低IgG水平的捐赠者血酶的安全性:前性,受控多中心研究的结果
Rainer Moog1, Teija Laitinen1, Uwe Taborski1
1Octapharma Plasma GmbH, Langenfeld, Germany.
概括
对于免疫球蛋白G (IgG) 水平较低的捐赠者来说,血合成是安全的. 这项研究发现,在三个或更多IgG测量低于6.0g/L的捐赠者中,不增加不良事件或感染,这表明继续捐赠是可行的.
科学领域:
- 免疫学 免疫学 免疫学
- 输血医学 输血医学
- 捐赠者安全 捐赠者安全
背景情况:
- 人们对血捐赠对免疫球蛋白G (IgG) 水平的长期影响存在担忧.
- 血酶是一种用于血捐赠的常见程序.
研究的目的:
- 为了确定反复出现低免疫球蛋白G (IgG) 水平的捐赠者是否需要永久延期.
- 评估IgG水平低于6.0g/L的捐赠者体内血酶的安全性.
主要方法:
- 前性,受控的多中心研究,分析健康志愿者捐献者的不良事件 (AE) 和感染.
- 捐赠者被分为个性化或标准的等离子体转化计划.
- 免疫球蛋白G (IgG) 水平每隔五次捐献后都会被监测一次;对水平低于6.0g/L的捐赠者进行了跟踪.
主要成果:
- 分析了来自15000多名捐赠者的160多万份捐款.
- 严重的副作用和感染的发生率在标准和个性化等离子体结合手臂中都很低.
- 在有三次或更多次IgG测量低于值的捐赠者中,没有观察到严重AE或感染的发病率增加.
结论:
- 对于免疫球蛋白G (IgG) 水平重复低的捐赠者来说,血合成是安全的和可行的.
- 目前的数据不支持在三次捐赠后IgG水平低于6.0g/L的捐赠者永久推迟捐赠.
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