Funk Markus B, Lohmann Annette, Guenay Serife, Henseler Olaf, Heiden Margarethe, Hanschmann Kay-Martin O, Keller-Stanislawski Brigitte
Department of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institute Langen, Germany.
Transfus Med Hemother. 2011;38(4):266-271. doi: 10.1159/000330372. Epub 2011 Jul 8.
METHODS: In order to evaluate the benefit of risk minimisation measures, reporting rates of transfusion-transmitted bacterial infections (TTBI) were calculated on the basis of annual reports and distributed blood components. Following the implementation of risk minimisation measures in 2003 and 2008, a comparison of pre- and post-implementation periods was performed. RESULTS: During a period of 14 years, 90 cases of TTBI were confirmed, 34 were caused by red blood cell (RBC) concentrates, 5 by fresh frozen plasma, and 51 by platelet concentrates (PCs). The overall reporting frequency was 1 TTBI in 1.91 million RBC units; 1 TTBI in 0.094 million PC units, and 1 TTBI-associated fatality in 0.57 million PC units. From 2001-2004 the reporting rate was 13.7 per million PC units; 2005-2008, after the implementation of pre-donation sampling; it was 10.8 per million PC units (p > 0.5). After limitation of the shelf life (2008), the reporting rate decreased to 4.49 per million PC units (p = 0.12), and one case of related fatality was reported. Agents with low pathogenicity were reported in 14 of 41 immunosuppressed patients (34%) but only in 1 of 13 patients with non-haematological/oncological diseases. CONCLUSION: TTBI and associated fatalities could be gradually reduced by the risk minimisation measures, but further strategies such as implementation of sensitive screening tests or pathogen-reducing approaches should be discussed.
方法:为评估风险最小化措施的益处,基于年度报告和分发的血液成分计算输血传播细菌感染(TTBI)的报告率。在2003年和2008年实施风险最小化措施后,对实施前后阶段进行了比较。结果:在14年期间,确诊90例TTBI,其中34例由红细胞(RBC)浓缩物引起,5例由新鲜冰冻血浆引起,51例由血小板浓缩物(PC)引起。总体报告频率为每191万个RBC单位中有1例TTBI;每9.4万个PC单位中有1例TTBI,每57万个PC单位中有1例与TTBI相关的死亡。2001 - 2004年报告率为每百万PC单位13.7例;2005 - 2008年,实施献血前采样后,为每百万PC单位10.8例(p>0.5)。在限制保存期限(2008年)后,报告率降至每百万PC单位4.49例(p = 0.12),并报告了1例相关死亡病例。41例免疫抑制患者中有14例(34%)报告了低致病性病原体,但非血液学/肿瘤疾病患者中仅1例报告了该病原体。结论:风险最小化措施可使TTBI及相关死亡逐渐减少,但应讨论进一步的策略,如实施敏感的筛查试验或病原体减少方法。