自身免疫疾病相关检测试剂注册技术要点分析

XIE Yi(Center for Medical Device Evaluation,NMPA,Beijing 100081,China)     

多模式医学图像的融合和配准技术

医学影像工程不断发展,出现了很多先进的成像设备,有力地支持了医学诊断和治疗。而以计算机技术为基础的成像后处理技术进一步提高了诊疗的可靠性。我们着重介绍了多模式医学图像融合和配准的技术内容和应用。     

增强现实技术的研究进展及临床应用概述

近年来,增强现实技术在军事、教育、医学等诸多领域不断发展,其基本原理是将虚拟建模图像与实际环境相结合,以增强用户对现实世界的感官。增强现实技术在各个领域均展现出了独特的优越性,尤其是在医学领域,为外科手术的精准及微创提供了全新的手段。本文就当前增强现实技术的相关进展进行综述。     

门急诊退号原因分析与改进

分析门急诊退号现状及原因,从构成患者忠诚度的服务质量、服务效果、客户关系维护、品牌战略、持续地良性主观体验和增值感受等5个方面,制定门急诊退号相应控制措施。实施后,退号占比由实施前的8.3%下降至5.9%（P＜0.05）。提高门急诊服务质量,形成患者忠诚,能够显著降低退号量。     

导航辅助射频温控热凝术中注册标记系统的改良

目的：改进导航辅助射频温控热凝术中的注册标记系统,使其更加无创,同时达到导航系统的精确要求。方法：采用热塑型塑料面罩,依照人体面部特征加热塑型,表面双侧颞部、眉弓中点和颧骨最高点安置6个塑料标记点．内部随意安置6个标记点。CT扫描获得影像学数据,输入SurgView—RFT电磁导航系统后,分别选用4个（内外各2个）、6个（内外各3个）和8个（内外各4个）标记点进行注册和配准,每组设置5种组合,每点读取3次坐标值,取平均值代入配准误差公式。采用SAS6．12软件包对数据进行t检验。结果：取4个标记点时．系统误差为f1．58_±0．25）mm;取6个标记点时,系统误差为（1．28±0．21）mm;当标记点数量达到8个时,导航系统的配准精度达（1．06±0．10）mm。4点组与6点组间有显著差异（P=0．0149）,6点组与8点组间无显著差异（P=0.1402）。结论：热塑型塑料面罩表面放置标记点可避免患者创伤,配准精度完全符合导航系统的要求和卯圆孔穿刺的特定要求,在应用中至少应有6个标记点。     

2002—2009年深圳市南山区社区高血压登记及管理趋势分析

目的了解深圳市南山区2002—2009年社区高血压登记管理的现状,分析社区高血压登记率和管理率的发展趋势,为制定社区高血压防治策略提供参考依据。方法采用Excel建立南山区2002—2009年社区高血压患者基本情况数据库,应用SAS8.1对数据进行分类汇总,运用Joinpoint回归进行高血压登记率和管理率的趋势分析。结果 2002—2009年南山区共登记高血压患者20232人,管理高血压患者12351人,登记率6.86%,管理率61.05%,登记率呈逐年上升趋势（2002—2007年APC=8.83%,P=0.002;2007—2009年APC=28.13%,P=0.007）,管理率呈逐年下降趋势（APC=-7.48%,P=0.002）;在进行管理的高血压患者中,男性患者占47.60%,女性患者占52.40%,40岁以上的患者占近95%,60岁以上的患者占约60%;南山区3所主要医院附属社区健康服务中心的高血压登记和管理情况蛇口医院最好,西丽医院和南山医院稍差。结论 8年来南山区社区高血压的登记率呈现逐年上升的趋势,而管理率呈现出下降的趋势,政府部门应逐渐增加社区健康服务中心的人员编制,保证慢性病医生的稳定性,不断提高社康医生医疗技术和卫生服务水平。     

Improving Accuracy and Completeness in the Collaborative Staging System for Stomach Cancer in South Korea

Background: Cancer staging enables planning for the best treatments, evaluation of prognosis, and predictionsfor survival. The Collaborative Stage (CS) system makes it possible to significantly reduce the proportion ofpatients labeled at an “unknown” stage as well as discrepancies among different staging systems. This study aimsto analyze the factors that influence the accuracy and validity of CS data. Materials and Methods: Data wererandomly selected (233 cases) from stomach cancer cases enrolled for CS survey at the Korea Central CancerRegistry. Two questionnaires were used to assess CS values for each case and to review the cancer registrationenvironment for each hospital. Data were analyzed in terms of the relationships between the time spent foracquisition and registration of CS information, environments relating to cancer registration in the hospitals,and document sources of CS information for each item. Results: The time for extracting and registering datawas found to be shorter when the hospitals had prior experience gained from participating in a CS pilot studyand when they were equipped with full-time cancer registrars. Evaluation of the CS information according tomedical record sources found that the percentage of items missing for Site Specific Factor (SSF) was 30% higherthan for other CS variables. Errors in CS coding were found in variables such as “CS Extension,” “CS LymphNodes,” “CS Metastasis at Diagnosis,” and “SSF25 Involvement of Cardia and Distance from EsophagogastricJunction (EGJ).” Conclusions: To build CS system data that are reliable for cancer registration and clinicalresearch, the following components are required: 1) training programs for medical records administrators; 2)supporting materials to promote active participation; and 3) format development to improve registration validity.     

Evaluation of the geometric accuracy of anatomic landmarks as surrogates for intrapulmonary tumors in image-guided radiotherapy

Objectives: The purpose of this study was to evaluate the geometric accuracy of thoracic anatomic landmarksas target surrogates of intrapulmonary tumors for manual rigid registration during image-guided radiotherapy(IGRT). Methods: Kilovolt cone-beam computed tomography (CBCT) images acquired during IGRT for 29 lungcancer patients with 33 tumors, including 16 central and 17 peripheral lesions, were analyzed. We selected the“vertebrae,” “carina,” and “large bronchi” as the candidate surrogates for central targets, and the “vertebrae,”“carina,” and “ribs” as the candidate surrogates for peripheral lesions. Three to six pairs of small identifiablemarkers were noted in the tumors for the planning CT and Day 1 CBCT. The accuracy of the candidate surrogateswas evaluated by comparing the distances of the corresponding markers after manual rigid matching basedon the “tumor” and a particular surrogate. Differences between the surrogates were assessed using 1-wayanalysis of variance and post hoc least-significant-difference tests. Results: For central targets, the residualerrors increased in the following ascending order: “tumor,” “bronchi,” “carina,” and “vertebrae;” there was asignificant difference between “tumor” and “vertebrae” (p = 0.010). For peripheral diseases, the residual errorsincreased in the following ascending order: “tumor,” “rib,” “vertebrae,” and “carina;” There was a significantdifference between “tumor” and “carina” (p = 0.005). Conclusions: The “bronchi” and “carina” are the optimalsurrogates for central lung targets, while “rib” and “vertebrae” are the optimal surrogates for peripheral lungtargets for manual matching of online and planned tumors.     

传染病报告信息系统与结核病信息管理系统的肺结核病患者报告及登记数据一致性分析

摘要:目的 分析广西4个县传染病报告信息管理系统（大疫情）与结核病信息管理系统（专报）分别报告和登记的肺结核患者数据的不一致率以及原因。方法 选择两系统分别导出的报告与登记数差异较大的A、B、C、D 4个县进行现场核查和统计分析。内容包括:数据预分析、定性访谈、现场核查和抽样调查。结果 两系统的平均报告登记一致率为32.45%,最低17.09%。疑似肺结核患者被排除后没有从专报向大疫情推送占65.41%;专报 82例转诊到位未收治和未排除的疑似肺结核病例,其中15例（18.29%）为流动治疗患者,实则并未到位及登记;5例（6.10%）无诊疗资料;62例有资料者中,9例（14.52%）涂阳肺结核患者没有得到收治,10例（16.13%）既往有抗结核治疗史的涂阴肺结核病患者由于无法定性,未得到及时处理,其余43例到位后均未进行收治或排除;抽查40例排除活动性肺结核病例的排除符合率为67.50%。结论 专报系统排除活动性肺结核患者数据没有向大疫情推送,是导致两个系统报告和登记数据不一致的主要原因;结防机构过度排除患者成为疫情丢失的隐患;到位未收治或未排除体现了部分基层结防机构工作责任心和积极性不足;流动治疗患者及既往有抗结核治疗史涂阴肺结核患者的管理、收治是目前专报系统登记和管理的空白区。应加强基层人员能力建设,建立和优化两系统报告与登记数据质量定期核查机制。