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输血传播细菌感染(TTBI)与血液成分责任评分2:对2000 - 2007年法国电子拟合数据库的回顾性分析。输血传播细菌感染验证工作组

[Transfusion transmitted bacterial infectious (TTBI) with blood component accountability score 2: Retrospective analysis of the French e-fit database 2000-2007. Groupe de travail–validation des IBTT (Working group for validation of transfusion-transmitted bacterial infections)].

作者信息

Delbosc A, Lafeuillade B, Petermann R, Eb F, Ounnoughene N

机构信息

Hémovigilance, agence régionale de santé de Franche-Comté, 3, avenue Louise-Michel, 25044 Besançon cedex, France.

出版信息

Transfus Clin Biol. 2011 Feb;18(1):26-35. doi: 10.1016/j.tracli.2010.12.002.

Abstract

PURPOSE OF THE STUDY

Transfusion transmitted bacterial infection is an adverse reaction occurring in a patient during blood transfusion and due to the presence of bacteria in the blood component. For each transfusion transmitted bacterial infection suspicion, clinical and biological investigations should allow to either affirm the accountability of the transfused product in the occurrence of the infection (accountability score 4) or exclude it (accountability score 0). However, among 60,175 adverse reaction sheets extracted from the French e-FIT database (AFSSAPS), 143 are classified as transfusion transmitted bacterial infection diagnosis and 97 of them show a score of accountability 2 (possible). This study aims to analyze these 97 adverse reaction sheets and search for the reasons that led the haemovigilance network actors not to refine the degree of accountability in line with an exclusion or a confirmation of transfusion origin.

METHOD

During collective reading sessions, each adverse reaction sheet among the 97 extracted was re-analyzed with an accountability criteria grid, built beforehand, and proposed in the technical guide sheet for transfusion transmitted bacterial infection (e-Fit AFSSAPS).

RESULTS

Among the 97 analyzed adverse reaction sheets with a score accountability of 2: 12.4 % were considered as "non-analysable"; 54% were reclassified in another diagnosis category: non haemolytic febrile reaction (n=12), unknown diagnosis (n=17); patient infection before transfusion (n=23); blood component's "smear" (n=9); retrograde contamination of blood component (n=5). Finally, only 18.5% adverse reaction sheets (n=18) were maintained with a true diagnosis of transfusion transmitted bacterial infection an accountability score of 2. These cases were in agreement with those described in number 2, 3 or 4 in the annex sheet "Fiche Technique TTBI". 70% of adverse reaction sheets reclassified under another diagnosis as transfusion transmitted bacterial infection had been declared between 2000 and 2004. In order to improve transfusion transmitted bacterial infection suspicions diagnosis approach and to guide the French haemovigilance network in the investigations following a transfusion transmitted bacterial infection suspicion, the group propose recommendations after each adverse reaction sheets category analysis.

CONCLUSION

The improvement measures taken as part of the French haemovigilance declaration framework allowed to perfect the data quality of transfusion transmitted bacterial infection. Progresses are still to be made to improve clinical and biological declaration, in order to precise the accountability of a blood component in the occurrence of an adverse transfusion transmitted bacterial infection effect. Tracking transfusion transmitted bacterial infection notifications by a group of experts at the national level is still recommended.

摘要

研究目的

输血传播细菌感染是患者在输血过程中因血液成分中存在细菌而发生的不良反应。对于每一例输血传播细菌感染疑似病例,临床和生物学调查应能够确认输血产品在感染发生中的责任(责任评分4)或排除其责任(责任评分0)。然而,在从法国电子FIT数据库(AFSSAPS)中提取的60175份不良反应报告中,143份被归类为输血传播细菌感染诊断,其中97份显示责任评分为2(可能)。本研究旨在分析这97份不良反应报告,并寻找导致血液警戒网络参与者未根据输血来源的排除或确认来细化责任程度的原因。

方法

在集体阅读会议期间,使用预先构建并在输血传播细菌感染技术指导手册(电子FIT AFSSAPS)中提出的责任标准网格,对提取的97份不良反应报告中的每一份进行重新分析。

结果

在97份责任评分为2的分析不良反应报告中:12.4%被认为“无法分析”;54%被重新归类到另一个诊断类别:非溶血性发热反应(n = 12)、不明诊断(n = 17);输血前患者感染(n = 23);血液成分“涂片”(n = 9);血液成分逆行污染(n = 5)。最后,只有18.5%的不良反应报告(n = 18)被维持为输血传播细菌感染的确诊,责任评分为2。这些病例与附件“输血传播细菌感染技术表”中第2、3或4项所述病例一致。在2000年至2004年期间宣布了70%被重新归类为输血传播细菌感染的另一种诊断的不良反应报告。为了改进输血传播细菌感染疑似病例的诊断方法,并在输血传播细菌感染疑似病例后指导法国血液警戒网络进行调查,该小组在对每个不良反应报告类别进行分析后提出了建议。

结论

作为法国血液警戒申报框架一部分采取的改进措施有助于完善输血传播细菌感染的数据质量。为精确血液成分在不良输血传播细菌感染效应发生中的责任,仍需在改进临床和生物学申报方面取得进展。仍建议由一组国家层面的专家跟踪输血传播细菌感染通知。

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