Serious adverse events and reactions in organ transplantation; a web-net tool-based nationwide system for reporting and monitoring.
Serious adverse events and reactions in organ transplantation; a web-net tool-based nationwide system for reporting and monitoring.
复制标题
器官移植中的严重不良事件和反应；
DOI：
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发表时间：
2015
影响因子：
1.1
通讯作者：
R. Danielewicz
中科院分区：
文献类型：
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作者：
J. Czerwiński;P. Kaliciński;R. Danielewicz
器官移植易受严重不良反应和事件的影响，这需要根据欧盟成员国指令2010/53/EU的要求建立一个监测和管理系统。波兰利用现代网络技术通过以下步骤实施了一个管理系统：1）制定事件和反应目录，2）编制和实施网络模块，3）操作程序，4）评估系统。该目录包括与器官采购相关的受体和活体捐赠者的反应和事件。作为网络工具www.rejestry.net的一个模块，引入了一个转介系统（400个机构参与）。通知包括有关位置、类型、描述、分析以及为解决和预防问题而采取的措施的信息。在2012-2013年期间，在3223个移植器官中记录了17起严重不良事件和112起反应（0.5%的事件和3.4%的反应）。主要病例包括：移植自肿瘤供体，早期受体死亡，早期移植物丢失和严重感染的传播。评估显示低估了“移植后30天内受体死亡”的通知数量，报告了92例反应中的74例（80%）。该系统是一个自我评估和传播有关潜在危险的信息的平台，包括在一个中心的事件/反应可被其他中心访问的情况下发出警报。然而，该系统不是惩罚性的，因为害怕披露移植中心的失败在监测过程中起着重要作用。
Organ transplantation is vulnerable to serious adverse reactions and events, which require a system for their monitoring and management, as required of EU Member States by Directive 2010/53/EU. A management system was implemented in Poland using modern network technologies through the following steps: 1) the development of a catalogue of events and reactions, 2) the preparation and implementation of the network module, 3) the operational procedures, 4) the evaluation system. The catalogue consists of reactions and events in recipients and living donors related to organ procurement. A referral system was introduced as a module of a web tool www.rejestry.net (400 participated institutions). Notification includes information regarding the location, type, description, analysis, and measures taken to resolve and prevent problems. During the period 2012-2013, 17 serious adverse events and 112 reactions were documented among 3223 transplanted organs (events in 0.5% and reactions in 3.4% of the cases). The major cases included: transplantation from a donor with neoplasia, early recipient death, early graft loss, and transmission of severe infection. Evaluation revealed underestimated number of notifications of "death of recipient within 30 post-transplant days", which reported 74 of the 92 reactions (80%) occurring in reality. The system is a platform for self-assessment and the dissemination of information regarding the potential dangers, including alarms in cases in which an event/reaction in one center is accessible to others. However, the system is not punitive, because the fear of disclosing failures in the transplant centers plays an important role in the monitoring process.