Lindquist M, Edwards I R, Bate A, Fucik H, Nunes A M, Ståhl M
Uppsala Monitoring Centre, Uppsala, Sweden.
Pharmacoepidemiol Drug Saf. 1999 Apr;8 Suppl 1:S15-25. doi: 10.1002/(sici)1099-1557(199904)8:1+<s15::aid-pds402>3.3.co;2-2.
From the inception of the WHO international drug monitoring programme, the main aim has been to detect signals of adverse reaction problems as early as possible. The Uppsala Monitoring Centre (UMC), is now in a better position to fulfil this mission. Using the latest technology, new tools have been developed which allow for rapid, robust and comprehensive data mining of the WHO database. Based on retrospective time scans made during the pilot phase the current threshold used is the 97.5% confidence level of difference from the generality of the database. To maximize the capacity for picking up signals, we intend to extend today's panel of expert consultants, as well as doing our own review. The new system includes an enhanced follow-up list of signals, a 're-signalling' procedure and a cumulative historical file of all drug-ADR associations. Already we produce some 50 signals per year, cisapride and tachycardia being an example of a controversial signal only recently accepted. With the addition of new tools for follow-up of important signals such as complex variable data mining techniques, and the combination of WHO ADR data with sales and prescription figures from the IMS, we will be able to provide more information that should benefit regulators, producers, prescribers, and most importantly, the users of medicines.
自世界卫生组织国际药品监测计划启动以来，其主要目标一直是尽早发现不良反应问题的信号。乌普萨拉监测中心（UMC）目前更有能力完成这一使命。利用最新技术，已开发出新工具，可对世界卫生组织数据库进行快速、强大且全面的数据挖掘。根据试点阶段进行的回顾性时间扫描，当前使用的阈值是与数据库总体差异的97.5%置信水平。为了最大限度地提高发现信号的能力，我们打算扩大目前的专家顾问小组，并开展我们自己的审查工作。新系统包括一份强化的信号跟踪清单、一个“重新发信号”程序以及所有药物与不良反应关联的累积历史档案。我们每年已经能产生约50个信号，西沙必利与心动过速就是一个直到最近才被接受的有争议信号的例子。通过增加用于跟踪重要信号的新工具，如复杂变量数据挖掘技术，以及将世界卫生组织的药品不良反应数据与IMS的销售和处方数据相结合，我们将能够提供更多信息，这应该会使监管机构、生产商、开处方者，以及最重要的是，药品使用者受益。
