准的实例对GB／T3359在医疗器械标准中的应用进行了解读,并通过与传统的计数抽样检验进行比较,得出医疗器械检验中采用GB／T3359进行计量抽样的优势所在。     

利用安卓智能移动设备助力医院设备管理

以医院信息网络为基础,利用安卓（Android）智能移动设备,开发平板电脑与无线局域网无缝连接的移动设备管理系统。系统的应用确保了设备的安全使用,提高了医疗设备的完好率和利用率,促进了医院数字化建设的发展。     

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。     

应用FibroTouch技术评价2型糖尿病肾病患者肝脏脂肪变性和纤维化程度及二者相关性

目的 利用FibroTouch技术,评价2型糖尿病肾病（DN）患者肝脏脂肪变性和肝脏纤维化的程度及二者的相关性。方法 选取2型糖尿病肾病患者90例。根据肾小球滤过率（eGFR）将其分为三组,eGFR≥90ml?min-1(1.73m2)-1为A组(30例),60ml?min-1?(1.73m2)-1≤eGFR＜90ml?min-1?(1.73m2)-1为B组（30例）,eGFR＜60 ml?min-1?(1.73m2)-1为C组（30例）,同时选取30名健康志愿者为对照组。应用FibroTouch技术获得肝脏脂肪衰减值（db/m）和肝脏硬度值（Kpa）。结果 各组肝脏脂肪衰减值和肝脏硬度值比较,A、B、C组均明显高于对照组（P均＜0.05）,B、C组均高于A组（P均＜0.05）,C组高于B组（P＜0.05）;肝脏脂肪衰减值和肝脏硬度值呈正相关关系（r=0.733,P＜0.01）。结论 应用FibroTouch技术可以准确、无创地评价DN患者的肝脏脂肪变性和纤维化程度,具有重要的临床意义。     

体表络脉是观察人体健康和疾病状况的窗口

络脉是气血运行的通道,也是病邪传入通道和病变部位。部分络脉在体表可见,其变化可反映人体气血阴阳和寒热虚实状态,也是观察人体健康和疾病状态的窗口。中医师通过观察皮肤、舌下、视网膜、虹膜、巩膜、结膜等部位络脉了解病情,糖尿病、高血压、动脉硬化等病患者在这些部位的络脉则发生明显变化。与肉眼观察相比较,用放大镜、显微镜等手段能大大提高我们的观察能力,能清晰观察到肉眼看不到的内容,更早、更准确地为我们提供疾病信息,其可作为体检、诊断的依据。     

醋酸染色和碘染色后肉眼观察在宫颈病变筛查中的应用价值

目的评价醋酸染色和碘染色在宫颈癌及其癌前病变的筛查中的应用价值。为降低经济欠发达地区的宫颈癌的发病率和死亡率提供依据。方法 2009年5月对来我院就诊的的30～59岁已婚妇女进行宫颈病变的普查。普查方法为用5%醋酸染色后肉眼观察（VIA）和2%碘染色后肉眼观察（VILI）,结果异常者进行阴道镜检查,并在阴道镜下活检取得最终病理诊断。结果 1897名附和条件的妇女参加普查,其中265例VIA或VILI阳性,176例行阴道镜下活检,经病理确诊CIN以上44例,其中CINⅠ25例,CINⅡ8例,CINⅢ及原位癌8例,早期浸润癌1例,宫颈癌2例。结论 VIA和VILI是一种经济有效的筛查方法,适用于在经济欠发达地区广泛推广。     

西宁市2011年食品、餐具质量抽检结果分析

目的 了解西宁市2011年餐饮服务食品、餐具安全现状,及时发现安全隐患,有效预防食品安全事故的发生,确保公众饮食安全.方法 按照分层随机抽样的原则,在全市4区3县抽检10类样品进行检测.结果 样品总合格率为93.65％.其中食用油检测合格率为78％；餐具检测合格率为68％;生活饮用水检测合格率为92％.结论 食用植物油中过氧化值超标、餐具烷基(苯)磺酸钠残留及饮用水致病菌超标成为影响市民食品安全卫生质量的主要问题.     

妊娠期B超检查结果分析在计划生育中的作用

目的：探讨用B超检查在计划生育中的应用价值。方法：对该方面的文献进行回顾性分析，总结其应用价值。结果：B超能清晰显示子宫的形状、子宫与附件的形态变化、胎儿的发育情况以及妊娠囊的形态。结论：B超检查较为方便，其对计划生育的检测有一定的应用价值。