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Evaluation of Radiopharmaceutical Adverse Reaction Reports to the British Nuclear Medicine Society from 2007 to 2016

机译:从2007年到2016年对英国核医学协会的放射性药物不良反应报告的评价

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This study sought to answer the calls that have been made for the European Association of Nuclear Medicine to restore its surveys of reported adverse reactions. We assessed all reports of adverse reactions to radiopharmaceuticals that were submitted to the British Nuclear Medicine Society (BNMS) online database (Radiopharmaceutical Adverse Events and Product Defects) from January 2007 to December 2016. Methods: This investigation was a pharma-covigilance-based, nonexperimental, cross-sectional study aimed at finding the prevalence of, and association between, radiopharmaceuticals and adverse reactions. Results: During the study period, there were 204 reports of radiopharmaceutical adverse reactions, of which 13 were considered invalid, primarily because of incomplete entries or because a causal relationship between the radiopharmaceutical and the adverse reaction could not be determined. Tetrofosmin (34 reports) and oxidronate (32 reports) had the highest prevalence, followed by medronate (21 reports) and then sestamibi and nanocolloid (14 reports each). Rash (84 reports), itching (46 reports), and vomiting (30 reports) were the 3 most frequently occurring adverse reactions. Most reports (96.8%) were for diagnostic radiopharmaceuticals. Conclusion: The prevalence of adverse reactions to radiopharmaceuticals reported in the BNMS database remains low, with a frequency of 3.1 reports per 100,000 administrations in 2013 and 2.5 per 100,000 administrations in 2015. In our review spanning 10 years, we did not find any particular concern about the use of radiopharmaceuticals.
机译:本研究寻求回答欧洲核检协会所做的呼叫,以恢复其报告的不良反应调查。我们评估了从2007年1月至2016年1月提交给英国核医学会(BNMS)在线数据库(RADIOPHARMATICAULESULICE和产品缺陷)向英国核医学会(BNMS)在线数据库(放射性药物不良事件和产品缺陷)的不良反应的报告。方法:这项调查是一个基于Pharma-Covileance,非目法,横断面研究旨在找到患病率,放射性药物和不良反应之间的患病率。结果:在研究期间,有204例放射性药物不良反应报告,其中13个被认为是无效的,主要是因为不完整的条目或因为无法确定的放射性药物和不良反应之间的因果关系而无法确定。四孢子(34个报告)和氧化氧膦酸(32次报告)具有最高的流行率,其次是中生(21个报告),然后是Sestamibi和纳米胶(每次报告)。皮疹(84报告),瘙痒(46报告)和呕吐(30个报告)是3个最常见的不良反应。大多数报告(96.8%)用于诊断放射性药物。结论:BNMS数据库中报告的放射性药物的不良反应患病率仍然很低,2013年每10万个主管部门报告的频率为3.1个报告,2015年每10万个主管部门2.5。在我们的审核10年内,我们没有发现任何特别关注关于使用放射性药物。

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