ETIOLOGY OF ALLERGIC REACTIONS IN PLATELET AND GRANULOCYTAPHERESIS DONORS

1984年2月，DTM从手动转为自动血小板 收集技术，为此获取了四个自动化单元 分离装置。在接下来的10年里，26名捐赠者正在接受 Fenwal CS-3000设备上的分离程序经历了急性 超敏反应。在此过程中发生了16个反应 血小板采集术，在粒细胞采集术中发生了10次反应 程序。这项研究的目的是确定过敏原 对这些反应负责。使用皮肤测试的组合， 放射变应原吸光试验和嗜碱性粒细胞组胺释放试验 免疫球蛋白介导的对环氧乙烷的敏化，环氧乙烷是一种用于灭菌的气体 塑料一次性分离工具包，在16例血小板采集中发现10例 捐献者和10名粒细胞分离捐赠者中有8人出现反应，但 在140名无反应的对照组中没有一人。据估计，多达1.0%。 在所有重复分离中，捐赠者可能会对环氧乙烷和 在捐献过程中出现过敏症状。10个人中的两个人 在粒细胞捐献过程中经历反应的皮肤呈阳性 对羟乙基淀粉的测试似乎对这种红色变得敏感 分离过程中的细胞沉降剂。尽管这些反应都不是 有生命危险，DTM正在继续测试采集者是否 对环氧乙烷和羟乙基淀粉的增感，并推迟 使个人不受随后CS-3000捐赠的影响。 这些研究的结果已向CS的制造商报告- 3000分离装置和CBER/FDA。随后也出现了类似的反应 由血浆分离捐赠者中的另一组报告。由于这些原因， 报道称，CS-3000一次性分离工具包的制造商更换了 试剂盒从环氧乙烷中灭菌的过程 一个主要涉及伽马灭菌的系统。这个 制造商表示，1995年后生产的套件不再含有 大量的环氧乙烷残留物。最近的过敏症 在DTM供者中发生的反应是在粒细胞分离期间发生的 程序于1995年8月进行。自那以后，没有注意到任何反应， 虽然大约2000名CS-3000血小板和粒细胞采集者 每年都会继续进行手术。

In February 1984, the DTM converted from manual to automated platelet collection techniques, acquiring for this purpose four automated cell separation devices. During the next 10 years, 26 donors undergoing apheresis procedures on the Fenwal CS-3000 device experienced acute hypersensitivity reactions. Sixteen reactions occurred during plateletpheresis, and 10 reactions occurred during granulocytapheresis procedures. The purpose of this study was to identify the allergen responsible for these reactions. Using a combination of skin tests, radioallergosorbent tests, and basophil histamine release assays, specific IgE-mediated sensitization to ethylene oxide, a gas used to sterilize the plastic disposable apheresis kits, was found in 10 of 16 plateletpheresis donors and 8 of 10 granulocytapheresis donors experiencing reactions, but in none of 140 non-reacting controls. it is estimated that as many as 1.0% of all repeat apheresis donors may become sensitized to ethylene oxide and experience allergic symptoms during donation. Two of the 10 individuals experiencing reactions during granulocyte donations had positive skin tests to hydroxyethyl starch and appeared to become sensitized to this red cell sedimenting agent during apheresis. Although none of these reactions was life-threatening, the DTM is continuing to test apheresis donors for sensitization to ethylene oxide and hydroxyethyl starch, and to defer sensitized individuals from subsequent CS-3000 donations. The results of these studies were reported to the manufacturer of the CS- 3000 apheresis device and to CBER/FDA. Similar reactions were subsequently reported by another group in plasmapheresis donors. As a result of these reports, the manufacturer of the CS-3000 disposable apheresis kits changed the process by which the kits are sterilized from an ethylene-oxide based system to one involving predominantly gamma sterilization. The manufacturer states that kits manufactured after 1995 no longer contain significant ethylene oxide residuals. The most recent hypersensitivity reaction to occur in a DTM donor was during a granulocytapheresis procedure in August 1995. No reactions have been noted since then, although about 2000 CS-3000 platelet- and granulocytapheresis donor procedures continue to be performed per year.