Department of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
Vox Sang. 2010 Jan;98(1):70-7. doi: 10.1111/j.1423-0410.2009.01232.x. Epub 2009 Aug 6.
In an observational cohort study (2006-2007) the Paul-Ehrlich-Institut collected epidemiological data to investigate the frequency and causes of TRALI.
Diagnosis of TRALI was confirmed according to criteria of the European Haemovigilance Network. Subsequent testing of white blood cell antibodies (WBC-Ab) against HLA or human neutrophil alloantigens was performed.
Of a total of 187 reported TRALI cases, 44 could be confirmed consisting of 35 cases of antibody-mediated TRALI and nine cases of non-immune-mediated TRALI. Eight of 44 affected patients (18%) had a fatal outcome, seven cases with WBC-Ab positive plasma donors and one case with red blood cell donors. WBC antibodies were found in one male and 39 female donors. In 34 female donors, a history of pregnancy was confirmed. WBC-Ab positive donors presented four HLA class I antibodies, 15 HLA class II antibodies, 13 HLA class I and class II antibodies, one HNA-2a, and seven HNA-3a antibodies. WBC antibodies matching with recipient antigens were found exclusively in 28 female donors; 26 FFP donors, one platelet donor and one red blood cell donor. Reporting frequency of immune-mediated TRALI was 1:66,000 for fresh frozen plasma, 1:2.86 million for red blood cell concentrates and 1:420,000 for platelet concentrates. Reporting frequency of TRALI-related fatalities was 1:285,000 for FFP.
Haemovigilance data show the significance of female donors with a history of pregnancy for the development of antibody-mediated TRALI. Manufacturing of FFP from male plasma and female donor screening for WBC-Ab could represent preventive measures.
在一项观察性队列研究（2006-2007 年）中，保罗-埃利希研究所收集了流行病学数据，以调查 TRALI 的频率和原因。
根据欧洲血液监测网络的标准，确诊 TRALI 诊断。随后对针对 HLA 或人类中性粒细胞同种抗原的白细胞抗体（WBC-Ab）进行后续检测。
在总共报告的 187 例 TRALI 病例中，有 44 例可确诊，其中 35 例为抗体介导的 TRALI，9 例为非免疫介导的 TRALI。在 44 名受影响的患者中，有 8 名（18%）有致命后果，其中 7 名血浆供者的 WBC-Ab 阳性，1 名红细胞供者的 WBC-Ab 阳性。在 44 名供者中，有 1 名男性和 39 名女性供者发现白细胞抗体。在 34 名女性供者中，确认有妊娠史。WBC-Ab 阳性供者存在 4 种 HLA Ⅰ类抗体、15 种 HLA Ⅱ类抗体、13 种 HLA Ⅰ和Ⅱ类抗体、1 种 HNA-2a 和 7 种 HNA-3a 抗体。仅在 28 名女性供者中发现与受者抗原匹配的白细胞抗体；在 26 名 FFP 供者、1 名血小板供者和 1 名红细胞供者中发现白细胞抗体。新鲜冰冻血浆免疫介导的 TRALI 的报告频率为 1:66000，浓缩红细胞为 1:28600000，浓缩血小板为 1:420000。FFP 相关死亡的报告频率为 1:285000。
血液监测数据显示，有妊娠史的女性供者在发生抗体介导的 TRALI 方面具有重要意义。从男性血浆中制造 FFP 和对女性供者进行 WBC-Ab 筛查可能是预防措施。
