Ounnoughene N, Sandid I, Carlier M, Joussemet M, Ferry N
Agence nationale de sécurité du médicament et des produits de santé (ANSM), direction des thérapies innovantes des produits issus du corps humain et des vaccins (BIOVAC), 143/147, boulevard Anatole-France, 92385 Saint-Denis cedex, France.
Transfus Clin Biol. 2013 May;20(2):182-92. doi: 10.1016/j.tracli.2013.02.019. Epub 2013 Apr 12.
This work aim to present the descriptive analysis of serious adverse reactions in donors (dSAR's), which were notified in 2010 and 2011 in the French national haemovigilance database "e-FIT" (Internet secured haemovigilance reporting system). Some data, which are necessary for this analysis, also come from the regional haemovigilance coordinators' reports (RHC). The other parts of haemovigilance in the context of donation, without donors adverse reactions, such as post-donation information (PDI), adverse events occurred in the blood collection steps of the transfusion chain and epidemiology are not subject to this work analysis. This work shows that the quality of the data gradually improved since the setting up of the notification system of dSAR's. These data are particularly rich in learning lessons, but are still improving. It allows us to confirm that donor's safety, blood components quality, while preserving the blood components self-sufficiency in France, remains a priority. For these reasons, it is important to continue this haemovigilance awareness and to implement necessary actions that would be required for the protection of the donor's health and comfort during donation.
这项工作旨在对2010年和2011年在法国国家血液警戒数据库“e-FIT”(互联网安全血液警戒报告系统)中通报的献血者严重不良反应(dSAR)进行描述性分析。该分析所需的一些数据也来自地区血液警戒协调员的报告(RHC)。献血背景下血液警戒的其他部分,如无献血者不良反应的献血后信息(PDI)、输血链采血步骤中发生的不良事件以及流行病学情况,均不在本工作分析范围内。这项工作表明,自dSAR通报系统建立以来,数据质量逐步提高。这些数据在吸取经验教训方面特别丰富,但仍在不断完善。它使我们能够确认,在保持法国血液成分自给自足的同时,献血者安全和血液成分质量仍然是优先事项。出于这些原因,继续开展这种血液警戒宣传并采取保护献血者献血期间健康和舒适度所需的必要行动非常重要。