ETIOLOGY OF ALLERGIC REACTIONS IN PLATELET AND GRANULOCYTAPHERESIS DONORS

1984年2月，输血医学科从手工采集血小板转为自动采集血小板。在接下来的10年中，26名使用Fenwal CS-3000设备进行单采术的供体发生了急性超敏反应。血小板去除术期间发生了16例反应，粒细胞去除术期间发生了10例反应。使用皮肤试验，放射性过敏吸附试验（RAST），嗜碱性粒细胞组胺释放试验的组合，我们发现特异性IgE介导的致敏环氧乙烷（EO）（一种用于消毒塑料一次性单采试剂盒的气体）在10 16血小板置换捐助者和8 10粒细胞置换捐助者经历的反应，但在没有140个无反应的控制。有记录的EO致敏的供体永久推迟后续单采献血。将这些研究的结果报告给CS-3000单采装置的制造商和FDA。由于这些报告，CS-3000一次性血液成分采集套件的制造商将其灭菌技术从主要的EO暴露改为主要的伽马辐照。自这一变化以来，仅记录了1995年8月和1998年3月DTM供体中的两例EO超敏反应病例。然而，1997年8月，另一家血液中心的一名献血者在血小板去除术期间发生急性致命性过敏反应，并在尸检时发现其IgE抗EO滴度较高。捐献者也有严重的哮喘病史。这是单采供血者对EO发生致死性过敏反应的第一份报告，重新提出了对所有单采供血者进行EO致敏性前瞻性筛查的问题。我们估计，在所有重复单采献血者中，多达1.0%的人可能对EO过敏，尽管只有一小部分过敏者会出现临床上明显的过敏反应。为了记录目前献血者中的EO致敏率，并将该致敏率与职业暴露于EO的个人进行比较，我们与CBER/FDA建立了合作关系。将使用已建立的RAST试验和实验性能源信息管理局IgE抗EO试验筛选约500名健康重复单采献血者。还将检测储存在疾病控制和预防中心的血清样本队列，这些血清样本来自假定因EO引起过敏反应的个体，以及来自国家健康和营养检查调查研究的大样本。

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.