大数据时代的药品安全主动监测:对照选择的挑战与机遇

电子医疗数据已成为大数据时代开展药品安全主动监测的重要资源。基于此确认药品与不良事件是否存在关联，要回归传统的流行病学研究设计，选取恰当的对照进行对比。本文主要阐述不同对照选取的原理、适用情形，介绍、评价并比较各种对照选取的思路与参数，引入对照选择批量化实现的进展性成果，以期为我国利用电子医疗数据开展上市后药品安全性监测提供方法学参考。     

Guillain-Barré syndrome in South-West Stockholm, 1973–1991, 3. Clinicoepidemiological subgroups

Using hierarchical cluster analysis, applied to 47 cases of Guillain-Barre Syndrome (GBS) incident in South-West Stockholm (SWS) during the period from January 1973 to June 1992, we identified three major clinicoepidemiological subgroups. The first subgroup, 25.5% of the cases (26.7 ± 6.7 years), recorded a peak incidence at ages 20–29 years and presented significant differences from other subgroups, a high proportion of cases with onset at low age preceded by respiratory infection (83.3%) and with normal motor conduction velocity (50.0%). Also found, were less affected biological parameters, a rapidly progressive course and independence in gait at one month after onset. A second subgroup, 27.7% of cases, was severely affected, clinically and functionally. It consisted predominantly of young individuals (22.7 ± 11.1 years), with a high incidence (69.2% of cases) in autumn. A third subgroup, comprising 40.47; of cases, was older (61.1 ± 11.0 years) and, in general, also severely affected. The incidence of this form appeared to be invariant with time.     

Natural killer cell activity and autologous mixed lymphocyte response of splenic,mesenteric lymph node,and colonic lymphocytes during DMH-induced colon carcinogenesis in the rat

Twoin vitro models of immune surveillance were used to examine the immune status of the gut-associated lymphoid tissue, mesenteric lymph nodes, and spleen during the early stages of 1,2-dimethylhydrazine (DMN)-induced colon tumorigenesis. DMH-and vehicletreated Fischer rats were sacrificed at one of three time points; one week, two months, or five months after cessation of treatment. Colonic, lymph node, and splenic natural killer cell cytolytic activity toward YAC-1 tumor targets and T-cell response to autologous la-induced balstogenesis were measured at each time point. We found little change in natural killer cell activity or T-cell proliferation induced by autologous Ia gene products at these time periods.This investigation was supported in part by grant CA26917 from the National Cancer Institute, Department of Health and Human Services.     

Application of the Population Health Approach to Drinking Water System Surveillance

A drinking water supply is a complicated system in its construction,operation,maintenance and need for public health surveillance.     

Epidemiological considerations following long-term surveillance of invasive group A streptococcal disease in The Netherlands, 1992–2003

A nationwide laboratory-based surveillance system for invasive group A streptococcal (GAS) infections was conducted in The Netherlands from March 1992 until December 2003. Until 1996, all isolates submitted were evaluated clinically and demographically. During this period there was a transition from passive to active surveillance for some of the participating laboratories, corresponding to a national coverage of 50%. During active surveillance, participating laboratories submitted twice as many isolates from invasive GAS disease, whereas the relative submission of isolates representing very severe manifestations (toxic shock-like syndrome, fatality) did not increase. From 1997 onwards, invasiveness was defined solely on the basis of source of isolation (without clinical evaluation). During the period of microbiological and clinical evaluation, microbiological evaluation alone was found to be specific (> 99%), but had limited sensitivity (66%). Estimation of the true rate of invasive GAS disease should be based on an active surveillance system with inclusion of both microbiological and clinical data.     

慢性病信息系统的指标及其收集方法的研究

目的 探讨我国目前慢性病监测系统应监测的指标、指标的收集方法。方法 DELPHI专家咨询法。结果 目前社区慢性病综合防治信息系统包括的指标有六方面内容，按照平均重要程度等级和排位的结果是死亡监测、发病或患病监测、危险因素监测、社区环境监测、疾病管理与卫生经济监测；指标的收集渠道应统一协调卫生系统的各个部门，包括医院、社区和各级疾病预防控制机构(CDC)以及公安和民政等部门；指标的收集方式主要依靠常规报告，部分指标通过流行病学调查来获得；监测指标的用途主要用于探测慢性病流行趋势和引起的疾病负担、确定防治重点、评价慢性病干预效果，以便更有效的防治慢性病；如何确保监测资料的质量和政府提供必须的费用是监测中比较普遍存在的问题。结论 死亡监测、发病或患病监测、行为危险因素监测应是慢性病综合防治信息系统应首选的内容。     

人群中病毒性肝炎的型别研究

作者于1987年2月16日～1988年2月15日在四川五个点211 639人群中监测急性病毒性肝炎。其发病率为167.74/10万,其中甲型肝炎占24.51％;乙型肝炎占38.31％;非甲非乙型肝炎占24.51％,EB病毒和巨细胞病毒所致肝炎各占3.38％;混合感染占5.92％。病毒性肝炎中有14.93％重叠感染。发病高峰在春季。发病率,男:女=1.75:1。甲型肝炎20岁以下年龄组、乙型肝炎20～39岁年龄组的发病率明显高于其他年龄组,非甲非乙型较分散,5～19岁相对多一些,其他型别年龄组间无明显差异。355例急性病毒性肝炎患者中43.9％有接触史,36.6％有注射史。