ETIOLOGY OF ALLERGIC REACTIONS IN PLATELET AND GRANULOCYTAPHERESIS DONORS

1984年2月，输血医学部将人工血小板采集技术改为自动血小板采集技术。在接下来的10年里，26名捐献者在Fenwal CS-3000设备上接受了分离程序，经历了急性过敏反应。血小板采集术共发生16次反应，粒细胞分离术中发生10次反应。采用皮肤试验、放射过敏原吸附试验(RAST)和嗜碱性粒细胞组胺释放试验相结合的方法，我们发现在发生反应的16名血小板捐献者中有10名捐献者对环氧乙烷(EO)(一种用于一次性塑料采集箱消毒的气体)有特异性的IgE介导的增敏作用，在发生反应的10名粒细胞剥离捐献者中有8名捐献者没有反应。有记录的促性腺激素敏感的捐赠者将永久推迟随后的分离捐献。这些研究的结果被报告给CS-3000分离设备的制造商和FDA。作为这些报告的结果，CS-3000一次性分离试剂盒的制造商将他们的灭菌技术从主要的EO暴露改变为主要的伽马照射。自这一变化以来，仅有两例记录在案的DTM供者的EO过敏反应病例，分别是1995年8月和1998年3月。然而，1997年8月，另一血液中心的一名献血者在血小板采集过程中发生急性致命性过敏反应，验尸结果发现其具有高滴度的IgE抗EO抗体。捐赠者也有很强的哮喘史。首次报道了一名采集者对EO的致命性过敏反应，这再次引发了对所有采集者进行EO致敏的前瞻性筛选的问题。我们估计，多达1.0%的重复采集者可能会对EO过敏，尽管只有一小部分致敏的人会有临床上明显的过敏反应。为了记录目前捐赠者中的EO敏感率，并将这一比率与职业暴露于EO的个人进行比较，我们与CBER/FDA建立了合作努力。将使用已建立的RAST测试和实验性的能量信息管理测试对大约500名健康的重复采血捐赠者进行IgE抗EO筛查。还将检测储存在疾病控制和预防中心的一组血清样本，这些样本来自被认为是由于EO引起的过敏反应的个人，以及来自国家健康和营养检查调查研究的大样本样本。

In February 1984, the Department of Transfusion Medicine converted from manual to automated platelet collection techniques. During the next 10 years, 26 donors undergoing apheresis procedures on the Fenwal CS-3000 device experienced acute hypersen-sitivity reactions. Sixteen reactions occurred during plateletpheresis and 10 reactions during granulocytapheresis procedures. Using a combination of skin tests, radioallergosorbent tests (RAST), and basophil histamine release assays, we found specific IgE-mediated sensitization to ethylene oxide (EO) (a gas used to sterilize the plastic disposable apheresis kits) in 10 of 16 plateletpheresis donors and 8 of 10 granulocytapheresis donors experiencing reactions, but in none of the 140 nonreacting controls. Donors with documented EO sensitization were permanently deferred from subsequent apheresis donations. The results of these studies were reported to the manufacturer of the CS-3000 apheresis device and to the FDA. As a result of these reports, the manufacturer of the CS-3000 disposable apheresis kits changed their sterilization techniques from predominantly EO exposure to predominantly gamma irradiation. Since this change, there have been only two documented cases of EO hypersensitivity reactions in DTM donors, in August 1995 and March 1998. However, in August 1997, a donor in another blood center had an acute fatal anaphylactic reaction during plateletpheresis and was found on postmortem testing to have high titer IgE anti-EO. The donor also had a strong history of asthma. This first report of a lethal allergic reaction to EO in an apheresis donor has reopened the question of prospective screening of all apheresis donors for EO sensitization. We have estimated that as many as 1.0 percent of all repeat apheresis donors may become sensitized to EO, although only a fraction of those who are sensitized will have clinically evident allergic reactions. To document the current EO sensitization rate among donors and to compare this rate with individuals who have occupational exposure to EO, we have established a collaborative effort with CBER/FDA. Screening of approximately 500 healthy repeat apheresis donors using both an established RAST test and an experimental Energy Information Administration test for IgE anti-EO will be performed. A cohort of serum samples stored at the Centers for Disease Control and Prevention and derived from individuals with allergic reactions presumed to be due to EO will also be tested, as well as a large sample of samples derived from the National Health and Nutrition Examination Survey study.