Babesia Infection through Blood Transfusions: Reports Received by the US Food and Drug Administration, 1997-2007
Babesia Infection through Blood Transfusions: Reports Received by the US Food and Drug Administration, 1997-2007
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DOI：
10.1086/595010
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发表时间：
2009-01-01
影响因子：
11.8
通讯作者：
Wise, Robert P.
中科院分区：
文献类型：
--
作者：
Gubernot, Diane M.;Lucey, Charles T.;Wise, Robert P.
背景人类巴贝斯虫病是一种临床表现从无症状到致命的疾病。虽然巴贝斯虫病不是全国性的报告，但美国的发病率似乎正在增加。巴氏杆菌感染是一种输血传播疾病。在1979-2007年期间，估计有70例报告，其中大多数病例是在过去十年中报告的。我们查询了以下3个美国食品药品监督管理局安全监测系统，以评估自1997年以来巴贝斯虫病报告的趋势：献血者和输血者的死亡报告、不良事件报告系统（包括MedWatch）和生物制品偏差报告系统。我们分析了死亡报告的时间范围、临床表现、患者和供体的人口统计学特征。自1997年以来报告的9例输血传播巴贝虫病死亡中有8例发生在过去3年（2005-2007年）内。4名受牵连的捐助者和5名患者生活在巴氏杆菌感染不是地方病的地区。在过去的十年中，越来越多的生物制品偏差报告提交给美国食品和药物管理局;不良事件报告系统没有收到任何报告。在近十年没有输血传播的巴贝斯虫病死亡报告后，美国食品和药物管理局从2005年11月起收到了8份报告。报告的死亡数量和生物制品偏离报告数量增加表明输血传播的巴贝虫病的发生率增加。在鉴别诊断中，即使在巴贝斯虫感染不流行的地区，医生也应该考虑免疫功能低下、近期有输血史的发热患者的巴贝斯虫病。准确和及时地报告巴贝斯虫病相关的供体和输血事件有助于美国食品和药物管理局制定适当的公共卫生控制措施。
Background. Human babesiosis is an illness with clinical manifestations that range from asymptomatic to fatal. Although babesiosis is not nationally notifiable, the US incidence appears to be increasing. Babesia infection is a transfusion-transmissable disease. An estimated 70 cases were reported during 1979-2007; most of these cases were reported during the past decade.Methods. We queried the 3 following US Food and Drug Administration safety surveillance systems to assess trends in babesiosis reporting since 1997: fatality reports for blood donors and transfusion recipients, the Adverse Event Reporting System (which includes MedWatch), and the Biological Product Deviations Reporting system. We analyzed fatality reports for time frames, clinical presentations, and patient and donor demographic characteristics.Results. Eight of 9 deaths due to transfusion-transmitted babesiosis that were reported since 1997 occurred within the past 3 years (2005-2007). Four implicated donors and 5 patients lived in areas where Babesia infection is not endemic. Increasing numbers of Biological Product Deviations Reports were submitted to the US Food and Drug Administration over the past decade; the Adverse Event Reporting System received no reports.Conclusions. After nearly a decade with no reported death due to transfusion-transmitted babesiosis, the US Food and Drug Administration received 8 reports from November 2005 onward. The increased numbers of deaths reported and Biological Product Deviations Reports suggest an increasing incidence of transfusion-transmitted babesiosis. Physicians should consider babesiosis in the differential diagnosis in immunocompromised, febrile patients with a history of recent transfusion, even in areas where Babesia infection is not endemic. Accurate and timely reporting of babesiosis-related donor and transfusion events assists the US Food and Drug Administration in developing appropriate public health-control measures.