Steere A C, Rifaat M K, Seligmann E B, Hochstein H D, Friedland G, Dasse P, Wustrack K O, Axnick K J, Barker L F
Transfusion. 1978 Jan-Feb;18(1):102-7. doi: 10.1046/j.1537-2995.1978.18178118551.x.
In November, 1974, eight patients in three hospitals had pyrogen reactions associated with the infusion of 25% Normal Serum Albumin from the same lot. The reactions were recognized because the same physician or nurse observed several patients having recurrent reactions or because a single patient receiving several vials had consecutive reactions. The remaining albumin in three vials associated with reactions had apparent endotoxin concentrations of 4, 16, and 32 ng/ml and that 22 vials from recalled supplies had a median concentration of 4 ng/ml (range: 2 to 64) as determined by the Limulus amebocyte lysate test, but the lot again passed the rabbit pyrogen test. In a prospective study to determine the efficacy of the Limulus test in quality control, patients had their temperatures taken hourly during albumin infusions and the remaining fluid was tested by the Limulus assay. The albumin in 443 of the 662 vials infused (65%) gave a positive test and 311 of these vials (45%) had apparent endotoxin concentrations of 4 to 64 ng/ml, but no patient had a reaction. Because of the limitations of both the rabbit pyrogen and Limulus test, the detection of some pyrogenic lots continues to depend on hospital surveillance and reporting os suspect reactions.
1974年11月，三家医院的8名患者在输注同一批次的25%正常血清白蛋白时出现了热原反应。这些反应得以被发现，是因为同一名医生或护士观察到几名患者反复出现反应，或者因为一名接受多瓶白蛋白的患者连续出现反应。与反应相关的三瓶白蛋白中剩余部分的内毒素浓度分别为4、16和32 ng/ml，通过鲎试剂试验测定，召回批次的22瓶白蛋白的内毒素浓度中位数为4 ng/ml（范围：2至64），但该批次白蛋白再次通过了家兔热原试验。在一项确定鲎试剂试验在质量控制中有效性的前瞻性研究中，患者在输注白蛋白期间每小时测量体温，剩余液体通过鲎试剂试验进行检测。输注的662瓶白蛋白中有443瓶（65%）检测呈阳性，其中311瓶（45%）的内毒素浓度明显为4至64 ng/ml，但没有患者出现反应。由于家兔热原试验和鲎试剂试验都存在局限性，一些热原批次的检测仍依赖于医院监测和可疑反应报告。
