ETIOLOGY OF ALLERGIC REACTIONS IN PLATELET AND GRANULOCYTAPHERESIS DONORS

血小板和粒细胞单采供体过敏反应的病因

• 批准号: 6161483
• 负责人: S F LEITMAN
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6161483
• 关键词: antiseptic sterilization; biomedical equipment safety; blood donor; chemical hypersensitivity; clinical biomedical equipment; clinical research; ethylenes; human subject; immunologic assay /test; leukapheresis; oxides; starch

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.

1984年2月，DTM从手动转换为自动血小板 收集技术，为此目的获得四个自动化单元 分离装置在接下来的10年里，26个捐助者正在接受 Fenwal CS-3000设备上的单采程序发生急性 超敏反应16个反应发生在 血小板单采术，粒细胞单采术期间发生10例反应 程序.本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， 放射性过敏吸附试验和嗜碱性粒细胞组胺释放试验，特异性 IgE介导的对环氧乙烷的致敏作用，环氧乙烷是一种用于对 16例血小板单采中10例发现一次性塑料单采包 10名粒细胞单采术供体中有8名出现反应，但 在140个无反应的对照组中没有。据估计， 的重复单采供体可能对环氧乙烷敏感， 在献血期间出现过敏症状。10个人中有2个 在粒细胞捐献过程中出现反应的患者皮肤呈阳性 测试羟乙基淀粉，似乎成为敏感，这种红色 单采期间的细胞沉降剂。尽管这些反应 是危及生命的，DTM正在继续测试单采献血者， 对环氧乙烷和羟乙基淀粉致敏， 敏感的个人从随后的CS-3000捐赠。 将这些研究的结果报告给CS的制造商， 3000个单采装置和CBER/FDA。类似的反应随后 另一个研究小组在血浆置换捐献者中报告。由于这些 报告称，CS-3000一次性单采试剂盒的制造商变更了 将试剂盒从基于环氧乙烷的 一个主要涉及伽马灭菌的系统。的 制造商表示，1995年以后生产的试剂盒不再含有 大量环氧乙烷残留。最近的过敏反应 DTM供体中发生的反应是在粒细胞单采术期间 1995年8月的程序。此后未发现任何反应， 尽管大约2000名CS-3000血小板和粒细胞单采术供体 每年继续进行手术。