Gubernot Diane M, Lucey Charles T, Lee Karen C, Conley Gilliam B, Holness Leslie G, Wise Robert P
Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852-1448, USA.
Clin Infect Dis. 2009 Jan 1;48(1):25-30. doi: 10.1086/595010.
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.
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.
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.
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.
人巴贝斯虫病是一种临床表现从无症状到致命的疾病。尽管巴贝斯虫病并非全国法定报告疾病，但美国的发病率似乎在上升。巴贝斯虫感染是一种可通过输血传播的疾病。1979年至2007年期间估计报告了70例病例；其中大多数病例是在过去十年中报告的。
我们查询了美国食品药品监督管理局的以下3个安全监测系统，以评估自1997年以来巴贝斯虫病报告的趋势：献血者和输血受者的死亡报告、不良事件报告系统（包括MedWatch）以及生物制品偏差报告系统。我们分析了死亡报告的时间框架、临床表现以及患者和献血者的人口统计学特征。
自1997年以来报告的9例因输血传播的巴贝斯虫病死亡病例中，有8例发生在过去3年（2005 - 2007年）。4名涉及的献血者和5名患者居住在巴贝斯虫感染非地方性流行的地区。在过去十年中，提交给美国食品药品监督管理局的生物制品偏差报告数量不断增加；不良事件报告系统未收到相关报告。
在近十年没有因输血传播的巴贝斯虫病死亡报告之后，美国食品药品监督管理局从2005年11月起收到了8份报告。报告的死亡病例数量增加以及生物制品偏差报告表明输血传播的巴贝斯虫病发病率在上升。医生在对免疫功能低下、发热且近期有输血史的患者进行鉴别诊断时，即使在巴贝斯虫感染非地方性流行的地区，也应考虑巴贝斯虫病。准确及时地报告与巴贝斯虫病相关的献血者和输血事件有助于美国食品药品监督管理局制定适当的公共卫生控制措施。
