Aullen J-P, Delbosc A, Ferrer Le Coeur F, Rivière P, Schlanger S
Direction des affaires sanitaires et sociales de Provence Alpes Côte d'Azur, rue Borde, Marseille cedex 08, France.
Transfus Clin Biol. 2010 Feb;17(1):20-7. doi: 10.1016/j.tracli.2009.11.002. Epub 2010 Feb 12.
Adverse transfusion effects with "unidentified diagnosis" are yearly notified on the French national database "e-FIT" in various numbers and with high interregional discrepancies. The aim of this work was to analyse them in order do reach a better understanding of these notifications.
On a total of 2499 "Fiches d'Effets Indésirables Receveurs" (FEIR) registered in 2006 in five French regions, 416 with "unidentified diagnosis" were analysed. Fifty-seven percent of them were kept classified in "unidentified diagnosis". Forty-three per cent of FEIR were reclassified, some in already proposed diagnostic categories (100 EIR), some in new proposed diagnostic categories (80 EIR) as: pathological context of the patient, pains linked to transfusion, hypotension.
The study confirms the necessity to re-examine the French notification system. It underlines the insufficiency of clinical and biological investigations, which could allow to reach accurate diagnosis. It gives prominence the necessity of taking into account the patient's pathology and targets at least two diagnoses of transfusion adverse effects which are not yet proposed on the FEIR model. This work brings an overture about evolution of the French haemovigilance database which will involve further developments.
法国国家数据库“e-FIT”每年都会通报各种数量且地区差异很大的“诊断不明”的输血不良反应情况。这项工作的目的是对其进行分析，以便更好地理解这些通报情况。
2006年在法国五个地区共登记了2499份“受血者不良反应记录”（FEIR），对其中416份“诊断不明”的记录进行了分析。其中57%仍归类为“诊断不明”。43%的FEIR被重新分类，一些被归入已有的诊断类别（100份EIR），一些被归入新提出的诊断类别（80份EIR），如：患者的病理情况、与输血相关的疼痛、低血压。
该研究证实有必要重新审视法国的通报系统。它强调了临床和生物学调查的不足，而这些调查本可实现准确诊断。它突出了考虑患者病理情况的必要性，并针对至少两种尚未在FEIR模型中提出的输血不良反应诊断。这项工作为法国血液警戒数据库的发展拉开了序幕，该数据库还将有进一步的发展。
