Intravenous immunoglobulin-associated thrombosis: is it such a rare event? Report of a pediatric case and of the Quebec Hemovigilance System
Intravenous immunoglobulin-associated thrombosis: is it such a rare event? Report of a pediatric case and of the Quebec Hemovigilance System
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DOI：
10.1111/trf.12897
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发表时间：
2015-03-01
期刊：
影响因子：
2.9
通讯作者：
Pastore, Yves
中科院分区：
文献类型：
--
作者：
Benadiba, Joy;Robitaille, Nancy;Pastore, Yves
背景静脉注射免疫球蛋白（IVIG）是治疗自身免疫性疾病的常用药物。副作用通常是轻微的，但严重的并发症，如血栓形成可能会发生。在Sainte-Justine医院的一名IVIG相关血栓并发症患者之后，回顾了向魁北克血液警戒系统（QHS）报告的严重不良事件（SAE）的发生率。结果QHS是罕见的国家血液警戒系统，包括IVIG报告近十年之一。在11年的延长期内（2003-2013年），有8例IVIG相关血栓形成病例，7例在成人中，1例在儿科人群中（分别为0.06例和0.17例/100，000 g IVIG）。单一的儿科病例发生在一个16岁的女性接受IVIG严重的免疫性血小板减少症。ConclusionThrombosis后IVIG是一种罕见的，但主要发生在成年人的SAE。这强调了正确报告IVIG SAE以改善血液警戒数据和研究此类罕见事件的重要性。
BackgroundIntravenous immunoglobulin (IVIG) is frequently given in autoimmune disorders. Side effects are usually mild but severe complications such as thrombosis may occur. After one patient with IVIG-associated thrombotic complication at Sainte-Justine Hospital, the incidence of serious adverse events (SAEs) reported to the Quebec Hemovigilance System (QHS) was reviewed.Study Design and MethodsThis study was a retrospective review of QHS database of IVIG-related thrombotic complications since 2003, including a case report of a pediatric patient.ResultsQHS is one of the rare national hemovigilance systems that have included IVIG reports for almost a decade. Over an extended period of 11 years (2003-2013), there have been eight cases of IVIG-related thrombosis, seven in adults and one in the pediatric population (respective rate of 0.06 case and 0.17 case per 100,000g of IVIG given). The single pediatric case occurred in a 16-year-old female receiving IVIG for severe immune thrombocytopenia.ConclusionThrombosis after IVIG is a rare though SAE occurring mostly in adults. This underlines the importance of properly reporting IVIG SAEs to improve hemovigilance data and study such rare events.