The German Haemovigilance System-reports of serious adverse transfusion reactions between 1997 and 2007
The German Haemovigilance System-reports of serious adverse transfusion reactions between 1997 and 2007
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DOI：
10.1111/j.1365-3148.2009.00947.x
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发表时间：
2009-12-01
影响因子：
1.5
通讯作者：
Funk, M. B.
中科院分区：
文献类型：
--
作者：
Keller-Stanislawski, B.;Lohmann, A.;Funk, M. B.
收集了1997年至2007年期间德国血液警戒系统的数据，并根据预定义的安全标准进行了评估。根据国家标准和国际输血学会（ISBT）的定义（符合规定的因果关系标准），对报告给Paul-Ehrlich-Institut的输血后疑似严重不良反应病例进行评价。疑似病例被评定为确认和未确认的输血反应。因果关系评估考虑了不良反应的临床过程，如有必要，还考虑了捐赠和生产信息。在5128例疑似严重不良反应中，1603例可以确认。关于绝对数字，最常记录的是急性输血反应（例如过敏反应、低血压和呼吸困难），其次是输血相关急性肺损伤（TRALI）、溶血反应、输血相关细菌感染和病毒感染。52例输血相关死亡中的大多数（各14例）是由于TRALI和急性输血反应（大多数为重度过敏反应）。关于给予的血液制品，免疫TRALI病例和TRALI相关致死性病程最常在给予新鲜冷冻血浆（FFP）后报告（分别为15/106和3.5/106单位），血小板浓缩液给药后输血相关细菌感染（7/106单位），使用浓缩红细胞后的急性溶血性输血反应（2.3/106单位）和输注红细胞或血小板浓缩物后的急性输血反应（分别为7.8/106和13/106单位）。尽管德国对血液制品的安全标准要求很高，但仍有空间通过有针对性的行动减少输血反应孤立病例的发生频率。
Data of the German Haemovigilance System were collected from 1997 to 2007 and assessed on the basis of pre-defined safety standards. Suspected cases of serious adverse reactions following transfusions reported to the Paul-Ehrlich-Institut were evaluated on the basis of national criteria, and the definitions of International Society of Blood Transfusion (ISBT) in compliance with defined causality criteria. The suspected cases were rated as confirmed and unconfirmed transfusion reactions. Assessment of causality took into consideration the clinical course of the adverse reaction and, if necessary, information about donation and manufacturing. Of the 5128 suspected serious adverse reactions, 1603 could be confirmed. Referring to the absolute figures, acute transfusion reactions (e.g. allergic reactions, hypotension and dyspnoea) were recorded most frequently, followed by transfusion-related acute lung injury (TRALI), haemolytic reactions, transfusion-related bacterial infections and virus infections. The majority of the 52 transfusion-related fatalities (14 each) were due to TRALI and acute transfusion reactions (mostly severe allergic reactions). Referred to the blood products administered, immune TRALI cases and TRALI-related fatal courses were most frequently reported after administration of fresh frozen plasma (FFP) (15/106 and 3.5/106 units, respectively), transfusion-related bacterial infections after administration of platelet concentrates (7/106 units), acute haemolytic transfusion reactions after administration of red blood cell concentrates (2.3/106units) and acute transfusion reactions after administration of red blood cell or platelet concentrates (7.8/106 and 13/106 units, respectively). Despite the high safety standard required for blood products in Germany, there is still room for reducing the frequency of isolated cases of transfusion reactions by targeted action.